[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nonsmall-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nonsmall-cell-lung-cancer":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,93,121,143,167,199,225,251],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641290","phase-1-a-phase-1-and-2-study-of-vmd-102-in-hepatocellular-carcinoma-and-other-solid-tumors-100641290",false,"NCT07636785","A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","SPKTAHC","Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and\u002For metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g\u002FdL (SI Units: 90 g\u002FL) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000\u002Fmm3 (60 x109\u002FL) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3 (1.5x109\u002FL) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\\u003C30% of the TBIL)\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and\u002For ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL\u002Fmin using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g\u002Fd\u002FL.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and\u002For tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs\u002Fsymptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU\u002FmL. Participants on active HBV therapy with viral loads \\\u003C100 IU\u002FmL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue\u002Forgan transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and\u002For substances abuse, Phosphatidylethanol (Peth) must be \\\u003C50 ng\u002FmL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","ALL","18 Years","75 Years",{"count":21,"type":22},111,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver\u002FHCC tumor models and preclinical toxicology and pharmacology studies support this study.",[29,30,31,32,33],"Hepatocellular Carcinoma (HCC)","Metastatic Uveal Melanoma","Renal Cell Carcinoma (RCC)","Nonsmall Cell Lung Cancer","Colorectal Cancer (CRC)","NOT_YET_RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":22},"2026-06",{"date":42,"type":22},"2031-12",{"name":44,"class":45},"VM Discovery, Inc.","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":65,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100461030","phase-1-safety-and-tolerability-of-pb-dotam-grpr1-in-adult-subjects-with-recurrent-or-metastatic-grpr-expressing-tumors-100461030","NCT05283330","Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors","A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants With Recurrent or Metastatic GRPR-expressing Tumors","1. Adult participants (age ≥ 18 years old) with any of the following advanced or metastatic solid tumors (documented history of histologically confirmed diagnosis):\n\n   1. Metastatic castration-resistant prostate cancer (mCRPC) including neuroendocrine prostate cancer (NEPC) (enrolled only in SAD and MAD Q6W)\n   2. HR+\u002FHER2- breast cancer (estrogen receptor\u002FER expression \\>10% of tumor cell nuclei stain, regardless of progesterone receptor\u002FPgR expression); HER2-negative including HER2-low (as per relevant ASCO\u002FCAP guidelines)\n   3. Colorectal cancer\n   4. Cervical cancer\n   5. Non-small-cell lung cancer (NSCLC)\n   6. Recurrent glioblastoma (only enrolled in MAD Q4W cohorts) with evidence of recurrent disease (RD) demonstrated by disease progression using modified Response Assessment in Neuro-Oncology (RANO 2.0) criteria. Note: If surgery is performed for GBM recurrence, pre-surgery MRI will be used for confirmation of RD and residual and measurable disease post-surgery is not required but surgery must have confirmed the recurrence diagnosis by MRI.\n2. Capable of giving signed informed consent\n3. All participants must have progressed on at least 2 prior systemic therapies, except for recurrent GB\n4. For participants with mCRPC: Prior orchiectomy and\u002For ongoing androgen deprivation therapy and a castrate level of serum testosterone (\\\u003C50 ng\u002FdL or \\\u003C1.7 nmol\u002FL)\n5. Presence of at least 1 measurable lesion per RECIST 1.1 as assessed by the Investigator (not applicable for GBM). At least 1 identified measurable lesion must show GRPR uptake in 203Pb-DOTAM-GRPR1 SPECT\u002FCT (uptake greater than that of the background) as assessed by the Investigator.\n6. For participants with prostate cancer that do not have measurable soft tissue disease, 203Pb-DOTAM-GRPR1 uptake in bone lesions \\> uptake in background is acceptable for eligibility.\n7. Eastern Cooperative Oncology Group (ECOG) status 0-1. Participants with ECOG status of 2 may be approved on a case-by-case basis in discussion with the Sponsor.\n8. Adequate bone marrow, hepatic, and renal function, as assessed by the following laboratory requirements:\n\n   1. White blood cell (WBC) ≥3000\u002F mm3 (≥ 3 x 109\u002FL)\n   2. Absolute neutrophil count (ANC) ≥1500\u002Fmm3 (≥1.5 x 109\u002FL)\n   3. Platelets ≥100,000\u002Fmm3 (≥ 100 x 109\u002FL)\n   4. Hemoglobin (Hb) ≥9.0 g\u002FdL\n   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3x upper limit of normal (ULN) or ≤ 5 x ULN in the presence of liver metastases\n   6. Total bilirubin: ≤1.5 x ULN, except if documented history of Gilbert's disease who are eligible if total bilirubin ≤ 3 x ULN\n   7. Adequate renal function defined by creatinine clearance (CLCR) ≥ 60 mL\u002Fmin calculated as follows: CLCR = eGFR in ml\u002Fmin\u002F1.73 m2 calculated by the Modified Diet in Renal Disease (MDRD) x participant body surface area (BSA) in m2 ÷ 1.73\n   8. Serum amylase and\u002For lipase ≤1.5 x ULN\n9. For women of childbearing potential (WOCBP) and men with partners of childbearing potential: be willing to use highly effective methods of contraception or sexual abstinence, if part of participant's lifestyle, throughout the study and for 7 months for WOCBP, 4 months for men after the last \\[212Pb\\]Pb-DOTAM-GRPR1 administration or for 10 days following \\[203Pb\\]Pb-DOTAM-GRPR1 administration and participant is not proceeding to 212Pb-DOTAM-GRPR1 treatment, as outlined in protocol.\n\n   Participants with Recurrent Glioblastoma:\n10. Having first or second glioblastoma recurrence, after standard therapy that includes prior radiation therapy (RT) and at least 12 weeks from completion of RT prior to first administration of 212Pb-DOTAM-GRPR1. In case surgery has been performed for GBM recurrence, the surgery has to be completed at least 4 weeks prior to 212Pb-DOTAM-GRPR1 treatment start, with post-surgery recovery without any complications related to surgical procedure.\n11. Presence of 203Pb-DOTAM-GRPR1 uptake by SPECT\u002FCT scan in the tumor lesion(s).\n12. Presence of Gadolinium enhancement in the MRI in the tumor lesion(s) shown at the time of diagnosis of tumor recurrence.",{"count":55,"type":22},48,[25],"A Phase 1 Open-Label, First-in-human, Dose Escalation and Expansion Study to Determine the Safety, Tolerability, Dosimetry, Pharmacokinetics, and Preliminary Efficacy of 212Pb-DOTAM-GRPR1 in Adult Participants with Recurrent or Metastatic GRPR-expressing Tumors",[59,60,61,62,63,64,32],"Cervical Cancer","Breast Cancer","Colon Cancer","NSCLC","mCRPC (Metastatic Castration-resistant Prostate Cancer)","Glioblastoma",[66,67,68,69,70,71,72,73,59,74,75,76,77,78,79,80,81],"Metastatic Cancer","Advanced Cancer","Recurrent Cancer","Prostate Cancer, Castration-Resistant","Metastatic Prostate Cancer","Breast Cancer, Hormone Receptor Positive","Non-Small Cell Lung Cancer","Colorectal Cancer","Glioblastoma, Recurrent","Radioligand Therapy","Targeted Radiation Therapy","Gastrin-Releasing Peptide Receptor or Bombesin receptor subtype-2","Targeted Alpha Therapy","Lead-212 Radiopharmaceutical Therapy","Lead-203 Radiopharmaceutical Diagnostic","SPECT\u002FCT","RECRUITING","2026-06-09",{"date":85,"type":38},"2026-06-11",{"date":87,"type":38},"2022-12-22",{"date":89,"type":22},"2032-05",{"name":91,"class":45},"Orano Med Theranostics, SAS",8,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":23,"phases":102,"briefSummary":104,"conditions":105,"keywords":106,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},"100638468","evaluating-the-efficacy-and-safety-of-ai-localization-models-in-multidisciplinary-team-care-for-nsclc-100638468","NCT07626736","Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC","Evaluating the Efficacy and Safety of AI Localization Models in Multidisciplinary Team Care for NSCLC: a Prospective, Controlled Clinical Trial Protocol","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. MDT (Multidisciplinary Team) discussion deems a systemic treatment plan necessary;\n3. Complete clinical, imaging, and molecular pathological data.\n\nExclusion Criteria:\n\n1. Stage I patients;\n2. Diagnosed with a thoracic tumor other than NSCLC;\n3. Lack of detailed medical data, or missing data;",{"count":101,"type":22},300,[103],"NA","The goal of this clinical trial is to evaluate the effectiveness and safety of a locally deployed artificial intelligence (AI) decision-support model in the multidisciplinary team (MDT) process for patients with non-small cell lung cancer (NSCLC).\n\nThe main questions it aims to answer :\n\nWhat is the level of agreement between treatment recommendations generated by the AI model and those made by a traditional MDT? How often do clinicians modify their final treatment decision after reviewing the AI model's recommendation? Researchers will compare treatment plans from the traditional MDT (Arm 1), the AI model (Arm 2), and the clinician's final decision after reviewing the AI output (Arm 3) to assess consistency, decision modification rates, and clinical efficiency.\n\nParticipants will:\n\nHave their clinical, imaging, and molecular data submitted to both the traditional MDT and the AI model for independent treatment recommendations Receive a final treatment plan determined by clinicians after reviewing both recommendations, with follow-up for safety and survival outcomes",[32],[72,107,108,109,110],"Multidisciplinary Team","Locally Deployed AI Model","Large Language Model","Treatment Decision-Making","2026-05-31",{"date":113,"type":38},"2026-06-04",{"date":115,"type":38},"2025-12-01",{"date":117,"type":22},"2028-12-31",{"name":119,"class":120},"Wen-zhao ZHONG","OTHER",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":46},"100382002","phase-2-pilot-study-of-performance-status-2-vs-performance-status-0-1-non-small-cell-lung-cancer-patients-treated-with-chemoimmunotherapy-100382002","NCT04253964","Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo\u002FImmunotherapy","Phase II Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-Small Cell Lung Cancer Patients Treated With Chemo\u002FImmunotherapy","Inclusion Criteria:\n\n* Patients must have a cytological or histological diagnosis of non-small cell lung cancer that is metastatic or unresectable for which standard curative measures do not exist.\n* No prior systemic treatment with either chemotherapy or immunotherapy for non-curative intent. Patients may have previously received cancer treatment with curative intent for prior early-stage disease.\n* At least 18 years old.\n* ECOG performance status of 0-2, as determined by the treating physician in the consult note.\n* Life expectancy of greater than 3 months.\n* Patients must have normal organ and marrow function as defined below:\n* absolute neutrophil count ≥1,000\u002FmcL\n* platelets ≥100,000\u002FmcL\n* Chemotherapy agents are known to be teratogenic, therefore women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign an IRB-approved informed consent document.\n\nExclusion Criteria:\n\n* Nonsmall cell lung cancer that is known at registration to be positive for a tumor activating alteration for which first line targeted therapy is indicated9; specifically, a targetable mutation in epidermal growth factor receptor (EGFR), gene rearrangement of anaplastic lymphoma kinase (ALK), gene rearrangement of c-ros oncogene 1 (ROS1), or mutation in B isoform of rapidly accelerated fibrosarcoma (B-Raf). For non-squamous subtypes, molecular testing of tumor and peripheral blood should be attempted for actionable biomarkers, but if there is an insufficient quantity of tumor material for testing and it is not feasible to attempt additional biopsies before starting systemic therapy, then these biomarker results are not necessary for inclusion on the study. For squamous subtype, molecular testing should be considered but is not necessary for inclusion on the study.\n* Known to have an active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, systemic corticosteroids, or immunosuppressive drugs).\n* History of (non-infectious) pneumonitis that required systemic corticosteroids.\n* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects with chemotherapy. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy, breastfeeding should be discontinued.",{"count":129,"type":22},105,[26],"This pilot study is configured as a non-inferiority comparison of Performance Status 2 patients with Performance Status 0-1 patients, with the goal of demonstrating non-inferiority in terms of efficacy (progression-free survival, overall survival) and safety (rates of adverse events, quality of life) when treating Performance Status 2 patients with the same first-line immunotherapy-based regimen as Performance Status 0-1 patients.",[32,133],"Performance Status","2026-03-17",{"date":136,"type":38},"2026-03-19",{"date":138,"type":38},"2020-07-01",{"date":140,"type":22},"2026-09",{"name":142,"class":120},"Wake Forest University Health Sciences",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":4,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":46},"100578597","phase-1-assessing-an-oral-egfr-inhibitor-dzd6008-in-patients-who-have-advanced-nsclc-with-egfr-mutations-tian-shan2-100578597","NCT06813365","Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)","A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (TIAN-SHAN2)","Inclusion Criteria:\n\n1. Patients must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR sensitizing mutation (Exon19del and\u002For L858R) from a local CLIA-certified laboratory (or equivalent).\n5. Provide adequate amount of pretreatment tumor samples for retrospective confirmation of EGFR mutations by the central laboratory.\n6. Part A: Failed (progressed or are intolerant) at least 1 prior EGFR TKI and platinum-based chemotherapy. Part B: Cohorts 1 and 2: Failed 1 prior third-generation EGFR TKI. Cohorts 3 and 4: Patients who are treatment naïve.\n\n   Note: Patients enrolled in the study should be representative of the population to meet the need for efficacy analysis in the population after TKI failure (e.g., including appropriate proportion and number of patients with the C797X mutation if possible)\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Patients with brain metastases must have a stable BM status.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n11. Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B).\n2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n3. Prior treatment with any of the following:1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration;2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration;3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening;4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration.5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration;6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration;7)Major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Patients with any other malignancy within 2 years of the first administration of study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.\n8. Patients with active infection including but not limited to HBV, HCV, HIV and active infection of COVID-19.\n9. Resting QTcF \\> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases which would preclude adequate absorption of DZD6008.\n12. Women who are pregnant or breastfeeding.\n13. Hypersensitivity to active or inactive excipients of DZD6008.\n14. Involvement in the planning and conduct of the study.\n15. Judgment by the investigator that the patients is unlikely to comply with study procedures",{"count":151,"type":22},190,[25],"This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.",[155],"Nonsmall-cell Lung Cancer",[157],"Lung Cancer, EGFR mutation","2025-12-23",{"date":160,"type":38},"2025-12-30",{"date":162,"type":38},"2024-06-12",{"date":164,"type":22},"2028-07-30",{"name":166,"class":45},"Dizal Pharmaceuticals",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":185,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":46},"100431655","patient-centered-optimal-integration-of-survivorship-and-palliative-care-100431655","NCT04900935","Patient-centered, Optimal Integration of Survivorship and Palliative Care","Inclusion Criteria:\n\n* Age 18 or older\n* MGH Cancer Center patient\n* Within 6 months of diagnosis of metastatic NSCLC with oncogenic driver mutation (EGFR, ALK, ROS1, RET)\n* Receiving targeted therapy\n* Ability to respond in English or Spanish\n\nExclusion Criteria:\n\n* Cognitive impairment or serious mental illness that limits ability to provide informed consent\n* Need for urgent palliative care or hospice referral\n* Pregnant women\n* Prisoners",{"count":174,"type":22},70,[103],"The goal of this study is to develop and test the feasibility of a supportive care model (POISE) for patients with metastatic Non-small Cell Lung Cancer (NSCLC). The main questions are\n\n* is POISE feasible to deliver and acceptable to patients\n* what is the effect of POISE on the distress patients feel related to their uncertain future, their confidence in their ability to manage cancer, and their understanding about what to expect Participants in the randomized controlled trial will receive either the new supportive care model, POISE, which consists of four visits with a trained palliative care clinician, or care as usual, and will be asked to complete three surveys.",[178,179,32,180,181,182,183,184],"Stage IV Non-small Cell Lung Cancer","Targeted Therapy","Carcinoma, Non-Small-Cell Lung","ALK-positive Non-small Cell Lung Cancer","EGFR Positive Non-small Cell Lung Cancer","Palliative Care","Survivorship",[178,179,32,180,181,182,186,187,188,189],"ROS1 Positive Non-Small Cell Lung Cancer","Palliative care","survivorship","RET Fusion positive Non-Small Cell Lung Cancer","2025-11-19",{"date":192,"type":38},"2025-11-24",{"date":194,"type":38},"2023-09-29",{"date":196,"type":22},"2027-09-01",{"name":198,"class":120},"Massachusetts General Hospital",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":23,"phases":209,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":4},"100460419","phase-1-xp-102-and-xp-102-in-combination-with-trametinib-in-advanced-solid-tumor-patients-with-a-braf-v600-mutation-100460419","NCT05275374","XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation","A Dose-escalation and Expansion Phase I\u002FIIa Study of XP-102 and XP-102 in Combination With Trametinib in Advanced Solid Tumor Patients With a BRAF V600 Mutation (ENHANCE)","ENHANCE","Inclusion Criteria:\n\n* ≥18 years of age\n* Advanced malignant solid tumor patients with a BRAF V600 mutation (limited to melanoma, colorectal cancer, non-small cell lung cancer, or thyroid cancer).\n* Must have failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Prior treatment with BRAF inhibitors and\u002For MEK inhibitors is permitted；\n* At least one measurable lesion (brain metastasis must not be the only measurable lesion) according to Response Evaluation Criteria in Solid Tumours (RECIST v1.1);\n* ECOG performance status of 0 or 1;\n* Expected survival ≥ 3 months;\n* Adequate liver, renal, coagulation, cardiac, and hematologic function.\n* A negative pregnancy test if female patient is of reproductive potential.\n* For men and women of reproductive potential, agreement to use an effective contraceptive method from the time of screening and throughout their time on study.\n* Patients must agree to, and be capable of, adhering to the study visit schedule and all other protocol requirements;\n* Patients must understand and voluntarily sign the written informed consent form, before the initiation of any study-specific procedures in the trial.\n\nExclusion Criteria:\n\n* Active central nervous system (CNS) lesions. However, patients with asymptomatic and brain metastases who received treatment (including targeted brain radiotherapy, surgical treatment, glucocorticoid or other treatments) without disease progression for ≥ 3 months are eligible.\n* Patients who received radiotherapy, immunotherapy, hormone therapy, targeted therapy, biotherapy, traditional Chinese medicine therapy, chemotherapy or any clinical trial treatment within 14 days before the first dose.\n* Patients who have persistent toxicity caused by previous chemotherapeutic drugs or radiotherapy has not recovered to lower than grade 2 (except hair loss) according to CTCAE version 5.0;\n* Patients who are allergic to active substances or excipients of XP-102 or trametinib.\n* Significant traumatic injury within 28 days before the first dose of the investigational drug, or if major surgery is anticipated during the course of study treatment;\n* According to the judgment of the investigator, patients with dysphagia, or any gastrointestinal diseases that may affect drug absorption or activity;\n* Administration of strong inhibitors or inducers of CYP3A4 liver metabolic enzymes within 14 days before the first dose of the investigational drug;\n* Patients who are receiving drugs that may prolong QT interval and unable or unwilling to stop treatment or switch to other alternative treatment before study enrollment;\n* Symptomatic active fungal, bacterial and\u002For viral infections; including known HIV, active hepatitis B, active hepatitis C or active syphilis infection.\n* Any poorly controlled disorders (such as serious mental, neurological, cardiovascular, respiratory, digestive, urinary, bleeding and coagulation, or other system diseases) that may significantly affect the clinical trial;\n* Other situations not suitable for participation in the study as judged by the investigator.",{"count":208,"type":22},221,[25,26],"This is a first-in-human multi-center study which will be conducted in advanced malignant solid tumors patients. The solid tumor type is limited to melanoma, colorectal, non-small-cell lung, and thyroid cancer with positive BRAF V600 mutation. This study is divided into three stages: Phase Ia: a dose-escalation phase of XP-102; Phase Ib: a dose-escalation and sample size expansion phase of XP-102 plus trametinib; Phase IIa: an expansion phase of XP-102 plus trametinib.",[212,213,214,73,215,32],"Cancer","BRAF V600 Mutation","Melanoma","Thyroid Cancer","2025-04-09",{"date":218,"type":38},"2025-04-10",{"date":220,"type":22},"2025-12-31",{"date":222,"type":22},"2028-12-30",{"name":224,"class":45},"Xynomic Pharmaceuticals, Inc.",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":232,"targetDuration":4,"studyType":23,"phases":234,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":46},"100345523","phase-1-tcr-t-cell-immunotherapy-of-lung-cancer-and-other-solid-tumors-100345523","NCT03778814","TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors","TCR-T Cells Targeting Cancer Cells for Immunotherapy of Lung Cancer and Other Solid Tumors: Phase I Clinical Trial","Inclusion Criteria:\n\n1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable\n2. Life expectancy \\>12 weeks\n3. Child-Pugh-Turcotte score \\\u003C7\n4. Adequate heart,lung,liver,kidney function\n5. Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay\n6. Informed consent explained to, understood by and signed by patient\u002F guardian. Patient\u002Fguardian given copy of informed consent. -\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Tumor size more than 25cm;\n3. Severe virus infection such as HBV, HCV, HIV, et al\n4. Known HIV positivity\n5. History of lung transplantation\n6. Active infectious disease related to bacteria, virus,fungi,et al\n7. Other severe diseases that the investigators consider not appropriate;\n8. Pregnant or lactating women\n9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday)\n10. Other conditions that the investigators consider not appropriate.",{"count":233,"type":22},30,[25],"Tumor organoids and TILs (and\u002For peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.",[32,237],"Solid Tumor, Adult",[239,240,241],"Lung Cancer; Solid Tumor","Immunotherapy","TCR-T Cell Therapy","2024-06-22",{"date":244,"type":38},"2024-06-25",{"date":246,"type":38},"2018-12-01",{"date":248,"type":22},"2036-12-30",{"name":250,"class":120},"Second Affiliated Hospital of Guangzhou Medical University",{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":46},"100527423","phase-2-a-study-of-hs-10365-in-patients-with-advanced-or-metastatic-ret-fusion-positive-non-small-cell-lung-cancer-100527423","NCT06147570","A Study of HS-10365 in Patients With Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy，Safety and Pharmacokinetics of HS-10365 as First-Line Treatment for Patients With Locally Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years.\n2. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC with RET fusion-positive, including recurrent or initial diagnosed Stage IIIB-IIIC\u002FIV NSCLC that is not suitable for radical surgery.\n3. A RET gene fusion is required by using tumor tissue for central testing.\n4. At least one measurable lesion in accordance with RECIST 1.1\n5. Eastern Cooperative Oncology Group (ECOG) performance status: 0\\~1.\n6. Estimated life expectancy \\>12 weeks.\n7. Reproductive-age women agree to use adequate contraception and cannot breastfeed while participating in this study and for a period of 6 months after the last dose. Likewise, men also consent to use adequate contraceptive method within the same time limit.\n8. Females must have evidence of non-childbearing potential.\n9. Signed and dated Informed Consent Form.\n\nExclusion Criteria:\n\n1. Treatment with any of the following:\n\n   Additional validated oncogenic drivers in NSCLC if known. Previous or current treatment with selective RET inhibitors or multi-kinase Inhibitor of RET.\n\n   Prior systemic therapy for metastatic disease. Treatment (including chemotherapy or immunotherapy) in the adjuvant\u002Fneoadjuvant setting is permitted if it was completed at least 6 months prior to relapse.\n\n   Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks of the first dose.\n\n   Major surgery (including craniotomy, thoracotomy, or laparotomy, etc.) within 4 weeks of the first dose of study drug.\n2. Inadequate bone marrow reserve or serious organ dysfunction.\n3. Uncontrolled pleural effusion or ascites or pericardial effusion.\n4. Known and untreated, or active central nervous system metastases.\n5. Active autoimmune diseases or active infectious disease\n6. Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.\n7. History of severe allergic reaction, hypersensitivity to any active or inactive ingredient of HS-10365 or to drugs with a similar chemical structure or class to HS-10365.\n8. The subject who is unlikely to comply with study procedures, restrictions, or requirements judged by the investigator.\n9. The subject whose safety cannot be ensured or study assessments would be interfered judged by the investigator.\n10. Pregnant women, breastfeeding women or woman who has a child-bearing plan during the study.\n11. History of neuropathy or mental disorders, including epilepsy and dementia",{"count":259,"type":22},62,[26],"HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.",[32],"2023-11-22",{"date":265,"type":38},"2023-11-27",{"date":267,"type":38},"2023-09-25",{"date":269,"type":22},"2028-08-31",{"name":271,"class":45},"Jiangsu Hansoh Pharmaceutical Co., Ltd."]