[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-stage-iv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-stage-iv":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,49,77,107,131,157,181,203,227,249,272,301,323,346,373,399,421,443,461,481,505,525,542,568,592],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100558524","phase-2-phase-ii-efficacy-study-of-repotrectinib-in-frail-andor-elderly-patients-with-ros1-rearranged-advanced-nsclc-100558524",false,"NCT06552234","Phase II Efficacy Study of Repotrectinib in Frail and\u002For Elderly Patients With ROS1-rearranged Advanced NSCLC","Open-label Phase II Efficacy Study of Repotrectinib in Frail (PS ≥2) and\u002For Elderly Patients With ROS1-rearranged Advanced NSCLC","REPOROS","Inclusion Criteria:\n\n* Eligible patients are defined as patients with\n\n  * Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at the time of inclusion and\u002For\n  * Age ≥ 70 years\n* Age ≥ 18 years\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an ROS1 gene rearrangement as by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing \\[NGS\\], Sanger sequencing, reverse transcription-polymerase chain reaction), Break-apart fluorescence in situ hybridization (FISH) or Immunohistochemistry (IHC) (confirmed by NGS or qPCR test).\n* Willing and able to provide written institutional review board (IRB)\u002Finstitutional ethics committee-approved Informed Consent.\n* At least 1 measurable target lesion according to RECIST (v1.1). CNS-only measurable disease as defined by RECIST (v1.1) is allowed.\n* Prior cytotoxic chemotherapy for advanced or metastatic disease is allowed. At the time of starting treatment with repotrectinib, at least 14 days or 5 half-lives (whichever is shorter) must have elapsed after discontinuation of prior cytotoxic chemotherapy (or at least 42 days for prior nitrosoureas, mitomycin C, and liposomal doxorubicin) and all side effects from prior treatments must have resolved to grade ≤ \\_1 (CTCAE Version 5.0 with the exception of alopecia.\n* Prior immunotherapy (e.g., anti-PD-1, anti-PDL1, anti-TIM3, anti-OX40) is allowed. At the time of starting treatment with repotrectinib, at least 14 days must have elapsed after discontinuation of prior immunotherapy treatment and all immune-related side effects from prior treatments must have resolved to grade ≤ \\_1.\n* No prior ROS1 TKI is allowed for the TKI naïve cohort.\n* Prior ROS1 TKI is allowed for the TKI pretreated cohort (max 30% of patients). At least 7 days or 5 half-lives (whichever is shorter) must have elapsed since completion of treatment with the last ROS1i prior to starting treatment with repotrectinib for subjects enrolling into the TKI-pretreated expansion cohorts. All side effects from prior treatments with ROS1i must have resolved to grade ≤ \\_1 prior to starting treatment with repotrectinib.\n\n  * Prior ROS1i allowed include crizotinib, ceritinib, lorlatinib, brigatinib, entrectinib, ensartinib, cabozantinib.\n* Subjects with symptomatic CNS metastases and\u002For asymptomatic leptomeningeal carcinomatosis are eligible.\n* Life expectancy ≥3 months\n* Subject affiliated to an appropriate social security system\n* Adequate hematologic and end-organ function, defined by the following laboratory\n\n  * ANC ≥ 1500 \u002Fmm3 without granulocyte colony-stimulating factor support\n  * Lymphocyte count ≥ 500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3 without transfusion\n  * Hemoglobin ≥ 9.0 g\u002FdL. Patients may be transfused to meet this criterion.\n  * INR or aPTT ≤ 1.5, upper limit of normal (ULN)\n  * This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be receiving a stable dose.\n  * ASAT, ALAT, and alkaline phosphatase ≤ 2.5xULN, with the following exceptions:\n  * Patients with documented liver metastases: ASAT and\u002For ALAT ≤ 5xULN\n  * Patients with documented liver or bone metastases: alkaline phosphatase \\\u003C 5xULN\n  * Serum bilirubin ≤1.25xULN\n  * Patients with known Gilbert disease who have serum bilirubin level ≤ 3xULN may be enrolled.\n  * Calculated creatinine clearance (CRCL) ≥ 45 mL\u002Fmin\n* Adequate method of contraception during the treatment period\n\n  * For Females:\n\nAll women of childbearing potential (WOCBP) must agree to avoid pregnancy during the study and must use a highly effective method of contraception during study treatment with repotrectinib and for at least 2 months following the final dose.\n\nHighly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), injectable or implantable contraceptives and abstinence.\n\nHormonal contraception must begin 7 days prior to the first dose of study treatment.\n\nDue to a potential loss of effectiveness of hormonal contraceptives caused by interaction with study intervention, if WOCBP use hormonal contraceptives (including oral hormonal contraceptives), they must use either another form of non-hormonal highly effective contraception or a reliable barrier method.\n\nFemale subjects must refrain from egg donation from screening through at least 2 months after the last dose of study drug.\n\n* For Males:\n\nMale participants with WOCBP partners must use latex condoms during treatment with repotrectinib and for 4 months following the final dose even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding.\n\nMale subjects must refrain from sperm donation from screening through at least 4 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Malignancies other than NSCLC within 2 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS ≥ 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\n* Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HBsAg) are eligible only if they are negative for HBV DNA. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA.\n* Active tuberculosis\n* Severe infections within 2 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina\n* Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study\n* Any other diseases, 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 or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* Patients with illnesses or conditions that interfere with their capacity to understand follow and\u002For comply with study procedures.\n* Concurrent participation in any therapeutic clinical trial\n* Patient deprived of liberty or placed under the authority of a tutor or a curator\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","ROS1 rearrangements are rare, accounting for only 1-2% of NSCLC cases, but have been associated with response to ROS1 inhibitors, such as crizotinib and entrectinib. However, many patients develop resistance to the tyrosine-kinase inhibitors (TKIs), creating a need for new treatments.\n\nRepotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies (Drilon 2018). Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements (TRIDENT-1 study), but there are limited evidence in frail populations, such as poor performance status patients and\u002For elderly patients, who are classically excluded from clinical trials or underrepresented.\n\nThe present study aims to assess the activity and tolerability of repotrectinib in frail (PS ≥2) and\u002For elderly patients with ROS1-rearranged advanced NSCLC.",[28,29],"NSCLC Stage IV","NSCLC, Stage III",[31,32,33,34,35],"tyrosine-kinase inhibitors","Frail patients","Elderly patients","ROS1 rearrangements","resistance","RECRUITING","2026-06-15",{"date":39,"type":40},"2026-06-16","ACTUAL",{"date":42,"type":40},"2024-10-01",{"date":44,"type":22},"2031-09",{"name":46,"class":47},"Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer","OTHER",20,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100481002","phase-1-a-phase-ibii-clinical-trial-of-m701-in-the-treatment-of-malignant-pleural-effusions-caused-by-nsclc-100481002","NCT05543330","A Phase Ib\u002FII Clinical Trial of M701 in the Treatment of Malignant Pleural Effusions Caused by NSCLC","A Phase 1, Multicenter, Open-label, Dose-increasing Study to Evaluate the Safety, Tolerability, PK\u002FPD and Preliminary Efficacy of M701, a Recombinant Epcam and CD3 Bispecific Antibody , in Patients With Malignant Pleural Effusions Caused by NSCLC","Inclusion Criteria:\n\n1. Males or females, aged \\> 18 years.\n2. Histologically- or cytologically-confirmed non-small cell lung cancer that has progressed after first line systemic therapy.\n3. Malignant pleural effusion diagnosed histologically or cytologically, with moderate or above moderate pleural fluid (sitting pleural fluid depth ≥ 4 cm via ultrasound, expected pleural fluid volume ≥ 500 mL) . Require clinical intervention and not treated yet.\n4. Patients who have an washout period of ≥ 4 weeks or 5 half-life of the drug (including radiotherapy, chemotherapy, immunotherapy, biologic, targeted, hormonal therapy, and 14 days for local radiotherapy) between the last systemic therapy and the first dose; however, no washout period is required if the subject has new pleural fluid or poor control of current pleural fluid after at least 2 cycle systemic therapy.\n5. Patients who had recovered to grade 0-1 of any toxic reaction to prior antineoplastic therapy as determined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) V5.0, with the exception of alopecia, hyperpigmentation and ≤ grade 2 neuropathy, hormone replacement hypothyroidism or other adverse events confirmed to have turned chronic.\n6. Patients with physical status ECOG score (PS) of 0-2.\n7. Patients with life expectancy ≥ 12 weeks.\n8. Bone marrow: absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL, platelet count ≥ 100 ×10\\^9\u002FL, hemoglobin ≥ 8.5 g\u002FdL (without blood transfusion within14 days of the first dose of study drug); Liver: bilirubin (TBIL)≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 3 x ULN ( ≤ 5 x ULN in case of liver metastases); Kidney: serum creatinine ≤1.5 x ULN.\n9. Patients must understand and voluntarily sign the written informed consent.\n\nExclusion Criteria:\n\n1. Patients with asymptomatic pleural fluid and not requiring clinical intervention, or bilateral malignant pleural fluid, or proposed perfusion of the chest cavity presenting with pleural fluid separation.\n2. Patients with central nervous system (CNS) metastases resulting in clinical symptoms or requiring therapeutic intervention; patients previously treated for brain metastases may be enrolled if they have been asymptomatic for ≥ 4 weeks prior to the first dose and have imaging indicating stable disease and do not require corticosteroid or anticonvulsant therapy.\n3. Patients with a known history of severe allergy to M701 drug components or antibody-like macromolecular drugs.\n4. Patients with contraindications to thoracentesis.\n5. Patients who have undergone major surgical procedures within 4 weeks prior to the first dose.\n6. Patients with extensive liver metastases (\\>70%).\n7. Patients with uncontrollable active infection (NCI-CTCAE V5.0 ≥ grade 2).\n8. Patients required long-term hormonal or immunosuppressive therapy, e.g. active autoimmune disease, maintenance therapy after organ transplantation, except that the following are allowed to enter screening: type I diabetes mellitus, hypothyroidism that can be controlled by replacement therapy only, skin diseases that do not require systemic therapy (e.g. vitiligo, psoriasis or alopecia).\n9. Patients with severe respiratory disease which, in the judgment of the investigator, makes them unsuitable for entry; or combined interstitial pneumonia.\n10. Patients with history of severe cardiovascular disease, including previous coronary artery bypass grafting or coronary stenting, myocardial infarction within 6 months, congestive heart failure (New York Classification of Cardiac Function Class III-IV) or unstable angina, or uncontrolled hypertension.\n11. Patients with QTc interval \\> 480 ms,family or personal history of long or short QT syndrome, clinically significant history of ventricular arrhythmias or implantation of a defibrillation device for ventricular arrhythmias.\n12. Patients with a history of (non-study tumour) malignancy (except squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other, non-invasive lesions that the investigator and sponsor agree have been cured and have a minimal risk of recurrence within 3 years) within 3 years prior to the date of first study drug administration.\n13. Patients who have active hepatitis B (HBV-DNA quantification ≥ 1 x 10\\^4 copies\u002FmL or 2000 IU\u002FmL), active hepatitis C (positive for hepatitis C antibodies and HCV-RNA above the lower limit of detection of the assay), active syphilis with positive HIV antibodies.\n14. Pregnant or breastfeeding woman,Plan to conceive within six months;\n15. Patients with a confirmed history of neurological or mental disorders, including epilepsy and dementia.\n16. Those that are deemed ineligible for this clinical trial by investigator.","75 Years",{"count":58,"type":22},96,[60,25],"PHASE1","This is a phase 1\u002Fphase 2, multicenter, open-label study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of M701 in patients with treatment of malignant pleural effusions caused by NSCLC.",[63,28],"Malignant Pleural Effusions",[63,65],"NSCLC","2026-05-11",{"date":68,"type":40},"2026-05-14",{"date":70,"type":40},"2022-09-30",{"date":72,"type":22},"2026-12-15",{"name":74,"class":75},"Wuhan YZY Biopharma Co., Ltd.","INDUSTRY",1,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},"100489803","phase-2-a-study-of-targeted-radiation-therapy-in-people-with-non-small-cell-lung-cancer-nsclc-100489803","NCT05657873","A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)","A Phase II Trial of Hepatic Ablation of Metastases to Modulate and Enhance Immunotherapy Response (HAMMER) in NSCLC","Inclusion Criteria:\n\n* Be greater than 18 years of age on day of signing informed consent.\n* Have a histologically confirmed diagnosis of stage IV NSCLC (includes patients who have progressed on durvalumab for Stage III NSCLC) without known mutations in (EGFR) or BRAF or rearrangements in ALK (anaplastic lymphoma kinase) or ROS-1.\n\n  o Patients with recurrent metastatic NSCLC following prior durvalumab for stage III disease are eligible provided this is their first immunotherapy course for metastatic disease (i.e., the planned anti-PD-(L)1-based regimen represents first-line systemic therapy in the metastatic setting).\n* Newly diagnosed metastatic non-small cell lung cancer (NSCLC), including both de novo and secondary metastatic disease, with one or more liver metastases\n* Plan to initiate standard of care anti-PD-(L)1 based immunotherapy +\u002F- platinum based chemotherapy for at least 3 cycles\n\n  o Regimens combining anti-CTLA-4 immunotherapy with anti-PD-1 (e.g., ipilimumab plus nivolumab) or anti-PD-L1 (e.g., tremelimumab plus durvalumab) immunotherapy are allowed.\n* Have a performance status of 0-2 on the ECOG Performance Scale.\n* Liver function tests:\n\n  * Total Bilirubin ≤ 1.5 x ULN\n  * AST\u002F ALT ≤ 5 x ULN\n* Eligible for L- SABR to all liver metastases as determined by the treating radiation oncologist\n* Patients with known HIV are eligible provided they are under treatment with effective anti-retroviral therapy with CD4 count \\>200 cells\u002Fmicroliter within 28 days prior to registration\n\nExclusion Criteria:\n\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* Patients with prior external beam radiation therapy to the liver.\n* Patients with known active Hepatitis B or Hepatitis C.\n* Patients with immunosuppression including pharmacological immunosuppression with chronic steroids or immune modulators like cyclosporin or methotrexate and patients with active autoimmune disease.\n* Patients who are pregnant or breastfeeding\n* Men or women not using effective contraception.",{"count":85,"type":22},68,[25],"The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy\u002FL-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer\u002FNSCLC.",[89,90,91,65,28],"Non Small Cell Lung Cancer","Non Small Cell Lung Cancer Metastatic","Non-small Cell Carcinoma",[93,90,91,94,95,65,28,96,97],"non small cell lung cancer","liver stereotactic ablative radiotherapy","L-SABR","Memorial Sloan Kettering Cancer Center","22-368","2026-05-06",{"date":100,"type":40},"2026-05-07",{"date":102,"type":40},"2022-12-09",{"date":104,"type":22},"2026-12-09",{"name":96,"class":47},9,{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":130},"100573409","phase-3-clinical-trial-of-n-803-plus-tislelizumab-or-prior-failed-immune-checkpoint-inhibitor-and-docetaxel-versus-docetaxel-monotherapy-in-participants-with-advanced-or-metastatic-non-small-cell-lung-cancer-who-have-acquired-resistance-to-immune-checkpoint-in-100573409","NCT06745908","Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint In","Randomized, Two-Cohort, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy","Eligibility Criteria:\n\nWomen and men of all races and ethnic groups are eligible for this trial.\n\nCohort A\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Pathologically confirmed stage IV NSCLC disease.\n4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \\[± 2 weeks\\]). Participants who received anti-PD-1\u002Fanti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1\u002Fanti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1\u002Fanti-PD-L1 mAb in their immediate prior line of therapy to be eligible.\n5. Participants with AGA must have 1 or more documented AGA(s): EGFR, ROS1, neurotrophic tyrosine receptor kinase (NTRK), B rapidly accelerated fibrosarcoma (BRAF), mesenchymal epithelial transition (MET) exon 14 skipping, rearranged during transfection (RET), Kirsten Rat sarcoma (KRAS) and HER2.\n6. Participants with AGA must meet the following criteria for advanced or metastatic NSCLC. Participants who have been treated with 1 or 2 prior lines of applicable targeted therapy that is locally approved (and is standard of care) for the participant's genomic alteration at the time of screening:\n\n   1. Participants who have tumors with EGFR L858R or exon 19 deletion mutations must have received prior osimertinib.\n   2. Participants who received a targeted agent as adjuvant therapy for early-stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose or received at least one additional course of targeted therapy for the same genomic alteration (which may or may not be same agent used in the adjuvant setting) for relapsed\u002Fprogressive disease.\n   3. Participants who have been treated with a prior tyrosine kinase inhibitor (TKI) must receive additional approved targeted therapy, if locally available and clinically appropriate, for the applicable genomic alteration, or the participant will not be allowed in the study.\n   4. Participants must also meet the inclusion criteria #4 listed above.\n7. ECOG performance status of 0 to 2.\n8. Measurable tumor lesions according to RECIST v1.1.\n9. Have a life expectancy of at least 3 months.\n10. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n11. Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.\n12. Participants with known HIV infection must be receiving anti retroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n1. Systemic autoimmune disease currently requiring treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma). The participant must have been off treatment for 180 days.\n2. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.\n3. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring treatment with systemic steroids; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.\n4. Participants with AGA of ALK.\n5. History of known active hepatitis B or C infection to be assessed within 6 months prior to enrollment using locally accepted standard of care measurements. (Resolved cases are allowed.)\n6. Active infection requiring antibiotic therapy.\n7. Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and\u002For spinal cord compression.\n8. Body weight ≤ 40 kg at screening.\n9. Active treatment with CYP3A4 inhibitors.\n10. Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).\n11. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n12. Participants with known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.\n13. Had major surgery within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery in the opinion of the treating Investigator.\n14. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. Absolute lymphocyte count \\\u003C institutional lower limit of normal (LLN) (ie, participant should have a normal lymphocyte count to enroll in the study).\n    2. Absolute neutrophil count ≤ 1,500 cells\u002Fmm3.\n    3. Platelet count ≤ 100,000 cells\u002Fmm3.\n    4. Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × upper limit of normal (ULN) or direct bilirubin is \\> ULN.\n    5. Aspartate aminotransferase (AST \\[serum glutamic-oxaloacetic transaminase; SGOT\\]) or alanine aminotransferase (ALT \\[serum glutamic pyruvic transaminase; SGPT\\]) \\> 1.5 × ULN.\n    6. Alkaline phosphatase (ALP) levels \\> 2.5 × ULN.\n    7. Hemoglobin \\\u003C 9.0 g\u002FdL.\n    8. Serum creatinine \\> 2.0 mg\u002FdL or 177 μmol\u002FL or creatinine clearance \\\u003C 40 mL\u002Fmin (using the Cockcroft-Gault formula below):\n\n    Female = \\[(140 - age in years) × weight in kg × 0.85\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] Male = \\[(140 - age in years) × weight in kg × 1.00\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n15. Have any of following:\n\n    1. Cirrhosis at a level of Child-Pugh B (or worse);\n    2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or\n    3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n16. Participation in an investigational drug study within 21 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.\n17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n18. Pregnant and nursing women.\n19. History of allergic reactions to tislelizumab.\n20. History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.\n21. Confinement in an institution by order of a court or authority.\n\nCohort B\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines.\n3. Pathologically confirmed stage IV NSCLC disease.\n4. Have acquired resistance to a regional Health Authority-approved immune plus platinum-based chemotherapy, defined as disease progression immediately following an initial response (of any duration) or stable disease (approximately 6 months duration \\[± 2 weeks\\]). Participants who received anti-PD-1\u002Fanti-PD-L1 mAb as first-line therapy may have received the combination of platinum-based chemotherapy and anti-PD-1\u002Fanti-PD-L1 mAb in the second line. Participants must have received platinum chemotherapy to be eligible. Participants must have received anti-PD-1\u002Fanti-PD-L1 mAb in their immediate prior line of therapy to be eligible.\n5. Participants who receive an immune CPI as consolidation therapy after chemoradiation are eligible if they show progression or recurrence within 3 months of their last CPI and must have received at least 6 months of exactly 1 line of prior CPI therapy. If that CPI is not approved for advanced NSCLC, then an approved alternative CPI will be used.\n6. If participants are positive for actionable genomic alteration (AGA), defined as a genomic alteration which has at least 1 regional Health Authority-approved targeted therapy. Participants MUST have received at least 1 targeted therapy or 2 or more if multiple lines of targeted therapies are approved in the region. Thus, participants must have exhausted regional Health Authority-approved targeted therapies for their specific AGA for first- or second-line NSCLC, then have acquired resistance to immune checkpoint therapy to be eligible. Participants must meet inclusion criteria #4.\n7. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of study medication. Participants with asymptomatic brain metastases (ie, no neurological symptoms, no requirements for corticosteroids, and no lesion \\>1.5 cm) may participate but will require regular imaging of the brain as a site of disease.\n8. ECOG performance status of 0 to 2.\n9. Measurable tumor lesion(s) according to RECIST v1.1.\n10. Have a life expectancy of at least 3 months.\n11. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n12. Agreement to practice effective contraception for female participants of child-bearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative serum pregnancy test at screening and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive associated with inhibition of ovulation, or an intrauterine device \\[IUD\\]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.\n13. Participants with known HIV infection must be receiving antiretroviral therapy and have an undetectable viral load at their most recent viral load test within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n1. Autoimmune disease currently requiring systemic treatment (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease, or autoimmune disease associated with lymphoma) except for autoimmune thyroiditis needing thyroid replacement and diabetes requiring insulin. The participant must have been off treatment for 60 days.\n2. History of any of the following: drug-induced severe cutaneous adverse reaction (SCAR), including, but not limited to Stevens-Johnson syndrome\u002Ftoxic epidermal necrolysis (SJS\u002FTEN), drug reaction with eosinophilia and systemic symptoms (DRESS), or dose-limiting immune-mediated reactions.\n3. History of allogeneic hematopoietic stem cell transplant or organ transplant requiring immunosuppression; or history of pneumonitis or interstitial lung disease requiring active treatment with systemic steroids or other systemic therapy; or a history of receiving systemic steroid therapy or any other immunosuppressive medication ≤ 3 days prior to study initiation. Daily steroid replacement therapy (eg, prednisone or hydrocortisone) and corticosteroids used to manage AEs are permitted.\n4. Have an active or uncontrolled hepatitis B and\u002For hepatitis C infection and are positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis B surface antigen \\[HBsAg\\], anti-hepatitis B surface antibody \\[anti-HBs\\], anti-hepatitis B core antibody \\[anti-HBc\\], or hepatitis B virus \\[HBV\\] DNA), and\u002For hepatitis C infection (as per hepatitis C virus \\[HCV\\] RNA) within 28 days of randomization. Participants are eligible if they:\n\n   1. Have received hepatitis B vaccination with only anti-HBs positivity and no clinical signs of hepatitis.\n   2. Have HbsAg+ with HBV infection for more than 6 months (ie, chronic HBV infection) meeting the following conditions:\n\n   i. HBV DNA viral load \\\u003C 2,000 IU\u002FmL. ii. Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST\u002FALT \\\u003C 3 ULN that are not attributable to HBV infection.\n\n   iii. Start or maintain antiviral treatment if clinically indicated as per the Investigator.\n\n   c. Have been curatively treated for hepatitis.\n5. Active infection requiring systemic antibiotic therapy (antiviral therapy is allowed).\n6. Have known active central nervous system (CNS) metastases, carcinomatous meningitis, and\u002For spinal cord compression.\n7. Body weight ≤ 40 kg at screening.\n8. Received a live vaccine ≤ 4 weeks prior to the first dose of study drug(s).\n9. Known history of severe hypersensitive reactions to docetaxel or to other drugs formulated with polysorbate 80.\n10. Had major surgery, myocardial infarction, and\u002For cerebrovascular accident within 28 days prior to study randomization. Participants must have fully recovered from the effects of prior surgery or illness in the opinion of the treating Investigator.\n11. Inadequate organ function, evidenced by the following laboratory results:\n\n    1. Absolute lymphocyte count \\\u003C institutional LLN (ie, participant should have a normal lymphocyte count to enroll in the study).\n    2. Absolute neutrophil count ≤ 1,500 cells\u002Fmm3.\n    3. Platelet count ≤100,000 cells\u002Fmm3.\n    4. Total bilirubin \\> 1.5 times the ULN, unless the participant has documented Gilbert's syndrome). Participants with documented Gilbert's syndrome are to be excluded if total bilirubin is ≥ 3 × ULN or direct bilirubin is \\> ULN.\n    5. Aspartate aminotransferase (AST \\[serum glutamic-oxaloacetic transaminase; SGOT\\]) or alanine aminotransferase (ALT \\[serum glutamic pyruvic transaminase; SGPT\\]) \\> 1.5 × ULN or \\> 5 times ULN for participants with liver metastases.\n    6. Alkaline phosphatase (ALP) levels \\> 2.5 × ULN, \\> 5 times ULN for participants with known bone metastases.\n    7. Hemoglobin \\\u003C 9.0 g\u002FdL.\n    8. Creatinine clearance \\\u003C 40 mL\u002Fmin (using the Cockcroft-Gault formula below):\n\n    Female = \\[(140 - age in years) × weight in kg × 0.85\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\] Male = \\[(140 - age in years) × weight in kg × 1.00\\] \u002F \\[72 × serum creatinine in mg\u002FdL\\]\n12. Have any of the following:\n\n    1. Cirrhosis at a level of Child-Pugh B (or worse);\n    2. Cirrhosis (any degree) and a history of hepatic encephalopathy; or\n    3. Clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis.\n13. Participation in an investigational drug study within 28 days prior to the start of treatment on this study, except for hormone lowering therapy in participants with hormone-sensitive cancer. Participating in any other interventional clinical trial during active participation in this clinical trial is not allowed.\n14. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n15. Pregnant and nursing women.\n16. History of prior adverse reaction to immunotherapy that led to its permanent discontinuation.\n17. Have a history of malignancy other than NSCLC, except:\n\n    1. Adequately resected non-melanoma skin cancer; or,\n    2. Curatively treated in situ disease or\n    3. Other curatively treated solid tumors, with no evidence of disease for ≥ 3 years; or\n    4. Hormone sensitive cancers treated only with hormone therapy.\n18. Other antineoplastic therapies intended to treat cancer, including herbal medicines or other prohibited concurrent medication(s) within 28 days prior to the start of treatment in the study.\n19. Confinement in an institution by order of a court or authority.","90 Years",{"count":116,"type":22},507,[118],"PHASE3","This is a randomized, two-cohort, open-label, phase 3, clinical trial to compare the efficacy and safety of N-803 plus tislelizumab and docetaxel (cohort A) or prior failed Health Authority-approved antiprogrammed death-1 (PD-1) or anti-programmed death-ligand 1 (PD-L1) CPI and docetaxel (cohort B) versus docetaxel monotherapy (cohorts A and B).\n\nFor each cohort, enrolled participants will be randomized 2:1 to treatment in the experimental arm or the control arm. For cohort A, the randomization will be stratified by geographical region (North America vs Europe vs Asia vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (epidermal growth factor receptor \\[EGFR\\]\u002Fanaplastic lymphoma kinase \\[ALK\\]\u002FROS proto-oncogene 1, receptor tyrosine kinase \\[ROS1\\] vs Other AGA vs No AGA).\n\nFor cohort B, the randomization will be stratified by geographical region (Americas vs Asia Pacific \\[PAC\\] vs Other), NSCLC histology (squamous vs nonsquamous), and actionable genomic alteration (AGA) (Yes vs No).",[28],"2026-04-30",{"date":123,"type":40},"2026-05-05",{"date":125,"type":40},"2025-10-01",{"date":127,"type":22},"2029-01",{"name":129,"class":75},"ImmunityBio, Inc.",19,{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":7},"100614423","trimpact-real-world-first-line-atezolizumab-use-in-stage-iv-nsclc-with-pd-l1-50-100614423","NCT07279402","TRIMPACT: Real-World First-Line Atezolizumab Use in Stage IV NSCLC With PD-L1 ≥50%","TRIMPACT: A Prospective Real-World Study of Atezolizumab Monotherapy as First-Line (Stage IV) Treatment in Patients With Non-Small Cell Lung Cancer With PD-L1 Tumor Cell Expression ≥50% and No Targetable Mutations","Inclusion Criteria:\n\n* Signed informed consent form.\n* Diagnosis of stage IV non-small cell lung cancer.\n* Male or female patients aged 18 years or older.\n* Patients who have been prescribed atezolizumab in accordance with routine clinical practice and the locally approved indication in Türkiye.\n* Patients who have received up to 3 cycles of atezolizumab at the screening visit.\n\nExclusion Criteria:\n\n* Patients who are not receiving atezolizumab for the treatment of lung cancer according to standard of care and the approved indication.\n* Known or suspected hypersensitivity to atezolizumab.\n* Pregnant or breastfeeding women.",{"count":139,"type":22},150,"OBSERVATIONAL","This prospective, multicenter, real-world observational study aims to evaluate the clinical outcomes of first-line atezolizumab monotherapy in patients with stage IV non-small cell lung cancer (NSCLC) with PD-L1 tumor cell expression ≥50% and no targetable mutations. The study aim to determine how atezolizumab performs in routine clinical practice with respect to survival, treatment response, and safety outcomes in this patient population in Türkiye.",[28,143,144,145],"PD-L1 Gene Mutation","Atezolizumab","Real World Study",[147],"NSCLC, PD-L1, Atezolizumab, Real World","2026-04-29",{"date":121,"type":40},{"date":151,"type":40},"2025-09-15",{"date":153,"type":22},"2027-10-01",{"name":155,"class":156},"Antalya Training and Research Hospital","OTHER_GOV",{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":76},"100635082","phase-2-a-phase-ii-study-of-sacituzumab-tirumotecan-in-combination-with-furmonertinib-in-patients-with-non-squamous-non-small-cell-lung-cancer-who-have-progressed-after-egfr-tki-and-platinum-based-chemotherapy-100635082","NCT07548060","A Phase II Study of Sacituzumab Tirumotecan in Combination With Furmonertinib in Patients With Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy","Tianjin Medical University Cancer Institute and Hospital","TROP-LUNG","Inclusion Criteria:\n\n* Histologically or cytologically confirmed non-squamous NSCLC that is locally advanced (Stage ⅢB\u002FⅢC) or metastatic (Stage Ⅳ) and not amenable to curative surgery and\u002For curative concurrent\u002Fsequential chemoradiotherapy \\[according to the 8th edition TNM staging system for lung cancer by the Union for International Cancer Control (UICC) and American Joint Committee on Cancer (AJCC)\\], with tissue or blood-based genetic testing showing EGFR-sensitive mutations (19del and L858R).\n* Subjects must have received prior EGFR-TKI therapy for locally advanced or metastatic disease and experienced treatment failure (documented radiographic disease progression), and must meet one of the following requirements: a) progressed after first- or second-generation EGFR-TKI, and histologically confirmed T790M-negative after treatment failure; b) progressed after third-generation EGFR-TKI regardless of T790M mutation status; and progressed after platinum-based chemotherapy or have chemotherapy intolerance.\n\nNote: For subjects who have received neoadjuvant or adjuvant EGFR-TKI therapy, if disease progression occurs ≤12 months from the last dose, this EGFR-TKI is considered first-line therapy for locally advanced or metastatic disease.\n\n* Male or female subjects aged ≥18 years and ≤75 years who have signed the informed consent form.\n* ECOG performance status of 0 or 1, with an expected survival \\>6 months.\n* Agree to provide previously stored tumor tissue specimens or undergo biopsy to collect tumor lesion tissue for biomarker analysis.\n* Adequate organ function: Laboratory tests must meet the following requirements: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count ≥100×10\\^9\u002FL, hemoglobin ≥90 g\u002FL, white blood cell count ≥3.0×10\\^9\u002FL; Liver function: Total bilirubin \\\u003C1.5× upper limit of normal (ULN), aspartate aminotransferase (AST\u002FSGOT), alanine aminotransferase (ALT\u002FSGPT), and alkaline phosphatase (ALP) ≤2.5×ULN; If liver metastases are present, AST and ALT ≤5.0×ULN; If liver and\u002For bone metastases are present, ALP ≤5.0×ULN. Renal function: Serum creatinine (Scr) ≤1.5×ULN; Urine routine test shows urine protein \\\u003C2(+); If baseline urine protein ≥2(+), 24-hour urine protein quantification must be ≤1.0 g; Coagulation function: International normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5×ULN.\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥50%.\n\n-Able to communicate effectively with the investigator and comply with study requirements for visits, treatment, laboratory tests, and other relevant regulations.\n\nExclusion Criteria:\n\n* Squamous cell carcinoma (including adenosquamous carcinoma and undifferentiated carcinoma); small cell lung cancer (including combined small cell and non-small cell lung cancer); patients who have previously received systemic therapy (prior adjuvant or neoadjuvant therapy is permitted).\n* Patients with symptomatic brain metastases at the start of treatment (patients with previously treated brain metastases are eligible if asymptomatic brain metastases persist for at least 4 weeks while on stable dose medication).\n* Patients who participated in an interventional oncology clinical trial concurrently during first-line therapy or within 30 days prior to first-line therapy.\n* History of tracheoesophageal fistula, gastrointestinal perforation or fistula, or intra-abdominal abscess within 6 months before treatment initiation.\n* Patients with severe cardiovascular or cerebrovascular diseases, including cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction within 6 months before enrollment, and significant vascular disease (including but not limited to aortic aneurysm requiring surgical repair or recent arterial thrombosis); patients with unstable angina, New York Heart Association (NYHA) class ≥II heart failure; mean resting corrected QT interval (QTc) \\>470 ms; any clinically significant resting ECG rhythm, conduction, or morphological abnormalities, such as complete left bundle branch block, third-degree heart block, second-degree heart block, interval \\>250 ms. Any factors increasing the risk of QTc prolongation or arrhythmic events, such as heart failure, electrolyte abnormalities (including: serum\u002Fplasma potassium \\\u003C LLN; serum\u002Fplasma magnesium \\\u003C LLN; serum\u002Fplasma calcium \\\u003C LLN), congenital long QT syndrome, family history of long QT syndrome, or sudden unexplained death in a first-degree relative under 40 years of age, or any concomitant medication known to prolong QT interval and cause torsades de pointes.\n* Uncontrolled systemic diseases as determined by the investigator:\n\n  1. Poorly controlled diabetes (fasting blood glucose ≥10 mmol\u002FL on two consecutive occasions);\n  2. Poorly controlled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg);\n  3. Presence of symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (\\>1 time\u002Fweek).\n* History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis at screening that cannot be ruled out by imaging examination.\n* Clinically significant pulmonary impairment due to concurrent lung disease, including but not limited to any underlying pulmonary disease (such as pulmonary embolism within 3 months before first dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may involve the lungs (i.e., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.\n* Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding.\n* Tumor invasion of surrounding vital organs and vessels (such as heart, esophagus, superior vena cava, etc.) or risk of developing tracheoesophageal fistula or esophagopleural fistula.\n* Toxicities from prior anti-tumor therapy that have not recovered to ≤Grade 1 (based on NCI CTCAE version 5.0 assessment) or to the level specified in inclusion\u002Fexclusion criteria (except for alopecia, fatigue, and other toxicities that the investigator deems pose no safety risk).\n* Known or suspected hypersensitivity to furmonertinib and sacituzumab tirumotecan and\u002For other components of their formulations.\n* Women of childbearing potential or male subjects who are unwilling to use effective contraception during the study or for 6 months after the last dose of study drug.\n* Active hepatitis B (positive hepatitis B surface antigen (HBsAg) requiring HBV-DNA testing; HBV-DNA ≥500 IU\u002FmL or higher than the lower limit of detection, whichever is higher) or hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection).\n* Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.\n* Other conditions that the investigator considers unsuitable for enrollment in addition to the above situations.",{"count":7,"type":22},[25],"Efficacy and Safety of Sacituzumab Tirumotecan Combined with Furmonertinib in Patients with Locally Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Who Have Progressed After EGFR-TKI and Platinum-Based Chemotherapy.",[28,169],"EGFR Gene Mutation",[65,171,172],"TROP-2 ADC","EGFR-TKI","2026-04-20",{"date":175,"type":40},"2026-04-23",{"date":177,"type":40},"2026-02-01",{"date":179,"type":22},"2028-01-22",{"name":162,"class":47},{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":23,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":202},"100398406","phase-1-combination-of-atezolizumab-and-pirfenidone-in-second-line-and-beyond-nsclc-100398406","NCT04467723","Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC","CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I\u002FII Study","Inclusion Criteria:\n\n* Participant or legal representative is able to provide written informed prior to performing any protocol-related procedures\n* Is willing and able to comply with scheduled visits, treatment schedule, laboratory testing and other requirements of the study\n* Men or women at least 18 years of age with histologically or cytologically confirmed non-small cell lung cancer\n* Previous history of other than lung cancer is allowed if no active treatment for that cancer within 1 year\n* Life expectancy of at least 6 months\n* De novo stage IV or recurrent NSCLC without actionable mutation (e.g. EGFR\u002F ALK\u002F ROS-1) that was previously treated with either PD-1 \u002F PD-L1 or the combination of PD1\u002FPDL1 and cytotoxic chemotherapy, no more than 2 systemic regimens for metastatic disease with measurable disease \\*. Maintenance therapy will be considered part of the 1 regimen\n* At least 1 measurable lesion\n* PDL1 TPS score less than 1% or unknown: first-line must be PD1\u002FPDL1 inhibitor in combination with chemotherapy\n* Early stage (I-III) NSCLC treated with adjuvant or neoadjuvant chemotherapy then PD1\u002FPDL1 inhibitor treatment for recurrent disease\n* Recurrent Unresectable stage III NSCLC treated with prior chemoradiation followed by maintenance PD1\u002FPDL1 inhibitor with measurable disease\n* Eastern Cooperative Group (ECOG) Performance Status 0 - 2\n* Is able to swallow oral medications\n* Adequate hematologic function\n* Adequate organ function\n\nExclusion Criteria:\n\n* The presence of any other concurrent severe and\u002For uncontrolled medical condition that would, in the investigator or treating physician's judgement, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol\n* Has received investigational agents within 14 days or 5 half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment\n* Has a known hypersensitivity to atezolizumab or pirfenidone\n* Has active medical or psychiatric illness that would interfere with the study treatment\n* Has uncontrolled diabetes\n* Has any of the following cardiac diagnoses:\n\nUnstable angina Myocardial infarction within 6 months Uncontrolled congestive heart failure Left ventricular ejection fraction \\\u003C 35%\n\n* Has a history of any Grade 3 or 4 toxicities to a prior checkpoint inhibitor treatment\n* Is pregnant or breast feeding\n* Uncontrolled HIV\n* Clinically diagnosed with grade 2 or 3 radiation-induced lung injury within the last 3 months prior to registering for the study\n* Has a history of idiopathic pneumonitis that required systemic agent including steroid\n* Has drug-induced pneumonitis\n* Has evidence of active pneumonitis on screening chest computed tomography (CT) scan\n* Smoker of more than 1 pack \u002F day\n* Has active peptic ulcer diagnosed within 4 weeks of enrollment\n* Active infection requiring systemic treatment\n* Current use of systemic antibacterial or antifungal agent\n* Prior monoclonal antibody within 4 weeks before study Day 1 Exception: The use of denosumab\n* Patient not recovered to ≤ Grade 1 from AEs due to agents administered more than 4 weeks earlier\n* Concurrent use of other investigational agents\n* Uncontrolled or symptomatic brain metastasis or leptomeningeal disease that requires use of steroids\n* Use of strong CYP1A2 inhibitors\n* Previous history of cancer with active treatment within less than 1 year of enrollment\n* Active auto-immune diseases",{"count":7,"type":22},[60,25],"The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.",[28,192],"NSCLC, Recurrent","2026-01-26",{"date":195,"type":40},"2026-01-28",{"date":197,"type":40},"2022-05-18",{"date":199,"type":22},"2027-08",{"name":201,"class":47},"University of Kansas Medical Center",2,{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":4},"100615864","phase-2-firmonertinib-160-mg-in-patients-with-egfr-mutant-advanced-nsclc-demonstrating-sd-after-8-week-induction-with-firmonertinib-80-mg-100615864","NCT07298148","Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating SD After 8 Week Induction With Firmonertinib 80 mg","A Multicenter, Prospective, Phase II, Single-Arm Study of Firmonertinib 160 mg in Patients With EGFR-Mutant Advanced NSCLC Demonstrating Stable Disease After 8 Week Induction With Firmonertinib 80 mg","Inclusion Criteria:\n\n* Age 18-75 years.\n* ECOG performance status 0-1; life expectancy ≥3 months.\n* Histologically\u002Fcytologically confirmed advanced\u002Fmetastatic non-squamous NSCLC unsuitable for curative therapy.\n* Documented EGFR 19del or L858R mutation.\n* No prior systemic therapy for advanced disease.\n* Stable disease after 8 weeks of Firmonertinib 80 mg daily.\n* more than 1 measurable lesion per RECIST v1.1.\n* Adequate hematologic, renal, hepatic, and coagulation function.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Hypersensitivity to Firmonertinib or related compounds.\n* Other actionable oncogenic drivers (ALK, ROS1, RET, BRAF, NTRK, MET, KRAS, except TP53\u002FRB1).\n* Prior EGFR-TKI therapy or prohibited concomitant medications.\n* Unresolved toxicities \\>CTCAE Grade 1 (except allowed conditions).\n* Symptomatic CNS metastases or spinal cord compression.\n* GI disorders impairing drug absorption.\n* Uncontrolled systemic diseases or active infections (HBV\u002FHCV\u002FHIV).\n* Interstitial lung disease (history or active).\n* Clinically significant cardiac abnormalities including QTc \\>470 ms or LVEF \\\u003C50%.\n* Pregnancy or breastfeeding.\n* Any condition compromising compliance.\n* CR, PR, or PD at completion of induction therapy.",{"count":211,"type":22},28,[25],"This study evaluates the efficacy and safety of Firmonertinib 160 mg once daily in patients with EGFR-mutant, advanced NSCLC who achieve stable disease after first-line Firmonertinib 80 mg for 8 weeks.",[28,215,216],"EGFR Positive Non-small Cell Lung Cancer","EGFR-TKI Sensitizing Mutation","NOT_YET_RECRUITING","2026-01-18",{"date":220,"type":40},"2026-01-21",{"date":222,"type":22},"2026-01-01",{"date":224,"type":22},"2032-12-31",{"name":226,"class":47},"Peking University Cancer Hospital & Institute",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":4},"100619070","phase-1-glecirasib-combined-with-ivonescimab-for-first-line-treatment-of-kras-g12c-mutated-nsclc-100619070","NCT07339839","Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated NSCLC","Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Multi-center, Phase I\u002FII Clinical Study","Inclusion Criteria:\n\n* Signed written informed consent.\n* Age ≥18 years.\n* Newly diagnosed, unresectable, locally advanced (ineligible for curative concurrent - chemoradiotherapy) or metastatic NSCLC per AJCC 9th edition.\n* KRAS G12C mutation confirmed by validated testing.\n* PD-L1 TPS ≥1%.\n* ≥1 measurable lesion per RECIST v1.1.\n* No prior systemic therapy for advanced\u002Fmetastatic NSCLC; prior adjuvant therapy allowed if completed \\>6 months before dosing and toxicities recovered to ≤Grade 1.\n* ECOG PS 0-2.\n* Life expectancy \\>3 months\n* Adequate organ function (hematologic, hepatic, renal, coagulation per protocol thresholds)\n* Negative pregnancy test for women of childbearing potential; adequate contraception for men and women through 3 months post-treatment\n* Willing and able to comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n* History of other malignancies (exceptions: cured basal cell carcinoma, cervical carcinoma in situ)\n* Predominant squamous NSCLC, small cell carcinoma, or neuroendocrine carcinoma.\n* Other actionable drivers (EGFR, ALK, ROS1, RET, BRAF, NTRK, MET, etc.).\n* Known hypersensitivity to study drugs.\n* Prior PD-1\u002FPD-L1 inhibitors or KRAS inhibitors.\n* Active autoimmune disease or autoimmune disease history requiring systemic therapy.\n* Systemic immunosuppressive therapy within 14 days prior to first dose.\n* Symptomatic ascites\u002Fpleural effusion needing recurrent drainage.\n* Significant cardiovascular disease (NYHA ≥2, MI within 1 year, uncontrolled arrhythmias).\n* Active infection, unexplained fever \\>38.5°C.\n* Interstitial lung disease or pneumonitis.\n* HIV infection or other immunodeficiency.\n* Live vaccines within 4 weeks.\n* Substance abuse, alcoholism, or psychiatric disorders impairing compliance.\n* Unable to swallow oral medication.\n* Any condition that may interfere with study participation or interpretation as judged by investigator.",{"count":235,"type":22},42,[60,25],"This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.",[28,239],"KRAS G12C","2026-01-05",{"date":242,"type":40},"2026-01-14",{"date":244,"type":22},"2026-03-01",{"date":246,"type":22},"2029-09-30",{"name":248,"class":47},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":76},"100512260","phase-1-peptide-vaccine-to-prevent-acquired-resistance-in-patients-with-advanced-alk-nsclc-100512260","NCT05950139","Peptide Vaccine To Prevent Acquired Resistance In Patients With Advanced ALK+ NSCLC","Pilot Study of a Prophylactic Cancer Peptide Vaccine in Advanced ALK+ NSCLC","ARCHER","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of stage IV NSCLC (or recurrent NSCLC not a candidate for definitive multimodality therapy)\n2. Documented ALK rearrangement as detected by: (1) fluorescence in situ hybridization (FISH), (2) immuno-histochemistry (IHC), (3) tissue next-generation sequencing (NGS), or (4) circulating tumor DNA (ctDNA) NGS\n3. Ongoing treatment with crizotinib, ceritinib, alectinib, brigatinib, or lorlatinib with at least stable disease ≥ 4 months\n4. No known presence of the specific ALK acquired resistance alterations targeted by the study vaccine\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n6. Males or females at least 18 years old\n\nExclusion Criteria:\n\n1. Known additional malignancy that is progressing or has required active treatment within the past 3 years. Adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors treated with potentially curative therapy are allowed.\n2. Cytotoxic chemotherapy within 14 days of first dose of study vaccine or concurrent with study vaccine\n3. Anti-neoplastic immunotherapy within 28 days of first dose of study vaccine or concurrent with study vaccine\n4. Systemic immune suppression:\n\n   1. Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted)\n   2. Other clinically relevant systemic immune suppression\n5. Symptomatic central nervous system (CNS) metastasis. Asymptomatic CNS disease requiring increasing dose of corticosteroids within 7 days prior to study enrollment is also not permitted\n6. Current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed",{"count":258,"type":22},12,[60,25],"The purpose of this study is to evaluate the safety of a cancer peptide vaccine to prevent or delay acquired resistance in advanced ALK+ lung cancer patients currently on ALK targeted therapy.",[28,262],"ALK Fusion Protein Expression","2025-09-18",{"date":265,"type":40},"2025-09-23",{"date":267,"type":40},"2024-05-13",{"date":269,"type":22},"2029-07",{"name":271,"class":47},"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins",{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":279,"minAge":280,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":23,"phases":283,"briefSummary":285,"conditions":286,"keywords":288,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":76},"100555447","a-study-on-the-efficacy-of-androgen-deprivation-therapy-combined-with-anti-pd-1-therapy-in-advanced-lung-cancer-100555447","NCT06512207","A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer","A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer","3.Inclusion Criteria:\n\n1. Male patients aged ≥60 years.\n2. ECOG performance status score of 0 \\~1.\n3. Expected survival time of more than 3 months.\n4. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.\n5. Patients who have not previously received any anti-PD-1 treatment.\n6. Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.\n7. At least one tumor lesion meeting the following criteria:\n\n   * No prior local treatments such as radiotherapy\n   * Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).\n   * Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).\n   * If only one measurable lesion, no prior local treatments such as radiotherapy.\n8. Ability to understand and voluntarily sign a written informed consent form.\n9. Willingness to follow the study protocol and follow-up examinations.\n\nExclusion Criteria:\n\n* Exclusion of cases that do not meet the inclusion criteria","MALE","60 Years",{"count":282,"type":22},80,[284],"NA","Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.",[29,287],"NSCLC, Stage IV",[289,290,65,291],"Androgen Deprivation Therapy （ADT）","Leuprorelin acetate","PD-1 inhibitor","2025-09-02",{"date":294,"type":40},"2025-09-09",{"date":296,"type":40},"2023-12-03",{"date":298,"type":22},"2026-06",{"name":300,"class":47},"Jinzhou Medical University",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":307,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":56,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":76},"100372985","phase-2-pemetrexed-and-carboplatin-with-or-without-anlotinib-hydrochloride-for-osimertinib-resistant-non-squamous-nsclc-100372985","NCT04136535","Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Osimertinib-resistant Non-squamous NSCLC","A Multicenter, Randomized, Phase II Study of Pemetrexed and Carboplatin With or Without Anlotinib Hydrochloride for Advanced or Locally-advanced Osimertinib-resistant Non-squamous Non-small Cell Lung Cancer (ALTER-L031)","PCA","Inclusion Criteria:\n\n1\\. 18 Years to 75 Years patients voluntarily participate in this study, signed and dated informed consent with good compliance and follow-up; 2. Confirmed as locally advanced and \u002F or metastatic non-squamous non-small cell lung cancer (NSCLC) by cytology or histology, the diagnosis should be completed at least 6 months after the end of chemotherapy if adjuvant chemotherapy and \u002F or neoadjuvant chemotherapy received (diagnosis based on sputum smear is not accepted) ; 3. Presence of EGFR activating mutations and previously disease progression to Osimertinib (previously treated with 1st \u002F 2nd generation EGFR-TKI or not)； 4. At least one target lesion that has accurate measurement by magnetic resonance imaging (MRI) or computed tomography (CT) (conventional CT≥20 mm or spiral CT≥10 mm) in at least 1 direction; 5. Life expectancy is at least 3 months; 6. ECOG PS Scoring: 0\\~1 point; 8. The main organs function are normally, the following criteria are met:\n\nBlood routine examination criteria (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli):\n\ni) hemoglobin (HB) ≥90g\u002FL ii) neutrophil absolute (ANC) ≥1.5×109\u002FL iii) platelet (PLT) ≥80×109\u002FL Biochemical tests meet the following criteria i) total bilirubin (TBIL) ≤1.5 times of upper limit of normal (ULN); ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5 ULN, if liver metastasis occurred, ALT and AST ≤5 ULN; iii) serum creatinine (Cr) ≤1.25 ULN or creatinine clearance (CCr)≥45mL\u002Fmin (Cockcroft-Gault formula).\n\n9.Female patients of childbearing age agree that contraceptive measures must be used within the study period and within 8 weeks after the end of the study drug treatment. The serum or urine test indicates unpregnancy within 7 days prior to the study. Male patients agree to have contraceptive use during the study period and within 8 weeks after the end of the study period or have had surgical sterilization.\n\nExclusion Criteria:\n\n1. Patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer) and lung adenosquamous carcinoma mixed with squamous carcinoma;\n2. Active brain metastases, cancerous meningitis, spinal cord compression, or imaging CT or MRI screening for brain or pia mater disease (a patient with brain metastases who have completed treatment and stable symptoms in 21 days before enrollment may be enrolled, but should be confirmed by brain MRI, CT or venography evaluation as no cerebral hemorrhage symptoms);\n3. Imaging (CT or MRI) shows that the distance between tumor lesion and the large blood vessel is ≤ 5 mm, or there is a central tumor that invades the local large blood vessel and the distance between tumor and bronchial tree is ≤ 2 cm; or there is a significant pulmonary cavity or necrotizing tumor;\n4. Uncontrollable hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg after optimal medical treatment);\n5. Suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including men with QTc interval ≥ 450 ms, women ≥ 470 ms); according to NYHA criteria, grades III to IV Insufficient function, or cardiac color Doppler ultrasound examination indicates left ventricular ejection fraction (LVEF) \\\u003C50%;\n6. Abnormal blood coagulation (INR \\> 1.5 or prothrombin time (PT) \\> ULN + 4 seconds or APTT \\> 1.5 ULN), with bleeding tendency or undergoing thrombolytic or anticoagulant therapy;\n7. Urine routine test protein ≥++, and confirmed 24 hours urine protein\\> 1.0 g;\n8. There is currently a peripheral neuropathy of ≥CTCAE 2 degrees, except for trauma;\n9. Respiratory syndrome (≥CTC AE grade 2 dyspnea), serous effusion (including pleural effusion, ascites, pericardial effusion) requiring surgical treatment;\n10. Long-term unhealed wounds or fractures;\n11. Serious infection (≥CTC AE Level 2 infection) requiring systemic antibiotics;\n12. decompensated diabetes or other ailments treated with high doses of glucocorticoids;\n13. Active or chronic hepatitis C or\u002Fand hepatitis B infection;\n14. Factors that have a significant impact on oral drug absorption, such as inability to swallow, chronic diarrhea, and intestinal obstruction;\n15. Patients have undergone major surgery within 4 weeks before enrollment or have severe trauma, fracture and ulcer;\n16. Severe weight loss (greater than 10%) within 6 weeks prior to enrollment;\n17. Clinically significant hemoptysis (daily hemoptysis greater than 50ml) within 3 months prior to enrollment; or significant clinically significant bleeding symptoms or defined bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ and above, or suffering from vasculitis;\n18. Events of venous\u002F arterious thrombosis occurring within the first 12 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n19. Patients have contraindication to platinum drugs (Cisplatin\u002FCarboplatin) and cytotoxic drug (Pemetrexed);\n20. Patients have anaphylactic reaction due to Anlotinib Hydrochloride or the excipient in investigational drug.\n21. Planned for systemic anti-tumor therapy during the study period or within 4 weeks prior to enrollment, including cytotoxic therapy, signal transduction inhibitors, immunotherapy (or use mitomycin C within 6 weeks prior to receiving investigational drug). Radiation-rehabilitation radiotherapy (EF-RT) was performed within 4 weeks before enrollment or limited-field radiotherapy was performed for planned tumor lesions within 2 weeks before enrollment.\n22. Patients with other situations which are not suitable for the study according to the researchers.",{"count":310,"type":22},105,[25],"Evaluate the efficacy and safety of Anlotinib Hydrochloride in combination with Pemetrexed and Carboplatin versus Pemetrexed and Carboplatin for advanced or locally-advanced Osimertinib-resistant non-squamous non-small cell lung cancer.",[28],"2025-07-17",{"date":316,"type":40},"2025-07-22",{"date":318,"type":40},"2021-11-18",{"date":320,"type":22},"2026-12-31",{"name":322,"class":47},"Fudan University",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":23,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":76},"100549637","outpatient-pulmonary-rehabilitation-in-non-small-cell-lung-cancer-receiving-immunotherapy-100549637","NCT06436625","Outpatient Pulmonary Rehabilitation in Non-small-cell Lung Cancer Receiving Immunotherapy","Outpatient Pulmonary Rehabilitation in Patients With Advanced Stage Non-small Cell Lung Cancer Receiving Immunotherapy: a Randomized Controlled Trial (OPAL-study)","OPAL","Inclusion criteria\n\n* Capable and willing to give signed informed consent, which includes compliance with the requirements\n* Age ≥ 18 years at the time of screening\n* Histological or cytological confirmed non-squamous non-small cell lung cancer\n* Previously untreated patients with histologically or cytologically documented metastatic (Stage IV according to Version 9 on the IASLC Staging Manual in Thoracic oncology) or recurrent NSCLC\n* World Health Organization (WHO)\u002FECOG PS of 0 or 1 at enrollment\n* At least 1 lesion not previously irradiated that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by CT or MRI scan must be performed within 28 days prior to randomization.\n* Stable disease (SD), partial response (PR) or complete response (CR) (according to RECIST 1.1) after four cycles of first line chemo-immunotherapy and planned maintenance therapy\n* No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies in advanced or metastatic therapy setting except ongoing first line immunotherapy\n\nExclusion criteria\n\n* Physical or cognitive condition or symptoms that contraindicate execution of physical exercise or participation in a clinical exercise-based trial\n* Symptomatic brain metastases\n* Bone metastases with risk of pathological fracture with exercise training as assessed by treating physician\n* Contraindication for immunotherapy\n* Existence of more than one primary tumor such as: mixed small cell and NSCLC histology; synchronous or metachronous tumors that could represent distinct primary tumors\n* Evidence of other active cancer disease\n* Any medical condition that might be worsened by exercise training including, but not restricted to severe congestive heart failure (NYHA III\u002FIV), unstable angina pectoris, myocardial infarction or cardiac surgery 6 months prior to randomization\n* Major surgical procedure (as defined by the investigator) within 28 days prior to randomization or planned during the next 56 days\n* Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements","120 Years",{"count":333,"type":22},70,[284],"The aim of this prospective study is to evaluate the effects of an outpatient pulmonary rehabilitation program on the quality of life, performance and tumor growth of metastatic lung cancer patients receiving ongoing immunotherapy.\n\nThe main questions it aims to answer are:\n\nThe primary objective of the study is to assess the effects of outpatient pulmonary rehabilitation (OPR) on exercise capacity measured by difference in the 6-minute walking test (6MWT) in patients with advanced stage lung cancer receiving immunotherapy measured by difference in the 6-minute walking test (6MWT).\n\nSecondary endpoints in this study include progression free survival (PFS) and the effect of OPR on long term exercise capacity measured by 6MWT (difference in 6MWT after week 15 and 24).\n\nResearchers will compare two groups of patients: one group of patients receives 6 weeks of outpatient pulmonary rehabilitation (intervention group), while the other patient group serves as control since this is standard of care to evaluate the effects of outpatient pulmonary rehabilitation.",[28],"2025-06-23",{"date":339,"type":40},"2025-06-26",{"date":341,"type":40},"2025-01-27",{"date":343,"type":22},"2028-01",{"name":345,"class":47},"Karl Landsteiner Institute for Lung Research and Pneumological Oncology",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":355,"conditions":356,"keywords":357,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":202},"100493179","molecular-landscape-analysis-and-clinical-implications-for-nsclc-patients-with-rare-mutations-100493179","NCT05701787","Molecular Landscape Analysis and Clinical Implications for NSCLC Patients With Rare Mutations","Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations","Inclusion Criteria:\n\n* Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc.\n* 18 years of age or older\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* None",{"count":354,"type":22},500,"Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC).\n\nMolecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC.\n\nDifferent rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.",[65,28,192],[65,358,359,360,361,362,363],"rare mutations","molecular landscape","next-generation sequencing (NGS)","targeted therapy","immunotherapy","chemotherapy","2025-05-20",{"date":366,"type":40},"2025-05-22",{"date":368,"type":40},"2019-01-01",{"date":370,"type":22},"2029-12-31",{"name":372,"class":47},"Shanghai Chest Hospital",{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":385,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":398},"100546965","phase-2-sacituzumab-govitecan-and-bevacizumab-for-nsclc-brain-metastases-100546965","NCT06401824","Sacituzumab Govitecan and Bevacizumab for NSCLC Brain Metastases","A Single Arm Phase II Study Evaluating Intracranial Efficacy of Sacituzumab Govitecan (SG) With Bevacizumab in Patients With Active, Asymptomatic Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n\n  1. Signed informed consent must be obtained prior to participation in the study.\n  2. Participant is an adult ≥ 18 years of age at the time of informed consent.\n  3. ECOG performance status ≤1.\n  4. Estimated life expectancy of 12 weeks or more.\n  5. Pathology proven metastatic non-squamous NSCLC\n  6. For those without an actionable oncogenic driver: progression on immunotherapy and\u002For platinum-doublet chemotherapy (concurrent or sequential, in any order). If contra-indication for immunotherapy: progression on platinum-doublet chemotherapy.\n  7. For those with an actionable oncogenic driver: progression on targeted therapy and platinum-doublet chemotherapy. For the latter group, previous ICI is allowed but not mandatory.\n  8. BM not in eloquent area (all patients have at least to be discussed with a neurologist, and preferably they are discussed in the local neuro-oncology MDT).\n  9. Maximum BM size 2 cm in longest diameter (for each BM).\n  10. At least one untreated brain metastasis ≥ 5mm:\n\n      1. Patients with largest measurable intracranial lesion ≥5 mm but \\\u003C10 mm may be allowed to enroll upon agreement with the principal investigator (for patients with target lesions of ≥ 5mm but \\\u003C10 mm, 1.5 mm slice thickness brain MRI is required).\n      2. Prior local treatment is permissible provided unequivocal progression in the lesion has since occurred (discussed in neuro-oncology MDT) or if new lesions have occurred.\n      3. For at least 7 days prior to first dose of SG and bevacizumab in this study: Patient must be asymptomatic from CNS metastases and on a stable dose of corticosteroids, with a maximum of 4 mg dexamethasone\u002Fday. Anti-epileptic dose should also be stable for 7 days.\n  11. Participant must have recovered from all toxicities related to prior treatments to grade ≤ 1 (CTCAE v 5.0). Exception to this criterion are alopecia and neuropathy of any grades.\n  12. Adequate organ function including the following laboratory values at the screening visit:\n\n      * Absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL (without growth factor support),\n      * Platelets ≥ 100 x 109\u002FL (without growth factor support),\n      * Hemoglobin (Hb) ≥ 6 mmol\u002Fl (= 9 g\u002Fdl) (7 days without transfusions or growth factor support),\n      * Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases\n      * Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5 × ULN if known liver metastases\n      * Serum albumin \\> 3 g\u002FdL\n      * Total bilirubin ≤ 1.5 ULN,\n      * Creatinine clearance ≥ 30 mL\u002Fmin by calculation using Cockcroft-Gault formula or based on 24-hour urine sample assessment.\n  13. Participant is capable of following instructions regarding study treatment administration, and must be able to communicate with the Investigator and comply with the requirements of the study procedures.\n  14. Negative serum or urine pregnancy test within 7 days prior to study treatment in women with childbearing potential. Patient must be willing to use effective methods of contraception. Female patients must be postmenopausal, surgically sterile, or they must agree to use a physical barrier method of contraception in addition to either an intrauterine device or hormonal contraception until at least 4 months after termination of study drug.\n\nExclusion Criteria:\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Leptomeningeal metastasis (based on MRI or CSF cytology, if strong suspicion despite negative MRI, CSF analysis should be done).\n  2. Previous treatment with TROP2 inhibitor or angiogenesis inhibitor.\n  3. Known hypersensitivity to the study drugs, its metabolites, or formulation excipient.\n  4. Positive serum pregnancy test or women who are breastfeeding.\n  5. Contra-indication for MRI.\n  6. History of allogeneic bone marrow or solid organ transplant.\n  7. Have had a prior anticancer biologic agent (ADC, ICI) within 4 weeks prior to enrolment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrolment and have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.\n\n     a. Note: Patients participating in observational studies are eligible.\n  8. Have not recovered (ie, ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.\n\n     1. Note: patients with any grade vitiligo or alopecia are an exception to this criterion and will qualify for the study.\n     2. Note: if patients received major surgery, they must have recovered adequately from the toxicity and\u002For complications from the intervention prior to starting therapy.\n  9. Have an active second malignancy. Note: patients with a history of malignancy that has been treated completely, with no evidence of active cancer for 3 years prior to enrollment, or patients with surgically cured tumours with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n  10. Met any of the following criteria for cardiac disease:\n\n      1. Myocardial infarction or unstable angina pectoris within 6 months of enrollment.\n      2. History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.\n      3. New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of \\\u003C 40%.\n  11. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrolment.\n  12. Have active serious infection requiring antibiotics.\n  13. Have known history of HIV-1 or 2 (or positive HIV-1\u002F2 antibody, if done at screening) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n  14. Have known active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n  15. Have other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.\n  16. Any medical condition that, in the investigator's or sponsor's opinion, poses an undue risk to the patient's participation in the study\n  17. Use of other investigational drugs (drugs not marketed for any indication) within 28 days or 5 half-lives (whichever is longer) of first dose of study drug.\n  18. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary embolism within 1 months of enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, uncontrolled pleural effusion, etc.); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc.); or prior pneumonectomy.\n  19. Contra-indications specific to bevacizumab\n\n      1. Inadequately controlled hypertension (defined as systolic blood pressure \\> 150 mmHg and\u002For diastolic blood pressure \\> 100 mmHg). Anti-hypertensive therapy to achieve these parameters is allowable.\n      2. Prior history of hypertensive crisis or hypertensive encephalopathy.\n      3. Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to start of treatment.\n      4. History of hemoptysis (≥ one-half teaspoon of bright red blood per episode) within 1 month prior to start of treatment.\n      5. Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).\n      6. Current or recent (within 10 days of start of treatment) use of aspirin (\\> 325 mg\u002Fday) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol.\n      7. Current use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes that has not been stable for \\> 2 weeks prior to start of treatment. The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR or aPTT is within therapeutic limits (according to the medical standard of the enrolling institution) and the patient has been on a stable dose of anticoagulants for at least 2 weeks prior to start of treatment.\n      8. Prophylactic anticoagulation for the patency of venous access devices is allowed, provided the activity of the agent results in an INR \\\u003C 1.5 × ULN and aPTT is within normal limits within 14 days prior to start of treatment.\n      9. Prophylactic use of low-molecular-weight heparin (i.e., enoxaparin 40 mg\u002Fday) is permitted.\n      10. Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of bevacizumab.\n      11. History of abdominal or tracheoesophageal fistula or gastrointestinal perforation within 6 months prior to start of treatment.\n      12. Clinical signs of gastrointestinal obstruction or requirement for routine parenteral hydration, parenteral nutrition, or tube feeding.\n      13. Evidence of abdominal free air not explained by paracentesis or recent surgical procedure.\n      14. Serious, non-healing wound, active ulcer, or untreated bone fracture.\n      15. Proteinuria, as demonstrated by urine dipstick or \\> 1.0 g of protein in a 24-hour urine collection. All patients with ≥ 2+ protein on dipstick urinalysis at baseline must undergo a 24-hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours.\n      16. Clear tumour infiltration into the thoracic great vessels is seen on imaging.\n      17. Clear cavitation of pulmonary lesions is seen on imaging.",{"count":7,"type":22},[25],"This study will evaluate whether the combination of sacituzumab govitecan (SG) and bevacizumab will result in shrinkage of brain metastases from patients with non-squamous non-small cell lung cancer (NSCLC), with disease progression on chemotherapy and immunotherapy.",[28,384],"Brain Metastases, Adult",[93,386,387,388],"brain metastases","bevacizumab","sacituzumab govitecan","2025-05-02",{"date":391,"type":40},"2025-05-06",{"date":393,"type":40},"2025-04-24",{"date":395,"type":22},"2027-04-01",{"name":397,"class":47},"Maastricht University Medical Center",3,{"id":400,"slug":401,"hasResults":12,"nctId":402,"briefTitle":403,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":406,"studyType":140,"phases":4,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":398},"100412731","lung-cancer-registry-100412731","NCT04654364","Lung Cancer Registry","Inclusion Criteria:\n\n* stage III A-C and IV A-B NSCLC\n* limited disease (LD) and extensive disease (ED) SCLC)\n* patients ≥ 18 years\n\nExclusion Criteria:\n\n\\- Due to the non-interventional design of the registry there are no specific exclusion criteria.",{"count":354,"type":22},"5 Years","Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.\n\nThis malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.\n\nDespite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.",[409,28,29,410,411],"Lung Cancer","SCLC, Extensive Stage","SCLC, Limited Stage","2025-04-09",{"date":414,"type":40},"2025-04-10",{"date":416,"type":40},"2020-08-18",{"date":418,"type":22},"2030-08",{"name":420,"class":47},"Arbeitsgemeinschaft medikamentoese Tumortherapie",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":23,"phases":429,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":442},"100460882","phase-2-additional-chemotherapy-for-egfrm-patients-with-the-continued-presence-of-plasma-ctdna-egfrm-at-week-3-after-start-of-osimertinib-1st-line-treatment-pace-lung-100460882","NCT05281406","Additional Chemotherapy for EGFRm Patients with the Continued Presence of Plasma CtDNA EGFRm At Week 3 After Start of Osimertinib 1st-line Treatment (PACE-LUNG)","Inclusion Criteria:\n\nPre-Screening Phase\n\n1. Provision of written informed consent for the pre-screening phase.\n2. Age ≥ 18 years\n3. Histologically confirmed stage IIIB or IV NSCLC\n4. Tumor positive for Ex19del or L858R EGFR mutation assessed according to local standard.\n5. Planned treatment with osimertinib 80mg\u002Fd 1st-line as SoC or ongoing treatment for a maximum of 28 days\n6. Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial osimertinib treatment\n7. Previously untreated with systemic treatment given as primary therapy for advanced or metastatic disease, except for osimertinib for a maximum of 28 days (see above)\n8. At least one measurable site of disease as defined by RECISTv1.1 criteria\n9. Female subjects of childbearing potential (WOCBP) should be using highly effective contraceptive measures and must have a negative urine or serum pregnancy test within 7 days prior to start of study treatment and must not be breast-feeding prior to start of trial. Further information in Appendix 20.7 (Definition of Women of Childbearing Potential and Acceptable Contraceptive Methods)\n10. Non-child-bearing potential must be evidenced by fulfilling one of the following criteria at screening:\n\n    * Post-menopausal defined as aged more than 50 years and amenorrheic 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 amenorrheic 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\nTreatment Phase\n\n1. Provision of informed consent for the screening and treatment phase prior to any study specific procedures, including screening evaluations that are not SoC.\n2. Persistent mEGFR ctDNA signal 21 to 28 days after osimertinib initiation for advanced of metastatic ex19del or L858R EGFR mutation positive NSCLC as assessed by a liquid biopsy during the pre-screening phase of the trial in the central laboratory.\n3. ECOG performance status 0-2.\n4. The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.\n5. Osimertinib no longer than 10 weeks before start of chemotherapy in the treatment phase\n\nExclusion Criteria:\n\nPre-Screening Phase\n\n1. History of another primary malignancy. Exceptions are:\n\n   * Malignancy treated with curative intent and with no known active disease ≥6 months before the first dose of IMP, and of low potential risk for recurrence\n   * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n   * Adequately treated carcinoma in situ without evidence of disease\n2. History of leptomeningeal carcinomatosis\n3. 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\n4. Previous enrolment in the present study.\n\nTreatment Phase\n\n1. Symptomatic CNS metastases. \\[Patients with asymptomatic brain metastases may be included.\\]\n2. History of leptomeningeal carcinomatosis\n3. 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 of CYP3A4 (at least 3 weeks prior) (Appendix 20.5). All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4.\n4. Osimertinib had to be withheld or administered at reduced dosage for toxicity management for more than 7 days or persistent unresolved toxicities which preclude study treatment.\n5. Any unresolved toxicities other than osimertinib from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy.\n6. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib. History of hypersensitivity to any of the chemotherapy drugs used.\n7. 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 including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n8. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n9. Any of the following cardiac criteria:\n\n   1. Mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value\n   2. 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   3. Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\u002Fplasma potassium \\\u003C LLN; Serum\u002Fplasma magnesium \\\u003C LLN; Serum\u002Fplasma calcium \\\u003C LLN), 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 Torsades de Pointes. \\[Note: Electrolyte abnormalities (hypokalaemia, hypomagnesaemia, hypocalcaemia) can be corrected to be within normal ranges prior to first dose. No more than two re-tests may be performed in order to meet this criterion.\\]\n10. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n11. Inadequate bone marrow reserve or organ function as demonstrated by any of the following laboratory values:\n\n    1. Absolute neutrophil count below lower limit of normal (\\\u003CLLN) \\*\n    2. Platelet count below lower limit of normal (\\\u003CLLN) \\*\n    3. Hemoglobin \\\u003C90 g\u002FL \\*\n\n       \\* The use of granulocyte colony stimulating factor support, platelet transfusion and blood transfusions to meet these criteria is not permitted.\n    4. Alanine aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    5. Aspartate aminotransferase \\>2.5 times ULN if no demonstrable liver metastases or \\>5 times ULN in the presence of liver metastases;\n    6. Total bilirubin \\>1.5 times ULN if no liver metastases or \\>3 times ULN in the presence of documented Gilbert's Syndrome \\[unconjugated hyperbilirubinaemia\\] or liver metastases;\n    7. Serum creatinine \\>1.5 times ULN concurrent with creatinine clearance \\\u003C60 mL\u002Fmin \\[calculated by Cockcroft and Gault equation\\]-confirmation of creatinine clearance is only required when creatinine is \\>1.5 times ULN.\n    8. INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before chemotherapy \\[Subjects under therapeutic anticoagulation are permitted.\\]\n12. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n13. Women who are pregnant or breast-feeding\n14. Male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 4 months (male patients) or 6 weeks (female patients) after the last dose of osimertinib and 6 months after the last dose of chemotherapy.\n15. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts \\[§ 40 Abs. 1 S. 3 Nr. 3a AMG\\].\n16. Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.\n17. Any chemotherapy, biologic, or hormonal therapy for cancer treatment used concurrently or within 6 months prior to first dose of study treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.\n18. Major surgery (as defined by the Investigator) within 4 weeks prior to starting the study; patients must have recovered from effects of preceding major surgery. Note: Local non-major surgery for palliative intent (e.g., surgery of isolated lesions) is acceptable",{"count":428,"type":22},50,[25],"PACE is a prospective multicenter single-arm investigator-initiated phase II trial that examines the value of a treatment escalation strategy by the addition of platinum-based doublet chemotherapy to osimertinib in patients with treatment-naïve NSCLC harboring L858R or del19 EGFR mutation who are suspected to have poor response upon single-agent TKI treatment.",[432,28],"NSCLC Stage IIIB","2025-02-20",{"date":435,"type":40},"2025-02-21",{"date":437,"type":40},"2021-11-12",{"date":439,"type":22},"2026-11",{"name":441,"class":47},"Goethe University",16,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":447,"acronym":4,"eligibilityCriteria":448,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":449,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":451,"conditions":452,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":459,"locationsCount":76},"100576674","ai-hope-lung-cancer-building-a-predictive-tool-for-metastatic-lung-cancer-100576674","NCT06788366","AI-HOPE Lung Cancer: Building a Predictive Tool for Metastatic Lung Cancer","Inclusion criteria:\n\n* Patients with histological or cytological diagnosis of NSCLC\n* Stage IV according to investigator's staging procedures (or any locally advanced tumour not feasible for local radical treatment)\n* Treatment with at least 1 cycle of mono-immunotherapy or chemo-immunotherapy (as per clinical practice)\n* Availability of follow-up\n\nExclusion criteria:\n\n* Patients with other thoracic tumours non-NSCLC (i.e. SCLC)\n* Stage other than IV or feasible for radical treatment upfront\n* Treatment within clinical trials (with combination regimens different from the aforementioned combinations)\n* Lost to follow-up",{"count":450,"type":22},2000,"The goal of our project is building a predictive response algorithm for patients with metastatic lung cancer, exploiting an artificial intelligence platform. It will collect patient information from all areas (clinical, laboratory, radiological, pathological) and analyse them, understanding connections and correlations, both at baseline and at pre-specified timepoints. It would lead to the development of a reliable and constantly evolving predictive score, able to continuously re-weight the importance of each variable as new data come in.\n\nSince the greatest clinical need is identifying non-responders to immunotherapy and chemo-immunotherapy combination (30% of all treated patients), these two populations are defined as the starting cohorts (Cohort A, immunotherapy alone, Cohort B, chemo-immunotherapy combinations).\n\nFor each cohort, three main questions are to be answered:\n\nQ1) Early progressors (defined as progressive disease or death within three months of treatment or at first radiological restaging) Q2) Toxicity (with a special focus on severe toxicities G≥3) Q3) Long survivors (defined as patients reaching an overall survival of at least 1.5x median overall survival in registrative trials)\n\nThe early identification of non-responders, high-risk patients (or on the other hand, long survivors) would help their healthcare planning, providing individualised follow-up strategies or prompting their inclusion in alternative treatments (eg clinical trials).\n\nFor all cohorts, first data entry will be retrospective and second data entry will be prospective (as validation set).",[28],"2025-01-20",{"date":455,"type":40},"2025-01-23",{"date":457,"type":40},"2024-02-12",{"date":320,"type":22},{"name":460,"class":47},"IRCCS San Raffaele",{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":217,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":4},"100564024","cancer-patient-remote-monitoring-for-timely-communication-study-100564024","NCT06623786","Cancer Patient Remote Monitoring for Timely Communication Study","CONNECT","Inclusion Criteria:\n\n* Signed Informed Consent Form\n* Age \\> 18 years at the time of study entry\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Life expectancy \\> 6 months\n* Patient is able and willing to use smart phone and a wearable device\u002Ftechnology\u002Fsensor\n\nExclusion Criteria:\n\n* Previous systemic treatment for metastatic or locally advanced disease",{"count":469,"type":22},100,"The study is designed as a prospective, single-arm observational, mixed-method study. Patients with stage IV NSCLC or inoperable mesothelioma will be included and will be treated with immunotherapy according to current guidelines and standard of care. Patients may receive either a PD1\u002FL1 inhibitor monotherapy or, if indicated, together with a CTLA4 inhibitor. Immunotherapy may be administered alone or together with chemotherapy as per site standard\u002Fphysician's choice. Patients will be given access to a mobile app. Patients will receive daily questions via the app to assess immune-related adverse events between clinic visits and their well-being.",[28],"2024-09-30",{"date":474,"type":40},"2024-10-02",{"date":476,"type":22},"2024-10",{"date":478,"type":22},"2026-04",{"name":480,"class":75},"Asklepios proresearch",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":23,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":76},"100556328","phase-3-stereotactic-body-radiotherapy-for-oligo-progression-metastatic-non-small-cell-lung-cancer-100556328","NCT06523673","Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer","Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study","OPPRESS","Inclusion Criteria:\n\n* Age ≥ 18 years. Gender is not limited.\n* Histologically and\u002For cytologically confirmed stage IV metastatic NSCLC.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.\n* Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.\n* Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography \u002F computertomography (PET\u002FCT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.\n* All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.\n* Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.\n* Expected survival time greater than 3 months.\n* Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count\u002Fdifferential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.\n* Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.\n* Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.\n\nExclusion Criteria:\n\n* Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.\n* Pregnant or lactating women.\n* Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.\n* Presence of untreated intracranial metastases or symptomatic progressive sites.\n* History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.\n* Serious active comorbidities that would interfere with treatment in this study.\n* History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.",{"count":490,"type":22},104,[118],"The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:\n\nDoes SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?\n\nResearchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.\n\nParticipants will:\n\nTake SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.",[494,28,495],"Metastatic Non-Small Cell Lung Cancer","OligoProgressive Metastatic Disease","2024-08-28",{"date":498,"type":40},"2024-08-30",{"date":500,"type":22},"2024-09",{"date":502,"type":22},"2027-09",{"name":504,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":76},"100554615","phase-2-cranial-radiotherapy-plus-chemoimmunotherapy-in-untreated-driver-mutation-negative-nsclc-with-stable-brain-metastasis-100554615","NCT06501391","Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Stable Brain Metastasis","Cranial Radiotherapy Plus PD-1\u002FPD-L1 Inhibitors and Chemotherapy in Patients With Driver-mutation Negative Non-small Cell Lung Cancer With Stable Brain Metastasis (BRILLIANT)","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* KPS score ≥ 70;\n* Negative genetic testing for common driver genes including EGFR, ALK, ROS-1;\n* Pathologically confirmed non-small cell lung cancer;\n* Clinical stage IV (AJCC, 8th edition, 2017);\n* Diagnosed with brain metastasis at the time of diagnosis, with at least one lesion in the brain with a diameter greater than 5mm on thin-section brain MRI;\n* Complete baseline assessment of systemic lesions before treatment, including enhanced brain MRI;\n* Informed consent from the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;\n* Patients judged by the researcher as unsuitable for brain MRI or stereotactic brain radiotherapy;\n* EGFR, ALK, or ROS1 gene mutations;\n* Active BMs that could not be controlled by symptomatic treatment, such as mannitol and dexamethasone\n* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;\n* Symptomatic interstitial lung disease or active infection\u002Fnon-infectious pneumonia;\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;\n* Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmia;\n* Other uncontrollable diseases or findings from physical examination or clinical experiments judged by the researcher to potentially interfere with the results or increase the risk of treatment complications for the patient;\n* Mixed with small cell lung cancer components;\n* Pregnant or lactating women;\n* Congenital or acquired immunodeficiency diseases including HIV, or history of organ transplantation, allogeneic stem cell transplantation;\n* Known HBV, HCV, active pulmonary tuberculosis infection;\n* Patients who have received tumor vaccines, or have been vaccinated with other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed, while nasal preparations are usually attenuated live vaccines and are not allowed);\n* Concurrent use of other immunomodulators, chemotherapy drugs, drugs in other clinical studies, and long-term use of corticosteroid treatment are not eligible for inclusion;\n* Patients allergic or contraindicated to PD-1\u002FPD-L1 inhibitors or chemotherapy drugs.",{"count":513,"type":22},54,[25],"Non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer, has a significant risk of brain metastasis (BM). Historically, the median overall survival for advanced NSCLC patients with BM was under six months with traditional chemotherapy. However, recent advancements with immune checkpoint inhibitors (ICIs) have shown promise, with some studies reporting improved intracranial objective response rates, progression-free survival, and overall survival when combined with chemotherapy.\n\nDespite these improvements, challenges remain, such as treatment resistance, recurrence, and the need for better therapeutic strategies. Local interventions like stereotactic radiotherapy (SRT) and whole brain radiation therapy (WBRT) have been crucial for treating BM, with SRT being particularly effective. The combination of immunotherapy and radiotherapy is emerging as a synergistic approach, with studies suggesting it may enhance local control and survival rates while maintaining safety.\n\nGuidelines recommend SRT for patients with limited BMs, and clinical data support the safety and efficacy of combining brain radiotherapy with immunotherapy. A meta-analysis and other studies have shown promising results with this combination, including local control rates and overall survival benefits, with manageable toxicities.\n\nHowever, there is still a need for more prospective clinical trials to verify the safety and efficacy of combining cranial radiotherapy with immunotherapy in NSCLC patients with BM, especially those without driver gene mutations. Therefore, we plan to conduct a phase 2 prospective study, focusing on combining brain radiotherapy with PD-1\u002FPD-L1 inhibitors. We will stratify eligible patients based on the status of BMs (active BM vs stable BM) .",[28,517],"Brain Metastases","2024-08-27",{"date":496,"type":40},{"date":521,"type":40},"2024-07-01",{"date":523,"type":22},"2027-07",{"name":322,"class":47},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":539,"leadSponsor":541,"locationsCount":76},"100554614","phase-2-cranial-radiotherapy-plus-chemoimmunotherapy-in-untreated-driver-mutation-negative-nsclc-with-active-brain-metastasis-100554614","NCT06501378","Cranial Radiotherapy Plus Chemoimmunotherapy in Untreated Driver-mutation Negative NSCLC With Active Brain Metastasis","Cranial Radiotherapy Plus PD-1\u002FPD-L1 Inhibitors and Chemotherapy in Untreated Driver-mutation Negative Non-small Cell Lung Cancer With Active Brain Metastasis (BRILLIANT-1)","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* KPS score ≥ 70;\n* Negative genetic testing for common driver genes including EGFR, ALK, ROS-1;\n* Pathologically confirmed non-small cell lung cancer;\n* Clinical stage IV (AJCC, 8th edition, 2017);\n* Diagnosed with brain metastasis at the time of diagnosis, with at least one lesion in the brain with a diameter greater than 5mm on thin-section brain MRI;\n* Active BMs that could not be controlled by symptomatic treatment, such as mannitol and dexamethasone\n* Complete baseline assessment of systemic lesions before treatment, including enhanced brain MRI;\n* Informed consent from the patient.\n\nExclusion Criteria:\n\n* Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years);\n* Severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.;\n* Patients judged by the researcher as unsuitable for brain MRI or stereotactic brain radiotherapy;\n* EGFR, ALK, or ROS1 gene mutations;\n* Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance;\n* Symptomatic interstitial lung disease or active infection\u002Fnon-infectious pneumonia;\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;\n* Patients with active infection, heart failure, myocardial infarction within 6 months, unstable angina, or unstable arrhythmia;\n* Other uncontrollable diseases or findings from physical examination or clinical experiments judged by the researcher to potentially interfere with the results or increase the risk of treatment complications for the patient;\n* Mixed with small cell lung cancer components;\n* Pregnant or lactating women;\n* Congenital or acquired immunodeficiency diseases including HIV, or history of organ transplantation, allogeneic stem cell transplantation;\n* Known HBV, HCV, active pulmonary tuberculosis infection;\n* Patients who have received tumor vaccines, or have been vaccinated with other vaccines within 4 weeks before starting treatment (Note: Seasonal influenza vaccines are usually inactivated vaccines and are allowed, while nasal preparations are usually attenuated live vaccines and are not allowed);\n* Concurrent use of other immunomodulators, chemotherapy drugs, drugs in other clinical studies, and long-term use of corticosteroid treatment are not eligible for inclusion;\n* Patients allergic or contraindicated to PD-1\u002FPD-L1 inhibitors or chemotherapy drugs.",{"count":533,"type":22},40,[25],"Non-small cell lung cancer (NSCLC), the most prevalent form of lung cancer, has a significant risk of brain metastasis (BM). Historically, the median overall survival for advanced NSCLC patients with BM was under six months with traditional chemotherapy. However, recent advancements with immune checkpoint inhibitors (ICIs) have shown promise, with some studies reporting improved intracranial objective response rates, progression-free survival, and overall survival when combined with chemotherapy.\n\nDespite these improvements, challenges remain, such as treatment resistance, recurrence, and the need for better therapeutic strategies. Local interventions like stereotactic radiotherapy (SRT) and whole brain radiation therapy (WBRT) have been crucial for treating BM, with SRT being particularly effective. The combination of immunotherapy and radiotherapy is emerging as a synergistic approach, with studies suggesting it may enhance local control and survival rates while maintaining safety.\n\nGuidelines recommend SRT for patients with limited BMs, and clinical data support the safety and efficacy of combining brain radiotherapy with immunotherapy. A meta-analysis and other studies have shown promising results with this combination, including local control rates and overall survival benefits, with manageable toxicities.\n\nHowever, there is still a need for more prospective clinical trials to verify the safety and efficacy of combining cranial radiotherapy with immunotherapy in NSCLC patients with BM, especially those without driver gene mutations. Therefore, we plan to conduct a phase 2 prospective study, focusing on combining brain radiotherapy with PD-1\u002FPD-L1 inhibitors. Though most of the current studies excluded patients with active BM, we believe that these patients need more attention. In this trial, we focus on patients with active BM and treat them with PD-1\u002FPD-L1 inhibitor, chemotherapy and SRT\u002FWBRT.",[28],{"date":496,"type":40},{"date":521,"type":40},{"date":540,"type":22},"2025-07",{"name":322,"class":47},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":279,"minAge":19,"maxAge":56,"enrollmentInfo":550,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":551,"conditions":552,"keywords":556,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":76},"100556979","erectile-dysfunctions-gonadotoxicity-and-sexual-health-assessment-in-men-with-lung-cancer-100556979","NCT06532149","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer","ERectile Dysfunctions, gOnadotoxicity and Sexual Health Assessment in Men With Lung Cancer (EROS)","EROS","Inclusion Criteria:\n\n* Diagnosis of advanced\u002Fmetastatic NSCLC\n* To be candidate to active treatment\n* Aged ≥ 18 anni (up to 75 years old)\n* To be sexually active in last 30 days before treatment start\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Written informed consent\n\nExclusion Criteria:\n\n* History of endocrine disorders, excepting for controlled hypothyroidism (surgical or non-surgical) treated with replacement levothyroxine since at least 2 years\n* Any cancer-related or medical condition that would interfere with the patient reported outcomes or laboratory assessment. Examples include, but are not limited to:\n* Cancer-related conditions that may preclude\u002Fundermine sexual activity (e.g. leptomeningeal carcinomatosis, pathological vertebral fractures, gonadic metastases, unstable spinal cord compression, uncontrolled neurological symptoms, surgical complications):\n\n  * History of chronic liver disease or hormonal replacement therapy (e.g. ADT for prostatic cancer)\n  * Participants who not adequately recovered from previous confirmed chemotherapy-induced gonadotoxicity (e.g. cisplatin)\n  * Chronic use of drugs with known effect on male sexuality, including opiates, anxiolytics, antidepressants, mood stabilizers, beta blockers (e.g. atenolol) and high dose diuretics\n  * Psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study\n  * Major psychological disorder and\u002For high distress level that would interfere with sexual function and the participant's ability to cooperate with the requirements of the study",{"count":282,"type":22},"Although many phase III clinical trials evaluate the quality of life as a secondary endpoint, male sexuality remains a neglected topic in oncology research. In light of the long-term efficacy of new-generation anticancer treatments for ANSCLC (i.e. targeted therapies and immunotherapy), there is a paucity of data about any detrimental effect on fertility and sexuality that could complicate the therapy proposal, especially in young patients.\n\nThe aim of this trial is to assess incidence of endocrine toxicity and sexual dysfuction in male patients receiving active treatment for ANSCLC",[28,553,554,555],"Sex Disorder","Hypogonadism, Male","Erectile Dysfunction",[65,557,558,555],"Sexual Health","Male hypogonadism","2024-08-08",{"date":561,"type":40},"2024-08-09",{"date":563,"type":22},"2024-08-05",{"date":565,"type":22},"2026-09-30",{"name":567,"class":47},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":578,"conditions":579,"keywords":582,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":76},"100534111","longitudinal-assessment-of-genomic-alterations-and-clonal-evolution-in-alk-positive-nsclc-galileo-project-100534111","NCT06234579","Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)","\"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate\".","GALILEO","Inclusion Criteria:\n\n* a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available)\n\n  b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days\n\n  c) ECOG PS 0-2\n\n  d) adult patients (aged ≥ 18 years) at the moment of diagnosis\n\n  e) signing of informed consent approved by the local Ethic Committee\n\nExclusion Criteria:\n\na) Diagnosis of lung cancer without ALK rearrangement\n\na) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study",{"count":577,"type":22},108,"The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.",[580,28,581],"ALK Gene Mutation","ALK Sensitizing Mutation",[583,65],"ALK mutation","2024-07-29",{"date":586,"type":40},"2024-07-31",{"date":588,"type":40},"2021-07-12",{"date":590,"type":22},"2026-07-31",{"name":567,"class":47},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":597,"acronym":4,"eligibilityCriteria":598,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":599,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":76},"100540184","phase-2-treatment-response-adapted-hybrid-radiotherapy-in-metastatic-non-small-cell-lung-cancer-receiving-first-line-immunotherapy-100540184","NCT06313541","Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy","A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy","Inclusion Criteria:\n\n* ECOG functional status score was 0-1.\n* Histologically confirmed stage IV primary NSCLC;\n* Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1 were negative;\n* Patients with brain metastases were eligible if they were neurologically asymptomatic and had stable disease without receiving systemic glucocorticoids;\n* According to the investigator's judgment, the patient does not need to receive palliative radiotherapy for any site at present;\n* Male\u002Ffemale of childbearing age agreed to use contraception (surgical ligation or oral contraceptive\u002Fintrauterine device plus condom) during the trial;\n* Life expectancy ≥3 months;\n* One week before enrollment, the organ function level met the following criteria:\n\n  ① Bone marrow function: hemoglobin ≥80g\u002FL, white blood cell count ≥4.0\\*10\\^9\u002FL or neutrophil count ≥1.5\\*10\\^9\u002FL, platelet count ≥100\\*10\\^9\u002FL;\n\n  ② Liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times upper limit of normal;\n\n  ③ Kidney: serum creatinine \\\u003C 1.5 times upper limit of normal or creatinine clearance ≥50ml\u002Fmin, urea nitrogen ≤200mg\u002FL; Serum albumin ≥30g\u002FL;\n* Patients must be able to understand and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* The patient had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granulomatosis), etc.\n* Symptomatic interstitial lung disease or active infectious\u002Fnon-infectious pneumonia;\n* Patients with risk factors for intestinal perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other known risk factors for intestinal perforation;\n* History of other malignant tumors;\n* Patients with active infection, heart failure, myocardial infarction, unstable angina or unstable arrhythmia within the past 6 months;\n* Medical examination or clinical findings, or other uncontrollable conditions that the investigator considers may interfere with the results or increase the patient's risk of treatment complications;\n* Patients who were considered by the investigator to have lesions requiring palliative and subtractive radiotherapy;\n* Mixed with small cell lung cancer components;\n* Lactating or pregnant women;\n* Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), organ transplantation or allogeneic stem cell transplantation;\n* Known HBV, HCV, active pulmonary tuberculosis infection;\n* Patients had received a cancer vaccine or received another vaccine within 4 weeks before starting treatment (note: injectable seasonal influenza vaccine is usually inactivated, so vaccination is allowed, while intranasal vaccine is usually live attenuated, so it is not allowed);\n* Patients with concurrent use of other immune agents, chemotherapy drugs, drugs in other clinical studies, and long-term use of cortisol were excluded.\n* Patients with mental disorders, substance abuse, or social problems that affect adherence were excluded from the study after physician review;\n* Patients who are allergic to or contraindicated to PD-1 monoclonal antibody or chemotherapy drugs.",{"count":600,"type":22},146,[25],"This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC",[28],"2024-06-04",{"date":606,"type":40},"2024-06-05",{"date":608,"type":40},"2024-04-10",{"date":610,"type":22},"2025-12-31",{"name":322,"class":47}]