[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-lung-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100616630","phase-2-a-phase-ii-clinical-study-of-skb571-as-monotherapy-in-patients-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-with-met-abnormalities-100616630",false,"NCT07308106","A Phase II Clinical Study of SKB571 as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","A Phase II Clinical Study to Evaluate the Safety and Efficacy of SKB571 for Injection as Monotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With MET Abnormalities","Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).\n2. Participants with histologically or cytologically confirmed NSCLC.\n3. Locally advanced or metastatic NSCLC with MET Abnormalities that has progressed after standard therapy.\n4. At least one measurable lesion as assessed by the investigator according to RECIST v1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose.\n6. Life expectancy ≥ 3 months as assessed by the investigator.\n7. Adequate organ and bone marrow function.\n8. Male and female participants must agree to use highly effective methods of contraception during the study treatment period.\n9. Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.\n\nExclusion Criteria:\n\n1. Participants with known active central nervous system (CNS) metastasis, and\u002For carcinomatous meningitis, brainstem metastasis, metastases to spinal cord, or spinal cord compression.\n2. Participants with other malignant tumors within 3 years prior to the first dose.\n3. Presence of any of the following cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors.\n4. Presence of severe and\u002For uncontrolled concomitant diseases.\n5. Participants with a history of interstitial lung disease (ILD) or a history of non-infectious pneumonitis.\n6. Clinically severe lung damage due to complications of lung disorder.\n7. Risk of esophagotracheal fistula or esophagopleural fistula, or tumor invasion or compression of surrounding vital organs and blood vessels.\n8. Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1.\n9. Known active pulmonary tuberculosis.\n10. Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.\n11. Active hepatitis B and hepatitis C.\n12. Positive test for human immunodeficiency virus (HIV) or a medical history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n13. Known allergy or hypersensitivity to SKB571 or its excipients; or a history of severe allergy to other monoclonal antibodies.\n14. Participants who have undergone major surgery within 4 weeks before the first dose or are expected to require major surgery during the study.\n15. Serious infection within 4 weeks before the first dose.\n16. Participants who have received systemic corticosteroid therapy with \\> 10 mg\u002Fday of prednisone or other immunosuppressive drugs within 2 weeks before the first dose of study treatment.\n17. Participants who have received a live vaccine within 30 days before the first dose, or plan to receive a live vaccine during the study.\n18. Pregnant or breastfeeding women.\n19. Have local or systemic diseases caused by non-malignant tumors, or diseases or symptoms secondary to tumors.\n20. Any condition that, in the investigator's opinion, interferes with the evaluation of study treatment, participant safety, or interpretation of study results, or any other condition that the investigator deems unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The aim of the study to evaluate the safety and efficacy of SKB571 for injection as monotherapy in patients with locally advanced or metastatic Non-Small Cell Lung Cancer with MET abnormalities. Eligible subjects will receive SKB571 monotherapy, until radiographic disease progression, intolerable toxicity, discontinuation of study treatment required by the subject, or other protocol-specified treatment discontinuation criteria, whichever occurs first.",[27],"Non-small Lung Cancer","RECRUITING","2026-05-06",{"date":31,"type":32},"2026-05-11","ACTUAL",{"date":34,"type":32},"2026-04-03",{"date":36,"type":21},"2029-03-31",{"name":38,"class":39},"Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":68},"100560870","phase-2-a-study-of-sotorasib-in-people-with-non-small-cell-lung-cancer-100560870","NCT06582771","A Study of Sotorasib in People With Non-Small Cell Lung Cancer","A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Written informed consent\n* Biopsy-proven metastatic or recurrent non-small cell lung cancer\n* KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing\n* No prior therapy in the advanced setting\n* Measurable disease per RECIST 1.1\n* Karnofsky performance status (KPS) ≥ 70%\n* Age ≥ 18\n* Adequate organ function\n\n  * Hemoglobin ≥ 9\\^9 g\u002FdL\n  * Platelets ≥ 75 x 10\\^9\u002FL\n  * Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9\u002FL\n  * AST \\\u003C 3 x ULN (if liver metastases are present, \\\u003C 5 x ULN)\n  * ALT \\\u003C 3 x ULN (if liver metastases are present, \\\u003C 5 x ULN)\n  * Alkaline phosphatase \\\u003C 2 x ULN (if liver or bone metastases are present,\\\u003C 3 xULN)\n  * Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits\n  * Serum creatinine \\\u003C 1.5 x ULN or if available, calculated or measured creatinine clearance \\> 30 mL\u002Fmin\u002F1.73 m\\^2\n\nIn addition, patients must:\n\n* Be willing to undergo pre-treatment and day 7-21 on-treatment tumor biopsies\n* Decline first-line chemotherapy and\u002For anti-PD-(L)1 therapy, or previously have experienced disease progression after adjuvant or consolidation chemotherapy or anti-PD-(L)1 therapy for early stage (I-III) NSCLC\n\nBefore enrollment, a woman must be either:\n\n* Not of childbearing potential: premenarchal; postmenopausal (\\>45 years of age with amenorrhea for at least 12 months); post-hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n* Of childbearing potential and practicing effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies, as described below:\n\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject), which is defined as refraining from heterosexual intercourse during the entire period of the study, including up to 6 months after the last dose of study drug is given. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not consider an acceptable contraceptive method\n* Have a sole partner who is vasectomized\n* Practicing 2 methods of contraception, including one highly effective method (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of intrauterine device \\[IUD\\] or intrauterine system \\[IUS\\], AND, a second method (e.g., condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or collusive cap \\[diaphragm or cervical\u002Fvault caps\\] with spermicidal foam\u002Fgel\u002Ffilm\u002F cream\u002Fsuppository) Subjects must agree to continue contraception throughout the study and continuing through at least 7 days after the last dose of study drug\n* NOTE: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin a highly effective method of birth control, as described above.\n* A woman of childbearing potential must have a negative serum (b-human chorionic gonadotropin \\[b-hCG\\]) at Screening\n* A man who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug.\n\ncontraception; placement of an intrauterine device \\[IUD\\] or intrauterine system \\[IUS\\]). If the subject is vasectomized, he must still use a condom (with or without spermicide), but his female partner is not required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Any radiotherapy within 1 week of starting treatment on protocol\n* Any major surgery within 1 week of starting treatment on protocol\n* Exposure to prior adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy for stage I-III disease within 12 weeks of start of initiation of sotorasib\n* Unresolved \\> grade 1 toxicity from any previous treatment\n* Prior history of \\> grade 1 pneumonitis from any previous treatment\n* Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, uncontrolled inflammatory GI disease (eg, Crohn's disease, ulcerative colitis)\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg) o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n\nPositive hepatitis C antibody (anti-HCV)\n\no NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n\n* Other clinically active or chronic liver disease\n* Currently enrolled in another investigational device or drug study, or less than 28 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)\n* Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives (whichever is longer) of the drug or its major active metabolite, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator\n* Use of strong inducers of CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the principal investigator\n* Use of P-gp substrates within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the principal investigator\n* Patients who do not agree to pre-treatment and on-treatment tumor biopsies during the informed consent process will be excluded from the study. Patients who agree to pre-treatment and on-treatment tumor biopsies, but in whom either biopsy is ultimately deemed unsafe by the investigators\u002Ftreatment team, will be allowed to participate in the study and will remain evaluable for the clinical endpoints.",{"count":49,"type":21},39,[24],"The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a \"first-line therapy\" since their cancer became advanced.)",[53],"Non Small Lung Cancer",[55,56,57],"Sotorasib","advanced KRAS G12C-mutant","24-049","2026-03-23",{"date":60,"type":32},"2026-03-25",{"date":62,"type":32},"2024-08-30",{"date":64,"type":21},"2026-08",{"name":66,"class":67},"Memorial Sloan Kettering Cancer Center","OTHER",7,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":40},"100608242","real-world-study-of-taletrectinib-in-advanced-ros1-nsclc-following-entrectinib-progression-100608242","NCT07199010","Real-world Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression","A Multicenter, Non-interventional, Observational Study of Taletrectinib in Advanced ROS1+ NSCLC Following Entrectinib Progression","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically or cytologically metastatic NSCLC (UICC\u002FAJCC TNM Staging System, 9th Edition, Stage Ⅳ).\n* At least one measurable target tumor lesion as accessed by RECIST v1.1 criteria.\n* Documented ROS1 gene fusion identified by an approved molecular testing method (FISH, RT-PCR, or NGS).\n* Progressed following entrectinib treatment, regardless of prior exposure to chemotherapy, antiangiogenic multikinase inhibitors, or immunotherapy.\n* Considered by the investigator to be candidates for Taletrectinib treatment ; OR Patients with ≤6 months of prior Taletrectinib exposure enrolled retrospectively. (Note: For retrospective patients deceased before enrollment, waiver of informed consent is required. Patients who initiated and discontinued treatment within 6 months prior to signing informed consent are eligible).\n* Signed Informed Consent.\n\nExclusion Criteria:\n\n* Patients with driver gene mutations\u002Falterations that have approved targeted therapies , including but not limited to EGFR, ALK, RET, etc.\n* Currently participating in other interventional clinical trials or having received investigational drug treatment within 4 weeks prior to enrollment .\n* Pregnancy or breastfeeding.\n* Patients with uncontrolled co-morbidities who are assessed by the investigator not to receive targeted therapy.\n* Other conditions that are assessed by the investigator to be unsuitable for enrollment in this study.",{"count":77,"type":21},50,"OBSERVATIONAL","This is a multicenter, non-interventional, observational real-world study to evaluate the efficacy and safety of Taletrectinib in ROS1-positive non-small cell lung cancer (NSCLC) following Entrectinib progression. Patients deemed eligible for Taletrectinib by their physicians were enrolled after providing informed consent. Taletrectinib will be administered according to clinical practice and data on treatment patterns, clinical outcomes, and safety will be collected during routine evaluations.",[27],"NOT_YET_RECRUITING","2025-09-22",{"date":84,"type":32},"2025-09-30",{"date":86,"type":21},"2025-10",{"date":88,"type":21},"2027-12",{"name":90,"class":39},"Innovent Biologics (Suzhou) Co. Ltd."]