[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung-cancer-metastatic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung-cancer-metastatic":254},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,44,71,101,137,165,193,219,242,265,304,329,352,383,408,431,456,481,502,525,548,569],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100573039","phase-2-a-study-of-stereotactic-radiosurgery-srs-and-standard-treatment-in-people-with-lung-cancer-that-has-spread-to-the-brain-100573039",false,"NCT06741085","A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain","ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics","Participant Inclusion Criteria: Screening\n\n* Age ≥ 18 years\n* Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution\n* At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)\n* Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)\n\nParticipant Exclusion Criteria: Screening\n\n* Unable to undergo contrast-enhanced MRI brain\n* Prior brain-directed radiotherapy\n* Evidence of leptomeningeal disease on MRI total spine and\u002For lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.\n* Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS\n* Active hematologic malignancy or a second solid tumor histology with known CNS tropism\n* Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study).\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.\n* Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and\u002For a progesterone agent)\n\nParticipant Inclusion Criteria: Randomization\n\n\\- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease\n\nParticipant Exclusion Criteria: Randomization\n\n* Progressive Disease (PD) with multiple lesions and\u002For other features that would warrant a change in systemic therapy, as determined by the primary treating provider\n* Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist\n* Intracranial Complete Response (CR)\n* More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI). However, no upper limit on the number of visible brain metastases is set at the time of initial diagnosis prior to treatment with TKI. For example, a patient who had 35 visible brain metastases at the time of diagnosis, but after three months of treatment with TKI had 10 visible brain metastases remaining will be eligible for enrollment and randomization","ALL","18 Years",{"count":19,"type":20},56,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.",[26],"Non Small Cell Lung Cancer Metastatic",[28,29,30],"somatic activating mutation in EGFR","consolidative stereotactic radiosurgery","tyrosine-kinase inhibitor","RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2024-12-13",{"date":39,"type":20},"2027-12",{"name":41,"class":42},"Memorial Sloan Kettering Cancer Center","OTHER",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100505700","value-of-screening-mri-brain-in-stage-iv-non-small-cell-lung-cancer-100505700","NCT05864794","Value of Screening MRI Brain in Stage IV Non-small Cell Lung Cancer","ValUe of Screening MRI Brain in Patients With Newly Diagnosed Stage IV Non-oncogene Addicted Non-small Cell Lung CANcer - The VULCAN Trial","VULCAN","Inclusion Criteria:\n\n* Histologically or cytologically confirmed stage IV metastatic NSCLC, not amenable to curative treatment.\n* Fit for systemic treatment (PS 0-2) according to standard of care.\n* No symptoms of brain disease disease assessed according to standard clinical care by the thoracic oncologist.\n\nExclusion Criteria:\n\n* Prior\u002Fconcomitant therapy for stage IV disease.\n* Oncogenic diver mutation (e.g. EGFR, ALK, ROS1, RET, MET, and BRAF) with approved targeted treatment.\n* Contraindications for MRI scan with contrast as per standard of care protocol of the institution.",{"count":53,"type":20},100,[55],"NA","Patients with newly diagnosed stage IV non-oncogene addicted NSCLC, who are fit for systemic treatment and don't have any symptoms of brain disease will undergo an MRI of the brain to screen for brain disease.",[26],[59,60],"brain metastasis","screening","2026-06-08",{"date":63,"type":35},"2026-06-09",{"date":65,"type":35},"2024-05-13",{"date":67,"type":20},"2028-12-31",{"name":69,"class":42},"University Medical Center Groningen",3,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":21,"phases":80,"briefSummary":81,"conditions":82,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"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":79,"type":20},68,[23],"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.",[83,26,84,85,86],"Non Small Cell Lung Cancer","Non-small Cell Carcinoma","NSCLC","NSCLC Stage IV",[88,26,84,89,90,85,86,41,91],"non small cell lung cancer","liver stereotactic ablative radiotherapy","L-SABR","22-368","2026-05-06",{"date":94,"type":35},"2026-05-07",{"date":96,"type":35},"2022-12-09",{"date":98,"type":20},"2026-12-09",{"name":41,"class":42},9,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":111,"conditions":112,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100636247","observational-multicenter-study-in-patients-receiving-chemotherapy-and-amivantamab-for-metastatic-non-small-cell-lung-cancer-100636247","NCT07563205","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer","Observational Multicenter Study in Patients Receiving Chemotherapy and Amivantamab for Metastatic Non-small Cell Lung Cancer as Part of an Early Access Program","OMAE","Inclusion Criteria:\n\n* Patient over 18 years old\n* Cohort A: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion treated with amivantamab-platimum based chemotherapy via an early access program in first line setting.\n* Cohort B: Patient with metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 19 or 21 treated with amivantamab-platimum based chemotherapy post osimertinib (with or without chemotherapy) via an early access program.\n* Patient covered by the French National Health Insurance system or by an approved third-party payer\n* Patient who does not object to the collection of their personal data for research purposes (an information sheet will be provided to all living participants; for deceased participants, documented non-opposition in the medical record is not required)\n\nExclusion Criteria:\n\n* Patient placed under legal guardianship or subject to a protective legal measure\n* Patient who explicitly refuses the collection or use of their personal data for research purposes\n* Patient not enrolled, managed, or followed at the investigating site by a qualified site investigator",{"count":53,"type":20},"OBSERVATIONAL","The purpose of this observational study is to understand how well a treatment combining chemotherapy and amivantamab works in real life, and how safe it is, in adults with metastatic non-small cell lung cancer (NSCLC) who have certain EGFR gene mutations.\n\nThe study includes two groups of people:\n\n* Group A: people with an EGFR exon 20 insertion who receive amivantamab together with platinum-based chemotherapy as their first treatment, through an early access program.\n* Group B: people with an EGFR exon 19 or exon 21 mutation who receive amivantamab with platinum-based chemotherapy after having been treated with osimertinib (with or without chemotherapy), also through an early access program.\n\nThe main question the study wants to answer is:\n\nHow long can the combination of amivantamab and chemotherapy keep the cancer from coming back or getting worse in these two groups of people?\n\nPeople already receiving amivantamab and chemotherapy for NSCLC through an early access program may be included. They will continue to be followed by their usual oncologist as part of their normal medical care. The study will simply collect their medical information from March 21, 2024 to October 21, 2025.\n\nNo extra tests or procedures are required. This is an observational study, carried out by the GFPC and partner centers in France.",[113,26,114,115,85,116,117,118,119],"Non-Small Cell Lung Cancer","Non Small Cell Lung Cancer NSCLC","Non Small Cell Lung Carcinoma","EGFR","EGFR Exon 20 Insertion Mutation","EGFR Exon 19 Deletion Mutation","EGFR Exon 21 Mutation",[121,122,123,124,125,126,85],"Lung Cancer","Non Small Cell lung cancer","Metastatic lung cancer","EGFR Exon 20","EGFR Exon 19","EGFR Exon 21","2026-04-24",{"date":129,"type":35},"2026-05-01",{"date":131,"type":35},"2025-11-19",{"date":133,"type":20},"2027-11-19",{"name":135,"class":42},"GFPC Investigation",16,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100625269","phase-2-treatment-in-patients-with-advanced-non-small-cell-lung-carcinoma-and-interstitial-lung-disease-100625269","NCT07420439","Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease","Phase II Trial Assessing 1st Line and 2nd Line Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease","Inclusion Criteria for both parts:\n\n* Informed, written and signed consent: Patients must have signed and dated the written informed consent form approved by the ethics committee in accordance with the legal and institutional framework. It must have been signed before protocol-related procedures that are not part of normal patient management are performed. Patients should be willing and able to adhere to the schedule of visits, treatment and laboratory tests.\n* Patients with radiological ILDs. All cases should be presented in a multidisciplinary board dedicated to ILD to confirm eligibility. In centres without a local multidisciplinary board dedicated to ILD, the national multidisciplinary board CAPID can be used.\n* NSCLC proven histologically. Cytological evidence is allowed if a cytoblock has been prepared.\n* Age ≥ 18 years old.\n* Performance status ≤ 2.\n* Stage IIIB or IIIC non-eligible to radiation therapy or IV (8th TNM classification, UICC 2015). For other less advanced stages but rejected for any local treatment, possible inclusion discussion with the sponsor.\n* Disease measurable according to RECIST criteria 1.1 per investigator assessment.\n* Adequate biological function: Creatinine clearance ≥ 45 mL\u002Fmin (Cockroft or MDRD or CKD-epi); neutrophils ≥ 1500\u002Fmm3; platelets ≥ 100,000\u002Fmm3; Haemoglobin ≥ 9 g\u002FdL; liver enzymes\\\u003C 3x ULN except for patients with liver metastases (\\\u003C 5x ULN); total bilirubin ≤ 1.5x ULN except for patients with proven Gilbert's syndrome (≤ 5x ULN) or patients with liver metastases (≤ 3.0 mg\u002FdL).\n* Life expectancy of at least 12 weeks.\n* For female patients of childbearing potential and patients with a partner of childbearing potential, agreement (by the patient and\u002For partner) to use one or more highly effective contraceptives (failure rate \\\u003C 1% per year when used correctly and regularly) and to continue using it for 7 months after the last dose of treatment. Men should not donate their sperm for the duration of the study and for at least 7 months after the last dose of treatment. Oral contraception should always be combined with another method of contraception because of potential interactions with treatment. Patients should always use a condom.\n* Patient covered by national health insurance.\n* Protected adults may participate in the study if they can make decisions regarding their medical treatment in accordance with the guardianship judgment.\n\nInclusion Criteria for first-line part:\n\n* Patient must be treatment naive for advanced or metastatic disease. Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease.\n* ILD criteria: any type of ILD and any level of severity are allowed Inclusion criteria specific to second-line part\n* Patients must have received one but no more than one platinum-based therapy for advanced or metastatic disease. Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease.\n* ILD severity criteria: Patients with ILDs with mild to moderate alteration of pulmonary function, defined by Forced Vital Capacity (FVC) ≥ 50% of the predicted value AND DLCO≥ 35% of the of the predicted value. All cases should be presented in a multidisciplinary board dedicated to ILD to confirm eligibility. In centers without a local multidisciplinary board dedicated to ILD, the national multidisciplinary board CAPID can be used.\n* ILD type criteria: Patient with idiopathic interstitial pneumonia (including IPF and NSIP) or secondary ILDs (including hypersensitivity pneumonia, pneumoconiosis, radiation pneumonitis) could be included. Will be excluded patients with ILDs secondary to connective tissue disease, vasculitis or granulomatosis (including but not limited to granulomatosis with polyangiitis, rheumatoid arthritis, Sjogren's syndrome, scleroderma, myositis\u002Fdermatomyositis, anti-synthetase syndrome). For sarcoidosis and for Interstitial pneumonia with autoimmune features (IPAF) inclusion could be confirmed based on a case-by-case discussion with the sponsor.\n* Available results for Immunoassay including antinuclear antibodies tested by immunofluorescence, rheumatoid factor, anti-CCP, Anti-dsDNA, Anti-Ro (SS-A), Anti-La (SS-B), Anti-ribonucleoprotein, Anti-Smith, Anti-topoisomerase (Scl-70), Anti-tRNA synthetase (Jo-1, PL-7, PL-12, Anti-PM-Scl, Anti-MDA-5), ANCA.\n\nExclusion criteria for both parts\n\n* Small cell lung cancer or tumor with mixed histology including a small cell component.\n* Known EGFR activating mutation or ALK or ROS rearrangements. Inclusion of patients with any other oncogene addiction (excluding KRAS mutations) should be discussed with the sponsor on a case-by-case level.\n* History of cancer or cancer active within 3 years except those with a negligible risk of metastasis or death treated curatively (such as adequately treated cervical cancer in situ, basal or squamous cell skin cancer or ductal carcinoma in situ curatively treated. For other types of cancer, please contact the IFCT). Patients with a history of prostate cancer in the last 5 years may be included in cases of localized prostate cancer of good prognosis according to the Amico classification (≤ T2a and Gleason score ≤ 6 and PSA ≤ 10 ng\u002FmL) and if they have been treated curatively (surgery or radiotherapy ± hormone therapy, without chemotherapy).\n* Acute exacerbation of interstitial lung disease less than 6 months ago. Exclusion criteria specific to first line part\n* Previous systemic therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy). Treatment for non-metastatic stage is not considered as a line if there is a time interval of at least 6 months between the last dose of treatment for non-metastatic stage and recurrent disease.\n\nExclusion criteria specific to second line part\n\n* History of severe allergy, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the pembrolizumab\u002Fnivolumab formulation.\n* Diagnosis of interstitial lung disease with manifestations of autoimmunity (IPAF) according to ATS\u002FERS criteria39 Inclusion may be considered on a case-by-case basis following discussion with the sponsor.\n* More than one line of treatment.\n* Any prior immunotherapy.\n* History of autoimmune disease, connective tissue disease, vasculitis or granulomatosis associated with but not limited to myasthenia gravis, myositis, autoimmune hepatitis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis.\n* Diagnosis of ILDs due to connective tissue disease, vasculitis or granulomatosis including but not limited to granulomatosis with polyangiitis, rheumatoid arthritis, Sjogren's syndrome, scleroderma, myositis\u002Fdermatomyositis, anti-synthetase syndrome. For sarcoidosis and for Interstitial pneumonia with autoimmune features (IPAF) inclusion could be confirmed based on a case-by-case discussion with the sponsor.\n* Corticosteroid therapy \\> 10 mg daily oral prednisone or equivalent.\n* Immunosuppressive therapy within two weeks prior to randomization.\n* Patients who have had major surgery ≤ 3 weeks before randomization.",{"count":145,"type":20},108,[23],"Lung cancer is a leading cause of cancer-related death worldwide. Interstitial Lung Diseases are closely associated with lung cancer either as complications or comorbidities to be considered for treatment.\n\nRecently, a survey concerning the management of lung cancer in patients with ILDs was conducted by the Interstitial Lung Diseases and Thoracic Oncology Assemblies of the European Respiratory Society. Out of 494 practitioners, mostly pulmonologists, this survey showed that the majority of metastatic patients with pulmonary fibrosis would not be treated (69%), but that 25% and 31% of clinicians would offer chemotherapy or immunotherapy, respectively.\n\nThe systemic therapy is not clearly codified. There is a risk of worsening of ILDs with most of the treatments used in lung cancer including surgery, radiation therapy or certain systemic therapies. The Japanese Society of Pneumology has recently published proposals for care. However, the Asian population is unique in its incidence of ILDs and the frequency of drug toxicities and these recommendations may not be relevant for other populations. Thus, data are still needed to validate carboplatin and weekly paclitaxel as the best regimen for first-line treatment of NSCLC patients with ILD in a caucasian population.\n\nIn 2nd line setting, immune checkpoint blocker (ICB) in monotherapy or associated with chemotherapy has become an essential part of the therapeutic arsenal in advanced NSCLC. Several agents have been shown to be superior to docetaxel, following platinum-based chemotherapy failure, and have resulted in several marketing authorizations for PD-1 inhibitors (nivolumab, pembrolizumab) and PD-L1 inhibitors (atezolizumab).\n\nThe long-term benefits of using ICBs as a second-line therapy are now clear. Survival at 5 years is 10% higher than that obtained with docetaxel alone.\n\nThe safety profile is well known in particular with a risk of pulmonary toxicity. It should be noted that in most trials, patients with ILDs were not included. Therefore, we do not have trial data from these pivotal trials in patients with concomitant ILD.\n\nTwo prospective studies are available on the use of nivolumab in the second-line setting in patients with idiopathic ILDs. The first, in an Asian population, included 6 patients. It showed an interesting response rate of 50% without grade III or IV pulmonary toxicity or worsening of at 12 weeks.\n\nFollowing this, the same team proposed a multicenter phase 2 study. Included patients had mild ILDs (VCf \\>80%) and were treated with nivolumab in 2nd line. The primary objective was PFS at 6 months. 18 patients were treated. 3 patients developed toxicity leading to discontinuation of nivolumab including 2 patients with grade 2 pneumonitis. PFS at 6 months was 56%, response rate was 39% and disease control achieved for 72% of patients.\n\nIn a recent prospective study in Asia, atezolizumab was administered to patients with moderate IPF and advanced NSCLC. The study was stopped prematurely due to a high incidence of inflammatory pneumonitis.\n\nThus, data are still needed to assess the safety of ICB in NSCLC patients with ILD in second line setting.",[26,149],"Interstitial Lung Disease (ILD)",[85,151,152,153],"ILD","chemotherapy","immunotherapy","NOT_YET_RECRUITING","2026-04-22",{"date":157,"type":35},"2026-04-27",{"date":159,"type":20},"2026-05-15",{"date":161,"type":20},"2028-11-15",{"name":163,"class":42},"Intergroupe Francophone de Cancerologie Thoracique",31,{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":176,"conditions":177,"keywords":180,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":192},"100604035","phase-3-a-study-to-learn-about-the-study-medicine-called-pf-08046054sgn-pdl1v-versus-docetaxel-in-adult-participants-with-previously-treated-programmed-cell-death-ligand-1-pd-l1-positive-non-small-cell-lung-cancer-nsclc-100604035","NCT07144280","A Study to Learn About the Study Medicine Called PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","PADL1NK-005: A Randomized, Phase 3, Open-Label Study to Evaluate PF-08046054\u002FSGN-PDL1V Versus Docetaxel in Adult Participants With Previously-Treated Programmed Cell Death Ligand 1 (PD-L1) Positive Non-Small-Cell Lung Cancer (NSCLC)","Inclusion Criteria\n\n* Histologically or cytologically confirmed diagnosis of NSCLC with locally advanced, unresectable Stage IIIB or IIIC not eligible for definitive chemoradiotherapy or metastatic (Stage IV: M1a, M1b, or M1c) disease per the American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System. Note: Participants with a neuroendocrine component or histology are not eligible.\n* PD-L1 expression on ≥1% of tumor cells based on local immunohistochemistry (IHC) testing with an assay utilizing the anti-PD-L1 monoclonal antibody clones 22C3 or SP263.\n* Participants who have NSCLC with known AGAs are permitted.\n* Able to provide any of the following tumor tissues for biomarker analysis:\n\n  * Archival specimen (preferably collected within 12 months after the last anticancer therapy) (see laboratory manual for details); or\n  * De novo biopsy from a tumor lesion, if medically feasible.\n* Participants must have received the following therapies and progressed during or relapsed after receiving their most recent prior therapy, or have been intolerant to their most recent therapy:\n\nParticipants with no known AGAs must fulfill 1 of the following conditions:\n\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, and unless contraindicated, a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n* Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.\n\nParticipants with known AGAs (eg, EGFR mutations, ALK translocations, or other relevant actionable mutations) must fulfill the following conditions:\n\n* Must have received at least 1 relevant AGA-targeted therapy if locally available and, in the opinion of the investigator, additional AGA-targeted therapy is not in the best interest of the participant\n* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant, neoadjuvant, or chemoradiotherapy setting.\n* May have received PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).\n\nExclusion Criteria\n\n* History of another malignancy within 3 years before the first dose of PF-08046054, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year overall survival \\[OS\\] ≥90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer.\n* Any central nervous system (CNS) lesions, unless definitively treated with CNS-directed local therapy (surgery and\u002For radiotherapy). Participants with definitively treated brain metastases are eligible if they meet the following criteria:\n\n  * The participant is on a stable dose of ≤10 mg\u002Fday of prednisone or equivalent for at least \\>14 days prior to randomization (if requiring steroid treatment).\n  * No clinical or radiographic progression in the CNS following CNS-directed definitive radiotherapy and\u002For surgery.\n  * Time since CNS-directed treatment is ≥28 days prior to randomization.\n* Participants with a history of leptomeningeal metastasis are excluded.\n* Prior treatment with an anti-PD-L1 agent (where indicated per protocol) within 5 half-lives.\n* Previous receipt of an MMAE-containing agent or prior docetaxel.\n\nThere are additional inclusion and exclusion criteria. The study center will determine if criteria for participations are met.",{"count":173,"type":20},680,[175],"PHASE3","The purpose of this study is to understand if PF-08046054 alone works well compared to standard-of-care docetaxel alone in participants with non-small cell lung cancer (NSCLC) with PD-L1 expression greater than or equal to 1% and had cancer progression during or after treatment with PD-L1 or PD-1 inhibitors, platinum-based chemotherapy, and targeted treatment regimen(s) for participants with known actionable genomic alterations (AGAs). Participants in this study must have cancer that has spread through their body or can't be removed with surgery or treated with definitive radiation.\n\nParticipants will randomly (like a flip of the coin) be assigned to either the PF-08046054 treatment group or the docetaxel treatment group. Participants in the PF-08046054 treatment group will receive an IV infusion (injected directly into the veins) twice during each 21-day cycle. Participants in the docetaxel treatment group will receive an IV infusion once during each 21-day cycle. Study participation may be up to 5 years if the participant's NSCLC is responding to treatment. The study team will see how each participant is doing with the study treatment during regular visits at the clinic.",[84,178,179],"Non-Small Cell Lung Cancer Metastatic","Non-Small Cell Lung Carcinoma",[181,85],"Non-small cell lung cancer NSCLC","2026-04-20",{"date":184,"type":35},"2026-04-21",{"date":186,"type":35},"2025-09-29",{"date":188,"type":20},"2032-03-10",{"name":190,"class":191},"Pfizer","INDUSTRY",305,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100628522","phase-iii-multicenter-randomized-controlled-clinical-study-of-three-dimensional-radiotherapy-for-primary-tumors-in-non-oligometastatic-stage-iv-non-small-cell-lung-cancer-100628522","NCT07462728","Phase III, Multicenter, Randomized Controlled Clinical Study of Three-Dimensional Radiotherapy for Primary Tumors in Non-Oligometastatic Stage IV Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Pathologically or cytologically confirmed stage IV NSCLC \\[9th edition, 2024\\];\n2. Non-oligometastatic disease (number of metastatic lesions \\> 5, regardless of the number of organs involved); patients with brain metastases must be conscious; the number of lung metastases must not affect lung function and allow for possible primary tumor radiotherapy;\n3. Treatment-naïve (no prior antitumor therapy); or disease control after 1-3 months of monotherapy with TKI, ALK inhibitor\u002FROS inhibitor; or disease control after 4-6 cycles of chemotherapy combined with immunotherapy;\n4. Age 18-80 years, ECOG 0-2 or KPS ≥70; no contraindications to radiotherapy, EGFR-TKI, ALK\u002FROS1 inhibitors, chemotherapy, or immunotherapy;\n5. No major organ dysfunction, or laboratory test results must meet the following criteria: Hematology , cardiac function, liver function , and renal function within normal ranges according to respective laboratory standards. Pulmonary function : FEV1 \\>50%, mild to moderate impairment of lung function.\n6. Signed informed consent before treatment (for radiotherapy, chemotherapy, immunotherapy, and targeted drug therapy);\n7. Good patient compliance with the treatment and follow-up.\n\nExclusion Criteria:\n\n1. Stage I-III NSCLC, oligometastasis (number of metastatic lesions ≤ 5), Stage IV NSCLC with malignant serous cavity effusion, or KPS ≤ 60;\n2. Patients with extensive liver metastases or lung metastases that have severely impaired liver or lung function;\n3. Patients with uncontrolled hypertension, diabetes, unstable angina, history of myocardial infarction, symptomatic congestive heart failure within the past 12 months, or uncontrolled arrhythmia; clinically diagnosed valvular heart disease; active bacterial, fungal, or viral infections; mental disorders; severe pulmonary dysfunction;\n4. Pregnant or lactating patients;\n5. Patients with a history of other active malignant tumors prior to enrollment, except for non-small cell lung cancer; excluding non-melanoma skin basal cell carcinoma, cervical carcinoma in situ, and cured early-stage prostate cancer;\n6. Patients with allergic constitution or known\u002Fsuspected allergy to any investigational drugs without alternative medications;\n7. Patients with poor compliance; Patients deemed unsuitable for participation in this trial by the investigator.","80 Years",{"count":201,"type":20},200,[55],"For patients with non-small cell lung cancer and more than five metastatic lesions (non-oligometastatic disease), does radical treatment of the primary lung lesion, in addition to pharmacotherapy, also provide benefits in terms of progression-free survival (PFS) and local control? Currently, there is limited clinical research on combining pharmacotherapy with radiotherapy for the primary lesion in non-oligometastatic patients. Therefore, this study aims to investigate whether radical radiotherapy targeting the primary lung lesion, in addition to pharmacotherapy, can improve local control and survival in non-oligometastatic patients, and whether the associated toxicities are acceptable.",[26,205],"Radiotherapy",[207,208,209],"non-oligometastatic NSCLC","radical radiotherapy of the primary lung lesion","pharmacotherapy with radiotherapy for the primary lesion","2026-03-08",{"date":212,"type":35},"2026-03-10",{"date":214,"type":20},"2026-03-30",{"date":216,"type":20},"2027-12-30",{"name":218,"class":42},"Guizhou Medical University",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":226,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":241},"100524290","phase-2-lazertinib--tepotinib-for-egfr-mutant-nsclc-in-met-overexpressed-or-amplified-who-progressed-after-lazertinib-treatment-100524290","NCT06106802","Lazertinib & Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment","Lazertinib and Tepotinib for EGFR Mutant NSCLC in MET Overexpressed or Amplified Who Progressed After Lazertinib Treatment: A Phase II Multi-center Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced or metastatic non-small cell lung cancer which is not amenable to treatment with a curative aim (e.g., surgery or radiation)\n2. Confirmed EGFR mutations (exon 19 deletion, L858R) with acquired resistance after first-line lazertinib treatment (either partial response, complete response or stable disease last more than 6 months after initiation of Lazertinib) - patient can maintain the treatment with prior EGFR treatment as beyond progression until the patient start the treatment per this protocol\n3. First-line cytotoxic chemotherapy received as palliative treatment is acceptable after the failure of Lazertinib (Patients with disease progression after adjuvant or neoadjuvant chemotherapy within 6 months are eligible to participate)\n4. Patient with MET amplification FISH GCN ≥5 and\u002For MET\u002FCEP7 ≥ 2 (If additional resistance mechanism to lazertinib, such as C797S, is observed with MET amplification, the recruitment needs to be discussed in advance with the principal investigator)\n5. Available tissue for MET FISH\n6. Age of 19 or more\n7. Performance status of Eastern Cooperative Oncology Group 0 to 2\n8. Expected minimum life expectancy of 12 weeks\n9. Adequate organ function\n\n   1. Absolute neutrophil count (ANC) ≥1500cells\u002Fmm3\n   2. Platelet count ≥100,000cells\u002Fmm3\n   3. Total bilirubin ≤1.5 x upper limit of normal(ULN)\n   4. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN (or ≤5.0 x ULN, if liver metastasis is present)\n   5. Creatinine level ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 45mL\u002Fmin (Calculated with Cockcroft- Gault equation)\n10. Available to provide the adequate tissue and blood for the genomic tests\n\n    \\- At least 20 unstained slide and 20 cc of blood at baseline and disease progression (If not, participant must be confirmed by the principal investigator\n11. Agreed to perform re-biopsy at the timepoint of disease progression\n12. Female subjects must either be of non-reproductive potential\n13. Subject willing and able to comply with the protocol\n14. Signed written informed consent\n\nExclusion Criteria:\n\n1. Previously treatment with any kind of EGFR TKI other than lazertinib\n2. All concurrent and\u002For other active malignant tumors requiring systemic therapy within 2 years prior to the initial administration of the investigational drug (However, the patient may participate if previous malignant tumor has been cured, and no further treatment is required)\n3. Uncontrolled central nervous system metastases\n4. Spinal cord compression, leptomeningeal carcinomatosis\n5. Uncontrolled systemic illness, including uncontrolled hypertension, active bleeding, or active infection\n6. Radiotherapy with a wide field of radiation within 2 weeks or radiotherapy with a limited field of radiation (localized radiotherapy or gamma knife surgery) for palliation within 1 week\n7. Any unresolved toxicities from prior therapy, greater than CTCAE grade 1\n8. Prior history of interstitial lung disease (ILD) or ILD like symptoms\n9. Mean QT interval corrected for heart rate (QTc) ≥ 470 ms\n10. No measurable lesion\n11. Unable to swallow the product due to refractory nausea, vomiting or chronic gastrointestinal disease","19 Years",{"count":228,"type":20},47,[23],"As the 3rd generation, EGFR TKI has become a standard treatment option for the 1st line therapy in EGFR mutated patients, the necessity for evaluating resistant mechanism to determine the matched subsequent therapeutic option has been highlighted. From the 1st line Osimertinib treatment, the heterogenous resistance mechanism has been observed showing most commonly by MET amplification (7-15%) followed by additional on-target EGFR mutation (6-10%), BRAF, PI3KCA, KRAS, HER2 mutation (13-14%) and still 40 to 50% remain unknown for the mechanism. (A. Leonetti et al.British Journal of Cancer(2019))\n\nBased on the observation showing the MET amplification as the most common resistance mechanism to the 3rd generation EGFR TKI treatment, the \"TATTON\" study, a multi-arm, phase IB trial, demonstrated early clinical data of Osimertinib in combined with savolitinib. Among the patients, c-MET amplified patients who were previously treated with 3rd generation EGFR TKI, a combination of Osimertinib and savolitinib, showed an objective response rate of 33% and median PFS of 5.5 months. (G. Oxnard et al. Annals of Oncology(2020))\n\nThe clinical efficacy of Osimertinib with savolitinib in MET overexpressed or amplification patients are reported from the global phase II, \"SAVANNAH\" study. The preliminary results from the SAVANNAH trial showed that Osimertinib plus savolitinib demonstrated an objective response rate of 49% in patients with a high level of MET overexpression and\u002For amplification, defined as IHC90+ and\u002For FISH 10+, whose disease progressed on treatment with Osimertinib. The highest ORR was observed in patients with a high level of MET who were not treated with prior chemotherapy (52%). In patients whose tumors did not show a high level of MET, the ORR was 9% (MJ Ahn, WCLC, 2022). There are ongoing global Phase III SAFFRON study to validate the outcome from SAVANNAH study.\n\nIt has been reported that around 62% of tumor in Osimertinib progressed sample has MET overexpression and\u002For amplification, and more than one-third (34%) met the defined high MET level cut-off.\n\nAs Lazertinib is about to be approved as the treatment option for the treatment naïve EGFR mutated NSCLC, it is also becoming important to develop a further treatment plan based on the MET amplification status. In this study, the investigators designed a phase II study based on the MET amplification status to evaluate the clinical efficacy of Lazertinib + tepotinib.",[178],"2026-02-19",{"date":234,"type":35},"2026-02-23",{"date":236,"type":35},"2024-06-11",{"date":238,"type":20},"2029-09-30",{"name":240,"class":42},"Samsung Medical Center",1,{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":241},"100612199","phase-2-risk-adapted-proteomic-guided-systemic-therapy-for-previously-untreated-advanced-non-small-cell-lung-cancer-100612199","NCT07250477","Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Participants must have histologically confirmed non-small cell lung cancer that is metastatic or unresectable (stage IIIC or IV), deemed appropriate to receive standard of care immune checkpoint inhibitor-based therapy given with palliative intent.\n* Age ≥18 years at the time of consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%).\n* Ability to understand and willingness to sign the informed consent form (ICF).\n* Stated ability and willingness to adhere to all protocol requirements while on study\n\nExclusion Criteria:\n\n* Tumor with known sensitizing alteration in ALK, EGFR, HER2, MET exon 14, NTRK, RET, or ROS1.\n* Medical comorbidities precluding immune checkpoint inhibitor-based therapy per treating investgator's discretion.\n* Previous systemic therapy for metastatic Stage IIIC or IV NSCLC. Patients who previously completed systemic therapy for early stage or locally advanced NSCLC ≥ 80 days prior to trial registration are eligible for inclusion.\n* Any condition that in the opinion of the investigator would interfere with the participant's safety or compliance while on study",{"count":19,"type":20},[23],"This is a phase 2, pragmatic, 1:1 randomized, open-label study that evaluates risk-adapted, proteomic-guided systemic therapy to improve 12-month progression free survival (PFS) among patients with previously untreated advanced non-small cell lung cancer.",[252,253,83,254,255],"Non-small Cell Lung Cancer Stage IIIC","Non-small Cell Lung Cancer Stage IV","Non-small Cell Lung Cancer Metastatic","Non-small Cell Lung Cancer Unresectable","2026-02-04",{"date":258,"type":35},"2026-02-09",{"date":260,"type":35},"2026-01-30",{"date":262,"type":20},"2036-12",{"name":264,"class":42},"University of California, Davis",{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":275,"briefSummary":277,"conditions":278,"keywords":283,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100615404","phase-1-a-phase-1b2-study-of-the-safety-and-efficacy-of-the-monoclonal-antibody-om-rca-01-in-patients-with-metastatic-tumors-expressing-fibroblast-growth-factor-receptor-1-100615404","NCT07292168","A Phase 1b\u002F2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1","A Phase 1b\u002F2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.","TAGNOT","Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form confirming voluntary participation in the study.\n2. Age ≥ 18 years at the time of consent.\n3. Body weight ≥ 50 kg.\n4. Histologically confirmed metastatic solid tumors:\n\n   1. clear-cell renal cell carcinoma;\n   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);\n   3. prostate cancer (castration-resistant adenocarcinoma);\n   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);\n   5. head and neck tumors (squamous carcinoma, salivary gland cancer).\n5. Immunohistochemical expression of FGFR1 of 2+ or higher.\n6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.\n7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.\n9. ECOG performance status 0 or 1.\n10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:\n\n    * Hemoglobin level ≥ 90 g\u002FL\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n    * Platelet count ≥ 100 × 10⁹\u002FL\n    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)\n    * Glomerular Filtration Rate (GFR) ≥ 30 mL\u002Fmin\n    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)\n    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)\n    * Serum calcium ≥ lower limit of normal\n    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)\n11. Life expectancy of more than 12 weeks.\n12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.\n13. Women capable of childbearing must be using an effective method of contraception.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.\n2. Presence of central nervous system (CNS) metastases and\u002For medullary carcinomatosis at the time of inclusion.\n\n   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:\n   * No evidence of new or progressive CNS metastases\n   * No ongoing steroid therapy\n   * Stable mental status sufficient to provide informed consent\n3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:\n\n   * Limit interpretation of study results,\n   * Prevent completion of the study protocol, or\n   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.\n4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.\n5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.\n6. Plans to conceive during the study period, current pregnancy, or lactation.\n7. Known HIV-positive status.\n8. Known active hepatitis B or C infection.\n9. Evidence of active bleeding or hemorrhagic diathesis.\n10. Radiation therapy within 14 days prior to inclusion.\n11. Receipt of any anti-tumor treatments including:\n\n    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or\n    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.\n12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.",{"count":274,"type":20},58,[276,23],"PHASE1","One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.\n\nThe goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:\n\n1. What medical problems do participants have when receiving drug OM-RCA-01?\n2. What dose of the drug should patients receive in the next studies?\n3. Does tumor growth slow down in patients receiving OM-RCA-01?\n\nAll patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.",[279,280,254,281,282],"Renal Cell Carcinoma Metastatic","Prostate Cancer Metastatic","Breast Cancer Metastatic","Head & Neck Cancer",[284,285,286,287,288,289,290,291,292,293],"metastatic cancer","resistance","monoclonal antibody","fibroblast growth factor receptor 1","OM-RCA-01","kidney cancer","prostate cancer","head & neck cancer","lung cancer","breast cancer","2026-01-20",{"date":296,"type":35},"2026-01-21",{"date":298,"type":35},"2025-12-02",{"date":300,"type":20},"2027-01-01",{"name":302,"class":42},"Kidney Cancer Research Bureau",5,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":303},"100507581","circulating-tumor-dna-guided-treatment-monitoring-in-advanced-lung-cancer-100507581","NCT05889247","Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer","Circulating Tumor DNA Guided Treatment Monitoring in Advanced Lung Cancer - a Randomized Interventional Study","PRELUCA","Inclusion Criteria:\n\n* Newly diagnosed, histologically verified, Non-Small Cell Lung Cancer (NSCLC)\n* Advanced or locally advanced disease without curative intended treatment options\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group (ECOG) score of Performance Status (PS) 0-1\n* Measurable disease according to the iRECIST criteria version 1.1.\n* Eligible to first line immunotherapy (monotherapy)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Targetable alterations in EGFR, ALK or ROS-1\n* Other active cancers",{"count":313,"type":20},350,[55],"The study is a prospective randomized interventional study including patients with advanced non-small cell lung cancer, receiving immunotherapy, with the aim of optimizing treatment monitoring. The study aims to investigate the clinical utility of liquid biopsy monitoring in order to reduce the numbers of inefficient treatments and needless toxicity - and to explore the cost-effectiveness and cost-utility of introducing liquid biopsy monitoring in daily clinical practice.",[254],[318,319],"liquid biopsy","treatment monitoring","2026-01-06",{"date":322,"type":35},"2026-01-09",{"date":324,"type":35},"2023-07-28",{"date":326,"type":20},"2032-06",{"name":328,"class":42},"Zealand University Hospital",{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":21,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":241},"100552505","phase-1-a-phase-ib-study-of-gc101-in-nsclc-100552505","NCT06473961","A Phase Ib Study of GC101 in NSCLC","An Open, Single-armed, Phase Ib Study to Evaluate the Safety and Efficacy Using Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer","MIZAR-005","Inclusion Criteria:\n\n* 1\\. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;\n* 2\\. Aged ≥18 years and ≤70 years, regardless of gender;\n* 3\\. Patients with unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual chemotherapy;\n* 4\\. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \\>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;\n* 5\\. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \\[see Appendix 4\\]) even after TIL sampling and resection of surgically resectable tissue;\n* 6\\. ECOG performance status 0-1;\n* 7\\. Expected survival time \\>3 months;\n* 8\\. With sufficient hematology and end-organ function as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:\n\n  * White Blood Cell (WBC)≥2.5×10\\^9\u002FL#\n  * Absolute Lymphocyte Count (ANC)≥1.5×10\\^9\u002FL;\n  * Absolute Lymphocyte Count(ALC)≥0.7×10\\^9\u002FL;\n  * Platelet≥100×10\\^9\u002FL#\n  * International Normalized Ratio#INR#≤1.5×ULN;\n  * Activated Partial Thromboplastin Time#APTT#≤1.5×ULN;\n  * Serum Creatinine (Scr)≤1.5mg\u002FdL (or 132.6μmol\u002FL) or Creatinine\n  * Clearance≥60mL\u002Fmin\n  * Urinalysis: urine protein less than 2+, or 24-hour urine protein \\\u003C1g;\n  * Alanine aminotransferase(AST\u002FSGOT) ≤3×ULN;\n  * Alanine aminotransferase (ALT\u002FSGPT) ≤3×ULN;\n  * Total Bilirubin(TBIL)≤1.5×ULN#\n* 9\\. \\* Premenopausal women who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) to one year after cell infusion, and the serum pregnancy test during the screening period must be negative; \\*Men who have not undergone sterilization surgery must agree to use effective contraception measures from the start of study treatment (preconditioning) until one year after cell infusion;\n* 10\\. No absolute or relative contraindications for surgery;\n* 11\\. Any melanoma treatment methods, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, tumor embolization, or traditional Chinese medicine\u002Fherbal medicine treatment with anti-tumor indications, must be stopped 28 days before infusion. If a small molecular targeted drug was used in the previous treatment, the withdrawal time can be shortened to 5 half-lives of the drug used;\n* 12\\. Good compliance and able to adhere to the study visit plan and other agreement requirements.\n\nExclusion Criteria:\n\n* 1\\. More than 5-line system therapy had been used in previous 3 years before screening period.\n* 2\\. Participation in a clinical trial of another drug or biologic therapy or receipt of a comparable cellular therapy within 28 days prior to infusion;\n* 3\\. Combination of 2 or more malignant tumors, except: Eradicated malignant tumors that have been inactive for ≥5 years prior to study entry and are at minimal risk of recurrence; adequately treated non-melanoma skin cancer or malignant nevus of freckle-like nevus without evidence of disease recurrence; adequately treated carcinoma in situ without evidence of disease recurrence;\n* 4\\. Has received live attenuated vaccination after signing informed consent or is scheduled to receive it during the study;\n* 5\\. Has not recovered from a prior procedure or treatment-related adverse reaction to ≤ grade 1 nci ctcae 5.0 (except for toxicities such as alopecia, etc., which in the judgment of the investigator pose no safety risk);\n* 6\\. Known history of allergy to streptomycin, ciprofloxacin, or micafungin or allergy to any component of the infused product formulation;\n* 7\\. Uncontrolled co-morbidities including, but not limited to, uncontrolled arterial hypertension (systolic blood pressure ≥160 mmhg and\u002For diastolic blood pressure ≥100 mmhg) even with standardized treatment or any unstable cardiovascular disease including transient ischemic attack, cerebrovascular accident, myocardial infarction, unstable angina pectoris within 6 months prior to enrollment; new york heart association ( nyha class iii or iv congestive heart failure with an ejection fraction \\\u003C50%; or severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias, degree ii-iii atrioventricular block, etc., requiring clinical intervention; ecg results showing clinically significant abnormalities or a qtcf ≥450ms (if the first test is abnormal, it may be retested at least 5 minutes apart twice and the combined result\u002Fmean value to determine eligibility) ;\n* 8\\. Patients with esophageal or gastric varices that require immediate intervention (e.g., taping or sclerotherapy) or are considered to be at high risk for bleeding based on the opinion of the investigator or consultation with a gastroenterologist or hepatologist, have evidence of portal hypertension (including splenomegaly detected on imaging), or have a prior history of variceal bleeding must have undergone endoscopic evaluation within 3 months prior to enrollment;\n* 9\\. Uncontrolled metabolic disorders, such as diabetes mellitus known to be uncontrolled, or other non-malignant organ or systemic diseases or secondary reactions to cancer, and which can lead to higher medical risk and\u002For uncertainty in survival evaluation;\n* 10\\. Hepatic encephalopathy, hepatorenal syndrome or child-pugh class b or more severe cirrhosis, liver failure;\n* 11\\. Comorbidity with other serious organic or psychiatric disease;\n* 12\\. Have an active systemic infection requiring treatment with positive blood cultures or imaging evidence of infection, including but not limited to active tuberculosis;\n* 13\\. Be hiv-positive, have a positive serologic test for syphilis, or have clinically active hepatitis a, b, or c, including viral carriers: Hepatitis b, excluding those who are HBsAg-positive; hepatitis c, excluding those who are HCVAb-positive;\n* 14\\. Active autoimmune diseases that still require systemic steroid hormones or other immunosuppressive drugs during the screening period (greater than 10 mg\u002F day of prednisone or equivalent doses of other hormones);\n* 15\\. Any nci ctcae5.0 immune-related adverse effect (irae) grade ≥ 3 during any prior period of immunotherapy receipt;\n* 16\\. History of organ allograft, allogeneic stem cell transplantation and renal replacement therapy; History of allogeneic t-cell and nk-cell therapy;\n* 17\\. Pulmonary fibrosis, interstitial lung disease (both past history and current), and acute lung disease; Patients with obstructive or restrictive lung disease with FEV1(forced expiratory volume in 1 second) of lung function ≤70%;\n* 18\\. Clinically uncontrollable third space effusions, such as pleural and abdominal effusions that cannot be controlled by drainage or other means prior to enrollment;\n* 19\\. Patients with clinically symptomatic central nervous system metastases (e.g., cerebral edema, need for hormonal intervention, or progression of brain metastases). Patients with prior treatment for brain metastases, such as clinical stability (mri) that has been maintained for at least 2 months and who have discontinued systemic hormone therapy (dose \\>10 mg\u002Fday prednisone or other equipotent hormone) for \\>4 weeks may be included;\n* 20\\. Women who are pregnant or breastfeeding;\n* 21\\. If the investigator believes that other circumstances are not suitable for enrollment.","70 Years",{"count":339,"type":20},20,[276],"20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.",[26,83],"2025-12-04",{"date":345,"type":35},"2025-12-11",{"date":347,"type":35},"2024-10-14",{"date":349,"type":20},"2027-07-01",{"name":351,"class":191},"Shanghai Juncell Therapeutics",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":370,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":339},"100586607","phase-2-palace-cemiplimab-trial-according-to-ctdna-levels-100586607","NCT06917573","PALACE: Cemiplimab Trial According to ctDNA Levels","Phase II Clinical Trial With an Adaptive Design According to Response to Cemiplimab Monotherapy Using ctDNA and Subsequent Treatment With Chemotherapy (CT) and Cemiplimab or Cemiplimab Monotherapy in First Line Advanced NSCLC Patients","PALACE","Inclusion Criteria:\n\n* Histologically confirmed stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy\n* PDL1 ≥50%\n* ECOG performance status 0-1\n* Patients aged ≥ 18 years\n* Prior adjuvant or neoadjuvant chemotherapy for early stage is permitted if completed at least 6 months prior to enrolment\n* Presence of at least one measurable lesion by CT-scan per RECIST version 1.1\n* Anticipated life expectancy \\>12 weeks\n* Correct hematological, hepatic and renal function\n* Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements\n* Patients must be accessible for treatment and follow-up\n* Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before enrolment.\n* All sexually active men and women of childbearing potential must use a highly effective contraceptive method during the study treatment and for a period of at least 4 months following the last administration of trial drugs\n\nExclusion Criteria:\n\n* Patients whose tumors harbor an activating mutation in EGFR, ALK translocation, or ROS Proto-Oncogene 1 (ROS1) rearrangements sensitive to available targeted inhibitor therapy\n* Patients with grade ≥2 neuropathy\n* Pregnant or breastfeeding women\n* Patients with a weight loss \\>10% within the previous 3 months\n* Patients with carcinomatous meningitis\n* Patients with a history of other malignant diseases within the past 3 years\n* Patients must have recovered from a major surgery at least 14 days prior to enrolment\n* Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol\n* Prior treatment with antineoplasic drugs or thoracic radiotherapy for any reason different from the ones specific in the inclusion criteria\n* Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease less than 6 months before enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy\n* Patients with a combination of small cell lung cancer and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n* Has known allergy or hypersensitivity to components of study drug\n* Significant comorbidities that preclude the administration of chemotherapy according to the investigator's criteria\n* Ongoing or recent evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments\n* Untreated brain metastasis(es) that may be considered active\n* Immunosuppressive corticosteroid doses within 4 weeks prior to the first dose of cemiplimab\n* Uncontrolled infection with hepatitis B or hepatitis C or human immunodeficiency virus; or diagnosis of immunodeficiency\n* History of interstitial lung disease or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.\n* History of documented allergic reactions or acute hypersensitivity reactions attributed to antibody treatments\n* Patients with a history of solid organ transplant\n* Receipt of live vaccines within 30 days of first study treatment\n* Women of childbearing potential, or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment prior to the start of the first treatment, during the study, and for at least 4 months after the last dose.",{"count":361,"type":20},63,[23],"This is an open-label, non-randomised, phase II, multicenter clinical trial. 63 stage IV or stage IIIB\u002FC not candidates for definitive chemo\u002Fradiotherapy or surgical resection non-small cell lung cancer (NSCLC) per the 8th edition TNM with no prior systemic anti-cancer therapy will be enrolled in this trial to determine whether therapy decision making based on ctDNA analysis improves overall survival.",[26,365,366,367,368,369],"Lung Diseases","Stage IV Non-small Cell Lung Cancer","Stage III Non-small Cell Lung Cancer","Respiratory Tract Neoplasms","Thoracic Neoplasms",[371,372,373,374],"Cemiplimab","ctDNA levels","Chemotherapy","Non-resectable non-small cell lung cancer","2025-11-17",{"date":131,"type":35},{"date":378,"type":35},"2025-07-29",{"date":380,"type":20},"2031-12-30",{"name":382,"class":42},"Fundación GECP",{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":110,"phases":4,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":241},"100607601","first-line-therapy-with-nivolumab-plus-ipilimumab-in-combination-with-chemotherapy-for-metatastatic-nsclc-nicrewo-trial-100607601","NCT07190677","First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic NSCLC (NICReWo Trial)","First-line Therapy With Nivolumab Plus Ipilimumab in Combination With Chemotherapy for Metatastatic Non-small Cell Lung Cancer: an Ambispective, Observational, Italian, Multicenter, Real World Study (NICReWo Trial)","NICReWo","Inclusion Criteria:\n\n* Diagnosis of stage IV or recurrent NSCLC (histologically or cytologically confirmed stage);\n* Decision to initiate a first-line treatment with nivolumab plus ipilimumab in combination with 2 cycles of platinum-based chemotherapy for the treatment of NSCLC according to the Italian label, independently of the study, in patients whose tumors have no sensitising EGFR mutation or ALK translocation;\n* Patient is at least 18 years of age at time of treatment decision;\n* Patient provided written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment;\n* Previous treatment with nivolumab and\u002For ipilimumab;\n* Patient already included in an interventional clinical trial for their advanced or recurrent NSCLC.",{"count":392,"type":20},300,"NICReWo is an Italy-wide, multicenter, observational, ambispective study, designed to collect real-life data during the early post-market authorization approval period of the combination nivolumab plus ipilimumab plus chemotherapy.\n\nData are retrospectively collected starting from January 2022 and will be prospectively collected until 31 December 2025, co-primary endpoints are to evaluate progression-free survival (PFS) and overall survival (OS) in a real world patient population. Secondary endpoints are overall response rate (ORR), duration of treatment and incidence of treatment-related adverse events (AEs). All data obtained for this study are recorded with an Electronic Data Capture (EDC) system using eCRFs (RedCap platform).",[26],[396,397,398],"Nivolumab","Ipilimumab","Real world","2025-09-20",{"date":401,"type":35},"2025-09-24",{"date":403,"type":35},"2025-01-17",{"date":405,"type":20},"2027-12-31",{"name":407,"class":42},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":415,"enrollmentInfo":416,"targetDuration":4,"studyType":21,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":241},"100581293","xingbai-ji-formula-combined-with-chemotherapy-and-sintilimab-in-metastatic-multi-target-mutation-negative-non-small-cell-lung-cancer-a-clinical-trial-100581293","NCT06848426","Xingbai Ji Formula Combined with Chemotherapy and Sintilimab in Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer: a Clinical Trial","A Clinical Study of Xingbaiji Formula in Combination with Chemotherapy and Sintilimab As First-Line Treatment for Metastatic Multi-Target Mutation-Negative Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Signed written informed consent.\n2. Age: 18-75 years, regardless of gender.\n3. Histologically or cytologically confirmed non-small cell lung cancer (NSCCC), including adenocarcinoma, squamous cell carcinoma, or large cell carcinoma, with negative EGFR, ALK, and ROS-1 mutations confirmed by next-generation sequencing (NGS). Stage IIIB-IV NSCLC as per AJCC 8th edition staging criteria (required evaluations: neck contrast-enhanced CT or ultrasound, chest contrast-enhanced CT, abdominal contrast-enhanced CT or ultrasound, brain contrast-enhanced MRI, bone scan, or whole-body PET\u002FCT).\n4. ECOG performance status ≤2 and life expectancy ≥3 months.\n5. Histologically or cytologically documented ineligibility for EGFR, ALK, or ROS-1 targeted therapies (written evidence required).\n6. At least one measurable lesion per RECIST v1.1. Lesions within prior radiation fields or post-local treatment may be selected if progression is confirmed.\n7. No prior systemic anti-tumor therapy for advanced disease. Adjuvant chemotherapy is permitted if ≥6 months have elapsed between recurrence and the last dose.\n\nExclusion Criteria:\n\n1. History of or concurrent other malignancies (excluding non-invasive tumors such as cured basal cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n2. Individuals with allergic reactions to the Xingbaiji formula;\n3. Patients with mixed small cell lung cancer or those with a small cell lung cancer component;\n4. Severe mental illness or cognitive impairment that would impede compliance with study protocols or follow-up requirements;\n5. Pregnant or lactating women (a pregnancy test must be performed to exclude pregnancy; women of childbearing age must agree to use effective contraception during the study);\n6. Presence of any major illness or significant laboratory abnormalities that may interfere with receiving Xingbaiji formula, chemotherapy, or immunotherapy; 7Any other conditions deemed by the investigators to render participation in the trial inappropriate.","75 Years",{"count":53,"type":20},[55],"Clinical Trial Protocol\n\nPrimary Objective:\n\nTo evaluate the efficacy of the Xingbaiji Formula combined with chemotherapy and Sintilimab as first-line therapy in patients with recurrent or metastatic Stage IIIB-IV EGFR\u002FALK\u002FROS-1 mutation-negative non-small cell lung cancer (NSCLC), using Objective Response Rate (ORR) of tumor lesions as the primary endpoint.\n\nSecondary Objectives:\n\nTo assess secondary endpoints including Progression-Free Survival (PFS), Quality of Life (QoL), immune-related indicators, and safety profile (e.g., incidence of adverse events), and to further evaluate the efficacy and safety of the combination therapy.\n\nRandomized Group Allocation:\n\nParticipants will be randomly assigned to two groups:\n\nControl Group\n\nRegimen for Advanced Non-Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Pemetrexed + Cisplatin\u002FCarboplatin via intravenous infusion, administered every 3 weeks (Q3W) for 4 cycles.\n\nAfter completion of 4 cycles, patients enter the maintenance phase: Sintilimab 200mg Q3W (up to 24 months) + Pemetrexed Q3W until disease progression, intolerable toxicity, death, or voluntary withdrawal.\n\nRegimen for Advanced Squamous NSCLC:\n\nDrugs and Dosage:\n\nSintilimab 200mg + Gemcitabine + Cisplatin\u002FCarboplatin via intravenous infusion, Q3W for 4-6 cycles.\n\nPost-treatment, patients receive Sintilimab 200mg Q3W maintenance until disease progression, intolerability, or completion of 2 years of Sintilimab therapy.\n\nExperimental Group Control Group Regimen + Xingbaiji Formula\n\nXingbaiji Formula Dosage:\n\n1. Granule No. 1: 10g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals.\n2. Granule No. 2: 5g\u002Fbag, dissolved in warm water. Administration: 1 bag orally, twice daily (morning and evening), after meals. Treatment Duration: Both granules are taken concurrently with chemotherapy for 6 months, then discontinued.",[113,420,421,253,254],"Non-small Cell Lung Cancer Recurrent","Non-small Cell Lung Cancer Stage IIIB","2025-02-23",{"date":424,"type":35},"2025-02-27",{"date":426,"type":20},"2025-03-10",{"date":428,"type":20},"2028-01-31",{"name":430,"class":42},"Jiangxi Provincial People's Hopital",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":438,"targetDuration":440,"studyType":110,"phases":4,"briefSummary":441,"conditions":442,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":454,"locationsCount":241},"100256852","clinical-research-platform-into-molecular-testing-treatment-and-outcome-of-non-small-cell-lung-carcinoma-patients-100256852","NCT02622581","Clinical Research Platform Into Molecular Testing, Treatment and Outcome of (Non-)Small Cell Lung Carcinoma Patients","CRISP","Inclusion Criteria:\n\nPatients who meet all of the following criteria are eligible for the project:\n\n* Age ≥ 18 years\n* Able to understand and willing to sign written Informed Consent and to complete patient-reported-outcome assessment instruments\n\nMain project (Metatstatic NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first-line systemic treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\"\n* Stage IV, or stage IIIB\u002FC (UICC8) if patient is ineligible for curative surgery and\u002For radiochemotherapy\n* Systemic therapy or best supportive care\n\nSatellite Stage I\u002FII\u002FIII (NSCLC):\n\n* Confirmed non-small cell lung cancer (NSCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment (including surgery and radiotherapy) or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Stage I, Stage II, stage IIIA, or stage IIIB\u002FC (UICC8)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nSatellite SCLC\n\n* Confirmed Small cell lung cancer (SCLC)\n* Informed consent no later than four weeks after start of first anti-tumor treatment or no later than four weeks after diagnosis for patients receiving \"best supportive care only\" (i.e. no anti-tumor treatment = no surgery, radiotherapy or systemic therapy)\n* Systemic (chemo)therapy and\u002For radiation therapy and\u002For surgery or best supportive care\n\nExclusion Criteria:\n\nnone",{"count":439,"type":20},12400,"3 Years","Open, non-interventional, prospective, multi-center clinical research platform with the main objective to assess molecular biomarker testing, treatment and outcome of patients with NSCLC or SCLC in Germany",[443,254,444,445,446,447],"Metastatic Non-small Cell Lung Cancer (NSCLC)","Non-small Cell Lung Cancer Stage II","Non Small Cell Lung Cancer Stage III","Small-cell Lung Cancer","Non-small Cell Lung Cancer Stage I","2025-02-14",{"date":450,"type":35},"2025-02-18",{"date":452,"type":35},"2015-12",{"date":39,"type":20},{"name":455,"class":42},"AIO-Studien-gGmbH",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":462,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":21,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":241},"100555889","phase-2-befotertinib-and-icotinib-for-nsclc-with-uncommon-egfr-mutations-100555889","NCT06517953","Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations","A Phase II Study to Assess Befotertinib and Icotinib as First-Line Treatment in Patients With Locally Advanced or Metastatic NSCLC and Uncommon EGFR Mutation(IcomBine, GASTO-10114)","IcomBine","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Pathologically confirmed adenocarcinoma of the lung, with locally advanced or metastatic disease and not amenable to curative surgery or radiotherapy (stage IIIB, IIIC or IV disease based on the eighth edition of the American Joint Committee on Cancer (AJCC) TNM classification). Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.\n3. Patients must be treatment-naive for locally advanced or metastatic NSCLC systemic antitumor therapy. Prior adjuvant and neo-adjuvant therapy (except for EGFR-TKIs) is permitted if have been completed at least 6 months prior to initiation of disease progression.\n4. Tissue or blood samples are confirmed by the central laboratory or research center as rare EGFR mutations, including exon 18 G719X, S768I in exon 20 and at least one of the L861Q mutations in exon 21;\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n6. Predicted survival ≥ 3 months.\n7. At least 1 measurable tumor lesion without radiotherapy as per RECIST v1.1.\n8. Agree to use effective contraception during the study period and for at least 3 months after completion of the study treatment.\n9. Provision of informed consent prior to any study procedure.\n\nExclusion Criteria:\n\n1. Combined with other malignancy(except for clinically cured in situ cervix carcinoma, basal cell or squamous epithelial skin cancer,thyroid papillary carcinoma).\n2. Prior treatment with any EGFR-TKIs.\n3. Prior treatment with any systemic antitumor therapy for locally advanced or metastatic NSCLC.\n4. Previous traditional chinese medicine with an antitumor indication within 2 weeks before the first dose of study drug.\n5. Previous major surgery within 4 weeks before the first dose of study drug,or planing to have major surgery during study.\n6. Symptoms or signs worsened within 2 weeks before the first dose of study drug.\n7. Any unresolved toxicities from prior treatment greater than NCI CTCAE v4.03 grade 2 or higher.\n8. Spinal cord compression,symptomatic or unstable central nervous system (CNS) metastases that require the use of steroids .Patients who have a stable CNS status for at least 4 weeks before treatment will be allowed to join the study.\n9. Any clinical evidence of serious or uncontrolled systemic disease,including uncontrolled hypertension after drug treatment,active bleeding diatheses, previous or present thrombus,uncontrolled cardiovascular and cerebrovascular diseases.\n10. Active infection including hepatitis B,hepatitis C,syphilis and human immunodeficiency virus (HIV).\n11. Mean resting corrected QT interval (QTcF) ≥450 msec,obtained from 3 ECGs or any clinically important abnormalities in rhythm,conduction, morphology of resting ECG or left ventricular ejection fraction (LVEF) ≤ 50%,etc.\n12. Previous history of interstitial lung disease(ILD),drug-induced interstitial lung disease,history of radiation-induced pneumonia requiring hormone therapy,or clinical evidence of active interstitial lung disease.\n13. Any instance that affects the patient's ability to swallow drug or oral malabsorption.\n14. Occur any laboratory indicator abnormalities as follow：\n\n    * absolute neutrophil count(ANC)\\\u003C1,500\u002FmcL\n    * platelets\\\u003C100,000\u002FmcL\n    * hemoglobin\\\u003C9.0 g\u002FdL\n    * AST\u002FALT\\>2.5 times the upper limit of normal (ULN)or \\>5 times the ULN in the presence of liver metastases\n    * total bilirubin(TBIL)\\>1.5 times the ULN if no liver metastases or \\> 3 times the ULN in the presence of liver metastases\n    * serum creatinine(SCr) \\>1.5 times the ULN or creatinine clearance ≥50 mL\u002Fmin.\n15. Patients with a known allergy or delayed hypersensitivity reaction to the any component of study drugs or their excipients.\n16. Within 1 week before the first dose of study drug currently receiving or need concomitant medications known to be potent inhibitors or inducers of CYP3A, CYP2D6,CYPC8 and CYP2C19,sensitive substrate of CYP3A and CYP2C9.\n17. Within 1 week before the first dose of study drug ongoing use of warfarin.\n18. Previous therapeutic clinical trial within 4 weeks before the first dose of study drug.",{"count":465,"type":20},23,[23],"This research study aims to explore the combination of two targeted drugs as first-line treatment for Non-Small Cell Lung Cancer (NSCLC) with uncommon EGFR mutation.",[254,469,470,471],"EGFR G719X","EGFR L861Q","EGFR S768I","2024-07-23",{"date":474,"type":35},"2024-07-25",{"date":476,"type":35},"2024-07-17",{"date":478,"type":20},"2027-12-24",{"name":480,"class":42},"Sun Yat-sen University",{"id":482,"slug":483,"hasResults":11,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":21,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":241},"100490632","phase-3-double-blind-study-to-evaluate-the-pk-efficacy-safety-and-immunogenicity-of-mb12-versus-keytruda-in-stage-iv-nsclc-100490632","NCT05668650","Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 Versus Keytruda® in Stage IV NSCLC","Randomized, Multicenter, Multinational, Double-blind Study to Evaluate the PK, Efficacy, Safety and Immunogenicity of MB12 (Proposed Pembrolizumab Biosimilar) Versus Keytruda® in Subjects With Stage IV NSCLC","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be included in the study:\n\n1. Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures.\n2. Greater than or equal to 18 years of age at the time of signing the ICF.\n3. Body weight ≥50 kg at Screening.\n4. Having newly diagnosed stage IV (defined by the eighth edition of the TNM classification) non-squamous NSCLC, without prior systemic treatment for the disease. For those subjects in whom the pleural or pericardial effusion is the only location of metastatic disease, confirmation of its malignant etiology is required.\n5. At least 1 radiographically measurable lesion per RECIST version 1.1, locally assessed.\n6. Programmed death-ligand 1 (PD-L1) expression ≥50%, locally determined by immunohistochemistry, as determined by a Food and Drug Administration (FDA) validated method.\n7. Life expectancy of at least 3 months.\n8. ECOG performance status of 0 to 1.\n9. Adequate hepatic, renal, hematologic, endocrine, and coagulation function, defined as:\n\n   1. Liver function: bilirubin level ≤1.5 × the upper limit of normal (ULN) (≤3 × ULN for subjects with Gilbert's syndrome), albumin level ≥ lower limit of normal (LLN), aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤2.5 × ULN in subjects without liver metastases or ≤5 × ULN in subjects with liver metastases.\n   2. Renal function: serum creatinine level ≤1.5 × ULN, calculated creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n   3. Hematologic function: absolute neutrophil count ≥1.5 × 109\u002FL; platelet count ≥100 × 109\u002FL, hemoglobin ≥9 g\u002FdL.\n   4. Endocrine function: thyroid stimulating hormone (TSH) within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.\n   5. Coagulation: international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days before the first dose of the study drug.\n10. Subjects with a negative COVID-19 test (done at the discretion of investigator or per local regulation) within previous 24 hours before randomization. In case of confirmed COVID-19 infection before Screening, documentation of resolution of infection by appropriate laboratory test is required.\n11. No history of prior malignancy, except for basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or cervical cancer in situ, or has undergone potentially curative therapy without evidence of disease recurrence for 3 years from the start of that therapy.\n12. Women of childbearing potential (WOCBP) must either abstain from sexual intercourse or employ highly effective contraception measures during the study and for at least 6 months after the last dose of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range for women under 50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 6 months after the last dose of the study drug.\n13. Male subjects, if not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 6 months after the last dose of the study drug. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the above mentioned duration.\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.\n2. Predominantly squamous cell histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible.\n3. Participation in another clinical trial or treatment with another investigational agent within 4 weeks or 5 half-lives before randomization, whichever is longer.\n4. Known actionable mutations for which there is an approved and available therapy.\n5. Known central nervous system metastases and\u002For carcinomatous meningitis.\n6. Previous systemic steroid therapy (prednisone at a dose of 10 mg or equivalent) within 3 days before the first dose of the study drug or receiving any other form of immunosuppressive medication. Subjects receiving daily steroid replacement therapy (daily prednisone at a dose of 5 to 7.5 mg or equivalent) could be included in the study.\n7. Subject who requires any other form of localized or systemic antineoplastic therapy during the study.\n8. Prior anti-programmed cell death-1 (anti-PD-1), anti-PD-L1, anti programmed death-ligand 2 (anti-PD-L2), anti-CD137, or anti cytotoxic T lymphocyte antigen (CTLA)-4 therapy (including ipilimumab or any other antibody or drug that specifically targets co stimulation of T cells or immune checkpoints).\n9. Prior systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks before the first dose of the study drug; have received thoracic radiation therapy of \\>30 gray (Gy) within 6 months before the first dose of the study drug. Palliative radiotherapy is allowed if completed \\>14 days before the first dose of the study drug.\n10. Known history of severe hypersensitivity to another monoclonal antibody.\n11. Active autoimmune disease which has required systemic treatment in the last 2 years before the first dose of the study drug (eg, disease modifying agents, corticosteroids, or immunosuppressive treatment). Replacement therapy (eg, thyroxine, insulin, or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency) is not considered a form of systemic treatment.\n12. Interstitial lung disease or pneumonitis requiring oral or intravenous steroids.\n13. Active infection or a previous infection requiring intravenous systemic treatment within 30 days before the first dose of the study drug.\n14. Subject who has received or is about to receive a live virus vaccination within 30 days before the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n15. Known history of human immunodeficiency virus (HIV)-1 or HIV-2.\n16. Known active tuberculosis or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C (hepatitis C antibody positive and hepatitis C virus \\[HCV\\] RNA positive).\n17. Subject who has received a solid organ\u002Ftissue allogeneic transplant.\n18. Known psychiatric disorders that could interfere with cooperation with study requirements.\n19. At the time of signing the ICF, the subject is a regular user (including \"recreational use\") of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol).\n20. Subject is pregnant or lactating or expecting to conceive during the study or up to 120 days after the last dose of the study drug.\n21. Immediate family member who is at the research site or sponsoring staff who is directly involved in this study",{"count":489,"type":20},174,[175],"This is a randomized, multicenter, multinational, double-blind, and parallel-group study to evaluate the PK, efficacy, safety and immunogenicity of MB12 (proposed pembrolizumab biosimilar) versus Keytruda® in subjects with newly diagnosed stage IV non-squamous NSCLC. This study is planned to be conducted in approximately 48 sites in 7 countries, a total of 174 subjects will be enrolled.\n\nEligible subjects will be randomized in a 1:1 ratio to receive MB12 or Keytruda® at a dose of 200 mg every 3 weeks. Subjects will be stratified by gender (male versus female) and ECOG status (0 versus 1) as both factors are considered to have the potential to influence PK properties of pembrolizumab to some extent.\n\nThe study will consist of 2 periods defined as follows:\n\n* Main Study Period from Screening up to Cycle 6 included.\n* Extended Treatment Period from Cycle 7 up to Week 52 for those subjects who demonstrate clinical benefit from the treatment (complete response \\[CR\\], partial response \\[PR\\], and stable disease \\[SD\\]). They will continue treatment until disease progression, intolerance to the study drug, treatment discontinuation for other reason, or up to Week 52, whichever occurs first.\n\nA Data Safety Monitoring Board (DSMB) will assess the safety data periodically and will recommend to the sponsor whether to continue, modify, or stop the trial on the basis of safety considerations. After the first 10 subjects have received at least 2 cycles of treatment, the DSMB will review the accumulated safety data, and the first meeting will take place. Subsequent meetings will be performed as per the DSMB charter.",[26],"2024-07-14",{"date":495,"type":35},"2024-07-16",{"date":497,"type":35},"2023-08-15",{"date":499,"type":20},"2024-12",{"name":501,"class":191},"Laboratorio Elea Phoenix S.A.",{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":4,"eligibilityCriteria":507,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":508,"targetDuration":4,"studyType":21,"phases":510,"briefSummary":511,"conditions":512,"keywords":513,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":4},"100519608","phase-2-t-cell-repertoire-sequencing-assessing-pembrolizumab-efficacy-in-advanced-non-small-lung-cancer-100519608","NCT06045767","T-Cell Repertoire Sequencing: Assessing Pembrolizumab Efficacy in Advanced Non-small Lung Cancer","Inclusion Criteria:\n\n* Participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n* Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n* Archival tumor tissue sample or newly obtained \\[core, incisional or excisional\\] biopsy of a tumor lesion not previously irradiated has been provided.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Aberration in a known targetable molecular driver.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.\n* Received prior systemic anti-cancer therapy for metastatic disease.\n* Received prior radiotherapy within 2 weeks of start of study intervention.\n* Major surgery within 14 days.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated or asymptomatic brain metastases may participate provided they are radiologically stable.",{"count":509,"type":20},30,[23],"This is a single site, non-randomized trial for the assessment of intravenous (IV) pembrolizumab (also known as MK-3475) combined with pemetrexed\u002Fplatinum-based chemotherapy in subjects with advanced or metastatic non-squamous non-small lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease and in whom directed therapy is not indicated. Approximately 30 subjects will be enrolled in this trial to examine the clonality and diversity dynamics matched with disease response evaluated by RECIST 1.1.",[254],[514,515],"T-cell repertoire","ctDNA","2024-05-30",{"date":518,"type":35},"2024-06-03",{"date":520,"type":20},"2024-06",{"date":522,"type":20},"2029-01",{"name":524,"class":42},"Ari Raphael",{"id":526,"slug":527,"hasResults":11,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":21,"phases":535,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":100},"100545207","phase-2-a-study-to-evaluate-the-combination-of-platinum-pemetrexed-based-chemotherapy-plus-lorlatinib-in-alk-positive-non-small-cell-lung-cancer-nsclc-with-exclusively-extracranial-disease-progression-on-lorlatinib-100545207","NCT06378892","A Study to Evaluate the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib","A Multicenter Single-arm Phase II Interventional Study to Evaluate the Activity and Safety of the Combination of Platinum-pemetrexed Based Chemotherapy Plus Lorlatinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) With Exclusively Extracranial Disease Progression on Lorlatinib.","ALK-PPL","Key Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of stage IV ALK positive NSCLC.\n* Patients must be in progression extracranially on Lorlatinib; Lorlatinib may be in first- or further-line, without limitations regarding previously received therapies.\n* Age at the time of signing the informed consent at least 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n* Patients must have measurable disease according to RECIST 1.1 by computed tomography (CT) and magnetic resonance imaging (MRI).\n* Radiologically confirmed multiple extracranial progression on Lorlatinib without progression in the central nervous system (CNS) defined as absence of CNS metastasis or CNS metastasis stable on Lorlatinib and\u002For stereotactic brain irradiation (SBRT).\n* Adequate organ function (kidney, bone marrow and liver).\n* Estimated life expectancy of at least 3 months irrespective of the diagnosis of ALK+ NSCLC.\n* For women of childbearing potential and males with partners of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study drugs.\n\nKey Exclusion Criteria:\n\n* Known hypersensitivity reaction to one of the compounds or substances used in this protocol.\n* Diagnosis of any secondary malignancy within the last 3 years except for: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, definitively treated nonmetastatic prostate cancer or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.\n* Patients deemed unsuitable by the investigator for treatment of chemo-Lorlatinib combination.\n* Presence of toxicities contraindicating the continuation of therapy with Lorlatinib.\n* Concomitant use of potent CYP3A4\u002F5 inducers.\n\nOther inclusion\u002Fexclusion criteria may apply.",{"count":534,"type":20},45,[23],"This study aims to evaluate the activity and safety of the combination of platinum-pemetrexed based chemotherapy plus Lorlatinib in ALK positive Non-Small Cell Lung Cancer (NSCLC) with exclusively extracranial disease progression on Lorlatinib. Platinum-pemetrexed based chemotherapy plus Lorlatinib will be administered for an induction phase of four cycles. Subsequently, patients with response or stability of disease at radiological assessment will start the maintenance phase with pemetrexed-Lorlatinib in 21-day cycles until progression, unacceptable toxicity, death, or withdrawal of consent.",[26,538],"ALK Gene Mutation","2024-04-22",{"date":541,"type":35},"2024-04-23",{"date":543,"type":35},"2024-03-15",{"date":545,"type":20},"2028-05",{"name":547,"class":42},"Centro di Riferimento Oncologico - Aviano",{"id":549,"slug":550,"hasResults":11,"nctId":551,"briefTitle":552,"officialTitle":553,"acronym":4,"eligibilityCriteria":554,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":415,"enrollmentInfo":555,"targetDuration":4,"studyType":21,"phases":557,"briefSummary":558,"conditions":559,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":241},"100522534","phase-1-an-early-stage-study-to-evaluate-oba01-for-injection-in-patients-with-dr5-positive-lamnsclc-100522534","NCT06083870","An Early Stage Study to Evaluate Oba01 for Injection in Patients With DR5 Positive LA\u002FmNSCLC","A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Oba01 for Injection in Patients With DR5 Positive LA\u002FmNSCLC","Inclusion Criteria:\n\n* Voluntary agreement to provide written informed consent.\n* Man or woman ≥ 18 years and ≤75 years of age at the time of enrollment.\n* Histologically and\u002For cytologically-confirmed locally advanced or metastatic NSCLC.\n* Measurable lesion according to RECIST 1.1.\n* Progression after systemic treatment for advanced NSCLC.\n* Available archived paraffin-embedded or fresh tumor tissue from the primary tumor or metastasis for submission to the central laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Measurable and\u002For non-measurable disease as per RECIST 1.1 criteria.\n* Adequate organ function as assessed by laboratory tests.\n* Male or female subjects of child-producing potential must agree to use avoidance of pregnancy measures during the study and for 6 months after the last day of treatment.\n\nExclusion Criteria:\n\n* Patient has received previous treatment with DR5 targeted regimen or antibody-MMAE conjugate.\n* Brain metastases unless asymptomatic, stable and not requiring steroids for at least 7 days prior to start of study treatment.\n* Subject with positive HCV-Ab, Anti-HIV or positive HBS-Ag with copies of HBV DNA \\> ULN.\n* Pregnancy, lactation, or breastfeeding.",{"count":556,"type":20},35,[276],"This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of Oba01 for injection in patients with DR5 positive LA\u002FmNSCLC.",[254],"2023-12-14",{"date":562,"type":35},"2023-12-20",{"date":564,"type":35},"2023-12-13",{"date":566,"type":20},"2026-07",{"name":568,"class":42},"Lu Shun",{"id":570,"slug":571,"hasResults":11,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":415,"enrollmentInfo":576,"targetDuration":4,"studyType":21,"phases":577,"briefSummary":578,"conditions":579,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":241},"100500743","phase-3-armatinib-alone-or-in-combination-with-srt-for-brain-metastases-egfr-mutated-non-small-cell-lung-cancer-100500743","NCT05800223","Armatinib Alone or in Combination With SRT for Brain Metastases EGFR-mutated Non-small Cell Lung Cancer","Prospective, Multicenter, Randomized Controlled, Phase III Clinical Study of Armatinib Alone or in Combination With Stereotactic Body Radiotherapy (SRT) for First-line Treatment of Brain Metastases From EGFR-mutated Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. aged 18 years or older (including 18 years) and up to 75 years (including 75 years)\n2. histologically confirmed NSCLC (by AJCC 8th edition lung cancer staging criteria)\n3. asymptomatic or minimally symptomatic brain metastases (i.e., headache, nausea, or seizures responding to dexamethasone\u002Fanalgesic\u002Fantiepileptic agents at a stable drug dose for at least 3 days);\n4. brain metastases must meet the following criteria on diagnostic MRI: at least one lesion that can be classified as measurable disease according to RANO-BM, ≤ 10 brain or brainstem metastases\n5. epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 (L858R) substitution mutation (alone or in combination with other EGFR mutations);\n6. no prior systemic therapy other than neoadjuvant therapy, adjuvant therapy, or concurrent chemotherapy for more than 3 months prior to study entry\n7. Eastern Cooperative Oncology Organization Group (ECOG) physical status score of 0 or 1 and no worsening in the previous 2 weeks, with a minimum expected survival of 12 weeks.\n8. good hematopoietic function, defined as absolute neutrophil count ≥ 1.5 × 109 \u002FL, platelet count ≥ 100 × 109 \u002FL, and hemoglobin ≥ 90 g\u002FL \\[no transfusion or erythropoietin (EPO-dependent) within 7 days\n9. good coagulation, defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN; if the subject is on anticoagulation therapy, as long as the PT is within the proposed range of anticoagulant medication\n10. good liver function, defined as a total bilirubin level ≤ 1.5 times the upper limit of normal (ULN); glutathione transaminase (AST) and glutamate transaminase (ALT) levels ≤ 2.5 times the ULN for patients without liver metastases; and AST and ALT levels ≤ 5 times the ULN for patients with documented liver metastases\n11. good renal function, defined as serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance ≥ 60 ml\u002Fmin; urine protein less than 2+ on routine urine examination, or 24-hour urine protein quantification \\\u003C 1 g\n12. Women of childbearing potential should have a negative urine or serum pregnancy test within 3 days prior to receiving the first dose of study drug (Week 1, Day 1).\n13. male patients should be using barrier contraception (i.e., condoms) from screening until 6 months after discontinuation of study treatment\n14. Subjects will voluntarily participate and sign an informed consent in writing.\n\nExclusion Criteria:\n\n1. Received any of the following treatments:\n\n   1. Currently participating in an interventional clinical study treatment or received another study drug within 4 weeks prior to the first dose\n   2. Received palliative intracranial radiation therapy prior to the first dose\n   3. Patient has undergone major surgery (including biopsy) or major trauma within 4 weeks prior to the first dose of study drug; patients who are expected to require major surgery during the study period\n   4. Patients previously treated with EGFR-TKI.\n2. patients with NSCLC EGFR driver gene negative or known severe allergic reactions (≥ grade 3) to TKIs drugs;\n3. patients who are unable to undergo MR examination\n4. brain metastases requiring surgical decompression;\n5. the presence of a previous solid organ or hematologic transplant; clinically active diverticulitis, abdominal abscess, gastrointestinal obstruction; the presence of clinically uncontrollable pleural effusion\u002Fperitoneal effusion\n6. malignancy other than non-small cell lung cancer within 5 years prior to enrollment, excluding adequately treated carcinoma in situ of the cervix, basal cell or squamous epithelial cell skin cancer of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ of the breast;\n7. having unremitting residual toxicity of prior therapy greater than CTCAE grade 1 at the time of initiation of study treatment, with the exception of alopecia and grade 2 neurotoxicity from prior chemotherapy;\n8. have any serious or poorly controlled systemic disease, such as active bleeding-prone body or active infection, as judged by the investigator. Chronic illnesses that do not require exclusion;\n9. the known presence of a psychiatric illness or substance abuse condition that may have an impact on compliance with trial requirements\n10. any serious or uncontrolled ocular pathology that, in the judgment of the physician, may increase the safety risk to the patient\n11. a known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive)\n12. patients who, in the judgment of the investigator, are likely to be poorly compliant with the procedures and requirements of the study.",{"count":392,"type":20},[175],"Objective:Patients with asymptomatic or minimally symptomatic Stage IV EGFR-positive NSCLC with baseline intracranial metastases.\n\nAim: To investigate the timing, efficacy and safety of radiotherapy in patients with EGFR positive brain metastases treated with armatinib alone or combined with stereotactic radiotherapy.\n\nMethod: Almonertinib: specification 55mg\u002Ftablet; The dosage is 110 mg \u002F day (2 tablets \u002F day) orally once a day; SBRT: 3-5 doses of 27-40 Gy",[254],"2023-03-23",{"date":582,"type":35},"2023-04-05",{"date":584,"type":35},"2023-01-01",{"date":586,"type":20},"2028-12",{"name":588,"class":42},"Shanghai Cancer Hospital, China"]