[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-non-small-cell-lung-cancer":42},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,89,115,140,160,187,216,246,260,284,304,326,353,408,429,457,489,514,536,556,577,602,623,642,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100607241","phase-3-study-to-evaluate-efficacy-and-safety-of-firmonertinib-compared-with-investigators-choice-of-egfr-inhibitor-as-first-line-treatment-in-participants-who-have-locally-advanced-or-metastatic-nsclc-with-egfr-p-loop-and-alpha-c-helix-compressing-pacc-uncommon-mutations-100607241",false,"NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.","ALL","18 Years",{"count":20,"type":21},480,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[27,28,29,30,31,32],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","NSCLC","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","Lung neoplasms","EGFR","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","RECRUITING","2026-07-01",{"date":79,"type":80},"2026-07-02","ACTUAL",{"date":82,"type":80},"2025-12-17",{"date":84,"type":21},"2030-12",{"name":86,"class":87},"ArriVent BioPharma, Inc.","INDUSTRY",78,{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100446879","phase-1-first-in-human-study-of-bay2927088-in-participants-who-have-advanced-non-small-cell-lung-cancer-nsclc-with-mutations-in-the-genes-of-epidermal-growth-factor-receptor-egfr-andor-human-epidermal-growth-factor-receptor-2-her2-100446879","NCT05099172","First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and\u002For Human Epidermal Growth Factor Receptor 2 (HER2)","An Open Label, First-in-human Study of BAY 2927088 in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) Harboring an EGFR and\u002For HER2 Mutation","Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced NSCLC, not suitable for definitive therapy or recurrent or metastatic NSCLC at screening (small cell or mixed histologies are excluded).\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease. Participants who do not have standard of care access due to any reason, are intolerant to, or are not eligible for standard treatments, may also be eligible.\n\nNote: Except for participants eligible for Group F and Group H (Expansion or Extension) who should have received no prior systemic treatment for locally advanced or metastatic disease.\n\n* Adequate archival tumor tissue (ideally taken after last targeted treatment and not older than 6 months) has to be available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant.\n* Measurable disease by RECIST v1.1 with at least one lesion not chosen for biopsy during the screening period (if a biopsy is taken during screening) that can be accurately measured at baseline with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements. A biopsied lesion should not be used as a target lesion for RECIST 1.1 tumor assessments (or, for participants in Expansion Group G and Group H, for RANO-BM tumor assessments). Previously irradiated lesions must have shown progression to be considered measurable.\n* Documented activating EGFR and\u002For HER2 mutation assessed by a Clinical Laboratory Improvement Amendments (CLIA)-certified (United States \\[US\\] sites) or an equally accredited (outside of the US) local laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Minimum life expectancy of 12 weeks.\n* Adequate bone marrow function as assessed by the following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Hemoglobin ≥ 9.0 g\u002FdL. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within 2 weeks prior to testing.\n  2. Platelets ≥ 100 × 10\\^9 cells\u002FL.\n  3. Absolute neutrophil count ≥ 1.5 ×10\\^9 cells\u002FL. Criteria must be met without the use of hematopoietic growth factors (e.g., G-CSF) within 2 weeks prior to testing.\n* Adequate kidney function as assessed by following laboratory test to be conducted within 7 days before the first dose of study treatment:\n\n  a. Estimated glomerular filtration rate (eGFR) \\> 50 mL\u002Fmin per 1.73 m\\^2 according to the Modification of Diet in renal Disease Study Group (MDRD) formula.\n* Adequate liver function as assessed by following laboratory tests to be conducted within 7 days before the first dose of study treatment:\n\n  1. Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN for participants with documented Gilbert-Meulengracht Syndrome, or for participants with hyperbilirubinemia considered due to liver metastasis).\n  2. Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor).\n\nExclusion Criteria:\n\n* Treatment with an EGFR tyrosine kinase inhibitor (TKI) ≤ 8 days or 5x the terminal phase, elimination half-lives, whichever is shorter, prior to the first dose of study drug.\n* Treatment with a systemic anti-cancer treatment (excluding EGFR TKIs as described above) ≤ 14 days prior to the first dose of study drug.\n* Radiation therapy, stereotactic radiosurgery (SRS) and palliative radiation ≤ 14 days prior to the first dose of study drug.\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of study drug.\n* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Participants with chronic, but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.\n* Any history of primary brain or leptomeningeal disease (symptomatic or asymptomatic), presence of symptomatic central nervous system (CNS) metastases, or CNS metastases that require local treatment (such as radiotherapy or surgery).\n* History of spinal cord compression or brain metastases with the following exceptions:\n\n  1. Participants with treated brain metastases that are asymptomatic at screening and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for at least 7 days prior to first dose of sevabertinib are eligible to enroll in Dose Escalation and Backfill.\n  2. Participants with treated brain metastases that are asymptomatic at screening are eligible in Dose Expansion\u002FExtension (with the exception of Group G and Group H) if all of the following criteria are met:\n\n     * there is no evidence of progression (new or enlarging brain metastases) 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     * Participants must be off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent) for 7 days prior to first dose of sevabertinib.\n  3. Participants with history of spinal cord compression \\>3 months from definitive therapy and stable by imaging (MRI or CT) during the screening period and clinically asymptomatic.\n  4. Expansion Group G and Group H: Participants with active (new or progressing) clinically stable brain metastases who do not require immediate CNS-directed treatment as per Investigator's judgement and who are off or receiving low-dose corticosteroids (≤10 mg prednisone or equivalent such as ≤ 1.5 mg\u002Fday dexamethasone) in the 7 days prior to first dose of sevabertinib are eligible.\n* History of congestive heart failure (CHF) Class \\>II according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment (e.g. ventricular arrhythmias, atrial fibrillation) or any clinically important abnormalities in rhythm, conduction or morphology or resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 msec).\n* Participants with:\n\n  1. Known human immunodeficiency virus (HIV), except as noted below: Participants with history of HIV infection are eligible at the Investigator's discretion provided that: • CD4+ T-cell (CD4+) counts are ≥ 350 cells\u002FuL • The participant has been on established antiretroviral therapy (ART) for at least 4 weeks prior to the start of study drug and has an HIV viral load less than 400 copies\u002FmL prior to start of the study treatment • The ART being used does not contain strong inducers or inhibitors of CYP3A4, and is not anticipated to cause overlapping toxicities with study drug • The participant has not had an opportunistic infection within the past 12 months\n  2. Active Hepatitis B infection (positive for Hepatitis B surface antigen \\[HbsAg\\]) and Hepatitis B virus \\[HBV\\] DNA).\n  3. Active Hepatitis C infection (positive anti-HCV Antibody and quantitative HCV RNA results greater than the lower limits of detection of the assay).\n\n     NOTE: Participants with history of chronic HBV or HCV infection are eligible at the Investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.\n* Use of strong CYP3A4 inhibitors and inducers from 14 days prior to first administration of study drug.",{"count":97,"type":21},400,[99,100],"PHASE1","PHASE2","Researchers are looking for a better way to treat people who have advanced non-small cell lung cancer (NSCLC), a group of lung cancers that have spread to nearby tissues or to other parts of the body.\n\nEpidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) are proteins that help cells to grow and divide. A damage (also called mutation) to the building plans (genes) for these proteins in cancer cells leads to a production of abnormal EGFR and\u002For HER2. These abnormal proteins drive the growth and the spread of the cancer. Several EGFR and\u002For HER2 mutations exist in the cancer cells. The study treatment, sevabertinib (BAY2927088), is expected to block the mutated EGFR and HER2 proteins which may stop the spread of NSCLC.\n\nThe main purpose of this study is to learn:\n\nEscalation, Backfill, and Expansion Part:\n\n* How safe is BAY2927088 for the participants?\n* What is the highest dose of BAY2927088 that can be tolerated (maximum tolerated dose) by or given to (maximum administered dose) the participants?\n* How does BAY2927088 move into, through, and out of the bodies of the participants?\n\nFor this, the researchers will measure the followings:\n\n* The number of participants with medical problems, also called adverse events and serious adverse events, and their severity\n* The number of participants who discontinue study treatment due to an adverse event.\n* The highest dose of BAY2927088 that the participants can take without having adverse events (maximum tolerated dose (MTD)) or the maximum dose that is tested and found to be safe for the participants in case MTD cannot be found out (maximum administered dose (MAD)) of BAY2927088\n* Number of participants experiencing adverse events that prevent an increase in the dose of BAY2927088 (dose-limiting toxicities (DLTs)) at each dose level\n* The (average) total level of BAY2927088 in the blood (also called AUC) after receiving single or multiple doses of BAY2927088\n* The (average) highest level of BAY2927088 in the blood (also called Cmax) after receiving a single or multiple doses of BAY2927088 Extension Part\n* How well does BAY2927088 work in participants?\n\nFor this, the researchers will measure the following:\n\n• Percentage of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)). This will be assessed by doctors other than the study doctor.\n\nThis study has 4 parts:\n\n* The escalation part aims to find the maximum daily amount (dose) of BAY2927088 that participants can receive.\n* The backfill part aims to test the doses of BAY2927088 that are considered safe in the escalation part by giving it to more participants. This will help find optimal doses of BAY2927088 that work well and are safe to be tested in the next part.\n* The expansion part aims to determine the dose of BAY2927088 to be tested in further studies.\n* The extension part aims to determine whether the selected dose of BAY2927088 from the expansion part works well.\n\nThe participants in this study will take the study treatment BAY2927088 in 3-week periods called \"cycles\". They will in general take BAY2927088 once or twice daily as a liquid\u002Ftablet by mouth until their cancer gets worse, they have medical problems, they leave the study, or the study is terminated. Participants will have no more than 5 visits per cycle.\n\nDuring the study, the study team will:\n\n* take blood and urine samples,\n* check the status of the cancer by doing computed tomography (CT) or magnetic resonance imaging (MRI) scans,\n* check the participants' overall health and heart health,\n* ask the participants questions about how they are feeling and what adverse events they are having.\n\nAn adverse event is considered \"serious\" when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important.",[103,104,105],"Advanced Non-small Cell Lung Cancer","EGFR Mutation","HER2 Mutation","2026-06-30",{"date":77,"type":80},{"date":109,"type":80},"2021-10-25",{"date":111,"type":21},"2029-06-29",{"name":113,"class":87},"Bayer",94,{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":139},"100644063","characterization-of-multi-omics-landscapes-and-ai-pathological-prediction-model-for-long-term-survival-in-nsclc-immunotherapy-100644063","NCT07668037","Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy","Characterization of Multi-Omics Landscapes in Long-Term Survival Following Immunotherapy and Development of an AI Pathological Prediction Model for Long-Term Survival Based on H&E-Stained Images in Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed advanced or locally advanced non-small cell lung cancer (NSCLC).\n* Patients derived from real-world data of multiple centers (including Cancer Hospital, Chinese Academy of Medical Sciences; Cancer Hospital of Shanxi, Chinese Academy of Medical Sciences \\[Shanxi Cancer Hospital\\]; and other participating centers) or from completed phase III clinical trials (e.g., Choice-01, Rationale-307, Rationale-304).\n* Patients who received first-line or later-line immune checkpoint inhibitor (ICI) monotherapy or ICI-based combination therapy.\n* Patients with complete clinical information and available follow-up data.\n\nExclusion Criteria:\n\n* Patients whose systemic therapy did not include an immunotherapy regimen.\n* Patients lost to follow-up.",{"count":123,"type":21},600,"OBSERVATIONAL","This study is a retrospective, multicenter, observational cohort study in patients with advanced or locally advanced non-small cell lung cancer (NSCLC). The aim of this study was to establish a long-term survival (LTS) versus short-term survival (STS) real-world cohort, to systematically characterize the multi-omics landscapes, and to develop and validate an artificial intelligence (AI) pathological prediction model based on routine H\\&E-stained images for predicting immune microenvironment features and long-term survival outcomes following immunotherapy.",[127,128,42],"Non-Small Cell Carcinoma of Lung","Immunotherapy","2026-06-22",{"date":131,"type":80},"2026-06-25",{"date":133,"type":80},"2026-05-01",{"date":135,"type":21},"2030-05-01",{"name":137,"class":138},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",1,{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":139},"100641634","a-study-to-investigate-treatment-patterns-and-effectiveness-of-tislelizumab-in-european-patients-with-resectable-or-advanced-non-small-cell-lung-cancer-nsclc-and-small-cell-lung-cancer-sclc-100641634","NCT07652736","A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC)","A Real-World Evaluation of Tislelizumab Treatment Patterns and Effectiveness in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer and Small Cell Lung Cancer","TITANS","Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if they meet all the following criteria:\n\n  1. Participants or their legal representative must sign written inform consent form (ICF)\n  2. Participants receive tislelizumab as part of routine clinical practice as determined by the treating physician per standard of care and in accordance with the SmPC, within the approved indications in the 4 cohorts described.\n\nNote: The decision to treat the patient with a tislelizumab-based regimen, as per its authorized indication, must have been made by the treating physician prior to and independent of the patient's consideration for participation in this study.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if they meet any of the following criteria:\n\n  1. Participants who are unable to understand all implications of study participation.\n  2. Participants who have contraindications for treatment with tislelizumab in the investigator's opinion or have any contraindication as listed in the SmPC of tislelizumab.\n  3. Participants who are deemed ineligible according to the investigator's opinion and the SmPC of tislelizumab.",{"count":149,"type":21},440,"The purpose of this study is to collect real-world data on treatment patterns and clinical outcomes in European patients receiving tislelizumab in routine clinical practice",[42,152],"Extensive-Stage Small Cell Lung Cancer",{"date":131,"type":80},{"date":155,"type":80},"2026-06-05",{"date":157,"type":21},"2030-11-17",{"name":159,"class":87},"BeOne Medicines",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":168,"type":21},626,[100,24],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[42,41],[173,174,43,41,175,176,177],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":179,"type":80},"2026-06-08",{"date":181,"type":80},"2020-12-02",{"date":183,"type":21},"2032-06-09",{"name":185,"class":87},"Mirati Therapeutics Inc.",770,{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":194,"enrollmentInfo":195,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":204,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":139},"100219375","phase-2-t-cell-receptor-immunotherapy-for-patients-with-metastatic-non-small-cell-lung-cancer-100219375","NCT02133196","T Cell Receptor Immunotherapy for Patients With Metastatic Non-Small Cell Lung Cancer","A Phase II Study Using Autologous Young Tumor-Infiltrating Lymphocytes Derived From Patients With Non-Small Cell Lung Cancer Following Non-Myeloablative Lymphocyte Depleting Preparative Regimen","* INCLUSION CRITERIA:\n\n  1. Measurable metastatic (stage IV) or unresectable non-small cell lung cancer (including but not limited to squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinomas) with at least one lesion that is resectable for TIL generation. (Note: neuroendocrine tumors are not eligible.)\n  2. Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n  3. All patients must have had at least one appropriate first line systemic therapy and progressed.\n  4. Clinical performance status of ECOG 0 or 1.\n  5. Age \\>= 18 years of age and \\\u003C= 72 years of age.\n  6. Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and for 12 months after the last dose of combined chemotherapy for individuals of childbearing potential (IOCBP) and for four months after treatment for individuals able to father a child.\n  7. Willing to sign a durable power of attorney\n  8. Able to understand and sign the Informed Consent Document\n\nI. Hematology:\n\n* Absolute neutrophil count \\> 1000\u002Fmm\\^3 without support of filgrastim\n* Normal WBC (\\>= 2500\u002Fmm\\^3).\n* Hemoglobin \\> 8.0 g\u002Fdl. Subjects may be transfused to reach this cut-off.\n* Platelet count \\>= 80,000\u002Fmm\\^3\n\n  j. Serology:\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\n  k. Chemistry:\n* Serum ALT\u002FAST \\\u003C= 2.5 times the upper limit of normal.\n* Serum creatinine \\\u003C= 1.6 mg\u002Fdl.\n* Total bilirubin \\\u003C= 2 mg\u002Fdl, except in patients with Gilbert's Syndrome, who must have a total bilirubin \\\u003C= 3 mg\u002Fdl.\n\n  l. IOCBP must have a negative pregnancy test or evidence that they are not pregnant (e.g., ultrasound or serial HCG measurements) prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\n  m. Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or local radiotherapy within the past 4 weeks, as long as related major organ toxicities have recovered to grade 1 or less.\n\nn. More than two weeks must have elapsed since any prior palliation for major bronchial occlusion or bleeding at the time the patient receives the preparative regimen, and patient's toxicities must have recovered to a grade 1 or less.\n\no. Subjects must be co-enrolled in protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are nursing because of the potentially dangerous effects of the treatment on the infant.\n2. Ongoing need for pharmacological immunosuppression, including steroids\n3. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other active or uncompensated major medical illnesses\n4. Major bronchial occlusion or bleeding not amenable to palliation.\n5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency\n\n   Disease and AIDS).\n6. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n7. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n8. For select patients with a clinical history prompting cardiac evaluation: last known LVEF \\\u003C= 45%.\n9. For select patients with a clinical history prompting pulmonary evaluation: known FEV1 \\\u003C= 50%\n10. Any of the following will exclude patients from the high-dose aldesleukin arm, but may be eligible for the low-dose aldesleukin arm:\n\n    * Greater than 2 invasive thoracic procedures\n    * Poor exercise tolerance\n    * Greater than 66 years of age\n    * Clinically significant patient history which in the judgment of the Principal Investigator would compromise the patient s ability to tolerate high-dose.\n11. Patients who are receiving any other investigational agents.","72 Years",{"count":196,"type":21},85,[100],"Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 100 patients. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause non-small cell lung cancer (NSCLC) tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with NSCLC who have a tumor that can be safely removed.\n\nDesign:\n\n* Work up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed\n* Surgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n* Leukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.}\n* Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.",[42,200,201,202,203],"Squamous Cell Carcinoma","Advanced NSCLC","Adenosquamous Carcinoma","Adenocarcinoma",[205,206,43,207],"Metastatic","Non-Small Cell Lung Cancer","Lung Cancer",{"date":179,"type":80},{"date":210,"type":80},"2014-10-23",{"date":212,"type":21},"2027-10-23",{"name":214,"class":215},"National Cancer Institute (NCI)","NIH",{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":231,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":245},"100610052","phase-3-symbiotic-lung-01--a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100610052","NCT07222566","Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Expected survival ≥12 weeks\n\nExclusion Criteria:\n\n* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C 1 cm are permitted.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Previous systemic anti-tumor therapy including:\n\n  1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n  2. Previous treatment with immunotherapy\n  3. Prior radiotherapy \\> 30 Gy to the lung \\\u003C 6 months of first dose of study intervention\n  4. Palliative local therapy \\\u003C 2 weeks before the first dose of study intervention;\n  5. Non-specific immunomodulatory therapy \\\u003C 2 weeks before the first dose.\n  6. Prior systemic anti-angiogenic therapy\n* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n* Prior and concomitant therapy:\n\n  1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \\\u003C 10 days to the first dose.\n  2. chronic antiplatelet therapy \\\u003C7 days to randomization.\n  3. live or attenuated live vaccine \\\u003C 4 weeks to the first dose.\n  4. current high-dose systemic corticosteroids.\n  5. prohibited concomitant medication(s) \\\u003C 21 days to the first dose.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":224,"type":21},1410,[24],"This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.\n* Is not a candidate for complete surgical resection or curative chemoradiotherapy.\n* Do not have known actionable genomic alterations\n* Be treatment naïve for advanced or metastatic disease\n\nParticipants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.\n\nEach participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:\n\n* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.\n* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.\n\nParticipants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.\n\nThe study will include regular visits for:\n\n* Treatment and health checks: while participant continues receiving treatment.\n* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.",[42,206,228,229,230,207],"Carcinoma, Non-Small-Cell Lung","Carcinoma, Non-Small-Cell Lung (NSCLC)","Metastatic Non Small Cell Lung Cancer",[232,233,234,235],"non-squamous NSCLC","squamous NSCLC","metastatic (Stage IV) squamous or non-squamous NSCLC","Advanced or Metastatic Non-Small Cell Lung Cancer","2026-06-03",{"date":238,"type":80},"2026-06-04",{"date":240,"type":80},"2026-01-06",{"date":242,"type":21},"2032-08-26",{"name":244,"class":87},"Pfizer",346,{"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":4,"targetDuration":4,"studyType":253,"phases":4,"briefSummary":254,"conditions":255,"keywords":4,"overallStatus":257,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":258,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":259,"locationsCount":4},"100574645","expanded-access-to-provide-sevabertinib-bay-2927088-for-the-treatment-of-locally-advanced-or-metastatic-nsclc-with-her2-mutation-100574645","NCT06761976","Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation","An Expanded Access Program to Provide Oral Sevabertinib (BAY 2927088) in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring an HER2 (Human Epidermal Growth Factor Receptor 2) Activating Mutation","Inclusion Criteria\n\n* Signed and dated written informed consent\n* Age ≥18 years\n* Histologically or cytologically confirmed locally advanced or metastatic NSCLC\n* Documented disease progression after treatment with at least one prior systemic therapy for advanced disease\n* Documented HER2 activating mutation\n* Expected minimum life expectancy of 12 weeks\n* Performance status of 0 or 1\n* Participants must be able to take oral medication\n* Blood test results within certain ranges\n* Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment\n* Adequate cardiac function\n* Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose\n* Ability to receive prescription of loperamide from the treating physician\n\nExclusion Criteria\n\n* Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy\n* Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2\n* Symptomatic or unstable brain metastases\n* Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP\n* Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease\n* Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation\n* Any uncontrolled intercurrent illness or condition including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, ongoing or active infection (including active clinical tuberculosis), renal transplant or psychiatric illness\u002Fsocial situations that would limit compliance\n* Pregnancy or lactation\n* History of clinically significant cardiac disease","EXPANDED_ACCESS","The purpose of this Expanded Access Program (EAP) is to provide access to sevabertinib, for participants previously treated with locally advanced or metastatic non-small cell lung cancer (NSCLC) with mutations in the human epidermal growth factor receptor 2 (HER2) gene, which have no other therapeutic option.",[103,256],"Cancer","AVAILABLE",{"date":238,"type":80},{"name":113,"class":87},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":270,"conditions":271,"keywords":272,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100572295","phase-2-reduced-ct--anti-pd-1-as-first-line-tx-in-vulnerable-older-adults-wadv-50-pd-l1-non-small-cell-lung-cancer-nsclc-100572295","NCT06731413","Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w\u002FAdv \u003C50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)","Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS \u003C50% Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)\n* Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation\n* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.\n* Age 70 or meeting frailty definition or above at the date of signing informed consent\n* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)\n* PD-L1 tumor proportion score (TPS) of less than 50%\n* Eastern Cooperative Oncology Group (ECOG) PS of 0-3\n* Have measurable disease based on RECIST 1.1 as determined by the local site investigator\u002Fradiology assessment\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Hemoglobin (Hgb) ≥ 8.0 g\u002FdL (transfusion permitted)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) \u002Falanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with life expectancy of less than 3 months at the time of enrollment\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)\n* Diagnosis of interstitial lung disease\n* Creatinine clearance of \\\u003C30 mL\u002Fmin\n* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible\n* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:\n\n  * Doses less than or equal to the equivalent of prednisone 10 mg daily\n  * Short courses of steroids that are discontinued prior to enrollment\n  * Inhaled, intranasal and\u002For topical steroids\n  * Dexamethasone taper for treating vasogenic edema associated with CNS disease",{"count":268,"type":21},40,[100],"Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent\u002Fmetastatic PD-L1 TPS\\\u003C50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.",[206,43,42,230],[273],"Non-Small Cell Lung Cancer, NSCLC","2026-05-29",{"date":276,"type":80},"2026-06-02",{"date":278,"type":80},"2025-02-11",{"date":280,"type":21},"2033-07-30",{"name":282,"class":138},"Virginia Commonwealth University",2,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":139},"100624851","phase-2-lorlatinib-plus-local-consolidation-therapy-in-alk-positive-advanced-non-small-cell-lung-cancer-100624851","NCT07415005","Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be included in this study:\n\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)\n2. Documented ALK re-arrangement as detected by: (1) FISH, (2) IHC, (3) tissue NGS, or (4) cfDNA NGS\n3. Subjects can be enrolled as (a) TKI naïve or (b) after\u002Fduring 12 weeks of first line lorlatinib treatment without disease progression or (c) ≤4 weeks of first line alectinib, brigatinib or ensartinib treatment without disease progression, those patients must be switched to lorlatinib.\n4. Candidate for local consolidation therapy in the opinion of the treating physician.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n6. Males or females ≥ 18 years. Because no dosing or adverse event data are currently available on the use of lorlatinib in combination with other agents in patients \\\u003C18 years of age, children are excluded from this study.\n7. Adequate organ function laboratory values, defined as:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL or at least 1000\u002Fmm3 .Platelet count at least 75,000\u002Fmm3 or at least 75 x 109\u002FL\n   2. Hemoglobin (Hb) at least 9 g\u002FdL (or 5.69 mmol\u002FL) at baseline\n   3. Serum creatinine ≤ 1.5 × ULN or ≥ 45mL\u002Fminute creatinine clearance for subjects with creatinine levels \\> 1.5 × the institutional ULN\n   4. Serum total bilirubin less than or equal to ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 × ULN\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN except for subjects with liver metastases for whom ALT and AST should be ≤ 5× ULN\n   6. International Normalized Ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants\n   7. Activated PTT (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy if PT or PTT is within therapeutic range of intended use of anticoagulant\n8. Female patients of childbearing potential must have a negative pregnancy test documented at time of screening.\n9. Female patients who:\n\n   1. Are postmenopausal for at least 1 year before the screening visit, OR\n   2. Are surgically sterile, OR\n   3. If they are of childbearing potential, agree to use a highly effective method of contraception from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse The effects of lorlatinib on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   \u003C!-- -->\n\n   1. Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   2. History of hysterectomy or bilateral salpingo-oophorectomy.\n   3. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   4. History of bilateral tubal ligation or another surgical sterilization procedure.\n   5. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide.\n\n   Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n10. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n    1. Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n    2. Agree to completely abstain from heterosexual intercourse\n    3. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of lorlatinib administration.\n11. Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of\n\n    ≤450 milliseconds (msec) in males or ≤470 msec in females.\n12. Voluntary agreement to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.\n13. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from this study:\n\n1. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated nonmelanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who have had at least 2 years elapsed since the completion of radical treatment and the adjuvant therapy, if any, of the other primary malignancy.\n2. Previously received any prior TKI, including ALK-targeted TKIs. Note: on-going first line alectinib, brigatinib, lorlatinib and ensartinib use as specified in the Inclusion criteria is allowed.\n3. Previously received more than 1 cycle of chemotherapy +\u002F-immunotherapy for locally advanced or metastatic disease.\n4. Symptomatic CNS metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted.\n5. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging).\n\n   Patients with leptomeningeal disease and without cord compression are allowed.\n6. The presence of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis at screening.\n7. Have a known or suspected hypersensitivity to lorlatinib or its excipients.\n8. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition that could affect oral absorption of the study drug.\n9. Have uncontrolled hypertension. Patients with hypertension as defined by current standard of practice should be under treatment on study entry to control blood pressure.\n10. Received radiation therapy within 14 days before randomization except for stereotactic radiosurgery (SRS) or stereotactic body radiation therapy.\n11. Had major surgery within 30 days of enrollment. Minor surgical procedures, such as catheter placement or minimally invasive biopsies, are allowed.\n12. Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to the following: a) Myocardial infarction within 6 months before enrollment. b) Unstable angina within 6 months before enrollment. c) New York Heart Association Class III or IV heart failure within 6 months before enrollment. d) History of clinically significant atrial arrhythmia (including clinically significant bradyarrhythmia), as determined by the treating physician. e) Any history of clinically significant ventricular arrhythmia.\n13. Had a cerebrovascular accident within 6 months before first dose of study drug.\n14. Have an ongoing or active infection, including the requirement for intravenous antibiotics.\n15. Subjects should not receive other anti-cancer agents (e.g., chemotherapy, immunotherapy, biologic therapy, and\u002For hormone therapy other than for replacement or appetite stimulant) while on treatment in this study.\n16. History of allergic reactions attributed to compounds of similar chemical or biologic composition to lorlatinib.\n17. Have a known history of human immunodeficiency virus (HIV) infection. Testing is not required in the absence of history.\n18. Pregnant women are excluded from this study because lorlatinib is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lorlatinib, breastfeeding should be discontinued if the mother is treated with lorlatinib. These potential risks may also apply to other agents used in this study -",{"count":291,"type":21},30,[100],"This is an open-label, multicenter, randomized phase 2 trial for patients with tyrosine kinase inhibitor-naïve ALKrearranged advanced NSCLC. Subjects are initially treated with lorlatinib for 12 weeks.",[42],"2026-04-29",{"date":297,"type":80},"2026-05-05",{"date":299,"type":80},"2026-04-24",{"date":301,"type":21},"2030-07-22",{"name":303,"class":138},"M.D. Anderson Cancer Center",{"id":305,"slug":306,"hasResults":12,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":312,"targetDuration":4,"studyType":22,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":283},"100476333","phase-1-a-trial-of-injectable-shr-a1811-in-combination-with-pyrotinib-or-shr-1316-in-subjects-with-advanced-non-small-cell-lung-cancer-100476333","NCT05482568","A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer","Phase IB\u002FII Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2","Inclusion Criteria:\n\n1. Ability to give informed consent, signed and dated IRB\u002FEC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements\n2. When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation\n3. The ECOG score is 0 or 1\n4. The expected survival is ≥12 weeks\n5. Subjects with advanced or metastatic non-small cell lung cancer\n6. Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided\n7. Subjects who have failed prior standard care or are intolerant to standard care\n8. There is at least one measurable lesion\n9. Vital organs are functioning well\n10. Heart function is good\n11. Agree to birth control\n\nExclusion Criteria:\n\n1. There are untreated or active central nervous system (CNS) tumor metastases\n2. Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration\n3. Systemic antitumor therapy was performed 4 weeks prior to study initiation\n4. Prior treatment with antibody-conjugated drugs\n5. Received \\>30 Gy chest radiation within 6 months prior to initial administration\n6. Palliative radiotherapy was completed within 7 days prior to initial administration\n7. Failure to recover from toxicity and\u002For complications of previous interventions to nCI-CTCAE ≤1\n8. The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected\n9. Received systemic immunosuppressant therapy within 14 days prior to the first study\n10. Subjects with known or suspected interstitial pneumonia\n11. In the first study, failure to swallow, chronic diarrhea, gastroenteritis, intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis, or other medical conditions or special conditions affecting drug administration and absorption occurred within 28 days prior to administration\n12. Presence of any active, known or suspected autoimmune disease\n13. Have poorly controlled or severe cardiovascular disease\n14. Previous or concurrent malignancy\n15. Subjects who developed a severe infection within 28 days prior to the first dose\n16. Active hepatitis B\n17. There were active tuberculosis patients within 1 year before enrollment\n18. There is a history of immunodeficiency\n19. Live attenuated vaccine was administered within 28 days prior to initial study administration or is expected to be administered during study treatment\n20. Subjects who are participating in another clinical study or who have had their first dose less than 4 weeks since the end of the previous clinical study (last dose) or 5 half-lives of the study drug, whichever is shorter\n21. Major surgery other than diagnosis or biopsy was performed within 28 days prior to initial administration\n22. People who are known to be allergic to sir-A1811, pyrrolitinib, or any of the components of SIR-1316\n23. History of severe allergic reactions to other monoclonal antibody\u002Ffusion protein drugs\n24. Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study\n25. Uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse and detention\n26. Any other conditions that, in the investigator's judgment, may increase the risk of study participation, interfere with study results, or make study participation unsuitable","75 Years",{"count":313,"type":21},324,[99,100],"This study was an open, multicenter, dose-increasing\u002Finvestigational Phase IB\u002FII clinical trial to evaluate the efficacy of SHR-A1811 in combination with other antitumor therapies in subjects with advanced non-small cell lung cancer with HER2 . It can be divided into two parts, Part A is the dose escalation and efficacy exploration study of SHR-A1811 combined with Pyrotinib, and Part B is the dose escalation and efficacy exploration study of SHR-A1811 combined with SHR-1316.",[103],"2026-04-17",{"date":319,"type":80},"2026-04-20",{"date":321,"type":80},"2022-09-15",{"date":323,"type":21},"2026-12",{"name":325,"class":87},"Jiangsu HengRui Medicine Co., Ltd.",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":333,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":139},"100499003","phase-1-study-of-aerosolized-antibiotics-and-pembrolizumab-in-advanced-non-small-cell-lung-cancer-100499003","NCT05777603","Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-small Cell Lung Cancer","Phase I Study of Aerosolized Antibiotics and Pembrolizumab in Advanced Non-Small Cell Lung Cancer","-INCLUSION CRITERIA:\n\n1. Histologically or cytologically non-small cell lung cancer confirmed by outside pathology report or via the Laboratory of Pathology, NCI.\n2. Have measurable disease, per RECIST 1.1, that is not amenable to surgery.\n3. PD-L1 Tumor Proportion Score (TPS) \\>=1% detected at any time since diagnosis, based on a pathology report from an outside hospital or Laboratory of Pathology, NCI. PD- L1 expression testing must be conducted using one of the FDA approved diagnostic devices listed here: https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fin-vitro-diagnostics\u002Flist- cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools.\n4. Patient s disease has progressed after FDA-approved frontline therapy for NSCLC.\n5. Age \\>=18 years.\n6. ECOG performance status \\\u003C=2.\n7. Must have adequate organ and marrow function as defined below:\n\n   * Leukocytes \\>=3,000\u002FmcL\n   * absolute neutrophil count \\>=1,500\u002FmcL\n   * platelets \\>=100,000\u002FmcL\n   * total bilirubin\\\u003CTAB\\>within normal institutional limits\n   * AST\u002FALT \\\u003C=2.5 X institutional upper limit of normal\n   * creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 (calculated based on CKD-EPI formula or directly measured) for participants with creatinine levels above institutional normal.\n8. Participants with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n9. Participants with new or progressive brain metastases (active brain metastases) are eligible if immediate CNS specific treatment is not required per standard of care and is unlikely to be required during the first cycle of therapy.\n10. Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within the 6 months before study treatment initiation are eligible for this trial.\n11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n13. Individuals of child-bearing potential (IOCBP) must agree to use effective contraception (e.g., hormonal intrauterine device \\[IUD\\], tubal ligation, partner has had prior vasectomy) beginning at study entry until 4 months after the completion of therapy. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the participant, is also acceptable.\n14. Breastfeeding participants must be willing to discontinue breastfeeding for the duration of study treatment.\n15. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Participants who are receiving any other investigational agents.\n2. Participants with ongoing Epstein-Barr virus or cytomegalovirus infection\n3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pembrolizumab, aztreonam, vancomycin and albuterol.\n4. Pregnancy (confirmed with beta-HCG serum or urine pregnancy test performed in individuals of childbearing potential at screening).\n5. Pulmonary function FEV1 (Forced Expiratory Volume in the first second) \\\u003C25% will be excluded based on the requirement of receiving aerosolized aztreonam.\n6. History of severe immune-related adverse events (irAEs), defined as any grade neurological or cardiac irAEs, any grade 3 or 4 irAE (except fully controlled endocrine irAEs with appropriate hormone supplementation), and any grade pneumonitis.\n7. Uncontrolled intercurrent illness that would limit compliance with study requirements.","120 Years",{"count":335,"type":21},23,[99],"Background:\n\nNon-small cell lung cancer (NSCLC) can be hard to treat and is often fatal. People with NSCLC commonly have changes in the bacteria that populate their lungs. These bacterial changes may aid tumor growth. Researchers want to find out if treating the bacteria, too, can help cancer treatment work better.\n\nObjective:\n\nTo test 2 inhaled antibiotics (aztreonam and vancomycin), combined with a standard cancer treatment, in people with NSCLC.\n\nEligibility:\n\nPeople aged 18 years and older with NSCLC that has returned or progressed after treatment and cannot be treated with surgery.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They may blow into a machine to test how well their lungs work. They will have imaging scans. They may need to have a small piece of tissue cut from their tumor (biopsy).\n\nParticipants will be treated in six 21-day cycles. They will visit the clinic to receive a drug for cancer treatment on the first day of each cycle. This drug will be administered through a tube attached to a needle inserted into a vein in the arm.\n\nThe 2 antibiotic drugs will be in the form of a fine mist that can be inhaled. Participants use a device to take these drugs at home. They will inhale aztreonam up to 3 times a day and vancomycin 1 or 2 times a day. They will take these drugs during only 3 of the treatment cycles.\n\nBiopsies and other tests will be repeated halfway through and after the study treatment.\n\nFollow-up visits will continue for 1 year after study treatment.",[339],"Advanced Non Small Cell Lung Cancer",[341,342,343,344],"Immune Checkpoint Inhibitor","lung microbiota","anti-PD1 antibody","inhaled antibiotic","2026-04-08",{"date":347,"type":80},"2026-04-09",{"date":349,"type":80},"2024-04-18",{"date":351,"type":21},"2028-06-01",{"name":214,"class":215},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":377,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":5},"100599900","phase-1-a-study-to-learn-about-the-study-medicine-called-pf-08046876-in-people-with-advanced-solid-tumors-100599900","NCT07090499","A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and\u002For signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol",{"count":361,"type":21},310,[99],"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules.",[365,366,367,42,368,369,370,371,372,373,374,375,376],"Advanced\u002FMetastatic Solid Tumors","Bladder Cancer","Urothelial Carcinoma","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer",[378,379,380,381,382,383,384,43,385,386,387,388,389,390,391,392,393,394,395,396,397,398,399],"B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6","2026-04-06",{"date":402,"type":80},"2026-04-07",{"date":404,"type":80},"2025-08-20",{"date":406,"type":21},"2029-07-08",{"name":244,"class":87},{"id":409,"slug":410,"hasResults":12,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":415,"targetDuration":4,"studyType":22,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":139},"100582855","phase-1-evaluation-of-jskn016-combination-therapy-in-subjects-with-nsclc-100582855","NCT06868732","Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC","Evaluation of JSKN016 Combination Therapy in Subjects With Advanced Non-Small Cell Lung Cancer: A Phase Ib Study","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, ≤ 75 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and\u002For radical radiotherapy.\n6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Recently archived or fresh tumor tissue samples are available.\n8. Have good organ function.\n9. Have no current birth plans and agree to contraception during the trial.\n\nExclusion Criteria:\n\n1. Presence of any small cell carcinoma component in histopathology.\n2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.\n4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.\n5. Adequate washout of previous therapy before the first dose.\n6. Gastrointestinal abnormalities with obvious clinical manifestations.\n7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.\n10. Previous treatment with docetaxel.\n11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.\n12. Previous history of allogeneic bone marrow or organ transplantation.\n13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.\n14. Pregnant and\u002For lactating females.\n15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and\u002For uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.",{"count":416,"type":21},288,[99],"This is a Phase Ib clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016 in combination therapy. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.",[103],"2026-03-25",{"date":422,"type":80},"2026-03-30",{"date":424,"type":80},"2025-04-02",{"date":426,"type":21},"2028-12-30",{"name":428,"class":87},"Jiangsu Alphamab Biopharmaceuticals Co., Ltd",{"id":430,"slug":431,"hasResults":12,"nctId":432,"briefTitle":433,"officialTitle":434,"acronym":435,"eligibilityCriteria":436,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":437,"targetDuration":4,"studyType":22,"phases":439,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":283},"100630359","phase-1-osimertinib-plus-capivasertib-in-nsclc-with-pik3caakt1pten-alterations-following-prior-1l-osimertinib-100630359","NCT07486648","Osimertinib Plus Capivasertib in NSCLC With PIK3CA\u002FAKT1\u002FPTEN Alterations Following Prior 1L Osimertinib","The Safety and Efficacy of Osimertinib Plus Capivasertib in EGFRm Advanced Non-small Cell Lung Cancer (NSCLC) Participants With PIK3CA\u002FAKT1\u002FPTEN Alterations Who Had Progressed on First-line Osimertinib Monotherapy or Plus Chemotherapy: a First-in-human, Phase Ib\u002FⅡa Study (PRECISION)","Precision","Inclusion criteria\n\nInformed consent\n\n1. Provision of signed and dated, written informed consent form (ICF) prior to any mandatory and non-mandatory study-specific procedures, sampling and analyses\n\n   Age\n2. Male or female age ≥18 years at the time of signing the ICF.\n\n   Type of participant and disease characteristics\n3. Histologically or cytologically confirmed non-squamous locally advanced or metastatic NSCLC which is not amenable to curative therapy.\n4. Documented EGFR sensitive mutations (exon19 deletion, L858R mutation) prior to the first-line EGFR-TKI therapy.\n5. Documented radiologic progression on first-line treatment with Osimertinib monotherapy or Osimertinib plus chemotherapy:\n\n   * Participants treated with Osimertinib in the adjuvant setting can be included if progression occurred \\\u003C 6 months after last dose.\n   * Participants must be immunotherapy (i.e., programmed cell death protein 1 \\[PD-1\\] inhibitor, programmed cell death protein 1 ligand 1 \\[PD-L1\\] inhibitor, Cytotoxic T-lymphocyte associated protein 4 inhibitor) naïve in the metastatic setting.\n   * Prior immunotherapy in the neoadjuvant or adjuvant setting is acceptable providing treatment was completed more than 6 months before metastatic\u002Frecurrent disease was diagnosed.\n6. Mandatory provision of the required number of FFPE tumour tissue samples for PIK3CA mutations and\u002For AKT1 mutations and\u002For PTEN loss-of-function (LOF) mutations testing, which fulfils the following requirements:\n\n   * Obtained following progression on previous Osimertinib monotherapy or Osimertinib plus chemotherapy as first-line treatment.\n   * Specimen to meet the requirements defined in the Central Laboratory Manual and Diagnostic Testing Manual.\n   * Have PIK3CA and\u002For AKT1 and\u002For PTEN alterations as determined by NGS testing by a sponsor designated central laboratory on tumour specimen collected following progression on prior Osimertinib treatment.\n7. At least one lesion, not previously irradiated, not biopsied during the screening period, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have short axis ≥ 15 mm) with CT or MRI, which is suitable for accurate repeated measurements. If only one measurable lesion exists, it is acceptable to be used if baseline tumour assessment scans are done at least 14 days after the screening tumour specimen collection is performed.\n8. Adequate bone marrow reserve and organ function as follows:\n\n   * Absolute neutrophils count (ANC) ≥1.5x109\u002FL.\n   * Platelets count ≥100x109\u002FL.\n   * Haemoglobin (Hb) ≥90g\u002FL.\n   * Total bilirubin ≤1.5 times upper limit of normal (ULN) or ≤3 times ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinaemia) or liver metastases.\n   * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5ULN (or ≤5 ULN in the presence of liver metastases).\n   * Serum Creatinine ≤1.5 ULN or creatinine clearance (CCr) ≥50mL\u002Fmin (measured or calculated by Cockcroft and Gault equation); confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n10. Patients with hepatitis B virus (HBV) are only eligible for inclusion if they meet all the following criteria:\n\n    * Demonstrated absence of hepatitis C virus (HCV) co-infection or history of HCV co-infection\n    * Demonstrated absence of human immunodeficiency virus (HIV) infection\n    * Participants with active HBV infection are eligible if they are:\n    * Receiving anti-viral treatment for at least 6 weeks prior to study treatment, HBV DNA is suppressed to \\\u003C100 IU\u002FmL and transaminase levels are below ULN.\n    * Participants with a resolved or chronic HBV infection are eligible if they are:\n    * Negative for HBsAg and positive for hepatitis B core antibody \\[anti-HBc IgG or total anti-HBc Ab\\]. In addition, patients should be referred to a local hepatologist and treated as per local guidelines.\n\n    or\n\n    • Positive for HBsAg, but for \\> 6 months have had transaminases levels below ULN and HBV DNA levels below \\\u003C100 IU\u002FmL or below the detectable limit of locally available test kit (i.e., are in an inactive carrier state). In addition, patients must be receiving anti-viral prophylaxis for 2-4 weeks prior to study treatment.\n\n    Patients with HIV are only eligible for inclusion if they meet all the following criteria:\n    * Demonstrated absence of HBV\u002F HCV co-infection\n    * Undetectable viral RNA load for 6 months\n    * CD4+ count of \\>350 cells\u002FµL\n    * No history of AIDS-defining opportunistic infection within the past 12 months\n\n    Stable for at least 4 weeks on the same anti-HIV medications.\n11. Ability to swallow and retain oral medications.\n12. Willingness and ability to comply with study and follow-up procedures. Reproduction\n13. Females must be using highly effective contraceptive measures, and must have a negative pregnancy test prior to start of dosing if of child-bearing potential, or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged 50 years or more and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments.\n    * Women under 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.\n    * Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n\n    Further information in Appendix C (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods).\n14. Male participants must be willing to use barrier contraception. Exclusion criteria\n\nMedical conditions\n\n1. Patients harbouring concurrent actionable driver mutations with locally approved targeted therapies (e.g., MET amplification) will be excluded.\n2. Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.\n3. Clinically significant abnormalities of glucose metabolism as defined by any of the following:\n\n   * Fasting glucose ≥7.0 mmol\u002FL (126 mg\u002FdL) or 2 hours after glucose solution intake, blood glucose ≥11.1 mmol\u002FL (200 mg\u002FdL).\n   * HbA1c ≥8.0% (63.9 mmol\u002Fmol) at screening. Note: for any patient with evidence of impaired glucose control or insulin resistance refer to the Capivasertib Toxicity Management Guidelines.\n4. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection (e.g. patients receiving treatment for infection) including hepatitis C and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B virus (HBV) infection, or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice) .\n\n   • Screening for chronic conditions is not required.\n5. Spinal cord compression, leptomeningeal metastasis, or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n6. Any of the following cardiac criteria:\n\n   * Mean resting corrected QTc \\>470 msec, obtained from triplicate electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value.\n   * History of QT prolongation associated with other medications that required discontinuation of that medication.\n   * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block and second-degree heart block.\n   * Medical history significant for arrhythmia (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted to enter the study based on the Investigator judgement with cardiologist consultation recommended.\n   * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as electrolyte abnormalities including:\n\n     * Hypokalaemia\\|\\* ≥ CTCAE Grade 2.\n     * Heart failure, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsade de Pointes.\n     * Correction of electrolyte abnormalities should be documented prior to first dose.\n   * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) Grade 2.\n7. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥2 years before the first dose of investigational product (IP) and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease.\n8. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment except for alopecia and grade 2 prior platinum-therapy related neuropathy. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention in the opinion of the Investigator may be included (e.g., hearing loss).\n9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of IP.\n10. Any other disease, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n\n    Prior\u002Fconcomitant therapy\n11. Prior or current treatment with a third-generation EGFR-TKI other than Osimertinib.\n12. Prior or current treatment with any PI3K\u002FAKT pathway inhibitors, including but not limited to: Capivasertib or other AKT inhibitors, PI3K inhibitors, or agents targeting key nodes in this pathway (e.g., PTEN-modulating therapies).\n13. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.\n14. Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study intervention or has not recovered from side effects of such therapy.\n15. Major surgery or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study. Procedures such as placement of vascular access, biopsy via mediastinoscopy or biopsy via video assisted thoracoscopic surgery (VATS) are permitted.\n16. Systemic therapy: Prior exposure to any anti-cancer agents other than those specified in the protocol (e.g. hormonal therapy such as luteinizing hormone releasing hormone \\[LHRH\\] agonists) without appropriate washout period before enrolment, for example, enrolment within 3 half-lives of a small molecule anti-cancer agent, or within 4 weeks for any antibody-based anticancer agents.\n17. Participants currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers (at least 3-week prior), moderate inducers (at least 2-week prior) or strong inhibitors of CYP3A4 (at least 2-week prior). All participants must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer or inhibitor effects on CYP3A4. Any concomitant medication that may interfere with Osimertinib safety and efficacy based on the prescribing information of Osimertinib and local clinical guidelines.\n\n    Prior\u002Fconcurrent clinical study experience\n18. Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.\n\n    Other exclusions\n19. History of hypersensitivity to active or inactive excipients of Capivasertib or Osimertinib or drugs with a similar chemical structure or class.\n20. Women who are currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant.\n21. Involvement in the planning and\u002For conduct of the study (applies to both Investigator staff and\u002For staff at the study site).",{"count":438,"type":21},53,[99,100],"The goal of this clinical trial is to learn if Osimertinib plus Capivasertib works to treat EGFRm advanced non-small cell lung cancer (NSCLC) in participants with PIK3CA\u002FAKT1\u002FPTEN alterations after progression on first-line Osimertinib (monotherapy or plus chemotherapy).\n\nThe main questions it aims to answer are:\n\nPart A:\n\n* Number of Dose-limiting toxicities (DLTs)\n* Adverse events (AEs)\u002Fserious adverse events (SAEs) (graded by CTCAE Version 5.0)\n* Recommended combined dose (RCD)\n\nPart B:Confirmed ORR assessed by the Investigator per RECIST 1.1 criteria.\n\nParticipants will:\n\nPart A:Take Capivasertib twice daily from day 1 to 4 of a 7-day cycle, Osimertinib will be given orally QD(once daily) at 80 mg throughout the study treatment period.\n\nPart B: Take Osimertinib (80mg QD, continuously) and Capivasertib(RCD,orally BID from day1-day 4 in 7-day cycle , 4 days on \u002F3 days off) till disease progression (PD) or unacceptable toxicity.",[442,443,444],"Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Advanced Non-small-cell Lung Cancer",[43,446],"Osimertinib plus Capivasertib","NOT_YET_RECRUITING","2026-03-23",{"date":450,"type":80},"2026-03-24",{"date":452,"type":21},"2026-05-15",{"date":454,"type":21},"2028-12-31",{"name":456,"class":138},"Shanxi Province Cancer Hospital",{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":464,"enrollmentInfo":465,"targetDuration":467,"studyType":124,"phases":4,"briefSummary":468,"conditions":469,"keywords":474,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":4},"100623087","peripheral-blood-etasts-for-predicting-efficacy-of-chemoimmunotherapy-in-nsclc-100623087","NCT07392073","Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC","Prospective Study of Changes in Peripheral Blood Effector Tumor Antigen-Specific T Cells for Predicting Efficacy of Chemoimmunotherapy in Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer (NSCLC)\n* Planned to receive PD-1 inhibitor combined with platinum-based chemotherapy (e.g., pembrolizumab + pemetrexed\u002Fcarboplatin)\n* Age 18-80 years\n* ECOG performance status 0-1\n* Expected survival ≥12 weeks\n* Adequate bone marrow function: ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL\n* Adequate hepatorenal function: Cr ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN\n* At least one measurable lesion per RECIST 1.1 criteria\n* Able to provide informed consent and comply with study procedures including serial blood sampling and imaging follow-up\n\nExclusion Criteria:\n\n* No measurable disease per RECIST 1.1 criteria\n* Tumor emergencies requiring immediate intervention (spinal cord compression, superior vena cava syndrome)\n* Active untreated central nervous system metastases or leptomeningeal disease\n* Prior treatment with immune checkpoint inhibitors within 4 weeks before enrollment\n* Chronic use of immunosuppressive agents (e.g., corticosteroids \\>10 mg\u002Fday prednisone equivalent)\n* Coagulation disorders (INR \\>1.5 or APTT \\>1.5×ULN) or ongoing anticoagulation therapy\n* Poor vascular access precluding serial venipuncture (\\>5 mL per draw)\n* Active hepatitis B (HBV DNA \\>2000 IU\u002FmL), hepatitis C, or HIV infection\n* Uncontrolled bacterial or fungal infection requiring systemic treatment\n* Pregnancy or lactation\n* Severe psychiatric disorder or communication barriers affecting informed consent or follow-up compliance\n\nWithdrawal Criteria:\n\n* Participant voluntary withdrawal with signed withdrawal statement\n* Major protocol violations: failure to receive ≥2 cycles of planned chemoimmunotherapy; missing ≥2 critical timepoint blood samples (baseline, cycle 2)\n* Uncontrollable grade ≥3 immune-related adverse events requiring permanent discontinuation of PD-1 inhibitor\n\nStudy Termination Criteria:\n\n* Disease progression confirmed by imaging per RECIST 1.1 or clinical progression requiring radiotherapy\n* Death or loss to follow-up \\>6 months\n* Unacceptable grade 4 treatment-related toxicity\n* Investigator determination that continued participation poses health risk to patient\n* Study terminated by ethics committee for scientific or administrative reasons","80 Years",{"count":466,"type":21},80,"24 Months","The goal of this observational study is to explore whether changes in peripheral blood effector tumor antigen-specific T cells (ETASTs) can predict treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) receiving chemoimmunotherapy. The study aims to:\n\n* Evaluate the relationship between ΔETAST levels (baseline to cycle 2) and progression-free survival\n* Compare the predictive performance of ΔETASTs with traditional biomarkers (PD-L1, TMB)\n* Assess whether ΔETASTs can identify patients more likely to benefit from PD-1 inhibitor plus chemotherapy\n\nParticipants will:\n\n* Provide peripheral blood samples at baseline and after cycle 2 of treatment\n* Undergo ETAST quantification using the CTT-NanoDT technology with TATAN nanoparticles\n* Have standard tumor assessments every 2 cycles according to RECIST 1.1 criteria\n* Be followed for progression-free survival and overall survival up to 24 months",[206,470,471,472,473,42],"Lung Adenocarcinoma","Lung Squamous Cell Carcinoma","Stage IIIB Non-Small Cell Lung Cancer","Stage IV Non-Small Cell Lung Cancer",[475,476,477,478,479],"Tumor Antigen-Specific T Cells","Effector T Cells","Circulating T Cells","Biomarkers","PD-1 Inhibitor","2026-02-02",{"date":482,"type":80},"2026-02-06",{"date":484,"type":21},"2026-04",{"date":486,"type":21},"2029-06",{"name":488,"class":138},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":22,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":511,"locationsCount":513},"100585947","phase-3-tepotinib-vs-standard-treatment-in-patients-with-advanced-met-exon-14-mutated-non-small-cell-lung-cancer-previously-treated-100585947","NCT06908993","Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated","A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer","COMET","Inclusion Criteria:\n\n1. Informed, written and signed consent:\n\n   * Patients must have signed and dated the written informed consent form approved by the ethics committee in accordance with the legal and institutional framework.\n   * It must have been signed before protocol-related procedures that are not part of normal patient management are performed. Patients should be willing and able to adhere to the schedule of visits, treatment and laboratory tests.\n2. Histologically proven advanced NSCLC.\n3. Presence of a METex14 mutation (based on local testing). Detection of METex14 mutation should be performed on a tissue sample if available. In case no tissue sample is available, detection of METex14 on a liquid biopsy is authorized. The sponsor should be consulted if there is any doubt about the nature of the mutation.\n4. Evidence of disease progression after at least one prior line of treatment including either a platinum-based chemotherapy or an anti-PD(L)1 agent or both.\n5. Has received no more than 2 prior lines of treatment.\n6. ECOG Performance Status 0-3.\n7. Brain metastases are allowed. If immediate local treatment is required, inclusion is possible once the latter is complete.\n8. Stage IIIB or IIIC non irradiable or stage IV (8th classification TNM, UICC 2015)\n9. Age ≥ 18 years.\n10. Adequate biological function:\n\n    * Creatinine clearance ≥ 30 ml\u002Fmin;\n    * Neutrophils ≥ 1500\u002Fmm3;\n    * Platelets ≥100,000\u002Fmm3;\n    * Haemoglobin ≥ 8 g\u002FdL;\n    * Liver enzymes \\\u003C 3x ULN except for patients with liver metastases (\\\u003C 5x ULN);\n    * Total bilirubin ≤ 1.5 x ULN except for patients with proven Gilbert's syndrome (≤ 5 x ULN) or patients with liver metastases (≤ 3.0 ULN).\n11. Protected adults may participate in the study if they are capable of making decisions regarding their medical treatment in accordance with the guardianship judgment.\n12. For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1.\n13. Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n14. Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n15. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. Prior treatment with a MET inhibitor (including crizotinib).\n2. Presence of another known driver oncogene alteration (including EGFR, HER2, KRAS, BRAF mutations or ALK, ROS1, RET fusions). In case of detection of any other driver alteration, inclusion should be discussed with the sponsor.\n3. ECOG Performance Status 4.\n4. Known hypersensitivity to tepotinib or its excipients.\n5. History of cancer within 3 years or active cancer except those with a negligible risk of metastasis or death, or those treated curatively. If a patient does not fulfil this criterion but the investigator considers that the benefit\u002Frisk balance is in favour of inclusion in the study, please contact IFCT.\n6. Inability to comply with study or follow-up procedures.\n7. Pregnant, lactating, or breastfeeding women.\n8. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications.\n9. History of idiopathic pulmonary fibrosis or active pneumonitis on chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.",{"count":498,"type":21},133,[24],"The hypothesize is that tepotinib is more effective than the investigator's choice of treatment in patients with MET-mutated NSCLC who have progressed after at least one first-line treatment.\n\nThe main benefit concerns patient access to tepotinib. There is currently no access to a new-generation MET TKI in France for METex14 patients, due to lack of comparative data. There are no phase III RCTs underway anywhere in the world. This study is the only opportunity, perhaps the last, to generate comparative data which, if positive, will enable the drug to be reimbursed. With this in mind, the methodology of this study was discussed with the HAS on several occasions beforehand, to ensure that it met their expectations. With a response rate of around 50% and a median progression-free survival of 11 months in previously-treated subjects based on clinical trials data, tepotinib is a key drug for METex14 NSCLC patients, who are generally elderly and frail, and for whom therapeutic options are limited.\n\nThe investigators expect to observe a benefit for patients treated with tepotinib compared to the control arm in terms of PFS, quality of life, objective response rate and duration of response. The overall survival benefit may be compromised by allowing patients in the control arm to cross over to tepotinib once they have progressed. However, the investigators have decided to maintain this crossover and consequently use PFS as the primary endpoint, as there is no clinical equipoise regarding the efficacy of tepotinib in METex14 NSCLC patients. The EMA has already approved tepotinib based on efficacy and safety data from clinical trials, and patients and investigators already consider this treatment as an important therapeutic option. Indeed, both ESMO and ASCO guidelines recommend the use of MET TKIs in these patients. In France, although neither tepotinib nor capmatinib are available, crizotinib, a multi-target TKI also active on MET, can be used off-label. If cross-over to tepotinib was not allowed in this trial, most patients would still benefit from cross-over to a MET TKI by receiving off-label crizotinib, which would in any case lead to a misinterpretation of the OS data. Therefore, the investigators believe it is preferable to control for cross-over and expose progressive patients in the control arm to tepotinib and use PFS as the primary endpoint.\n\nToxicity of MET TKIs is considered as manageable. In the VISION trial, of 313 patients treated with tepotinib (median age: 72 years), 109 (34.8%) experienced grade ≥3 treatment-related adverse events, leading to discontinuation in 46 patients (14.7%). Rates of adverse events (AE) were broadly consistent irrespective of prior therapies. Edema, the most common adverse event of clinical interest (AECI), was reported in 67.1% (grade ≥ 3, 11.2%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and\u002For treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild\u002Fmoderate: hypoalbuminemia, 23.6% (grade ≥ 3, 3.5%); creatinine increase, 22.0% (grade ≥ 3, 1.0%); nausea, 23.3% (grade ≥ 3, 0.6%), diarrhea, 22.4% (grade ≥ 3, 0.3%), decreased appetite (grade ≥ 3, 0.3%), and ALT increase, 14.1% (grade ≥ 3, 2.2%). GI AEs typically occurred early and resolved in the first weeks10,13.\n\nGiven the efficacy of tepotinib, the manageable safety profile, and the oral administration of tepotinib, the investigators anticipate that treatment with tepotinib will be associated with improved quality of life.\n\nTreatments offered in the control group correspond to standard treatments for advanced NSCLC in second line or beyond. In terms of prior lines of treatment, the eligibility criteria of the trial are aligned with the EMA label of tepotinib: \"indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and\u002For platinum-based chemotherapy\". The investigators have not included platinum-based chemotherapy as a treatment option in the control arm, considering that patients who are eligible to platinum-based chemotherapy should have received this regimen in first-line, as per ESMO guidelines14. Given the low efficacy of immunotherapy in patients with oncogene addiction, it is unlikely that some patients would receive immunotherapy alone as first-line treatment. Thus, the absence of platinum-based chemotherapy as a treatment choice in the control arm seems reasonable and will reduce the heterogeneity of this arm.",[339,502],"MET Exon 14 Mutation",[504,502,505],"Tepotinib","Non Small Cell Lung Cancer","2025-12-09",{"date":82,"type":80},{"date":506,"type":80},{"date":510,"type":21},"2028-07-15",{"name":512,"class":138},"Intergroupe Francophone de Cancerologie Thoracique",29,{"id":515,"slug":516,"hasResults":12,"nctId":517,"briefTitle":518,"officialTitle":519,"acronym":4,"eligibilityCriteria":520,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":521,"enrollmentInfo":522,"targetDuration":4,"studyType":22,"phases":524,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":139},"100601029","phase-1-hs-it101-injection-for-advanced-nsclc-100601029","NCT07105176","HS-IT101 Injection for Advanced NSCLC","A Phase Ib Single-arm Clinical Study of HS-IT101 Injection for Advanced NSCLC","Inclusion Criteria:\n\n* Age: 18-70 years (inclusive).\n\nDiagnosis:\n\nHistologically\u002Fcytologically confirmed advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC) .\n\nTumor Sampling:\n\n≥1 lesion untreated with radiotherapy\u002Flocal therapy within 28 days for TIL preparation (tissue weight ≥0.050 g).\n\nTarget Lesion:\n\n≥1 measurable lesion per RECIST v1.1, untreated with radiotherapy\u002Flocal therapy (unless treatment occurred \\>28 days before sampling with documented progression).\n\nPerformance Status: ECOG score ≤1. Survival: Life expectancy ≥3 months.\n\nOrgan Function:\n\nHematology: ANC ≥1.5×10⁹\u002FL, PLT ≥90×10⁹\u002FL, HGB ≥90 g\u002FL (no transfusion\u002Ferythropoietin within 14 days).\n\nLiver: ALT\u002FAST ≤2.5×ULN (≤5×ULN if liver metastases); TBil ≤1.5×ULN (≤3×ULN for Gilbert syndrome).\n\nKidney: Serum Cr ≤1.5×ULN or Ccr ≥60 mL\u002Fmin (Cockcroft-Gault formula). Coagulation: APTT ≤1.5×ULN; INR\u002FPT ≤1.5×ULN.\n\nCardiac Function:\n\nLVEF ≥50% by echocardiography; QTcF ≤470 ms (Fridericia formula: QTcF = QT\u002FRR⁰·³³).\n\nBaseline SpO₂ \\>91% (room air). Note: If QTcF is abnormal initially, repeat twice at ≥5-minute intervals and use mean value for eligibility.\n\nToxicity Recovery: All treatment-related adverse events resolved to CTCAE v5.0 ≤Grade 1 (except alopecia\u002Fnon-risk toxicities per investigator) before tumor sampling.\n\nContraception: Effective non-pharmacological contraception from informed consent until 1 year post-TIL infusion.\n\nCompliance: Capable of understanding the trial, voluntarily signing informed consent, and adhering to protocol visits\u002Fprocedures.\n\nExclusion Criteria:\n\n* Severe Hypersensitivity: History of severe hypersensitivity to drugs used in the study (including but not limited to cyclophosphamide, fludarabine, IL-2, gentamicin, amphotericin B, or components of TIL infusion).\n\nUncontrolled Comorbidities:\n\nPoorly controlled hypertension (resting SBP ≥160 mmHg or DBP ≥100 mmHg despite medication).\n\nCongestive heart failure (NYHA Class III\u002FIV).\n\nCardiovascular Events (within 6 months):\n\nDeep vein thrombosis, pulmonary embolism, myocardial infarction, severe\u002Funstable arrhythmia, angina, PCI, ACS, CABG, stroke, TIA, or cerebral embolism.\n\nActive Autoimmune Disease:\n\nRequires systemic therapy during the study period (Exceptions: Eczema, vitiligo, psoriasis, alopecia, or Graves' disease stable without systemic therapy for 2 years; hypothyroidism on hormone replacement; type 1 diabetes on insulin).\n\nTransplantation History: Solid organ or hematopoietic stem cell transplantation.\n\nImmunosuppressive Therapy:\n\nUse of immunosuppressants (e.g., steroids) within 4 weeks before tumor sampling (Allowed: Physiologic glucocorticoid doses ≤12 mg\u002Fm²\u002Fday hydrocortisone equivalent; topical\u002Fnasal steroids).\n\nRecent Anticancer Therapy:\n\nSystemic anticancer treatment within 4 weeks before preconditioning (including investigational drugs; washout \\\u003C5 half-lives if \\\u003C4 weeks).\n\nPlanned participation in other interventional trials.\n\nActive Infections:\n\nHIV\u002Fsyphilis antibody-positive; active HBV\u002FHCV (Allowed: HBsAg\u002FHBeAg+ if HBV DNA below LLN; HCV Ab+ if HCV RNA below LLN).\n\nActive systemic infection or tuberculosis requiring treatment. Recent Surgery\u002FTrauma: Major surgery or significant trauma within 4 weeks before screening; elective surgery planned during the study.\n\nPoor Wound Healing: Surgery-related complications or delayed healing increasing risks of TIL therapy (per investigator judgment).\n\nOther Malignancies: Additional primary malignancy within 5 years (Exceptions: Curatively treated basal\u002Fsquamous cell carcinoma or carcinoma in situ).\n\nSevere Respiratory Disease: History of severe ILD, COPD, pulmonary insufficiency, or symptomatic bronchospasm.\n\nGastrointestinal Complications: Surgical-required GI bleeding, bowel ischemia, or perforation.\n\nCNS Involvement:\n\nLeptomeningeal metastasis; uncontrolled\u002Funtreated CNS metastases (Exceptions: Asymptomatic lesions \\\u003C1 cm, stable for ≥4 weeks without steroids\u002Fanticonvulsants).\n\nPrior Cell Therapy: Previous treatment with similar cellular products. Pregnancy\u002FLactation: Pregnant or breastfeeding women.\n\nOther Exclusions:\n\nPsychiatric disorders, alcoholism, drug abuse, or other conditions deemed unsuitable by the investigator.","70 Years",{"count":523,"type":21},12,[99],"An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.",[42],"2025-08-18",{"date":529,"type":80},"2025-08-19",{"date":531,"type":21},"2025-08-30",{"date":533,"type":21},"2027-08-30",{"name":535,"class":87},"Qingdao Sino-Cell Biomedicine Co., Ltd.",{"id":537,"slug":538,"hasResults":12,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":4,"eligibilityCriteria":542,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":543,"targetDuration":4,"studyType":22,"phases":545,"briefSummary":546,"conditions":547,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":554,"locationsCount":139},"100591426","phase-3-ssgj-707-in-advanced-non-small-cell-lung-cancer-100591426","NCT06980272","SSGJ-707 in Advanced Non-Small Cell Lung Cancer","A Randomized Controlled, Multi-center Phase III Clinical Trial of SSGJ-707 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Willing to participate in the study voluntarily, agree to comply with and complete all study procedures, and sign the Informed Consent Form (ICF).\n2. At least 18 years of age at the time of signing the ICF, regardless of gender.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n4. Life expectancy of at least 12 weeks.\n5. Histologically or cytologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC).\n6. No prior systemic anti-tumor treatment for locally advanced or metastatic NSCLC.\n7. At least one measurable tumor lesion as a target lesion according to RECIST v1.1 criteria.\n\nExclusion Criteria:\n\n1. Presence of small cell carcinoma components in histological pathology.\n2. Presence of EGFR-sensitive mutations or ALK fusion-positive NSCLC.\n3. Known BRAF V600E mutation, MET exon 14 skipping mutation, NTRK fusion, RET fusion, or ROS1 fusion-positive NSCLC.\n4. Presence of brainstem, leptomeningeal, spinal cord metastasis or compression.\n5. Unresolved toxicity from prior anti-tumor treatment, defined as toxicity not returning to NCI CTCAE Version 5.0 Grade 0 or 1.\n6. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.\n7. History of immunodeficiency; positive for HIV antibodies;\n8. Known active tuberculosis (TB);\n9. Known history of severe allergy to any component of the investigational drug, or history of severe allergic reactions to chimeric or humanized antibodies.\n10. Pregnant or breastfeeding women.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":544,"type":21},420,[24],"This trial is a Phase III study. All patients are stage IIIB\u002FC (unsuitable for radical therapy) or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of SSGJ-707 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.",[42],"2025-06-23",{"date":550,"type":80},"2025-06-24",{"date":552,"type":80},"2025-06-20",{"date":454,"type":21},{"name":555,"class":87},"Shenyang Sunshine Pharmaceutical Co., LTD.",{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":562,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":563,"targetDuration":4,"studyType":22,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":4},"100579357","phase-1-pharmacokinetic-study-of-hs-10241-tablets-in-subjects-with-hepatic-impairment-and-normal-hepatic-function-100579357","NCT06823245","Pharmacokinetic Study of HS-10241 Tablets in Subjects with Hepatic Impairment and Normal Hepatic Function","Inclusion Criteria:\n\n* Inclusion criteria:\n\nAll participants must meet all of the following conditions:\n\n1. Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;\n2. The subjects agree to have no plans to conceive or donate sperm\u002Feggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);\n3. On the day of signing the informed consent form, both males and females must be at least 18 years old;\n4. The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-32 kg\u002Fm2 (including both ends);\n5. Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL\u002Fmin.\n\nSubjects with normal hepatic function must also meet all of the following conditions:\n\n1\\) When screening, the following demographic matching criteria must be met:\n\n1. BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;\n2. Age matching with the matched hepatic impairment group, with a mean of ± 5 years;\n3. Gender matching with the matched hepatic impairment group，with the same number of individuals for each gender;\n\nSubjects with liver dysfunction must also meet all of the following conditions:\n\n1. Chronic liver injury caused by primary liver disease (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.) in subjects with hepatic impairment classified as A or B by Child Pugh grading (see Appendix 3 for Child Pugh grading).\n2. Researchers determine that the hepatic function status of the subjects has been stable for at least 2 months based on their clinical symptoms and other examination results available during screening (as determined by the researchers).\n3. Individuals who have a stable medication regimen for treating hepatic impairment, complications, and other accompanying diseases for at least 14 days prior to taking the investigational drug, and whose medication does not require adjustment (including medication type, dosage, or frequency, except for diuretics, insulin, and other medications); Or those who have not taken medication.\n\nExclusion Criteria:\n\n* All participants who meet the following exclusion criteria are not eligible for this study:\n\n  1. Those who have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion, and have been deemed unsuitable for inclusion by the researchers;\n  2. Individuals who are prone to allergic reactions or have an allergic constitution (such as those who are allergic to pollen, two or more drugs\u002Ffoods), or those who are known to be allergic to the study drug or any component of the study drug;\n  3. Individuals who have donated blood or lost blood ≥ 400 mL within the first 3 months of screening, or have received blood transfusions or used blood products, or intend to donate blood during the trial period or within 1 month after the trial ends;\n  4. Individuals who have used strong or moderate inducers or inhibitors of CYP3A and CYP2C9 enzymes within the previous month of screening (see Appendix 4);\n  5. Prior to administration, any proton pump inhibitors (PPIs), H2 receptor antagonists, local antacids, oral alkaline drugs, or other drugs that reduce gastric acid secretion were used, and HS-10241 was administered within 7 half lives of the aforementioned drugs;\n  6. Individuals who have participated in any other clinical trials within the previous 3 months and have used study drugs or plan to participate in other clinical trials during the study period (those who have not been given the study drug or placebo after enrollment may be included);\n  7. Individuals who have consumed a special diet (including dragon fruit, mango, grapefruit, and\u002For xanthine diet, chocolate) and\u002For consumed excessive amounts of tea, coffee, grapefruit\u002Fgrapefruit juice, and\u002For caffeinated beverages (an average of 8 or more cups per day, 200 mL per cup) within 2 weeks prior to administration;\n  8. Individuals who smoke an average of 10 or more cigarettes per day within the first 3 months of screening;\n  9. Screening for alcoholics within the first 3 months, i.e. those who consume more than 14 units of alcohol per week (1 unit=360 mL of beer, 45 mL of strong liquor with an alcohol content of 40%, or 150 mL of wine) or have a positive alcohol screening result;\n  10. Individuals with a history of drug use, substance abuse, or a positive urine drug test;\n  11. Pregnant or lactating women, or women of childbearing age who test positive for pregnancy;\n  12. Not suitable for those who undergo venipuncture or have a history of needle and blood dizziness;\n  13. Other reasons why researchers believe it is not suitable for inclusion.\n\nSubjects with normal hepatic function should be excluded if they meet any of the following exclusion criteria:\n\n1. History of liver injury;\n2. Individuals who have previously or currently suffered from any clinically serious diseases such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or any other diseases that can interfere with the test results;\n3. Abnormalities in physical examination, vital signs, laboratory tests, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and other examinations have clinical significance as determined by the researchers;\n4. Those who are positive in any index screening of hepatitis B surface antigen, hepatitis C antibody, HIV antigen\u002Fantibody or Treponema pallidum antibody;\n5. Individuals who have used any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements (excluding topical preparations that exert local effects) within 14 days prior to drug administration.\n\nIf a subject with hepatic impairment meets any of the following exclusion criteria, they should be excluded:\n\n1. The subject has any of the following conditions: ① Having undergone liver transplantation in the past; ② Having undergone partial hepatectomy in the past; ③ Patients who are suspected of or diagnosed with liver cancer or other malignant tumors (except for specific cancers that have been surgically removed and completely cured, such as basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix; except for patients with liver cancer who have received radical treatment and have no recurrence; except for patients with liver cancer at BCLC stage 0)；④ Patients with liver failure; ⑤ Those who had rupture and bleeding of esophageal and gastric varices within 3 months before screening; ⑥ Patients with biliary cirrhosis, extrahepatic biliary obstruction and other diseases, and who are deemed by the investigator as not suitable to participate in this trial;\n2. The laboratory test results during screening meet any of the following criteria: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\>10 × ULN; (b) Absolute neutrophil count (NE #)\\\u003C0.75 × 109\u002FL; (c) Hemoglobin (HGB)\\\u003C60 g\u002FL; (d) Alpha fetoprotein (AFP)\\>100 ng\u002FmL;\n3. Individuals who test positive for HIV antigen\u002Fantibody screening; If the Treponema pallidum antibody is positive, the Rapid Plasma Reactive Protein (RPR) test should be added. If RPR is also positive, it should be excluded;\n4. In addition to the primary liver disease itself, those who have previously or currently suffered from other serious organ systemic diseases, including but not limited to uncontrollable gastrointestinal, respiratory, renal, neurological, blood, endocrine, tumor, immune, psychiatric or cardiovascular diseases, or clinical laboratory tests that have clinical significance and have been determined by the research doctor to be unsuitable for participation in this study.",true,{"count":564,"type":21},32,[99],"This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function.",[103],"2025-02-07",{"date":570,"type":80},"2025-02-12",{"date":572,"type":21},"2025-02-28",{"date":574,"type":21},"2025-07-31",{"name":576,"class":87},"Jiangsu Hansoh Pharmaceutical Co., Ltd.",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":124,"phases":4,"briefSummary":587,"conditions":588,"keywords":589,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":139},"100430540","retrospective-observational-study-on-prediction-of-response-to-pd-1-immunotherapy-in-patients-with-nsclc-100430540","NCT04886401","Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with NSCLC","Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with Non Small Cell Lung Cancer Mass Tissue Imaging HyperIONTM","PREDICTION","Inclusion Criteria:\n\n* Adult patients\n* Advanced NSCLC with PD-L1 TPS of 50% or greater\n* Administration of first line pembrolizumab between January 2017 \\& December 2019\n\nExclusion Criteria:\n\n* Auto-immune disease\n* Prior exposure to immunotherapy\n* First dose pembrolizumab administered after December 2019",{"count":586,"type":21},50,"Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)\u002Fprogrammed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment.\n\nThe purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.",[339],[590,591,592],"pembrolizumab","biomarkers","multiplex imaging","2025-02-04",{"date":595,"type":80},"2025-02-06",{"date":597,"type":80},"2021-04-16",{"date":599,"type":21},"2025-05-16",{"name":601,"class":138},"University Hospital, Brest",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":139},"100478000","phase-1-efficacy-and-safety-of-ibi351-in-combination-with-chemotherapy-in-advanced-non-squamous-non-small-cell-lung-cancer-subjects-with-kras-g12c-mutation-100478000","NCT05504278","Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation","An Open-label, Multi-center Phase Ib\u002FIII Study Evaluating the Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation","Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation\n2. Unresectable or metastatic disease\n3. Adequate organ function\n4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.\n\nExclusion Criteria:\n\n1. History of intestinal disease or major gastric surgery or inability to swallow oral medications\n2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).\n3. Active brain metastases.",{"count":610,"type":21},144,[99],"This Phase Ib\u002FIII study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.",[42],"2025-01-22",{"date":616,"type":80},"2025-01-27",{"date":618,"type":80},"2022-09-20",{"date":620,"type":21},"2027-07-31",{"name":622,"class":87},"Innovent Biologics (Suzhou) Co. Ltd.",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":4,"eligibilityCriteria":628,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":629,"targetDuration":4,"studyType":22,"phases":631,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":641,"locationsCount":4},"100575684","phase-2-evaluation-of-jskn016-in-the-treatment-of-advanced-non-small-cell-lung-cance-a-phase-ii-clinical-study-100575684","NCT06775483","Evaluation of JSKN016 in the Treatment of Advanced Non-small Cell Lung Cance： a Phase II Clinical Study","Inclusion Criteria:\n\n1. Voluntarily participate and sign the informed consent form.\n2. Age ≥ 18 years old, male or female.\n3. Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0 or 1.\n4. Expected survival ≥ 3 months.\n5. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) that is not suitable for radical surgery and\u002For radical radiotherapy, and meets one of the following conditions: EGFR sensitive mutations, and failed treatment with EGFR-TKI; Driver gene negative, treated with PD-1\u002FL1 inhibitors and a platinum-containing chemotherapy and treatment failure; Positive driver gene, failure of corresponding standard therapy;\n6. At least one extracranial measurable lesion at baseline according to RECIST 1.1 criteria.\n7. Recently archived or fresh tumor tissue samples are available.\n8. Have good organ function.\n9. Have no current birth plans and agree to contraception during the trial.\n\nExclusion Criteria:\n\n1. Presence of any small cell carcinoma component in histopathology.\n2. Subjects with other malignant tumors within 5 years prior to enrollment, and other tumors have been cured through local therapy, such as cured cutaneous squamous cell carcinoma, basal cell carcinoma, non-primary invasive bladder cancer, and prostate\u002Fcervical\u002Fbreast cancer in situ.\n3. Presence of brainstem, meningeal metastases, spinal cord metastases or compression, leptomeningeal metastases, or history of carcinomatous meningitis; Presence of active brain metastases.\n4. During the screening period, imaging shows that the tumor invades, compresses, or occurs in the surrounding important organs (such as the heart and pericardium, trachea, esophagus, superior vena cava, etc.) or there is a risk of esophageal tracheal fistula or esophageal pleural fistula.\n5. Adequate washout of previous therapy before the first dose.\n6. Gastrointestinal abnormalities with obvious clinical manifestations.\n7. Presence of clinically severe respiratory impairment caused by pulmonary disease complications.\n8. Presence of cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n9. Prior treatment with topoisomerase I inhibitors (e.g., irinotecan, topotecan), antibody-drug conjugates containing topoisomerase I inhibitors (e.g., DS-8201, HER3-DXd, DS-1062), or targeting TROP2 or HER3.\n10. Previous treatment with docetaxel.\n11. Have an uncontrolled infection, a history of immunodeficiency, a positive human immunodeficiency virus (HIV) test, or a history of AIDS.\n12. Previous history of allogeneic bone marrow or organ transplantation.\n13. Known allergy to any component of the study drug, and previous history of severe allergic reaction to other antibody drugs.\n14. Pregnant and\u002For lactating females.\n15. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors, which can lead to higher medical risk and\u002For uncertainty in survival evaluation, such as tumor leukemia response , cachexia manifestations, etc.",{"count":630,"type":21},220,[100],"This is a Phase II clinical study conducted in China to evaluate the treatment of advanced non-small cell lung cancer with JSKN016. The enrolled subjects are all in the locally advanced or metastatic stage of non-small cell lung cancer.The study is divided into two parts. The main objective of part I is to assess the efficacy and safety of JSKN016 in selected subjects with advanced non-small cell lung cancer. The main objective of part II is to compare the efficacy of JSKN016 and docetaxel in subjects with advanced non-small cell lung cancer.",[103],"2025-01-13",{"date":636,"type":80},"2025-01-15",{"date":638,"type":21},"2025-01-17",{"date":640,"type":21},"2027-11-30",{"name":428,"class":87},{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":22,"phases":651,"briefSummary":652,"conditions":653,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":654,"lastUpdatePostDateStruct":655,"startDateStruct":657,"completionDateStruct":659,"leadSponsor":661,"locationsCount":139},"100524334","phase-2-imaging-advanced-nsclc-patients-undergoing-pd-1pd-l1-directed-therapy-using-18f-farag-100524334","NCT06107374","Imaging Advanced NSCLC Patients Undergoing PD-1\u002FPD-L1 Directed Therapy Using [18F]-FARAG","Imaging of T-cell Activation With [18F]F-araG in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients Undergoing PD-1\u002FPD-L1 Directed Therapy","Inclusion Criteria:\n\n1. Histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy for advanced\u002Fmetastatic disease.\n2. Measurable disease.\n3. ECOG performance status of 0, 1 or 2.\n4. Subjects are willing to be followed at the University of Iowa.\n\nExclusion Criteria:\n\n1. Serious comorbidities that in the opinion of the investigator\u002Fsponsor could compromise protocol objectives.\n2. Pregnant women or nursing mothers.\n3. Patients with severe claustrophobia.",{"count":650,"type":21},20,[100],"This pilot study uses \\[18F\\]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors. The study's main objectives are to quantify the change in \\[18F\\]F AraG PET signal before and while on CkIT therapy and to correlate this change in \\[18F\\]F AraG PET signal with radiographic response.\n\nTo explore these objectives, eligible subjects will undergo pre- and on - CkIT treatment \\[18F\\]F AraG PET\u002FCT scans, and will be followed up for 12 months for assessment of radiographic and clinical outcomes. This study is a single-site, open label, non randomized, single arm pilot trial. Patients and care providers will not be blinded to any part of the study.",[339],"2024-10-22",{"date":656,"type":80},"2024-10-24",{"date":658,"type":80},"2023-11-01",{"date":660,"type":21},"2026-03-31",{"name":662,"class":87},"CellSight Technologies, Inc.",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":4,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":311,"enrollmentInfo":670,"targetDuration":4,"studyType":22,"phases":671,"briefSummary":672,"conditions":673,"keywords":4,"overallStatus":447,"whyStopped":4,"lastUpdateSubmitDate":674,"lastUpdatePostDateStruct":675,"startDateStruct":677,"completionDateStruct":679,"leadSponsor":680,"locationsCount":139},"100561046","phase-1-clinical-trial-of-tqb2928-in-combination-with-a-third-generation-epidermal-growth-factor-receptor-egfr-tyrosine-kinase-inhibitor-tki-in-patients-with-advanced-non-small-cell-lung-cancers-100561046","NCT06585059","Clinical Trial of TQB2928 in Combination With a Third-Generation Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) in Patients With Advanced Non-Small Cell Lung Cancers","A Phase Ib Clinical Study of TQB2928 in Combination With a Third-Generation EGFR TKI in Patients With Advanced Non-Small Cell Lung Cancers","Inclusion Criteria:\n\n* Age: 18-75 years; Eastern Cooperative Oncology Group (ECOG) score: 0-1; Expected survival of more than 3 months；\n* Locally advanced or metastatic NSCLC diagnosed by histology or cytology\n* The major organs are functioning well；\n* Negative serum pregnancy test within 7 days prior to the first dose and must be a non-lactating subject, female and male subjects of childbearing potential should agree to use contraception for the duration of the study and for 6 months after the end of the study；\n* Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.\n\nExclusion Criteria:\n\n* Current concomitant presence of other malignancies within 5 years prior to the first dose;\n* Unresolved toxicity above CTCAE Grade 1 due to any prior anti-tumor therapy;\n* Significant surgical treatment, biopsy, or significant traumatic injury within 28 days prior to the first dose;\n* Long-term unhealed wounds or fractures;\n* Cerebrovascular accident (including transient ischemic attack, intracerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to the first dose;\n* A history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;\n* Subjects with any severe and\u002For uncontrolled disease;\n* History of live attenuated vaccination within 2 weeks prior to the first dose or planned live attenuated vaccination during the study;\n* Previous history of unexplained severe allergies, hypersensitivity to monoclonal antibodies or exogenous human immunoglobulins, or hypersensitivity to TQB2928 injection or excipients in pharmaceutical formulations;\n* According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patients or affect the completion of the study, or subjects who are considered to be unsuitable for enrollment for other reasons.",{"count":650,"type":21},[99],"This is a Phase Ib study to evaluate the safety, tolerability, and efficacy of TQB2928 in combination with third-generation EGFR TKIs in subjects with advanced non-small cell lung cancer, and to determine the recommended Phase II dose (RP2CD).",[103],"2024-09-03",{"date":676,"type":80},"2024-09-05",{"date":678,"type":21},"2024-09",{"date":323,"type":21},{"name":681,"class":87},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd."]