[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-nsclc":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,82,0,25,[9,56,70,102,127,152,186,220,246,276,298,331,370,404,452,475,504,529,550,593,629,661,690,711,731],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100053417","phase-1-neoadjuvant-inhaled-azacytidine-with-platinum-based-chemotherapy-and-durvalumab-medi4736---a-combined-epigenetic-immunotherapy-aza-aegean-regimen-for-operable-early-stage-non-small-cell-lung-cancer-nsclc-100053417",false,"NCT06694454","Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","Phase I\u002FII Study of Neoadjuvant Inhaled Azacytidine With Platinum-Based Chemotherapy and Durvalumab (MEDI4736) - a Combined Epigenetic-Immunotherapy (AZA-AEGEAN) Regimen for Operable Early-Stage Non-Small Cell Lung Cancer (NSCLC)","* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed, resectable per standard of care stage IB-IIIA non-small cell lung cancer (NSCLC) irrespective of programmed death-ligand 1 (PD-L1) expression. Note: Confirmation is required by NCI Laboratory of Pathology (LP).\n* Willingness to undergo tumor resection surgery per standard of care (SOC) guidelines following induction therapy (platinum chemotherapy and durvalumab).\n* Participants must have disease that can be safely accessed via bronchoscopic, thoracoscopic, or percutaneous biopsy techniques, and be willing to undergo tumor biopsy before treatment.\n* No prior therapy for the NSCLC.\n* Measurable disease per RECIST 1.1\n* Age \\>= 18 years.\n* Body weight \\> 30kg.\n* ECOG Performance Status \\\u003C= 1\n* Participants must have adequate pulmonary reserve evidenced by predicted post-op FEV1 and adjusted DLCO \\>= 40% at screening.\n* Participants must have pCO2 \\\u003C= 45 and pO2 \\>=60 on room air by arterial blood gas (ABG) if O2 sat by pulse oximetry is\\\u003C= 92% on room air at screening.\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes \\>3,000\u002FmicroL\n  * Absolute neutrophil count \\>1,500\u002FmicroL (without transfusion or cytokine support)\n  * Absolute lymphocyte count \\> 800\u002FmicroL\n  * Platelets \\>100,000\u002FmicroL\n  * Hemoglobin \\>= 9.0 g\u002FdL\n  * Prothrombin time (PT) no more than 2 seconds above the upper limit of normal (ULN)\n  * Total bilirubin OR Direct bilirubin \\\u003C 1.5 X institutional upper limit of normal OR \\\u003C= ULN for participants with total bilirubin \\>= 1.5 ULN\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C 2.5 X institutional ULN\n  * Serum albumin \\>= 2.0 mg\u002FdL\n  * Creatinine OR Creatinine clearance (eGFR) \\\u003C= 1.6 mg\u002Fml OR \\>60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization, abstinence) for the duration of the study treatment and up to 6 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use a highly effective method of contraception for 14 months.\n\nIndividuals able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 3 months after the last dose of the study drug(s). Note: participants who have cisplatin as part of SOC chemo must agree to use an effective method of contraception for 11 months. We also will recommend these individuals with partners of childbearing potential to ask partners to be on highly effective birth control (hormonal, intrauterine device (IUD), surgical sterilization).\n\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 3 months after the last dose of the study drug(s).\n* Participants with history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness are included if on appropriate antiretroviral therapy with HIV viral load \\\u003C400 copies\u002FmL.\n* Participants must agree to not donate blood from the study entry and up to 3 months after the last dose of the study drug(s).\n* Participants must be co-enrolled in protocol 06C0014: Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies .\n* The ability of a participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Medically inoperable because of clinical co-morbidities.\n* Participants with T4 tumors invading the diaphragm, mediastinum, carina, trachea, esophagus, heart, great vessels, recurrent laryngeal nerve, or vertebral body.\n* Participants who experienced serious immune adverse events that required discontinuation of immune checkpoint inhibitor therapy for a prior non-NSCLC malignancy.\n* History of known EGFR or ALK alterations in the tumor.\n* History of active autoimmune disease including colitis, nephritis, hypophysitis, or neuropathy, with the exceptions of:\n\n  --Diabetes type I, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment.\n* History of pneumonitis or interstitial lung disease.\n* Clinically significant cardiovascular\u002Fcerebrovascular disease as follows:\n\n  * cerebral vascular accident\u002Fstroke (within 6 months prior to study treatment initiation)\n  * myocardial infarction (within 6 months prior to study treatment initiation)\n  * unstable angina, congestive heart failure (New York Heart Association Classification Class \\>= II, https:\u002F\u002Fmanual.jointcommission.org\u002Freleases\u002FTJC2016A\u002FDataElem0439.html#:\\~:text=Class%20II%20%2D%20Mild%20symptoms%20(mild,Class%20IV%20%2D%20Severe%20limitations), serious cardiac arrhythmia, clinically significant bleeding or clinically significant pulmonary embolism at screening.\n* Active Hepatitis A (HAV), Hepatitis B (HBV) (HbsAg reactive), or Hepatitis C (HCV) (HCV RNA \\[qualitative\\] is detected) at screening.\n* Other active infections requiring systemic therapy at screening.\n* Positive beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.\n* Systemic corticosteroids at doses above physiologic levels (\\> 10 mg of prednisone or equivalent per day), or inhaled corticosteroids within 14 days before study treatment initiation. Administration of steroids through a route known to result in a minimal systemic exposure (i.e., topical, intro-ocular, or intra-articular) is allowed.\n* Major surgical procedure within 28 days prior to the study treatment initiation. Note: Local surgery of isolated lesions for palliative intent is acceptable provided other site(s) of disease is available for response assessment.\n* History of allogenic organ transplantation.\n* History of another primary malignancy except for malignancy treated with curative intent and with no known active disease \\>= 5 years before the study treatment initiation.\n* Administration of live attenuated vaccines within 30 days prior to study treatment initiation. Note: Administration of inactivated vaccines (e.g., inactivated influenza vaccines) is permitted before or during the study.\n* Administration of investigational drug on other clinical trial within 14 days prior to study treatment initiation.\n* History of hypersensitivity to Mannitol.\n* Herbal and natural remedies that may have immune-modulating effects within 7 days prior to study treatment initiation.\n* Uncontrolled intercurrent illness evaluated by history and physical exam or situation that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.",[29,30,31,32,33],"Non-small Cell Lung Cancer (NSCLC)","Carcinoma, Non-Small Cell Lung","Non-Small Cell Lung Carcinoma","Non Small Cell Lung Cancer","Non Small Cell Lung Carcinoma",[35,36,37,38,39,40,41,42],"immune checkpoint inhibitor (CPI)","pathologic complete response (pCR)","aerosolized drug delivery","immunosuppressive tumor microenvironment (TME)","reversible epigenetic mechanisms","DNA demethylating agents","nebulizer treatment","AZA","RECRUITING","2026-07-10",{"date":46,"type":47},"2026-07-13","ACTUAL",{"date":49,"type":22},"2026-07-16",{"date":51,"type":22},"2034-12-31",{"name":53,"class":54},"National Cancer Institute (NCI)","NIH",1,{"id":57,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":69,"locationsCount":55},"100569454",{"count":21,"type":22},[25,26],"Background:\n\nLung cancer is the leading cause of cancer-related death worldwide. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Surgery to remove the tumors is the standard treatment for people diagnosed with early stages of NSCLC. Despite complete removal of these tumors, many recur (happen again). An FDA-approved drug combination to treat early-stage NSCLC prior to the surgery is durvalumab plus standard chemotherapy. The FDA approved infusion drug azacytidine \\[AZA\\] is used to treat several diseases because it can rapidly kill dividing cells (including cancer cells) but it is not approved for NSCLC. An inhaled (aerosolized) form of AZA is also not approved for NSCLC. However, researchers want to know if an inhaled version of AZA can help improve treatment of people with NSCLC because inhaled AZA goes directly into the lungs with limited absorption into the bloodstream.\n\nObjective:\n\nTo find the safest and most effective dose of inhaled AZA in participants with early-stage non-small cell lung cancer (NSCLC) that can still be removed by surgery.\n\nEligibility:\n\nAdults aged 18 and older with operable early-stage NSCLC. Participants will be required to also enroll in NIH protocol 06C0014 which allows for pre- and post-treatment biopsies and bloodwork to be obtained for additional research studies.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. Their medical records will be reviewed. They will have imaging scans and tests of their heart and lung functions. Participants will be required to have a tissue sample (biopsy) taken of their tumor prior to receiving study drug and again during surgery after Cycle 3; airway tissue biopsies and collection of collect bronchial (lung) fluid may also be done.\n\nParticipants will receive the study treatment for 3 cycles. Each cycle is 21 days. They will need to come to the NIH Clinical Center (CC) on days 1-4 of Cycles 1-3.\n\nAZA will be given as a drug mist that can be inhaled (like the type of mist in an asthma inhaler) using a nebulizer at the NIH Clinical Center (CC) for 3 days in a row (consecutive days) during the first week of each cycle. The participant will inhale the AZA drug mist for 20 to 30 minutes each time. Participants will also receive durvalumab and a specific 2-drug assigned chemotherapy by intravenous (IV) infusion on day 4 of each cycle.\n\nParticipants will have a follow-up visit 2 weeks after their last dose of study drugs. Then they will have planned surgery to remove the tumors.\n\nParticipants will have additional follow-up visits at the NIH CC about 1 and 3 months after the surgery, and then for every 3 months for up to 3 years.\n\n...",[29,30,31,32,33],[35,36,37,38,39,40,41,42],"2026-07-01",{"date":65,"type":47},"2026-07-02",{"date":67,"type":22},"2026-07-07",{"date":51,"type":22},{"name":53,"class":54},{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100615317","phase-3-phase-iii-study-of-datopotamab-deruxtecan-versus-docetaxel-in-previously-treated-trop2-positive-advanced-or-metastatic-non-squamous-nsclc-without-actionable-genomic-alterations-100615317","NCT07291037","Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations","A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","TROPION-Lung17","Inclusion Criteria:\n\n* Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:\n\n  * Participants must have documented negative test results for epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and ROS proto-oncogene 1 (ROS1) genomic alterations.\n  * Has no known tumour genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition (MET) exon 14 skipping, Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C, human epidermal growth factor receptor 2 (HER2) or any other actionable driver oncogenes for which there are locally approved and available targeted first-line therapies.\n  * Prospectively assessed trophoblast cell surface protein 2 (TROP2) normalised membrane ratio (NMR) positive.\n* Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n* Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)\u002Fanti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1\u002Fanti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.\n* Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.\n* At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n* Adequate bone marrow reserve and organ function within 7 days before randomisation.\n\nExclusion Criteria:\n\n* Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.\n* NSCLC disease that is eligible for definitive local therapy alone.\n* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.\n* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.\n* Clinically significant corneal disease.\n* Has active or uncontrolled hepatitis B or C virus infection.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* History of non-infectious interstitial lung disease (ILD)\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Severe pulmonary function compromise per Investigator discretion.",{"count":79,"type":22},400,[81],"PHASE3","TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).",[29],[76,85,86,87,88,89,90,91],"Non-small cell lung cancer (NSCLC)","Advanced non-squamous NSCLC","Metastatic non-squamous NSCLC","Datopotamab deruxtecan (Dato-DXd; DS-1062a)","Docetaxel","Trophoblast cell surface protein 2 (TROP2)","Normalised membrane ratio (NMR)","2026-06-30",{"date":63,"type":47},{"date":95,"type":47},"2025-10-31",{"date":97,"type":22},"2029-01-29",{"name":99,"class":100},"AstraZeneca","INDUSTRY",205,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":113,"conditions":114,"keywords":115,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100529208","phase-3-sacituzumab-tirumotecan-mk-2870-in-combination-with-pembrolizumab-versus-pembrolizumab-alone-in-metastatic-non-small-cell-lung-cancer-nsclc-with-programmed-cell-death-ligand-1-pd-l1-tumor-proportion-score-tps--50-mk-2870-007-100529208","NCT06170788","Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)","A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)","TroFuse-007","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC\n\n  * Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy\n  * Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory\n  * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.\n  * A life expectancy of at least 3 months.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.\n* Has Grade ≥2 peripheral neuropathy.\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.\n* Received prior systemic anticancer therapy for their metastatic NSCLC.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received radiation therapy to the lung that is \\>30 Gy within 6 months of start of study intervention.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Known intolerance to sacituzumab tirumotecan or pembrolizumab and\u002For any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.\n* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease (ILD) that required steroids or has current pneumonitis\u002FILD.\n* Active infection requiring systemic therapy\n* Concurrent active Hepatitis B and Hepatitis C virus infection.\n* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease.\n* History of allogeneic tissue\u002Fsolid organ transplant.\n* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.",{"count":111,"type":22},614,[81],"The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.\n\nAll participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.",[29],[116,117,118],"Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)",{"date":65,"type":47},{"date":121,"type":47},"2023-12-15",{"date":123,"type":22},"2030-05-27",{"name":125,"class":100},"Merck Sharp & Dohme LLC",220,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":23,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":151},"100636466","phase-3-a-study-to-compare-setidegrasib-asp3082-with-docetaxel-in-people-with-non-small-cell-lung-cancer-with-a-kras-g12d-mutation-100636466","NCT07566052","A Study to Compare Setidegrasib (ASP3082) With Docetaxel, in People With Non-small Cell Lung Cancer With a KRAS G12D Mutation","A Randomized, Open-label, Phase 3 Study of Setidegrasib (ASP3082) Versus Docetaxel in Participants With KRAS G12D-mutated Locally Advanced (Unresectable) or Metastatic Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on or After Platinum Based Chemotherapy and Checkpoint Inhibitor Therapy (CPI)","Inclusion Criteria:\n\n* Participant has histologically confirmed locally advanced (unresectable) or metastatic non-small cell lung cancer (NSCLC) with documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation result status, based on local or central testing.\n\n  * The participant's positive KRAS G12D mutation result (either in tumor tissue or plasma ctDNA) must be available prior to randomization.\n  * If the participant is enrolling based on a local testing result, the result may have been based on tissue or liquid (blood) testing. If the participant is enrolling via central testing, the eligibility sample must be from tissue.\n* Participant must have progressed or experienced disease recurrence on or after platinum based chemotherapy (which includes but is not limited to platinum combinations with pemetrexed, paclitaxel, etoposide or gemcitabine) in combination with anti-PD-1\u002FPD-L1 antibody OR platinum-based chemotherapy and anti-PD-1\u002FPD-L1 antibody (in either order) sequentially in the locally advanced (unresectable) or metastatic setting (participant who received anti PD-1\u002Fanti-PD-L1 antibody or platinum-based chemotherapy as first-line therapy in the locally advanced \\[unresectable\\] or metastatic setting may have received the combination of platinum-based chemotherapy and anti PD1\u002Fanti PD L1 antibody in the second line locally advanced \\[unresectable\\] or metastatic setting).\n\n  * No additional treatments are allowed in the locally advanced (unresectable) or metastatic setting, with the exception of: Anti-vascular endothelial growth factor (VEGF) therapy (e.g., bevacizumab), when administered in combination with platinum-based chemotherapy and\u002For anti-PD-1\u002FPD-L1 as part of a standard regimen in the locally advanced (unresectable) or metastatic setting and\n  * Anti-CTLA-4 antibodies (e.g., ipilimumab, tremelimumab), when administered in combination with anti-PD-1\u002FPD-L1 (with or without platinum-based chemotherapy) as part of a standard regimen in the locally advanced (unresectable) or metastatic setting.\n  * For the purposes of eligibility, for a participant who has received prior neoadjuvant or adjuvant therapy and has had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting (for those who received perioperative therapy, the entire course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting).\n  * For the purposes of eligibility, for a participant with a history of unresectable Stage III disease who has received prior multi-modal therapy and has had recurrence on or within 6 months of completion of therapy, the multi-modal therapy will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting. If chemoradiation was followed by treatment with checkpoint inhibitor therapy (CPI) without documented progression between chemoradiation and CPI, the entire treatment course will be counted as a line of systemic therapy in the locally advanced (unresectable) or metastatic setting, for the purposes of eligibility.\n  * Maintenance therapy following platinum doublet-based chemotherapy is not considered a separate line of therapy.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview) and agrees to follow the contraceptive guidance from the time of informed consent through ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n  * Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable. (Note that this is stricter than some docetaxel product information\u002Flabeling documents due to the uncertainty regarding excretion of docetaxel in human milk.)\n  * Must not donate ova starting at first administration of study intervention and throughout the investigational period and for ≥ 6 months after the final setidegrasib administration or ≥ 2 months after the final docetaxel administration, as applicable.\n* Participant consents to and provides a baseline tumor tissue and plasma specimen during prescreening and\u002For screening.\n* Participant has an ECOG performance status of 0 or 1 within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Participant has known untreated or symptomatic central nervous system (CNS) metastases. Participant with previously treated brain metastases may be eligible if they have stable CNS disease for ≥ 2 weeks prior to randomization, all neurologic symptoms have returned to baseline, there is no evidence of new or enlarging brain metastases on brain imaging performed within 28 days prior to randomization and they are receiving ≤ 10 mg\u002Fday of prednisone or equivalent. Participants with untreated CNS metastases, even if asymptomatic, are not eligible.\n* Participant has mixed small-cell lung cancer and NSCLC histology.\n* Participant has leptomeningeal disease as a manifestation of the current malignancy.\n* Participant has another prior malignancy active (i.e., requiring treatment, including hormonal therapies, or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed.\n* Participant has known hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen \\[HBsAg\\]-positive or anti HBV core antibody-positive) or known hepatitis C virus (HCV) (defined as HCV RNA \\[qualitative\\] detected) infection.\n* Participant with human immunodeficiency virus (HIV) infection may be eligible if the participant has not had an opportunistic infection within the past 12 months. Participant must be on established antiretroviral therapy for ≥ 4 weeks, have a CD4+ T cell ≥ 200 cells\u002FµL and must have an HIV viral load \\\u003C 400 copies\u002FmL prior to randomization (HIV testing is not required unless mandated by the local health authority).\n* Participant has current grade ≥ 2 peripheral neuropathy.\n* Participant has uncontrolled pleural effusion, pericardial effusion or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Participant with PleurX catheters in place may be considered for the study with medical monitor approval.\n* Participant has received therapeutic or palliative radiation therapy within 14 days prior to randomization (see first Exclusion Criteria for CNS metastases); participant must have recovered from all radiotherapy related toxicity to ≤ grade 1, with the exception of alopecia (any grade of alopecia allowed).\n* Participant has a known actionable mutation for which an approved targeted therapy is locally available, including, but not limited to, KRAS G12C mutation, EGFR mutation (exon 19 deletions, exon 21 L858R point mutation, T790M, exon 20 insertion), ALK or ROS1 rearrangement, NTRK fusion, NRG1 fusion, BRAF V600E mutation, MET exon 14 skipping mutation, RET rearrangement or HER2 activating mutation.\n* Participant has received prior treatment with either docetaxel or a KRAS-targeting agent (including KRAS directed inhibitors, degraders, siRNA, vaccines and cellular therapies).\n* Participant requires treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450 (CYP)3A or CYP2D6 or strong inhibitors of organic anion transporting polypeptide 1B1 (OATP1B1) or organic anion transporting polypeptide 1B3 (OATP1B3).",{"count":135,"type":22},356,[81],"Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. The first treatment is usually chemotherapy, given with another treatment that targets specific proteins on cancer cells. If the cancer gets worse, the next main treatment is usually a medicine called docetaxel. This treatment doesn't stop most people's cancer from getting worse for very long. Other treatments are needed to improve outcomes in people with NSCLC.\n\nGenes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Many people with NSCLC have a faulty KRAS gene in their tumor. One such change in the KRAS gene is called a G12D mutation. Researchers are looking for ways to stop the actions of abnormal proteins made from the KRAS G12D mutation.\n\nSetidegrasib (ASP3082) is thought to remove some of the abnormal proteins made from the faulty KRAS gene. Before setidegrasib can become available as a treatment, studies need to be done.\n\nThis study is for people with NSCLC with a faulty KRAS gene in their tumor. In this study, some people will be given setidegrasib and some people will be given docetaxel. The main aims are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel, and if they live for longer. Other aims are to check tumor response, symptoms, how the body processes setidegrasib, and its safety, compared with docetaxel.\n\nThe main aims of study are to learn how long people who are given setidegrasib live with cancer without it getting worse, compared to people who are given docetaxel and if people who are given setidegrasib live for longer compared to people who are given docetaxel.\n\nPeople in this study will be adults with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They have had no more than 2 previous treatments for their cancer. The key reasons people cannot take part are if they have different faulty genes in their tumor which can be targeted with other treatments, have symptomatic or untreated cancers that have spread from the lung into the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomeningeal disease), or they have recently had other active cancers that required treatment.\n\nIn this study, people will either receive setidegrasib or docetaxel. Whether people receive setidegrasib or docetaxel is decided by chance, not by the study doctor. Both study treatments are given slowly through a tube into a vein (infusion). People will continue to receive study treatment until their cancer gets worse, they can't tolerate the study treatment, they start other cancer treatment, they or the doctor decides the person should stop receiving study treatment, or sadly, they pass away. Some people on docetaxel may be able to switch to setidegrasib during the study if their cancer becomes worse. There will be safety checks at each visit, and the doctors will continue to check for medical problems and people's wellbeing throughout the study. People will continue to have scans of their tumor every 6 weeks for the first year, then every 9 weeks until their cancer becomes worse. After people's cancer becomes worse, clinic staff will telephone people every 12 weeks to check on their cancer.",[29],[85,140,141,142,89],"ASP3082","setidegrasib","KRAS G12D","2026-06-29",{"date":92,"type":47},{"date":146,"type":47},"2026-04-28",{"date":148,"type":22},"2030-06-30",{"name":150,"class":100},"Astellas Pharma Global Development, Inc.",5,{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":161,"briefSummary":162,"conditions":163,"keywords":169,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":185},"100623492","phase-1-study-of-rason-inhibitors-in-combination-with-ivonescimab-in-patients-with-solid-tumors-100623492","NCT07397338","Study of RAS(ON) Inhibitors in Combination With Ivonescimab in Patients With Solid Tumors","A Phase 1\u002F2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients With Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically confirmed, locally advanced or metastatic solid tumor malignancy with documented RAS mutation in KRAS, HRAS, or NRAS.\n* Received and progressed or been intolerant to prior standard therapy (Part 1 Dose Exploration).\n* Non-squamous NSCLC without a treatable driver mutation in other oncogenes that has not received prior systemic treatment (Arms A \\& B for Part 2 Dose Expansion).\n* Solid tumor or CRC previously treated with no more than 2 prior lines of therapy for advanced disease and progressed or been intolerant to prior standard therapies (Arm C for Part 2 Dose Expansion).\n* Measurable disease per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation, endocrine).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Head and neck squamous cell carcinoma.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 4 weeks prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Other inclusion\u002Fexclusion criteria may apply.",{"count":160,"type":22},370,[25,26],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RAS(ON) inhibitors in combination with ivonescimab in adults with advanced or metastatic solid tumors with a RAS mutation.",[164,165,29,166,167,168],"Advanced Solid Tumors","Metastatic Solid Tumors","NSCLC","Colorectal Cancer (CRC)","CRC",[164,165,170,166,171,168,172,173,174,175,176],"Non-small Cell Lung Cancer","Colorectal Cancer","RAS","NRAS","KRAS","HRAS","RAS Mutation","2026-06-26",{"date":143,"type":47},{"date":180,"type":47},"2026-01-30",{"date":182,"type":22},"2029-05",{"name":184,"class":100},"Revolution Medicines, Inc.",6,{"id":187,"slug":188,"hasResults":12,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":203,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":55},"100642407","phase-1-phase-i-study-of-jfi447-68gaga-dfc413-and-comparison-to-ffg233-68gaga-nns309-in-patients-with-solid-tumors-100642407","NCT07630961","Phase I Study of JFI447 [68Ga]Ga-DFC413 and Comparison to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Phase I, Open Label First in Human Study to Evaluate the Imaging Characteristics, Safety, Biodistribution and Pharmacokinetics of JFI447 [68Ga]Ga-DFC413, and Compare to FFG233 [68Ga]Ga-NNS309 in Patients With Solid Tumors","Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Age ≥ 18 years old.\n3. ECOG performance status ≤ 2.\n4. Patients with one of the following indications (regardless of lines of prior therapy):\n\n   Locally advanced unresectable or metastatic PDAC, NSCLC, HR+\u002FHER2- ductal or lobular BC, TNBC, CRC or STS.\n5. Patients must have at least one measurable lesion per RECIST v1.1 as measured by local Investigator (by conventional MRI or CT scan).\n6. Patients must have an available archival tumor sample at the screening visit. If multiple archival tumor samples are available, the most recent will be requested. Exceptions may be made after documented discussion with Novartis.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Out-of-range laboratory values defined as:\n\n   * Estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured based on 24-hour urine collection)\n   * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\> 3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n   * Alanine aminotransferase (ALT) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5.0 x ULN\n   * Aspartate aminotransferase (AST) \\> 3.0 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5.0 x ULN\n   * Absolute Neutrophil Count \\\u003C 1.0 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Platelet count \\\u003C 75 x 109\u002FL\n2. Unmanageable urinary tract obstruction or urinary incontinence. If ureteral obstruction can be managed with the placement of ureteral stents, this exclusion criterion does not apply.\n3. Known hypersensitivity to 68Ga-DFC413 or 68Ga-NNS309 or their excipients.\n4. Any serious uncontrolled infection (acute or chronic), such as, but not limited to, bacterial, viral or fungal infections, confirmed by clinical evidence, imaging, and\u002For relevant positive laboratory tests (e.g., blood cultures, PCR for DNA\u002FRNA). If a serious infection develops, it must resolve or be adequately controlled prior to 68Ga-DFC413 and\u002For 68Ga-NNS309 initiation.\n5. Surgery or major invasive procedure within 4 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n6. Radiation therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n7. Change in anticancer therapy within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n8. Radiological contrast administration within 48 hours prior to 68Ga-DFC413 or 68Ga-NNS309 administration.\n9. Initiation or increasing doses of corticosteroids, TGF-β signaling inhibitors or immunomodulators within 2 weeks prior to 68Ga-DFC413 or 68Ga-NNS309 administration or between the two imaging agents.\n10. Known additional malignancy that is progressing or requires active treatment.\n11. Inability to complete the required investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).\n12. Presence of CTCAE version 5.0 ≥ Grade 2 toxicity due to prior cancer therapy, except for neuropathy (inclusion of patients with neuropathy of ≤ Grade 2 is permitted) and alopecia.\n13. Any medical condition that would, in the Investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures (including radiation safety precautions), or interpretation of study results.\n14. Pregnant women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.\n15. Nursing (breast-feeding) women. Women who do not breast feed for 12 hours after 68Ga-DFC413 and\u002For 68Ga-NNS309 administration, but express and discard breast milk, are eligible.\n16. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, unless they use highly effective methods of contraception (failure rate \\\u003C1% per year) for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309.\n\n    Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. hormonal profile confirming menopause and\u002For age-appropriate history of vasomotor symptoms).\n\n    Highly effective contraception methods include:\n    * Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n    * Bilateral tubal ligation, female sterilization (have had bilateral oophorectomy with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking 68Ga-DFC413 or 68Ga-NNS309. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n    * Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient.\n    * Use of oral (estrogen and progesterone), injected, or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate \\\u003C 1%), for example, hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment.\n\n    If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent (IC).\n17. Sexually active males unwilling to use a condom during intercourse for 12 hours after the administered radioactive dose of 68Ga-DFC413 and 68Ga-NNS309. A condom is required for all sexually active male patients to prevent them from fathering a child and\u002For to prevent delivery of study treatment via seminal fluid to their partner. In addition, male patients must not donate sperm for the time period specified above. If local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the IC.\n\nOther protocol-defined inclusion\u002Fexclusioncriteria may apply.",{"count":194,"type":22},66,[25],"The purpose of Part 1 of this study is to evaluate the imaging characteristics, safety, biodistribution and pharmacokinetics of \\[68Ga\\]Ga-DFC413, and in Part 2 compare to \\[68Ga\\]Ga-NNS309 in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), HR+\u002FHER2- ductal and lobular breast cancer (BC), triple negative breast cancer (TNBC), colorectal cancer (CRC), and soft tissue sarcoma (STS). In Part 2 of this study (comparison of \\[68Ga\\]Ga-DFC413 and \\[68Ga\\]Ga-NNS309), not all indications might be explored.",[198,29,199,200,201,167,202],"Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)","HR+\u002FHER2- Ductal Breast Cancer (BC)","HR+\u002FHER2- Lobular Breast Cancer (BC)","Triple Negative Breast Cancer (TNBC)","Soft Tissue Sarcoma (STS)",[204,205,206,207,208,209,210,211],"metastatic pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)","HR+\u002FHER2- ductal breast cancer (BC)","HR+\u002FHER2- lobular breast cancer (BC)","triple negative breast cancer (TNBC)","colorectal cancer (CRC)","soft tissue sarcoma (STS)","radioligand imaging","2026-06-25",{"date":177,"type":47},{"date":215,"type":47},"2026-06-23",{"date":217,"type":22},"2028-01-22",{"name":219,"class":100},"Novartis Pharmaceuticals",{"id":221,"slug":222,"hasResults":12,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":23,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":238,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100620736","phase-3-a-study-to-evaluate-pumitamig-versus-durvalumab-following-concurrent-chemoradiation-therapy-in-participants-with-unresectable-stage-iii-non-small-cell-lung-cancer-nsclc-rosetta-lung-201-100620736","NCT07361497","A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)","ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 Study of Pumitamig Monotherapy Compared to Durvalumab in Participants With Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy.","Inclusion Criteria\n\n* Participants must have a histologically- or cytologically-confirmed diagnoses of non-small cell lung cancer (NSCLC) with unresectable Stage III disease.\n* Participants must have received at least 2 cycles of platinum-based concurrent chemoradiotherapy (a total dose of radiation of at least 54 Gy).\n* Participants must have no progressive disease (PD) following treatment with concurrent chemoradiotherapy (CCRT).\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.\n\nExclusion Criteria\n\n* Participants with non-squamous histology must not have documented Epidermal Growth Factor Receptor (EGFR) and anaplastic lymphoma kinase (ALK) rearrangements.\n* Participants must not have an active autoimmune disease.\n* Participants must not have significant cardiovascular impairment such as uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, major thrombotic or embolic events or major hemorrhagic events within 6 months prior to randomization, or significant risk of pulmonary hemorrhage.\n* Participants must not have advanced\u002Fclinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or current or suspected ILD or pneumonitis.\n* Participants must not have any prior anticancer therapy (outside of CCRT) for locally advanced Stage III disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":228,"type":22},850,[81],"A study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)",[29],[233,234,235,236,237],"Pumitamig","Locally advanced","Unresectable","Stage 3 Non-small Cell Lung Cancer (NSCLC)","CA2660001",{"date":177,"type":47},{"date":240,"type":47},"2026-03-16",{"date":242,"type":22},"2033-12-31",{"name":244,"class":100},"Bristol-Myers Squibb",255,{"id":247,"slug":248,"hasResults":12,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":23,"phases":255,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":269,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},"100620737","phase-3-a-study-to-evaluate-the-efficacy-of-pumitamig-versus-pembrolizumab-in-participants-with-previously-untreated-advanced-non-small-cell-lung-cancer-and-pd-l1--50-rosetta-lung-202-100620737","NCT07361510","A Study to Evaluate the Efficacy of Pumitamig Versus Pembrolizumab in Participants With Previously Untreated Advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%. (ROSETTA Lung-202)","ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With PD-L1 ≥ 50%.","Inclusion Criteria\n\n* Participants must have a histologically or cytologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC) (squamous and nonsquamous) with Stage IIIB\u002FIIIC or Stage IV disease.\n* Participants must have a programmed death ligand-1 (PD-L1) expression ≥ 50%.\n* Participants must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Participants must have no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n\nExclusion Criteria\n\n* Participants must not have any documented actionable genomic alteration (AGA) for which first-line (1L) approved therapies are indicated.\n* Participants must not have any symptomatic untreated central nervous system (CNS) metastases, leptomeningeal metastases (carcinomatous meningitis) or spinal cord compression.\n* Participants must not have any significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias, or major thrombotic or embolic events or major hemorrhagic events (within 6 months prior to randomization), or significant risk of pulmonary hemorrhage.\n* Participants must not an active autoimmune disease.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":254,"type":22},750,[81],"The purpose of this study is to evaluate the efficacy of Pumitamig versus Pembrolizumab in participants with previously untreated advanced Non-Small Cell Lung Cancer and PD-L1 ≥ 50%.",[258],"Non-Small Cell Lung Cancer (NSCLC)",[258,260,261,262,263,264,233,265,266,267,268],"1L NSCLC","Programmed death ligand-1 (PD-L1)","Frst line NSCLC","Advanced NSCLC","Metastatic NSCLC","Pembrolizumab","ROSETTA LUNG-202","ROSETTA LUNG","CA2660002",{"date":177,"type":47},{"date":271,"type":47},"2026-03-12",{"date":273,"type":22},"2031-10-14",{"name":244,"class":100},272,{"id":277,"slug":278,"hasResults":12,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":291,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100603707","phase-1-a-study-of-gilteritinib-in-adults-with-advanced-alk-positive-non-small-cell-lung-cancer-nsclc-100603707","NCT07140016","A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)","A Phase 1b Study of Gilteritinib in Participants With Locally Advanced or Metastatic NSCLC With ALK Rearrangement After Prior Treatment With an ALK Inhibitor","Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with a documented anaplastic lymphoma kinase (ALK) rearrangement and is not amenable to curative intent treatment.\n* Participant is willing to submit, prior to enrollment, a fresh tumor tissue sample that was collected after completion of the most recent anti-cancer treatment and before the first dose of study intervention. If it is not medically feasible for a participant to provide a fresh tumor tissue sample, enrollment into the study should be confirmed with the Astellas medical monitor. In this case, an archival tumor tissue sample must be provided.\n* Participant must have at least one prior line of ALK inhibitor-based therapy and meet one of the following criteria:\n\n  * Participant received alectinib as the only prior ALK inhibitor regimen. Participant is ineligible or unable to tolerate approved and available second-line therapy or is determined to potentially benefit from gilteritinib in this setting. Participant is eligible if chemotherapy was received in the neoadjuvant or adjuvant setting, and relapse or disease progressed after 12 months from completion of the treatment.\n  * Participant received lorlatinib as one of the prior ALK inhibitor regimens.\n* Participant has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.\n* Participant must have had progression or recurrence of NSCLC during or following receipt of the most recent therapy.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of childbearing potential (WOCBP).\n  * WOCBP who has a negative urine or serum pregnancy test within 7 days prior to the first dose of study intervention and agrees to follow the contraceptive guidance from the time of informed consent through at least 180 days after final study intervention administration.\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 60 days after final study intervention administration.\n* Female participant must not donate ova starting at the first administration of study intervention and throughout the investigational period and for 180 days after final study intervention administration.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 120 days after final study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 120 days after final study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 120 days after final study intervention administration.\n* Participant must meet the criteria as indicated on the clinical laboratory tests.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study\u002Fparticipating in the present study.\n\nExclusion Criteria:\n\n* Participant has known oncogenic driver alterations other than ALK rearrangement.\n* Participant has symptomatic central nervous system (CNS) metastases or leptomeningeal metastasis.\n* Participant has a history of malignancy other than NSCLC within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix or malignancy considered cured with minimal risk of recurrence).\n* Participant had major surgery (e.g., requiring general anesthesia) within 4 weeks prior to first dose of study intervention, or will not have fully recovered from surgery, or has surgery planned during the study treatment.\n* Participant has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior anti-cancer treatment.\n* Participant has\u002Fhad febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to first dose of study intervention.\n* Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.\n* Participant has a history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association Class III-IV within 6 months prior to the first dose of study intervention.\n* Participant has a history of interstitial pneumonia.\n* Participant had completed target therapy, radiotherapy, chemotherapy, biologics and\u002For immunotherapy within 14 days prior to first dose of study intervention.\n* Participant requires treatment with strong inducers of cytochrome P450 (CYP) 3A.\n* Participant requires treatment with concomitant drugs that target serotonin 5HT1 or 5HT2B receptors or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the participant.\n* Participant has received any investigational therapy within 14 days or 5 half-lives, whichever is longer, prior to screening.\n* Participant has a mean Fridericia-corrected QT interval (QTcF) of \\> 450 msec at screening.\n* Participant has known active hepatitis B virus (HBV) infection (defined as hepatitis B surface antigen (HBsAg)-positive and\u002For anti-HBV core antibody-positive) or known active hepatitis C virus (HCV) infection (defined as HCV RNA \\[qualitative\\] detected).\n\n  * Participant with HBsAg-positivity and\u002For anti-HBV core antibody-positivity but with a negative HBV DNA PCR assay is permitted with appropriate antiviral prophylaxis or routine monitoring according to local practice.\n  * Participant who has been curatively treated for HCV infection is permitted if he\u002Fshe has documented sustained virologic response of 12 weeks.\n* Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications.\n* Participant has echocardiogram (ECHO) or multigated acquisition scan (MUGA) at screening revealing left ventricular ejection fraction \\\u003C 45%.\n* Participant has any condition that makes the participant unsuitable for study participation.\n* Participant has a known or suspected hypersensitivity to gilteritinib or any components of the formulation used.",{"count":284,"type":22},40,[25],"Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty. Some people with non small cell lung cancer (NSCLC) have a faulty ALK gene. ALK stands for anaplastic lymphoma kinase. People with NSCLC who have the faulty ALK gene are called ALK-positive. ALK inhibitors are an approved treatment for people with ALK positive NSCLC. Some people stop responding to treatment with ALK inhibitors over time due to more changes happening in their faulty ALK gene, so there is an unmet medical need. Gilteritinib is an approved treatment for people with acute myeloid leukemia (AML) with the faulty FLT3 gene who haven't responded to previous treatment, or their cancer came back after previous treatment. Gilteritinib also blocks changes in the ALK gene which could help people with ALK-positive NSCLC. A study needs to be done with gilteritinib in people with ALK-positive NSCLC.\n\nThe main aim of the study is to check the safety of gilteritinib in people with ALK-positive NSCLC and if they tolerate gilteritinib.\n\nPeople in this study will be adults with locally advanced or metastatic ALK-positive non-small cell lung cancer (NSCLC). Locally advanced means the cancer has spread to nearby tissue. Metastatic means the cancer has spread to other parts of the body. They have stopped responding to treatment with ALK inhibitors, including alectinib or lorlatinib, over time. The key reasons people cannot take part are if they have symptomatic cancers in the brain or nervous system, their cancer has spread to the thin tissue that covers the brain and spinal cord (leptomengingeal metastasis), have recently had or planning to have major surgery, have certain heart conditions, or have recently had an infection, a stroke or mini-stroke.\n\nPeople in the study will take tablets of gilteritinib once a day in a 28-day cycle. They may be given up to 2 different doses of gilteritinib. People in the study will start on the lower dose but can eventually switch to the higher dose if they tolerate the lower dose and meet the safety checks.\n\nWhilst taking gilteritinib, people will have regular scans of their tumors. People will continue taking gilteritinib until their cancer gets worse, they have medical problems from gilteritinib that they can't tolerate, they ask to stop taking gilteritinib, they start other cancer treatment or, sadly pass away. People will visit the clinic about 7 days and then 30 days after they stop taking gilteritinib. They will be asked about any medical problems and will have a safety check. After this, people who stopped taking gilteritinib, but their cancer hadn't become worse, will continue to have regular scans of their tumors. If their cancer does get worse, they will no longer have scans of their tumors. After finishing gilteritinib, people will be phoned every 12 weeks to check on their health. People will be in the study for up to 4 years, depending on how they respond to gilteritinib.",[29,288],"Anaplastic Lymphoma Kinase (ALK) Positive",[85,288,290],"gilteritinib",{"date":177,"type":47},{"date":293,"type":47},"2025-09-22",{"date":295,"type":22},"2029-12-31",{"name":150,"class":100},16,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":315,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100528549","phase-1-study-of-rason-inhibitors-in-patients-with-advanced-ras-mutated-nsclc-100528549","NCT06162221","Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC","A Platform Study of RAS(ON) Inhibitors in Patients With RAS-Mutated Non-Small Cell Lung Cancer (NSCLC)","Inclusion criteria:\n\nAll Patients (unless otherwise noted):\n\n* ≥ 18 years of age\n* ECOG PS is 0 to 1\n* Adequate organ function as outlined by the study\n* Received prior standard therapy appropriate for tumor type and stage\n* Must have pathologically documented, locally advanced or metastatic KRAS G12C-mutated solid tumor malignancy (not amenable to curative surgery) (Subprotocol A)\n* Must have pathologically documented, locally advanced or metastatic RAS-mutated NSCLC (Subprotocol B)\n* Must have pathologically documented, locally advanced or metastatic RAS G12D-mutated NSCLC (Subprotocol C and Subprotocol D)\n\nExclusion criteria:\n\nAll Patients:\n\n* Primary central nervous system (CNS) tumors\n* Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs\n* Major surgery \\\u003C 28 days of first dose\n* Active or history of interstitial lung disease (ILD) or pneumonitis requiring steroids\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":306,"type":22},616,[25,26],"The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other.\n\nThe first four subprotocols include the following:\n\nSubprotocol A: RMC-6291 +\u002F- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +\u002F- RMC-6236 + SOC Subprotocol D: RMC-9805",[310,311,312,313,314],"Non-Small Cell Lung Cancer, NSCLC","KRAS, NRAS, HRAS-mutated NSCLC","KRAS G12C-mutated Solid Tumors, Lung Cancer","Lung Cancer Stage IV, Advanced Solid Tumor, Cancer","RAS G12D-mutated NSCLC",[166,316,176,317,318,319,320,321,322,323],"KRAS G12C","KRAS G12X","Non-Small Cell Lung Cancer","Lung Cancer","Lung Cancer Stage IV","Advanced Solid Tumor","Cancer","RAS G12D",{"date":92,"type":47},{"date":326,"type":47},"2024-01-18",{"date":328,"type":22},"2028-12",{"name":184,"class":100},93,{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":338,"targetDuration":340,"studyType":341,"phases":4,"briefSummary":342,"conditions":343,"keywords":347,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":362,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":367,"locationsCount":55},"100644656","management-strategy-of-1l-lorlatinib-with-hyperlipidemia-in-stage-iiib-iv-alk-positive-nsclc-100644656","NCT07674524","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC","Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLC: A Multi-center Prospective Study in China","Inclusion Criteria:• Inclusion Criteria (Part A and Part B)\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment (Part A and Part B):\n\n1. Diagnosis:\n\n   1. Histologically or cytologically confirmed locally advanced \\[defined as Stage IIIB\u002FC per AJCC v7.0 and not amenable to multimodality treatment\\] or metastatic (Stage IV) ALK-positive NSCLC; ALK status must be confirmed by Ventana ALK (D5F3) Companion Diagnostic (CDx) IHC (Ventana ULTRA or XT platform), FISH, PCR, next-generation sequencing (NGS), or circulating tumor DNA (ctDNA) testing;\n   2. At least one measurable target lesion per RECIST v1.1, not previously irradiated; brain metastases are allowed;\n2. No prior systemic therapy for advanced (Stage IIIB\u002FC not amenable to multimodality treatment) or metastatic (Stage IV) disease;\n3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2;\n4. Age ≥ 18 years;\n5. Hyperlipidemia during first-line lorlatinib treatment, with ULN ≤ TC \\\u003C 12.93 mmol\u002FL (Grade 1-3);\n6. Life expectancy ≥ 6 months;\n7. Negative serum pregnancy test at screening for women of childbearing potential. Non-childbearing potential must meet at least one of the following:\n\n   1. Postmenopausal status: regular menstrual cessation ≥ 12 months with no other pathological or physiological cause (serum FSH level may be used to confirm postmenopausal status, if applicable);\n   2. Hysterectomy and\u002For bilateral oophorectomy;\n   3. Medically confirmed ovarian failure; All other women (including those with tubal ligation) are considered of childbearing potential;\n8. Provide signed and dated informed consent from the patient (or legal representative), indicating full understanding of the study-related information.\n\nPart B Additional Inclusion Criteria\n\nPatients with at least one prior major ASCVD event, or baseline LDL-C ≥ 4.9 mmol\u002FL ± high-risk factors.\n\nMajor ASCVD events:\n\n1. Acute coronary syndrome (ACS) within the past 1 year;\n2. History of myocardial infarction (excluding recent ACS);\n3. History of ischemic stroke;\n4. Symptomatic peripheral artery disease (PAD), including prior revascularization or amputation.\n\nHigh-risk factors (prioritized):\n\n1. Premature coronary artery disease (male \\\u003C 55 years; female \\\u003C 65 years);\n2. Familial hypercholesterolemia;\n3. History of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI);\n4. Diabetes mellitus;\n5. Hypertension;\n6. Chronic kidney disease (CKD) stage 3-4;\n7. Current smoker. -\n\nExclusion Criteria:\n\nExclusion Criteria (Part A and Part B)\n\n1. Mixed squamous cell carcinoma, large cell carcinoma, or small cell lung cancer\n2. Prior systemic anticancer therapy for NSCLC, including chemotherapy, biologic therapy, immunotherapy, or any investigational drug\n3. Diagnosed genetic hypercholesterolemia (e.g., familial hypercholesterolemia, Part A only) or secondary dyslipidemia with a clear etiology (e.g., hypothyroidism, uncontrolled diabetes, nephrotic syndrome)\n4. Known allergy or history of severe adverse reaction to any study drug (including lorlatinib, statins, ezetimibe, or evolocumab)\n5. Presence of other severe diseases that may affect study compliance or outcome assessment, including advanced renal failure (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or severe hepatic impairment (Child-Pugh Class C)\n6. Pregnant or lactating women, or fertile individuals (male or female) unwilling to use effective contraception during the study\n7. Currently participating in another interventional clinical study that may interfere with this study; patients expected to be unable to complete follow-up or the first tumor efficacy assessment; patients with mental or psychological disorders who cannot provide informed consent or comply with study requirements (including treatment and follow-up)\n\nPart B Additional Exclusion Criteria\n\nSubjects meeting any of the following criteria will not be included in this clinical study:\n\n1. Major surgery within 4 weeks prior to randomization; minor surgery (e.g., port placement) is permitted provided the incision is adequately healed\n2. Radiotherapy within 2 weeks prior to enrollment, including stereotactic or partial brain radiotherapy. Patients who complete whole brain radiotherapy within 4 weeks prior to randomization, or palliative radiotherapy outside the CNS within 48 hours prior to randomization, are also excluded\n3. Gastrointestinal abnormalities including: inability to take oral medication; need for parenteral nutrition; prior surgery affecting absorption (e.g., total gastrectomy, gastric banding); active inflammatory bowel disease, chronic diarrhea, symptomatic diverticular disease; treatment for active peptic ulcer within the past 6 months; malabsorption syndrome\n4. Known or suspected severe hypersensitivity to the study drug or any of its excipients\n5. History of extensive, disseminated, or bilateral disease, or current Grade 3-4 interstitial fibrosis\u002Finterstitial lung disease, including but not limited to: pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, bronchiolitis obliterans, and pulmonary fibrosis\n6. Active malignancy within 3 years prior to randomization (excluding NSCLC, non-melanoma skin cancer, localized prostate cancer not requiring immediate treatment, or any carcinoma in situ)\n7. Concurrent use within 12 days prior to first lorlatinib dose of:\n\n   1. Strong CYP3A inhibitors (e.g., grapefruit juice or grapefruit\u002Frelated citrus fruits \\[Seville oranges, pomelos\\]; boceprevir, cobicistat, conivaptan, itraconazole, ketoconazole, posaconazole; ritonavir alone or with danoprevir, elvitegravir, indinavir, lopinavir, paritaprevir, ombitasvir, dasabuvir, saquinavir, tipranavir; telaprevir, troleandomycin, voriconazole. Topical use such as 2% ketoconazole cream is permitted where applicable)\n   2. Known narrow therapeutic index CYP3A substrates (e.g., astemizole, terfenadine, cisapride, pimozide, quinidine, tacrolimus, cyclosporine, sirolimus, alfentanil, fentanyl \\[including transdermal patch\\], or ergot alkaloids \\[ergotamine, dihydroergotamine\\]) (withdrawn from U.S. market)\n   3. Known strong CYP3A inducers (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's Wort)\n   4. Known narrow therapeutic index P-gp substrates (e.g., digoxin)\n8. Other severe acute or chronic medical or psychiatric conditions, including suicidal ideation or behavior within the past 1 year, that may increase the risk of study participation or study drug use, or laboratory abnormalities that may interfere with interpretation of study results, and patients deemed by the investigator to be unsuitable for enrollment\n9. Participation in another investigational drug study within 2 weeks prior to enrollment and\u002For during the study period",{"count":339,"type":22},160,"24 Years","OBSERVATIONAL","For Patients and Families\n\nBrief Title: Management of 1L Lorlatinib with Hyperlipidemia in ALK+ Advanced NSCLC\n\nWhat is this study about?\n\nThis study is for people with ALK-positive non-small cell lung cancer (NSCLC) who are taking lorlatinib (Lorbrena®) as their first treatment and have developed high cholesterol (hyperlipidemia) as a side effect.\n\nWhy is this study needed?\n\nLorlatinib is a highly effective targeted therapy, but it frequently causes elevated cholesterol and triglycerides. There is currently no standard guideline on how to best manage this side effect. This study aims to find the best approach to control lipid levels while on lorlatinib treatment.\n\nWhat will happen in this study?\n\nThe study has two parts:\n\n* Part A (Observational) : About 100 participants. Doctors manage hyperlipidemia according to routine clinical practice. Researchers simply observe and record which lipid-lowering treatments are used and how well they work.\n* Part B (Randomized Controlled Trial) : 60 participants with high-risk factors are randomly assigned to either:\n* Intensive treatment: rosuvastatin + ezetimibe + evolocumab\n* Standard treatment: rosuvastatin + ezetimibe\n\nWhat tests are involved?\n\n* Blood tests for lipid levels at baseline, Weeks 4, 8, 20, and 24\n* Routine CT or MRI scans for tumor assessment\n* Some participants in Part B may have a non-invasive vascular ultrasound (FMD) test\n* Total participation per patient: up to 7 months\n\nIs this study safe?\n\n* ✅ Approved by the Ethics Committee of Sun Yat-sen University Cancer Center\n* ✅ All drugs used (lorlatinib, statins, ezetimibe, evolocumab) are already approved and widely used\n* ✅ An independent Data Monitoring Committee (DMC) monitors safety throughout the study\n* ✅ Participants may withdraw at any time without affecting their regular care\n\nFor Healthcare Providers\n\nStudy Title: Management strategy of 1L Lorlatinib with Hyperlipidemia in Stage IIIB-IV ALK positive NSCLC: A multi-center prospective study in China\n\nSponsor \u002F Investigators: Sun Yat-sen University Cancer Center (PI: Prof. Zhang Li)\n\nStudy Type:\n\n* Part A: Observational, prospective, real-world cohort study\n* Part B: Prospective, randomized controlled trial (RCT)\n\nEstimated Enrollment: 160 participants (Part A: \\~100, Part B: 60)\n\nStudy Duration: Approximately 4 years (anticipated completion: December 2029)\n\nKey Inclusion Criteria:\n\n* Stage IIIB-IV ALK+ NSCLC (confirmed by IHC, FISH, PCR, NGS, or ctDNA)\n* No prior systemic therapy for advanced\u002Fmetastatic disease\n* ECOG PS 0-2\n* Age ≥ 18 years\n* Hyperlipidemia (ULN ≤ TC \\\u003C 12.93 mmol\u002FL, Grade 1-3) while on first-line lorlatinib\n* At least one measurable lesion per RECIST v1.1\n* Life expectancy ≥ 6 months\n\nPrimary Endpoints:\n\n* Part A: Describe real-world treatment patterns for hyperlipidemia management\n* Part B: Percentage change in LDL-C from baseline to Week 12\n\nOversight:\n\n* Independent Data Monitoring Committee (DMC)\n* Trial Management Committee\n* Ethics Committee of Sun Yat-sen University Cancer Center (Approval No. B2026-159-01)\n\nParticipating Centers: 8 sites across China",[258,344,345,346],"Hyperlipidemia","ALK Gene Mutation","ALK-positive",[348,349,344,350,351,352,353,354,355,356,357,358,359,360],"Lorlatinib","ALK-positive NSCLC","Lipid management","Statin","Ezetimibe","Evolocumab","PCSK9 inhibitor","Real-world study","Randomized controlled trial","Prospective study","Endothelial function","FMD","Multi-center","NOT_YET_RECRUITING","2026-06-24",{"date":143,"type":47},{"date":365,"type":22},"2026-08-01",{"date":295,"type":22},{"name":368,"class":369},"Sun Yat-sen University","OTHER",{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":377,"enrollmentInfo":378,"targetDuration":4,"studyType":23,"phases":380,"briefSummary":381,"conditions":382,"keywords":386,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":403},"100641972","phase-1-study-of-177lulu-dwj155-and-68gaga-dwj155-in-patients-with-solid-tumors-100641972","NCT07660055","Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors","Inclusion Criteria:\n\n* Male or female patients age ≥ 18 years.\n* Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:\n* Dose Escalation:\n\n  * Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting\n  * Advanced HR+\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC with AGAs who have received prior treatment\n  * Measurable disease as determined by RECIST version 1.1.\n* Dose Expansion:\n\n  * Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting\n  * Advanced HR+\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR+\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR-\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR-\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC with AGAs, who have received prior treatment\n  * Advanced NSCLC without known AGAs who have received prior treatment.\n  * Advanced gastric\u002FGEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting\n  * Measurable disease as determined by RECIST version 1.1.\n\nExclusion Criteria:\n\n* Out-of-range laboratory values defined as:\n\n  * Creatinine clearance \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured)\n  * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\>3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n  * Alanine aminotransferase (ALT) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5 x ULN\n  * Aspartate aminotransferase (AST) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5 x ULN\n  * Lipase \\> 1.5 x ULN\n  * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Platelet count \\\u003C 100 x 109\u002FL\n* Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.\n* Use of transfusion support ≤4 weeks prior to imaging agent administration.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Unmanageable urinary tract obstruction or urinary incontinence.\n* Any serious uncontrolled infection (acute or chronic).\n* Pregnant or breastfeeding women.\n* Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:\n\n  * Prior treatment with any therapeutic radiopharmaceutical\n  * \\\u003C 10 half-lives for any imaging radiopharmaceutical\n  * ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy\n  * ≤ 6 months for lung-directed external beam radiotherapy\n* Patients with non-tumor uptake of \\[68Ga\\]Ga-DWJ155 in tissues or organs that, in the opinion of the investigator, increases the risk associated with \\[177Lu\\]Lu-DWJ155 treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":379,"type":22},156,[25],"The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \\[177Lu\\]Lu-DWJ155 and the safety and imaging properties of \\[68Ga\\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+\u002FHER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric\u002Fgastroesophageal junction (GEJ) cancer, and bladder cancer.",[383,29,384,385],"Breast Cancer","Gastric\u002FGastroesophageal Junction (GEJ) Cancer","Bladder Cancer",[387,85,388,389,390,391,392,393,394,395],"Breast cancer","Bladder cancer","Gastric\u002Fgastroesophageal junction (GEJ)","Radioligand therapy (RLT)","[177Lu]Lu-DWJ155","[68Ga]Ga-DWJ155","Human Epidermal Growth Factor Receptor 2 (HER2)","FML539","FKL480","2026-06-19",{"date":215,"type":47},{"date":399,"type":47},"2026-06-16",{"date":401,"type":22},"2032-05-24",{"name":219,"class":100},3,{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":409,"acronym":4,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":23,"phases":413,"briefSummary":414,"conditions":415,"keywords":428,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":444,"startDateStruct":445,"completionDateStruct":447,"leadSponsor":449,"locationsCount":451},"100614270","phase-1-a-study-of-ide892-as-monotherapy-and-combination-in-mtap-deleted-advanced-solid-tumors-100614270","NCT07277413","A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors","A Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE892 as Monotherapy and Combination Therapy in Participants With MTAP-Deleted Advanced Solid Tumors","Inclusion Criteria:\n\n* Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.\n* Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma \\[pleural or peritoneal\\], gastroesophageal cancers \\[squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers\\], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC \\[adenocarcinoma, squamous cell carcinoma, and adeno-squamous\\] or UC \\[including mixed urothelial-squamous histology\\]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).\n* Are willing and able to provide blood\u002Ftumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.\n* Must be willing and able to provide the blood\u002Fserum\u002Fplasma samples\n* Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)\n* Have at least 1 measurable lesion according to RECIST version 1.1\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1\n* Have life expectancy \\> 3 months\n* Have adequate bone marrow and organ function\n* Able to swallow and retain orally administered study drug\u002FIMP.\n* Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures\n* Male and female: willing to use contraception\n\nExclusion Criteria:\n\n* Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids\n* Have a known primary central nervous system (CNS) malignancy\n* Have had other malignancies within 2 years prior to the first dose, with some exceptions\n* Impaired cardiac function or clinically significant cardiac diseases\n* Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter\n* Have a history of severe infections within 4 weeks prior to the start of study treatment\n* Hypertension (e.g., \\> 150\u002F100 mmHg) that cannot be controlled by medications despite optimal medical therapy\n* Other acute or chronic medical or psychiatric condition\n* Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening\n* Known or suspected viral hepatitis with a positive test at screening\n* Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1\n* Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks\n* Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP\n* Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein\n* Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4\u002F5, Strong inhibitors of P-gp and\u002For BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP\n* Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study\n* Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892\n* Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and\u002For Protein arginine N-methyltransferase (PRMT) inhibitor\n* Major surgery within 4 weeks before study entry\n* Prior irradiation to \\> 25% of the bone marrow\n* Known or suspected hypersensitivity to IDE892\n\nDisease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1\u002FPD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.\n* If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.\n\nEligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)\n\n* Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors\n* Must have progressed following at least 1 prior line of therapy\n* Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease",{"count":412,"type":22},260,[25],"This is a multicenter clinical study to evaluate the safety, efficacy, and Pharmacokinetics (PK) of IDE892 as monotherapy and in combination with other agents including IDE397 in participants with methylthioadenosine phosphorylase (MTAP)-deleted advanced solid tumors within indications of interest.",[416,417,418,419,420,421,385,422,423,424,425,426,427],"NSCLC Adenocarcinoma","Gastroesophageal Cancer (GC)","Gastric Adenocarcinoma","Adenocarcinoma of Esophagus","Squamous Cell Car. - Esophagus","Urothelial Carcinoma (UC)","Mesothelioma","Pleural Mesothelioma","Peritoneal Mesothelioma","Non-Small Cell Lung Cancer NSCLC","Pancreatic Cancer","Biliary Tract Carcinoma",[429,430,431,432,433,434,435,436,437,438,439,440,441,442,443],"MTAP deletion","MTAP loss","MTAP-deficient tumors","homozygous MTAP loss","IDE892","IDE397","MAT2A inhibitor","PRMT5","advanced solid tumors","metastatic cancer","recurrent cancer","dose escalation","dose expansion","phase 1 clinical trial","ctDNA",{"date":215,"type":47},{"date":446,"type":47},"2026-03-04",{"date":448,"type":22},"2028-04-30",{"name":450,"class":100},"IDEAYA Biosciences",14,{"id":453,"slug":454,"hasResults":12,"nctId":455,"briefTitle":456,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":23,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":4},"100644326","phase-1-a-study-to-learn-about-the-study-medicine-called-ponsegromab-in-adults-with-lung-cancer-associated-significant-weight-loss-100644326","NCT07663630","A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Weight Loss","AN INTERVENTIONAL, PHASE 1B, DOUBLE-BLIND, RANDOMIZED, SPONSOR-OPEN, 2-ARM STUDY TO INVESTIGATE THE EFFECT OF PONSEGROMAB ON SKELETAL MUSCLE MASS AND PHYSICAL FUNCTION IN ADULT PARTICIPANTS WITH NON-SMALL CELL LUNG CANCER ASSOCIATED CACHEXIA","Key Inclusion Criteria:\n\n* Signed Informed Consent\n* Documented histological or cytologic diagnosis of NSCLC with each of the following:\n\n  1. locally advanced, unresectable, stage III disease (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system); and\n  2. measurable disease at time of screening (assessment per RECIST v1.1); and\n  3. must have completed platinum-based chemotherapy concurrent with radiation therapy, within 7 to 42 days prior to the randomization; and\n  4. no evidence of progression of disease following definitive, platinum-based, concurrent chemoradiation therapy; and\n  5. must be due to receive consolidation immunotherapy with durvalumab for up to 12 months, with the first dose of blinded study intervention to coincide with the first dose of durvalumab +\u002F- 7 days; and\n  6. absence of actional genomic mutations (eg, EGFR, ALK).\n* Cachexia defined by Fearon criteria:\n\n  1. BMI \\\u003C20 kg\u002Fm2 and involuntary weight loss of \\>2% within 6 months prior to screening; or\n  2. Involuntary weight loss of \\>5% over the past 6 months prior to screening irrespective of BMI\n* Participant has been evaluated and determined that available anticachexic treatments have either been administered with no positive effect or the participant is not suitable for these treatments.\n* Participants who are assessed by the investigator to have an ECOG PS ≤1.\n\nKey Exclusion Criteria:\n\n* Current active reversible causes of decreased food intake, as determined by the investigator. These causes may include, but are not limited to:\n\n  1. NCI CTCAE Grade 3 or 4 oral mucositis\n  2. Mechanical obstructions interfering with the participant's ability to eat\n* Receiving tube feedings or parenteral nutrition (either total or partial) at the time of screening or randomization.\n* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification.\n* Cachexia caused by reasons other than NSCLC, as determined by the investigator (eg, severe COPD).\n* Mixed small cell and non-small cell lung cancer histology.\n* Undergoing major surgery within 4 weeks prior to randomization or planned major surgical procedures during the study.\n* History of immune-related adverse event(s) in setting of immunotherapy that required treatment with systemic corticosteroids.\n* Chronic use of systemic corticosteroid.\n* History of any secondary malignancy in the last 2 years, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ.\n* Symptomatic brain metastasis or leptomeningeal disease.\n* Any Grade ≥3 pulmonary disease unrelated to underlying malignancy including, but not limited to:\n\n  1. Severe asthma requiring systemic corticosteroids within 30 days prior to first dose of study intervention or not well controlled with low-dose inhaled corticosteroids\u002Flong-acting beta-2 agonists.\n  2. Severe chronic obstructive pulmonary disease requiring supplemental oxygen or systemic corticosteroids.\n  3. Clinically severe and\u002For Grade 4 pulmonary emboli within 3 months of the first dose of study intervention. Pulmonary emboli in main or lobar pulmonary arteries are also excluded.\n  4. Any autoimmune or inflammatory disorders with significant pulmonary parenchymal involvement at time of screening (ie, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc).\n* Renal disease requiring dialysis or eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m².\n* History of severe liver disease or cirrhosis, unrelated to metastatic cancer. LFT abnormalities at the time of screening; confirmed by a single repeat test if deemed necessary: AST or ALT level ≥ 3 x ULN (\\>5 x ULN if liver involvement by the tumor), alkaline phosphatase \\> 3 x ULN (\\>5 x ULN if liver involvement by the tumor and\u002For in case of bone metastases), or total bilirubin level ≥ 1.5 x ULN (For Gilbert's syndrome, direct bilirubin \\> ULN is exclusionary).\n* Left ventricular ejection fraction \\\u003C50% on screening echocardiogram (or MUGA scan).",{"count":460,"type":22},80,[25],"Study to investigate the effect of ponsegromab on skeletal muscle mass and physical function in adult participants with non-small cell lung cancer associated cachexia.",[29,464],"Cachexia",[466],"non-small cell lung cancer, cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue","2026-06-17",{"date":215,"type":47},{"date":470,"type":22},"2026-07-22",{"date":472,"type":22},"2029-03-29",{"name":474,"class":100},"Pfizer",{"id":476,"slug":477,"hasResults":12,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":485,"briefSummary":486,"conditions":487,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":503},"100452820","phase-1-study-of-zanzalintinib-in-combination-with-immuno-oncology-agents-in-participants-with-solid-tumors-100452820","NCT05176483","Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors","A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors","STELLAR-002","Key Inclusion Criteria:\n\n* Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic.\n* Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.\n* Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy.\n\n  * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose.\n* Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component.\n\n  * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)\u002FProgrammed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy.\n  * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma.\n* Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate.\n\n  * Must have progressed during or after one novel hormone therapy (NHT) given for castration-sensitive locally advanced (T3 or T4) or metastatic castration-sensitive prostate cancer (CSPC), M0 CRPC, or mCRPC.\n* Expansion Cohort 4 (UC, ICI-naive): Participants with histologically confirmed unresectable, locally advanced or metastatic transitional cell carcinoma of the urothelium (including the renal pelvis, ureter, urinary bladder, or urethra).\n\n  * Must have progressed during or after prior first-line platinum-based combination therapy, including participants who received prior neoadjuvant or adjuvant platinum-containing therapy with disease recurrence \\\u003C 12 months from the end of last therapy.\n  * Must have received no more than 1 prior line of systemic anticancer therapy for unresectable, locally advanced or metastatic disease.\n* Expansion Cohort 5 (post enfortumab vedotin \\[EV\\] and ICI): Participants with histologically confirmed unresectable, locally advanced or metastatic predominant urothelial carcinoma.\n\n  * Progressive disease following prior EV or ineligible for EV, and progression following prior PD-1\u002FPD-L1 inhibitor or ineligible for PD-1\u002FPD-L1 inhibitor.\n  * Prior receipt of platinum-based therapy allowed but not required.\n  * Prior therapy with other agents allowed but not required.\n* Expansion Cohort 6 (nccRCC): Participants with unresectable advanced or metastatic nccRCC of the following subtypes: Papillary, unclassified RCC, and translocation-associated, Fumarate Hydratase (FH) deficient and Succinate Dehydrogenase (SDH) deficient. Among the eligible histologic subtypes, sarcomatoid features are allowed.\n\n  * No prior systemic anticancer therapy is allowed except adjuvant or neoadjuvant therapy if disease recurrence occurred at least 6 months after the last dose.\n* Expansion Cohort 7 (HCC): Participants with locally advanced, or metastatic and\u002For unresectable HCC that is not amenable to curative treatment or locoregional therapy.\n* Expansion Cohort 8 (NSCLC): Participants with Stage IV non-squamous NSCLC with positive PD-L1 expression (tumor proportion score \\[TPS\\] 1-49%) and without prior systemic anticancer therapy for metastatic disease.\n* Expansion Cohort 9 (NSCLC): Participants with Stage IV non-squamous NSCLC who have radiologically progressed following treatment with one prior immune checkpoint inhibitor (anti-PD-1 or anti-PD-L1) for metastatic disease.\n* Expansion Cohort 10 (CRC): Participants with histologically confirmed unresectable, locally advanced, or metastatic adenocarcinoma of the colon or rectum.\n* Expansion Cohort 11 (HNSCC): Participant with inoperable, refractory, recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx. PD-L1 combined positive score (CPS) ≥1.\n* Expansion Cohort 12 (ccRCC): Participants with unresectable advance or metastatic RCC with a clear cell component, including participants who also have a sacromatoid feature.\n\n  * Must have received no more than two prior lines of systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma\n* Expansion Cohort 13 and Cohort 14 (ccRCC 1L): Participants with unresectable advanced or metastatic RCC with a clear component, including participants who also have a sacromatoid feature.\n* For all Expansion Cohorts except Cohort 3: Measurable disease per RECIST 1.1 as determined by the Investigator.\n* For Expansion Cohorts 1 - 11 Only: Archival tumor tissue material, if available, or fresh tumor tissue if it can be safely obtained.\n* Recovery to baseline or ≤ Grade 1 common terminology criteria for adverse events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and\u002For stable on supportive therapy.\n* Karnofsky Performance Status (KPS) ≥ 70%.\n* Adequate organ and marrow function.\n* Sexually active fertile participants and their partners must agree to use highly effective methods of contraception.\n* Females of childbearing potential must not be pregnant at screening.\n\nKey Exclusion Criteria:\n\n* For all Dose-Escalation cohorts: Prior treatment with zanzalintinib. For all Expansion Cohorts: Prior treatment with zanzalintinib, nivolumab, ipilimumab or relatlimab with the following exceptions: Prior PD-1\u002FPD-L1, Lymphocyte-activation gene 3 (LAG-3) and cCytotoxic T lymphocyte associated protein 4 (CTLA-4) targeting therapy for locally advanced or metastatic disease is allowed for Cohort 2 (ccRCC), Cohort 5 (UC), Cohort 9 (NSCLC), and Cohort 12 (ccRCC), and prior treatment in the neoadjuvant or adjuvant setting is allowed for Cohort 13 and Cohort 14 (ccRCC 1L).\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC), Cohort 10 (CRC), and Cohort 12: Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* For Cohort 3 (mCRPC): Receipt of abiraterone within 1 week; cyproterone within 10 days; or receipt of flutamide, nilutamide, bicalutamide, enzalutamide, or other androgen receptor inhibitors within 2 weeks before first dose of study treatment.\n* For all Dose-Escalation Cohorts and Expansion Cohort 2 (ccRCC), Cohort 3 (mCRPC), Cohort 5 (UC), Cohort 9 (NSCLC) and Cohort 10 (CRC), and Cohort 12: Receipt of any type of anticancer antibody or systemic chemotherapy within 4 weeks before first dose of study treatment.\n* Any complementary medications (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks before first dose of study treatment.\n* Prior external radiation therapy for bone metastasis within 2 weeks, for other tumor sites within 4 weeks, and prior radium-223 therapy within 6 weeks before first dose of study treatment, unless otherwise specified.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.\n* Concomitant anticoagulation with oral anticoagulants, except for specified direct factor Xa inhibitors.\n* Administration of a live, attenuated vaccine within 30 days prior to first dose.\n* Uncontrolled, significant intercurrent or recent illness.\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 460 ms for females and \\> 450 ms for males per electrocardiogram (ECG) within 14 days before first dose of study treatment.\n* Participants with inadequately treated adrenal insufficiency.\n* Pregnant or lactating females.\n* Any other active malignancy within two years before first dose of study treatment, except for superficial skin cancers, or localized, low-grade tumors deemed cured and not treated with systemic therapy. Incidentally diagnosed prostate cancer is allowed if assessed as stage ≤ T2N0M0 and Gleason score ≤ 6.\n* For Cohort 2 (ccRCC, 2L): Receipt of a prior triplet therapy including a VEGFR-TKI, a PD1 targeting mAb, and a CTLA-4 mAb.\n* For Cohort 3 (mCRPC): Receipt of a taxane-based chemotherapy for mCRPC.\n* For Cohort 4 (UC, ICI-naïve): Participants who have had recurrence within the 6 months of completing adjuvant anti-PD-(L)1 treatment.\n* For Cohort 6 (nccRCC, 1L): Participants with chromophobe, renal medullary carcinoma, or pure collecting duct nccRCC.\n* For Cohort 7 (HCC):\n\n  * Documented hepatic encephalopathy (HE) within 6 months before the first dose.\n  * Clinically meaningful ascites (ie, ascites requiring paracentesis or escalation in diuretics) within 6 months before randomization.\n  * Participants who have received any local anticancer therapy including surgery, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MWA), transarterial chemoembolization (TACE), or transarterial radioembolization (TARE) within 28 days prior to first dose.\n  * Participants with known fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma\n* For Cohort 10 (CRC, 2L+): Receipt of prior therapy with regorafenib and\u002For trifluridine + tipiracil (TAS-102).\n* For Cohort 11 (HNSCC): Primary tumor site of the nasopharyngeal area.\n* For Cohorts 1 (ccRCC, 1L), 2 (ccRCC, 2L), 4, 5 (UC), 7 (HCC), 8 (NSCLC 1L PD-L1 low), 9 (NSCLC, 2L+), 10 (CRC, microsatellite stable \\[MSS\\], 2L+), and 11 (HNSCC):\n\n  * Troponin T (TnT) or I (TnI) \\> 2 × institutional upper limit of normal (ULN).\n\nNote: Additional Inclusion and Exclusion criteria may apply.",{"count":484,"type":22},1314,[25],"This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors.\n\nIn the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.",[488,489,421,490,491,29,167,492,493,494],"Renal Cell Carcinoma (RCC)","Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Solid Tumor","Hepatocellular Carcinoma (HCC)","Head and Neck Squamous Cell Carcinoma (HNSCC)","Clear Cell Renal Cell Carcinoma (ccRCC)","Non-Clear Cell Renal Cell Carcinoma (nccRCC)",{"date":496,"type":47},"2026-06-22",{"date":498,"type":47},"2021-12-14",{"date":500,"type":22},"2030-06-28",{"name":502,"class":100},"Exelixis",122,{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":519,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":528},"100634506","phase-1-a-study-to-investigate-the-safety-pharmacokinetics-and-preliminary-efficacy-of-ide574-therapy-in-adult-participants-with-advanced-solid-tumors-100634506","NCT07540572","A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors","An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer","Inclusion Criteria:\n\nArchival Tissue sample for testing\n\n* Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on\u002Fafter at least one line of standard of care therapy or are intolerant to additional effective therapies.\n* Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4\u002F6 inhibitor\n* Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only)\n* Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \\\u003C60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1.\n* Have adequate bone marrow, renal and liver function.\n* Life expectancy of \\>3 months\n* Able to safely administer and retain orally administered study treatment\n* Able to comply with contraceptive\u002Fbarrier requirements\n\nKey Exclusion Criteria:\n\n* Known symptomatic brain metastases or leptomeningeal metastasis\n* Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor.\n* Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574.\n* Have active liver or biliary disease.\n* Have active, uncontrolled bacterial, fungal, or viral infection\n* Have clinically significant cardiac abnormalities and\u002For blood clotting events within 6 months before the first dose\n* If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1\n* Prior irradiation to \\>25% of the bone marrow.\n* Known or suspected hypersensitivity to IDE574\u002Fexcipients or components (Parts 1 \\& 2) or fulvestrant\u002Fexcipients or components (Part 2 only)","99 Years",{"count":339,"type":22},[25],"IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7.\n\nThe purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.",[516,29,517,518],"ER+, HER 2- Breast Cancer","Castration-resistant Prostate Cancer (CRPC)","Microsatellite Stable (MSS) Colorectal Carcinoma",[516,29,517,518,520,521],"KAT6A\u002FB","KAT7","2026-06-12",{"date":399,"type":47},{"date":525,"type":47},"2026-03-17",{"date":148,"type":22},{"name":450,"class":100},11,{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":4,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":23,"phases":538,"briefSummary":539,"conditions":540,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":55},"100484574","phase-2-pembrolizumab-for-advanced-nsclc-and-ps-2-3-100484574","NCT05589818","Pembrolizumab for Advanced NSCLC and PS 2-3","A Phase II Study of the Effects of Pembrolizumab on Quality of Life for Patients With Treatment-Naïve, Advanced or Metastatic NSCLC and Poor Performance Status","Inclusion Criteria:\n\n* Men and women, aged 18 years and older, with locally advanced NSCLC who are ineligible for definitive surgical resection or concurrent chemoradiation, or metastatic NSCLC\n* Patients must not have received any systemic therapy for metastatic cancer\n* Patients must not have received any PD-1 or PD-L1 inhibitor\n* ECOG performance status of 2 or 3 at the time of consent and on the first day of therapy\n* Patients may not have a molecular alteration in ALK, ROS1, EGFR, BRAF, NTRK, RET, MET, or any other gene for which first-line FDA approved targeted therapy exists.\n* Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period.\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS directed therapy is not required and is unlikely to be required during the first cycle of therapy.\n* Patients with HIV on effective anti-retroviral therapy with an undetectable viral load within 6 months are eligible for this trial.\n* Adequate organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,000\u002FmcL\n  * Platelets ≥ 100,000\u002Fmcl\n  * Total bilirubin ≤ 1.5 x ULN\n  * AST (SGOT)\u002FALT (SPGT) ≤ 3 x ULN or ≤5 x ULN if liver metastases present\n  * GFR (Cockroft-Gault) ≥ 30 mL\u002Fmin\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 3 days prior to C1D1 of pembrolizumab therapy. For the purposes of this trial, WOCBP are defined as women who have had a menstrual period within the last 48 months.\n* Provision of signed and dated informed consent form\n* Ability to take the study medication, and complete the study questionnaires\n* Stated willingness to comply with all study procedures for the duration of the study\n* For women of reproductive potential, agreement to use highly effective contraception during study treatment and for at least 4 months after the final dose\n* For men of reproductive potential, agreement to use condoms or other methods to ensure effective contraception with female partners of reproductive potential\n\nExclusion Criteria:\n\n* Autoimmune conditions requiring \\>10mg prednisone (or its equivalent) of daily therapy or other systemic immunosuppressive therapy.\n* Patients who are receiving other investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patients with known leptomeningeal disease for which CNS therapy is required\n* Pregnant or lactating patients",{"count":537,"type":22},45,[26],"This single center open-label trial will enroll a single cohort of patients with advanced non-small cell lung cancer (NSCLC) who are ineligible for treatment with curative intent due to 1) disease stage IV, or 2) inability to tolerate intensive surgery or chemo-radiation. Patients will be eligible for the trial if ISMMS reviewed samples from tumor biopsy have a PDL-1 TPS ≥ 1% and have ECOG performance status rated 2 or 3. All patients will receive anti PD-1 therapy with pembrolizumab 200mg IV every 3 weeks, during which patients will also undergo serial QOL assessments.\n\nThis trial will follow a phase II single arm, open label design. The study will enroll 45 patients evaluable for the primary endpoint of which will be change in QOL as measured by the EORTC's QLQ-C30 between Day 1 and Day 84 +\u002F- 7 days. Secondary outcomes including evaluation for development of confounding mental health conditions will be evaluated via serial HADS assessments. Concomitant radiographic assessment with PET\u002FCT, regardless of the doses of pembrolizumab received, will allow for evaluation of secondary efficacy outcomes, including disease response by RECIST 1.1 criteria.",[258],"2026-06-11",{"date":543,"type":47},"2026-06-15",{"date":545,"type":47},"2023-12-05",{"date":547,"type":22},"2027-05",{"name":549,"class":369},"Icahn School of Medicine at Mount Sinai",{"id":551,"slug":552,"hasResults":12,"nctId":553,"briefTitle":554,"officialTitle":555,"acronym":4,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":23,"phases":558,"briefSummary":559,"conditions":560,"keywords":570,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":403},"100632708","phase-1-dose-determining-study-of-exs74539-rec-4539-in-participants-with-select-solid-tumors-100632708","NCT07517198","Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors","A Phase 1, Multicenter, Open-Label, Dose-Escalation Study to Assess Safety, Tolerability, and Efficacy of EXS74539 as Monotherapy in Participants With Select Solid Tumors","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of the following solid tumors:\n\n  * SCLC\n  * High grade neuroendocrine or small cell carcinomas of non-lung origin\n  * Non-small cell lung cancer \\[NSCLC\\]\n  * Prostate cancer\n  * Ovarian cancer\n  * Renal carcinoma \\[clear and non-clear cell\\]\n  * Head and neck squamous cell carcinoma\n  * Hepatic cancer\n  * Gastric cancer\n  * Triple-negative breast cancer \\[TNBC\\]\n* Participant disease should have progressed, relapsed or the participants should have been intolerant to at least one prior standard systemic therapy for their respective underlying malignancy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression due to disease. Participants with brain metastases must be clinically stable and off corticosteroids and anticonvulsants for ≥1 month prior to study treatment and not require any specific intervention for brain metastases.\n* Active and clinically significant infection requiring systemic antibacterial, antiviral, or antifungal therapy \\\u003C7 days of the first scheduled dose of the study treatment.\n* Significant cardiac abnormalities.\n* Major surgery within 28 days prior to the start of study treatment.\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",{"count":284,"type":22},[25],"The primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.",[490,561,562,563,29,564,565,566,492,567,568,569],"Small Cell Lung Cancer (SCLC)","High Grade Neuroendocrine Cancer","Small Cell Carcinomas of Non-lung Origin","Prostate Cancer","Ovarian Cancer","Renal Carcinoma (Clear and Non-clear Cell)","Hepatic Cancer","Gastric Cancer","Triple-negative Breast Cancer (TNBC)",[571,561,572,573,85,574,575,576,577,578,579,580,581,582,583],"Solid Tumors","High grade neuroendocrine cancer","Small cell carcinomas of non-lung origin","Prostate cancer","Ovarian cancer","Renal carcinoma (clear and non-clear cell)","Head and neck squamous cell carcinoma (HNSCC)","Hepatic cancer","Gastric cancer","Triple-negative breast cancer (TNBC)","LSD1 inhibitor","EXS74539","REC-4539","2026-06-09",{"date":586,"type":47},"2026-06-10",{"date":588,"type":47},"2026-04-13",{"date":590,"type":22},"2029-03",{"name":592,"class":100},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":601,"targetDuration":4,"studyType":23,"phases":603,"briefSummary":604,"conditions":605,"keywords":611,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100518120","phase-1-ko-2806-monotherapy-and-combination-therapies-in-advanced-solid-tumors-100518120","NCT06026410","KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors","Phase 1, First-in-Human, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of KO-2806 When Administered as Monotherapy and in Combination Therapy in Adult Patients With Advanced Solid Tumors","FIT-001","Inclusion Criteria:\n\n* At least 18 years of age.\n* Histologically or cytologically confirmed advanced solid tumors\n\n  * Arm #1 (KO-2806 monotherapy): Patients who have progressed on, or are refractory to, standard of care (SOC) treatments with advanced solid tumors, specifically: HRAS-mutant and\u002For amplified tumors (any solid tumor type); HRAS overexpression (only for HNSCC tumors); KRAS and\u002For NRAS, and\u002For HRAS-mutant and\u002For amplified NSCLC or CRC; KRAS-mutant and\u002For amplified PDAC\n  * Arm #2 (Combination): Patients who have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic RCC with predominantly clear cell subtype; non-clear cell RCC patients who are either treatment-naïve or have received any prior systemic treatment for locally advanced and metastatic RCC.\n  * Arm #3 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC, CRC, or PDAC.\n  * Arm #4 (Combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #5 (Cabozantinib monotherapy): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #6 (Cabozantinib rollover to combination): Patients must be cabozantinib-naïve and have received at least 1 prior systemic therapy with IO-based treatment for locally advanced or metastatic ccRCC, but no more than 3 prior systemic anticancer therapies.\n  * Arm #7 (Combination): Patients who have received at least 1 prior systemic therapy including available approved SOC treatments for KRAS G12C-mutant locally advanced or metastatic NSCLC\n* Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Karnofsky Performance Status of 70 or higher with no clinically significant deterioration over the previous 2 weeks.\n* Acceptable liver, renal, endocrine, and hematologic function.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Any use of anticancer therapy within 14 days or 5 half-lives (whichever is shorter) of Cycle 1 Day 1.\n* Prior treatment with an FTI or HRAS inhibitor.\n* Major surgery, other than local procedures, within 28 days prior to Cycle 1 Day 1, without complete recovery.\n* Spinal cord compression, leptomeningeal disease, or clinically active CNS metastases.\n* Toxicity (excluding alopecia) from prior therapy that has not been completely resolved to baseline at the time of consent.\n* Active or prior documented autoimmune or inflammatory disorders within the past 5 years prior to Cycle 1 Day 1 (with exceptions).\n* Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.\n* Inability to swallow, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the trial drugs.\n* Inadequate cardiac and\u002For vascular function, including receipt of treatment for unstable angina, myocardial infarction, and\u002For cerebrovascular attack within the prior 6 months, mean QTcF ≥470 ms, or Class II or greater congestive heart failure.\n* Other invasive malignancy within 2 years.\n* Other protocol-defined exclusion criteria may apply.",{"count":602,"type":22},300,[25],"This first-in-human (FIH) dose-escalation and dose-validation\u002Fexpansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.",[606,607,167,608,493,609,610],"Solid Tumors With HRAS Alterations","Non Small Cell Lung Cancer (NSCLC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Renal Cell Carcinoma (Kidney Cancer)","Non Clear Cell Renal Cell Carcinoma (nccRCC)",[175,174,173,612,613,614,615,166,616,617,618,168],"Farnesyltransferase inhibitor (FTI)","Tyrosine Kinase inhibitor (TKI)","Phase 1","KRAS G12C inhibitor","ccRCC","RCC","PDAC","2026-06-04",{"date":621,"type":47},"2026-06-08",{"date":623,"type":47},"2023-10-18",{"date":625,"type":22},"2027-04",{"name":627,"class":100},"Kura Oncology, Inc.",38,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":377,"enrollmentInfo":636,"targetDuration":4,"studyType":23,"phases":637,"briefSummary":638,"conditions":639,"keywords":640,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":660},"100509970","phase-3-a-study-evaluating-sotorasib-platinum-doublet-combination-versus-pembrolizumab-platinum-doublet-combination-as-a-front-line-therapy-in-participants-with-stage-iv-or-advanced-stage-iiibc-nonsquamous-non-small-cell-lung-cancers-codebreak-202-100509970","NCT05920356","A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)","A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB\u002FC Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\n* No history of systemic anticancer therapy in metastatic\u002Fnon-curable settings\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy\n* Symptomatic (treated or untreated) brain metastases\n* Gastrointestinal (GI) tract disease causing the inability to take oral medication\n* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina\n* Prior therapy with a KRAS G12C inhibitor",{"count":254,"type":22},[81],"The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.",[258],[641,319,642,643,644,265,645,646,647,166,648,649,650,651],"Oncology","PD-L1","KRAS p.G12C","Sotorasib","Carboplatin","Pemetrexed","CodeBreaK 202","PD-L1 Negative","AMG 510","LUMAKRAS ®","LUMYKRAS ®","2026-06-03",{"date":619,"type":47},{"date":655,"type":47},"2023-11-16",{"date":657,"type":22},"2032-06-29",{"name":659,"class":100},"Amgen",383,{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":673,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":689},"100519207","phase-1-study-of-rmc-9805-in-participants-with-kras-g12d-mutant-solid-tumors-100519207","NCT06040541","Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors","Inclusion Criteria:\n\n* Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage\n* ECOG performance status 0 or 1\n* Adequate organ function\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Known or suspected leptomeningeal or active brain metastases or spinal cord compression\n* Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication\n* Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":669,"type":22},604,[25],"This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.",[29,167,608,164],[674,166,168,618,170,319,171,675,426,676,677,678,679,680,174,681],"KRAS G12D (ON)","Colon Cancer","Metastatic Cancer","Pancreatic Ductal Adenocarcinoma","Pancreatic Neoplasms","Colorectal Neoplasms","Gastrointestinal Neoplasms","Colonic Neoplasms","2026-06-02",{"date":652,"type":47},{"date":685,"type":47},"2023-09-07",{"date":687,"type":22},"2027-04-30",{"name":184,"class":100},17,{"id":691,"slug":692,"hasResults":12,"nctId":693,"briefTitle":694,"officialTitle":695,"acronym":696,"eligibilityCriteria":697,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":23,"phases":700,"briefSummary":701,"conditions":702,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":703,"lastUpdatePostDateStruct":704,"startDateStruct":705,"completionDateStruct":706,"leadSponsor":708,"locationsCount":710},"100615097","phase-2-study-to-assess-the-efficacy-and-safety-of-rina-s-in-participants-with-non-small-cell-lung-cancer-100615097","NCT07288177","Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer","A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer","RAINFOL-05","Key Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.\n* Participant must have radiological disease progression while on or after receiving the most recent regimen.\n* Participants either may have actionable genetic alterations (AGAs) or no AGAs.\n* Participant has measurable disease according to RECIST v1.1.\n* Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.\n\nKey Exclusion Criteria (all study cohorts):\n\n* Participant has NSCLC with histology other than adenocarcinoma\n* Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.\n* Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and\u002For surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.\n\nNote: Other protocol-defined Inclusion and Exclusion criteria may apply.",{"count":699,"type":22},240,[26],"This Phase 2 study will be conducted in different countries around the world with up to about 240 participants.\n\nThe purpose of this study is to evaluate how well Rina-S works against lung cancer.\n\nThe treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo.\n\nThe treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.\n\nParticipation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging\u002FX-rays) to monitor whether the study treatment is safe and effective.",[29],"2026-06-01",{"date":682,"type":47},{"date":180,"type":47},{"date":707,"type":22},"2028-11-22",{"name":709,"class":100},"Genmab",22,{"id":712,"slug":713,"hasResults":12,"nctId":714,"briefTitle":715,"officialTitle":716,"acronym":4,"eligibilityCriteria":717,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":718,"targetDuration":4,"studyType":23,"phases":720,"briefSummary":721,"conditions":722,"keywords":4,"overallStatus":361,"whyStopped":4,"lastUpdateSubmitDate":723,"lastUpdatePostDateStruct":724,"startDateStruct":725,"completionDateStruct":727,"leadSponsor":729,"locationsCount":55},"100637602","phase-1-study-of-lt-010391-in-participants-with-kras-g12d-mutant-solid-tumors-100637602","NCT07624214","Study of LT-010391 in Participants With KRAS G12D-Mutant Solid Tumors","A Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of LT-010391 Tablets in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation","Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced solid tumors harboring a KRAS G12D mutation;\n* Failed standard therapy, intolerant to standard therapy, or no standard therapy is available;\n* ECOG Performance Status of 0 or 1;\n* Adequate organ function\n\nExclusion Criteria:\n\n* History of ≥2 primary malignancies within 5 years prior to signing informed consent, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other malignancies considered cured;\n* Primary central nervous system (CNS) tumors\n* leptomeningeal metastases, brainstem metastases, or spinal cord compression confirmed by imaging (regardless of symptoms) Other inclusion\u002Fexclusion criteria may apply.",{"count":719,"type":22},198,[25],"This study is to evaluate the safety and tolerability of of LT-010391 as monotherapy in participants with KRAS G12D mutant advanced solid tumors",[29,167,608,164],"2026-05-31",{"date":652,"type":47},{"date":726,"type":22},"2026-07",{"date":728,"type":22},"2029-04",{"name":730,"class":100},"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.",{"id":732,"slug":733,"hasResults":12,"nctId":734,"briefTitle":735,"officialTitle":736,"acronym":4,"eligibilityCriteria":737,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":738,"targetDuration":4,"studyType":23,"phases":740,"briefSummary":741,"conditions":742,"keywords":745,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":746,"lastUpdatePostDateStruct":747,"startDateStruct":748,"completionDateStruct":750,"leadSponsor":752,"locationsCount":151},"100619816","phase-1-study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-solid-tumors-100619816","NCT07349537","Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Phase 1\u002F1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy.\n* Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage.\n* Measurable per RECIST v1.1\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Primary central nervous system (CNS) tumors\n* Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and\u002For inhibitors).\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to receiving study drug(s).\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.",{"count":739,"type":22},574,[25],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.",[29,167,743,608,618,168,166,426,744,164],"Pancreatic Adenocarcinoma","Lung Cancer (NSCLC)",[164,426,677,618,171,168,319,170,166,172,174,176],"2026-05-28",{"date":703,"type":47},{"date":749,"type":47},"2026-01-08",{"date":751,"type":22},"2028-10",{"name":184,"class":100}]