[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Intergroupe Francophone de Cancerologie Thoracique\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":235},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,46,76,103,132,156,182,208],{"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":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100625269","phase-2-treatment-in-patients-with-advanced-non-small-cell-lung-carcinoma-and-interstitial-lung-disease-100625269",false,"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.","ALL","18 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26,27],"Non Small Cell Lung Cancer Metastatic","Interstitial Lung Disease (ILD)",[29,30,31,32],"NSCLC","ILD","chemotherapy","immunotherapy","NOT_YET_RECRUITING","2026-04-22",{"date":36,"type":37},"2026-04-27","ACTUAL",{"date":39,"type":20},"2026-05-15",{"date":41,"type":20},"2028-11-15",{"name":43,"class":44},"Intergroupe Francophone de Cancerologie Thoracique","OTHER",31,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100580710","phase-2-evaluating-ivonescimab-as-a-potential-treatment-for-pleural-mesothelioma-patients-whose-cancer-has-returned-after-previous-immunotherapy-and-chemotherapy-100580710","NCT06840834","Evaluating Ivonescimab as a Potential Treatment for Pleural Mesothelioma Patients Whose Cancer Has Returned After Previous Immunotherapy and Chemotherapy","Assessment of Ivonescimab as Salvage Treatment in Relapsing Pleural Mesothelioma Patients, Previously Treated by Immunotherapy and Standard Chemotherapy","Bi-MAPS","Inclusion Criteria:\n\n1. Signed Informed consent. Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n\n   Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n2. Histologically-proven Pleural Mesothelioma (no cytology allowed, biopsies by thoracoscopy recommended).\n\n   Note: pathology certification by national expert network NETMESO\u002FMESOPATH should be checked as already done in routine in France by NETMESO regional expert MTB for PM (or similar national certification if the patient had his\u002Fher PM diagnosis obtained outside France, e.g. Belgium).\n3. Documented progression by CT with iodine injection according to modified RECIST 1.1 for mesothelioma (mRECIST 1.1; pleural thickness perpendicular to the chest wall or mediastinum of 7mm or more, on 2 positions, at 3 separate levels on transverse cuts of CT-scan, at least 1cm apart, the sum of 6 measurements defining a pleural unidimensional measure), or according to RECIST 1.1 for mediastinal nodes or metastatic lesion, after maximum 2 lines including immunotherapy by nivolumab ± ipilimumab, and standard P\u002FP chemotherapy \\[with (maximum 40% total of patients) or without bevacizumab\\], sequentially (regardless of treatment order), or first-line combining standard chemotherapy + IO (pembrolizumab or other IO investigational drug but no anti-angiogenic drug).\n4. Measurable disease according to mRECIST 1.1.\n5. ECOG PS 0 or 1.\n6. Weight loss \\\u003C10% within 3 months of study entry.\n7. Age ≥18 years.\n8. Life expectancy \\>3 months.\n9. Available pathological samples (at least 10 slides from the thoracoscopy biopsies) for centralized PD-L1, MTAP, immunohistochemistry, and NGS \u002F transcriptome analyses, all slides being centrally reviewed by the French panel MESOPATH for mesothelioma histological certification. If archival tissue is either insufficient or unavailable, the patient may still be eligible upon discussion with IFCT.\n10. Adequate biological functions:\n\n    Creatinine Clearance ≥45 mL\u002Fmin (Cockroft or MDRD or CKD-epi); neutrophils\n\n    ≥1500\u002Fmm3; platelets ≥100 000\u002Fmm3; haemoglobin ≥9 g\u002FdL; AST and ALT \\\u003C3 x ULN, total bilirubin \\\u003C2 x ULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤5 x ULN and a baseline total bilirubin ≤2 x ULN), urine protein \\\u003C2+ or 24 hours urine protein quantification \\\u003C1.0 g, prothrombin time (PT) or international normalized ratio (INR) ≤1.5 x ULN, and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless abnormalities are unrelated to coagulopathy or are secondary to prophylactic coagulation).\n11. Women of childbearing potential and sexually active should use a highly effective contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) within 24 hours prior to the start of study drug.\n12. For male subjects who are sexually active with women of childbearing potential, an efficacious contraception method should be used during the treatment and during the 6 months following the last dose.\n13. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. ECOG PS\\>1.\n2. Previous treatment for PM by more than 2 lines of systemic treatment, or by bevacizumab (or another anti-angiogenic \u002F anti-VEGF pathway drug) except if combined with P\u002FP chemotherapy \\[scheme validated by ASCO, NCCN, and ESMO guidelines\\] in maximum 40% of the total of recruited patients (n=15).\n3. Suspicion of hyperprogressive disease or rapid tumour progression when treated by previous IO (i.e. progressive disease within 9 weeks of treatment by previous nivolumab ± ipilimumab or alternative immunotherapy, starting from C1D1 or from randomization if previous experimental immunotherapy).\n4. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.\n5. Peritoneal, pericardial or tunica vaginalis testis mesothelioma, without any pleural involvement at the time of diagnosis.\n6. Previous diagnosis of adenocarcinoma from any anatomic site within the previous 3 years, with the exception of prostate adenocarcinoma history in case of localized prostate cancer with good prognostic factors according to d'Amico classification (\\\u003CT2a, Gleason score ≤6 and PSA ≤10 ng\u002Fml), provided they were treated in a curative modality (surgery or radiotherapy, without any chemotherapy).\n7. Previous or active cancer within the previous 3 years (except for already treated in situ carcinoma of the cervix, or basal cell skin cancer, treated or not).\n8. Uncontrolled pleural effusion despite previous (talc or other) pleurodesis, requiring thoracocentesis (by pleural aspiration) more often than every 21 days. However, patients with efficient indwelling pleural catheter (IPC) are eligible.\n9. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and the beginning of the treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids (\\>10 mg prednisone equivalent daily) or mannitol infusions, are allowed.\n10. Radiotherapy needed at initiation of treatment, except bone palliative radiotherapy on a painful or compressive tumour site (in this case, target lesions should not be selected in the irradiated zone).\n11. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before registration date, or history of severe toxicity (grade 3\u002F4) by immune mechanism linked to another immunotherapy treatment for any kind of disease.\n12. Systemic treatment with corticosteroids with a dose \\>10 mg prednisone equivalent daily, within 14 days before initiation of the treatment. Inhaled, nasal or topical corticosteroids are allowed.\n13. History of active autoimmune disease, needing systemic immunosuppressive drug, including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular thrombosis associated with anti-phospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, Guillain-Barré syndrome within previous 15 years, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    Patients with type I diabetes, or hypothyroidism, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment or \\>10 mg daily oral steroids, or benign sicca syndrome (Sjogren) without interstitial lung disease (ILD), or history of past Guillain-Barre syndrome beyond 15 previous years, totally reversible with no sequelae, no systemic immunosuppressive treatment during the last 20 years, are allowed to be included. Patients with Grave's disease or psoriasis not requiring systemic therapy within the previous two years from are allowed to be included.\n14. Active inflammatory intestinal disease (diverticulosis, Crohn's disease, haemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhoea.\n15. Pre-existing moderate or severe ILD as assessed by the diagnostic CT-scan and decrease of TLCO higher than 35% from theoretical normal values linked to such ILD.\n16. Major surgical procedures or serious trauma within 4 weeks prior to inclusion or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to registration.\n17. History of bleeding tendencies or coagulopathy, or clinically significant bleeding symptoms or risk within 4 weeks prior to inclusion, including but not limited to: gastrointestinal bleeding; haemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots), note: transient haemoptysis associated with diagnostic bronchoscopy is allowed; nasal bleeding \u002F epistaxis (bloody nasal discharge is allowed); need for therapeutic anticoagulant therapy within 14 days prior to inclusion. Note: prophylactic anticoagulation for deep vein thrombosis \u002F pulmonary embolism or to maintain venous patency is allowed.\n18. Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy.\n19. History of major diseases before registration, specifically:\n\n    1. Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade 2) or vascular disease (e.g. aortic aneurysm at risk of rupture) that required hospitalization within 12 months prior to inclusion, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g. poorly controlled arrhythmias, myocardial ischemia). Patients with a significant cardiac history, even if controlled, should have a LVEF \\>45%.\n    2. History of oesophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses or acute gastrointestinal bleeding within 6 months before inclusion.\n    3. History of arterial thromboembolic event, venous thromboembolic event of Grade 3 and above as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 6 months prior to inclusion.\n    4. Acute exacerbation of chronic obstructive pulmonary disease within 4 weeks prior to inclusion.\n    5. History of perforation of the gastrointestinal tract or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to inclusion.\n20. Imaging during the screening period shows that the patient has:\n\n    1. Radiologically documented evidence of major lung blood vessel invasion or encasement by cancer.\n    2. Radiographic evidence of lung intratumor cavitation.\n21. Active uncontrolled infection including active tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequelae of cured viral hepatitis are allowed to be included. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not represent a contraindication provided the patient was treated for at least 6 months by anti-tuberculosis antibiotic treatment.\n22. Patients with a known history of a positive test for HIV or known AIDS who have not received effective antiretroviral therapy (ART) for the last 4 weeks and who have an HIV viral load \\>200 copies\u002FmL, regardless of CD4+ T-cell count.\n23. Living attenuated vaccine received within the 30 previous days; mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed.\n24. Inability to comply with study or follow-up procedures as estimated by the referent investigator.\n25. Known allergy or hypersensitivity to study treatment or any excipient.\n26. Concomitant treatment with another experimental treatment or participation in another clinical trial.\n27. Patient who is subject to legal protection or who is unable to express his will.",{"count":55,"type":20},38,[23],"Multicentre, open-label, single arm phase II study for patients with PM previously treated by immunotherapy and standard chemotherapy. 38 patients will be given second or third-line treatment with ivonescimab 20mg\u002Fkg every 3 weeks.\n\nAn estimated 38 patients will be enrolled in approximately 20 centres. Patients will be treated for a maximum of 2 years, until disease progression, unacceptable toxicity, withdrawal of consent or another discontinuation criterion is met.\n\nThe null hypothesis is disease control rate (DCR) at 12 weeks ≤ 30%. The alternative hypothesis is DCR ≥ 55% at 12 weeks.",[59],"Pleural Mesotheliomas",[61,62,63,64,65],"pleural mesothelioma","ivonescimab","bispecific antibody","anti-VEGF","anti-PD-1","RECRUITING","2026-03-13",{"date":69,"type":37},"2026-03-16",{"date":71,"type":37},"2025-06-30",{"date":73,"type":20},"2028-03-31",{"name":43,"class":44},20,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100610936","phase-2-trial-assessing-fianlimab-plus-cemiplimab-plus-chemotherapy-or-cemiplimab-plus-chemotherapy-in-patients-with-pleural-mesothelioma-100610936","NCT07234058","Trial Assessing Fianlimab Plus Cemiplimab Plus Chemotherapy or Cemiplimab Plus Chemotherapy in Patients With Pleural Mesothelioma","A Non-Comparative Phase IIR Trial Assessing Fianlimab Plus Cemiplimab Plus Pemetrexed-Platinum Chemotherapy or Cemiplimab Plus Pemetrexed-Platinum Chemotherapy for Treatment-Naive Pleural Mesothelioma (PM) Patients","LAG-MAPS","Inclusion Criteria:\n\n1. Signed written Informed Consent.\n\n   * Subjects must have signed and dated an IEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care.\n   * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n2. Histological diagnosis (no cytology allowed, thoracoscopy biopsy recommended).\n3. Non resectable PM as evaluated by a specialist MTB comprising a specialized thoracic surgeon.\n4. Measurable disease by CT with iodure injection according to RECIST 1.1 modified criteria for mesothelioma (pleural thickness perpendicular to the chest wall or mediastinum of 7 mm or more, on 2 positions, at 3 separate levels on transverse cuts of CT-scan, at least 1 cm apart, the sum of 6 measurements defining a pleural unidimensional measure), or according to RECIST1.1 criteria for mediastinal nodes or metastatic lesion.\n5. ECOG PS 0 and 1.\n6. Weight loss \\\u003C10% within 3 months of study entry.\n7. Chemo-naive and immuno-naive.\n8. Age ≥18 years, \\\u003C76 years.\n9. Life expectancy \\>3 months.\n10. Available pathological samples (at least 10 slides from the thoracoscopy pleural biopsy sample).\n11. Adequate biological functions: creatinine clearance ≥45 mL\u002Fmin (Cockroft or MDRD or CKD-epi); neutrophils ≥1500\u002Fmm3; platelets ≥100 000\u002Fmm3; haemoglobin ≥9g\u002FdL; AST and ALT \\\u003C3 x ULN, total bilirubin \\\u003C2 x ULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤5 x ULN and a baseline total bilirubin ≤2 x ULN).\n12. WOCBP\\* must have a negative serum (beta-hCG) at screening.\n\n    \\*WOCBP are defined as women who are fertile following menarche until becoming postmenopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient to determine the occurrence of a postmenopausal state. The above definitions are according to the CTFG guidance. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.\n13. Male study participants with WOCBP partners are required to use condoms during the study and until 6 months after the last dose of study treatment unless they are vasectomised or practice sexual abstinence.\n14. Vasectomised partner or vasectomised study participant must have received medical assessment of the surgical success.\n\n    NB: Periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and LAM are not acceptable methods of contraception. Female condom and male condom should not be used together.\n15. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the entire trial and until 6 months after last treatment.\n16. All men must agree not to donate sperm during the trial and for 6 months after receiving the last therapy dose.\n17. As recommended in current French guidelines, a firm recommendation of radiation therapy for thoracocentesis tracts (3 x 7Gy) is made for patients with thoracocentesis or thoracoscopy within 2 months before accrual, with a firmly recommended interval between thoracoscopic procedure (removal of drains) and radiation of no more than 42 days. A 7-day interval between the end of radiotherapy and the initiation of treatment should be respected.\n\nExclusion Criteria:\n\n1. ECOG PS\\>2.\n2. Previous cancer treatment including chemotherapy or immunotherapy with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody.\n3. Pleural effusion as the only radiological abnormality without measurable pleural thickness or mediastinal node enlargement.\n4. Peritoneal, pericardial or tunica vaginalis testis mesothelioma.\n5. Previous diagnosis of adenocarcinoma from any anatomic site within the previous 5 years, with the exception of prostate adenocarcinoma history within the previous 5 years, in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (\\\u003CT2a, score de Gleason ≤6 and PSA ≤10 ng\u002Fml) provided they were treated in a curative way (surgery or radiotherapy, without any chemotherapy). Previous or active cancer within the previous 5 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not).\n6. Uncontrolled pleural effusion requiring frequent thoracocentesis (needing thoracoscopic pleural pleurodesis before possible accrual).\n7. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and the beginning of immuno-chemotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, are allowed.\n8. Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, or radiotherapy on thoracic drain or puncture routes.\n9. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomisation date, or history of severe toxicity (grade 3\u002F4) by immune mechanism linked to another immunotherapy treatment for any kind of disease.\n10. Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the treatment. Inhaled, nasal or topic corticosteroids are allowed.\n11. History of active autoimmune disease, needing systemic immunosuppressive drug, including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular thrombosis associated with anti-phospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, recent Guillain-Barré syndrome within previous 15 years, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    Patients with type I diabetes, or hypothyroidy, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment or over 10 mg daily oral steroids, or benign sicca syndrome (Sjogren) without interstitial pulmonary disease, or history of past Guillain-Barré syndrome beyond 15 previous years, totally reversible with no sequalae, no systemic immunosuppressive treatment during the last 20 years, can be included. Patients with Grave's disease or psoriasis not requiring systemic therapy within the last two years from randomisation can be included.\n12. Active inflammatory intestinal disease (diverticulosis, Crohn disease, haemorrhagic recto-colitis, coeliac disease) requiring systemic treatment, or any serious chronic intestinal disease with uncontrolled diarrhoea.\n13. History or current evidence of significant (CTCAE grade ≥2) local or systemic infection (e.g. cellulitis, pneumonia, septicaemia) requiring systemic antibiotic treatment within 2 weeks prior to the first dose of trial medication.\n14. Active uncontrolled infection requiring therapy including active tuberculosis. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not consist of a contra-indication provided the patient was treated during at least 6 months by anti-tuberculosis antibiotic treatment.\n15. Uncontrolled infection with HIV, HBV, or HCV infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection.\n\n    Notes:\n    1. Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.\n    2. Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards and must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n    3. Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.\n    4. Patients with HIV or hepatitis must be reviewed by a qualified specialist (e.g. infectious disease or hepatologist) managing this disease prior to commencing and regularly throughout the duration of their participation in the trial.\n16. Received a live vaccine within 30 days of planned start of study medication. Live or live attenuated vaccination with replicating potential. If a patient intends to receive a COVID-19 vaccine before the start of study drug, participation in the study should be delayed at least 1 week after any COVID-19 vaccination. During the treatment period, it is recommended to delay COVID-19 vaccination until patients are receiving and tolerating a steady dose of study drug. A vaccine dose should not be less than 48 hours before or after study drug dosing. mRNA and adenovirus vector anti-SARS-CoV2 vaccine are allowed.\n17. General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6 months), history of stroke within the 6 previous months, history of myocarditis. Patients with a significant cardiac history, even if controlled, should have a LVEF \\>45%.\n18. TnT or troponin I TnI \\> 2x institutional ULN at baseline. Patients with TnT or TnI levels between \\>1 to 2xULN are permitted if repeat levels within 24 hours are ≤ 1x ULN. If TnT or TnI levels are \\>1 to 2xULN within 24 hours, the subject may undergo a cardiac evaluation and be considered for treatment by the investigator based on cardiological medical judgement in the patient's best interest.\n19. Known hypersensitivity to the active substances or to any of the excipients.\n20. Pre-existing moderate or severe lung interstitial disease as assessed by the diagnosis CT-scan and decrease of TLCO higher than 35% from theoretical normal values linked to such interstitial disease.\n21. Inability to comply with study or follow-up procedures as estimated by the referent investigator.\n22. Pregnant or breastfeeding women.\n23. Women of childbearing potential (WOCBP)\\* who are unwilling to practice highly effective contraception prior to the initial dose\u002Fstart of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:\n\n    1. Stable use of combined (oestrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening;\n    2. Intrauterine device; intrauterine hormone-releasing system;\n    3. Bilateral tubal occlusion\u002Fligation;\n    4. Vasectomized partner (provided that the male vasectomized partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has obtained medical assessment of surgical success for the procedure); or\n    5. Sexual abstinence†. \\*Pregnancy testing and contraception are required for WOCBP. †Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drugs. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.\n24. For patients receiving cisplatin: patients with hearing problems; creatinine clearance \\\u003C60 ml\u002Fmin; patients concomitantly receiving phenytoin with prophylactic aim.","75 Years",{"count":86,"type":20},126,[23],"This is a multicentre, phase IIR, double non-comparative arm trial, with an initial safety run for the anti-LAG3 arm.\n\nApproximately 40 sites will participate in the study and will enroll 126 patients with treatment-naive, unresectable malignant PM.\n\nTreatment will be administered in 21-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent or for 2 years immunotherapy maximum.\n\nOnce the patient discontinues study treatment, the treatment period will end and the patient will enter the follow-up period. No cross-over is allowed between arms.",[59],[61,91,92,93,65],"cemiplimab","fianlimab","anti-LAG3","2026-02-09",{"date":96,"type":37},"2026-02-11",{"date":98,"type":20},"2026-02",{"date":100,"type":20},"2029-09",{"name":43,"class":44},37,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100588170","phase-3-tarlatamab-vs-standard-of-care-chemotherapy-in-patients-with-pre-treated-advanced-pulmonary-or-gastroenteropancreatic-poorly-differentiated-neuroendocrine-carcinomas-necs-100588170","NCT06937905","Tarlatamab vs Standard of Care Chemotherapy in Patients With Pre-treated Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)","A GCO Trial Exploring the Efficacy and Safety of Tarlatamab Versus Investigator-choice Chemotherapy in Pre-treated Patients With Advanced, Pulmonary or Gastroenteropancreatic Poorly Differentiated Neuroendocrine Carcinomas (NECs)","TARLANEC","Inclusion Criteria:\n\n1. Signed Informed consent:\n\n   * Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n   * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing\n2. Age ≥ 18 years.\n3. WHO Performance status 0 - 1.\n4. Life expectancy \\> 12 weeks.\n5. Histologically proven and centrally confirmed poorly differentiated neuroendocrine carcinoma (NEC): large cells for lung NEC (WHO 2015 classification), and large and small cells for extra-gastroenteropancreatic (assessed on archived tissue, with possible pre-screening during first-line).\n6. Expression of DLL3 in at least 1% of tumor cells (assessed on archived tissue, with possible pre-screening during first-line)\n7. Tumor progression following one platinum based line of therapy.\n8. Unresectable locally advanced or metastatic stage.\n9. At least one measurable target lesion according to RECIST v1.1 per investigator assessment. The radiological assessment has to be done within the timelines indicated.\n10. Adequate organ function: creatinine clearance \\> 50 mL\u002Fmin, Neutrophils count ≥ 1500\u002Fmm3; Platelets \\> 100 000\u002Fmm3 ; Hemoglobin \\> 9 g\u002FdL; AST and ALT \\\u003C 3 x ULN (upper limit of normal) with total bilirubin ≤ 2 × ULN except subjects with documented Gilbert's syndrome or liver metastasis, who must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 3.0 mg\u002FdL.\n11. Full recovery from all toxicities associated with prior treatment, to acceptable baseline status, or a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) grade of 0 or 1, except for toxicities not considered a safety risk, such as alopecia or vitiligo.\n12. Availability of tumor material for central review processes and translational research projects.\n13. Absence of any unstable systemic disease and any psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up schedule.\n14. Females of childbearing potential who are sexually active with a non-sterilized male partner must use a highly effective method of contraception for 28 days prior to the first dose of investigational product, and must agree to continue using such precautions for 7 months after the final dose of investigational product; cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. They must also refrain from egg cell donation for 7 months after the final dose of investigational product.\n15. Men who are sexually active with women of childbearing potential will be instructed to adhere to contraception for a period of 6 months after the last dose of treatment.\n16. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. Well-differentiated neuroendocrine tumor (NET G1, G2 and G3 according to digestive WHO 2017 classification or typical\u002Fatypical carcinoid tumor according to lung WHO 2015 classification)\n2. Previous treatment targeting DLL3\n3. More than one line of systemic therapy in the metastatic setting. Chemotherapy for non-metastatic stage is not considered as first-line if there is a time interval of at least 6 months between the last dose of chemotherapy for non-metastatic stage and the initiation of first-line chemotherapy for metastatic\u002Frecurrent disease.\n4. Small cell lung NEC (except as a minor \\\u003C30% component in mixed tumors)\n5. Known EGFR activating mutation or ALK or ROS1 rearrangement for lung NEC\n6. Untreated or symptomatic central nervous system (CNS) metastases:\n\n   * Subjects with asymptomatic CNS metastases are eligible if clinically stable for at least 4 weeks and do not require intervention (including use of corticosteroids).\n   * Subjects with treated brain metastases are eligible provided the following criteria are met:\n\n     * Subject is asymptomatic from brain metastases\n     * Whole brain radiation or surgery was completed at least 2 weeks prior to first dose of study treatment (stereotactic radiosurgery completed at least 7 days prior to first dose of study treatment)\n     * Any CNS disease is clinically stable, subject is off steroids for CNS disease for at least 5 days (unless steroids are indicated for a reason unrelated to CNS disease), and subject is off or on stable doses of anti-epileptic drugs at least 14 days prior to first dose of study treatment\n7. Leptomeningeal metastasis\n8. Patients with a recent history of other malignancies except adequately treated non-melanoma skin cancer, and curatively treated in-situ cancer. Patients with history of solid tumors, including adenocarcinoma, treated in a curative way with or without chemotherapy and without any evidence of disease \\>2 years before randomisation can be included as well.\n9. Major surgery within 28 days prior to initiation of study treatment.\n10. Myocardial infarction and\u002For symptomatic congestive heart failure (New York Head Association class \\> class II) within 12 months prior to initiation of study treatment.\n11. History of arterial thrombosis (e.g. stroke or transient ischemic attack) within 12 months prior to initiation of study treatment.\n12. Symptoms and\u002For clinical and\u002For radiological signs suggestive of uncontrolled and\u002For acute active systemic infection within 7 days prior to first administration ofstudy treatment. Patient with active infection requiring parenteral antibiotic therapy. Upon completion of parental antibiotic therapy and resolution of symptoms, the patient may be considered eligible under the infection criterion.\n13. Known sensitivity and\u002For immediate hypersensitivity to any component of study treatment.\n14. History of primary immunodeficiency, history of organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.\n15. Patients with immune pneumonitis, pituitary or thyroid disorders, or pancreatitis under treatment with immuno-oncology agents.\n16. Patients reporting infusion-related reactions or severe, life-threatening or recurrent immune-mediated adverse events (grade 2 or higher), including events leading to permanent discontinuation of immuno-oncology agents.\n17. Presence of an indwelling line or drain (including the following: percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, peritoneal drain or catheter, pericardial drain or catheter, drain catheter or thoracic drain for pleural fluid collection).\n18. Patient with a diagnosis of immunodeficiency or undergoing systemic corticotherapy or any other form of immunosuppressive therapy within 7 days prior to administration of the first dose of study treatment.\n19. Known acute or chronic B or C hepatitis by serological evaluation. Patients with serological sequellae of hepatitis (antibodies test serologically positive for virus) without hepatitis could be included.\n20. Known Human immunodeficiency virus infection\n21. Patients who are pregnant or breast-feeding, or planning to become pregnant or breast-feed during the trial and within 7 months after the last dose of study treatment.\n22. Male not wishing to abstain from sperm donation during the trial and within 6 months of the last study treatment.\n23. Vaccination with live or attenuated virus vaccines is not permitted during the 28 days prior to administration of the first dose of treatment, and for the duration of the study. Vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) should be avoided during selection, at least 14 days before the first day of treatment. Live, non-replicating smallpox vaccines (such as Jynneos) against monkeypox infection are permitted during the study (except during cycle 1) in accordance with the center's standard of care and internal recommendations.\n24. Active autoimmune disease requiring systemic therapy (except replacement therapy) within the last 2 years or any other disease requiring immunosuppressive therapy during the study.\n25. Patients with other concurrent severe and\u002For uncontrolled medical disease which could compromise participation in the study.",{"count":112,"type":20},129,[114],"PHASE3","Based on the efficacy of tarlatamab in patients with small-cell lung cancer, we aim to assess the efficacy of tarlatamab in patients with Advanced, pulmonary (large-cell only) or gastroenteropancreatic neuroendocrine carcinoma.",[117],"Neuroendocrine Carcinoma",[119,120,121,122,123,124],"Neuroendocrine Carcinoma of Lung (Large cells)","Gastroenteropancreatic Neuroendocrine Carcinoma","IFCT","FFCD","GERCOR","GCO",{"date":96,"type":37},{"date":127,"type":37},"2026-02-06",{"date":129,"type":20},"2030-08-01",{"name":43,"class":44},40,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100566547","phase-2-adjuvant-chemotherapy---cemiplimab-and-sequential-hypofractionated-radiotherapy-in-unfit-or-elderly-patients-with-stage-iii-lung-cancer-100566547","NCT06656598","Adjuvant Chemotherapy +\u002F- Cemiplimab and Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Stage III Lung Cancer","A Multicenter Randomized Open Label Phase II Study Evaluating the Efficacy and the Tolerance of Immunochemotherapy and of Sequential Hypofractionated Radiotherapy in Unfit or Elderly Patients With Unresectable Stage III Non Small Cell Lung Cancer","SPORADIC","Inclusion Criteria:\n\n1. Patients must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n2. Patients must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n3. Age ≥ 18 years.\n4. Histologically or cytologically confirmed locally advanced non small cell lung cancer (NSCLC) stage IIIA non resectable, IIIB or IIIC accordingly to 8th classification TNM, UICC 2015.\n5. Patients over 70 years of age with Eastern Cooperative Oncology Group Performance Status (ECOG PS) PS of 0 to 1.\n\n   Or Patients under 70 years of age with ECOG PS of 0 to 1 and a score ≥ 3 according to the Charlson comorbidity criterion or ECOG PS 2.\n6. Patients eligible for treatment with sequential radio-chemotherapy validated by multidisciplinary committee.\n7. Measurable disease according to RECIST 1.1.\n8. Respiratory function:\n\n   * FEV1 ≥ 40% of theoretical value,\n   * DLCO ≥ 40%.\n9. Bone marrow function:\n\n   * absolute neutrophil count (ANC) ≥ 1.5.109\u002FL,\n   * platelets ≥ 100.109\u002FL,\n   * hemoglobin ≥ 9 g\u002Fdl.\n10. Renal and hepatic function:\n\n    * estimated creatinine clearance ≥ 45 ml\u002Fmin,\n    * bilirubin ≤1.5xULN,\n    * AST ALT ≤3xULN,\n    * Albumin ≥28g\u002Fdl.\n11. Participant has national health insurance coverage.\n12. Effective method of contraception during the treatment and during the 6 months following the last dose for patients of childbearing potential and for male subjects who are sexually active with a woman of childbearing potential.\n\nExclusion Criteria:\n\n1. Immunotherapy or chemotherapy contra-indicated.\n2. Patients eligible for treatment with concomitant radio-chemotherapy validated by multidisciplinary committee.\n3. Stage I or II NSCLC.\n4. Previously received a treatment with anti-PD1\u002FPDL1, anti-CTLA, or other antineoplastic immunotherapy or chemotherapy for NSCLC.\n5. Histology other than primary non-small cell lung cancer.\n6. Patients with an activating EGFR mutation or ALK or ROS1 translocation.\n7. Metastatic NSCLC including brain metastasis.\n8. Patients not eligible for curative radiotherapy (tumor extension, predictable dose constraints that cannot be met).\n9. Severe uncontrolled comorbidities or severe intercurrent disease: acute coronary syndrome less than 3 months old, unstable angina, heart failure with LVEF ≤30%, uncontrolled hypertension, Child B or C cirrhosis, severe sepsis, myocarditis or any other active conditions that would contraindicate chemotherapy, immunotherapy, or radiotherapy in the opinion of the investigator.\n10. Weight loss ≥15% of total body weight in the last 6 months.\n11. ECOG PS upper 2\n12. Active autoimmune pathology. History of autoimmune pathology including myasthenia, Guillain-Barre syndrome, lupus erythematosus, antiphospholipid syndrome, Wegener's granulomatosis, glomerulonephritis, inflammatory bowel disease, vasculitis, sarcoidosis, uveitis. Autoimmune thyroid pathologies under replacement therapy as well as type 1 diabetes under insulin are authorized.\n13. History of idiopathic pulmonary fibrosis, organized pneumopathy or signs of active interstitial pulmonary pathology on CT scan.\n14. Any immunosuppressive therapy received within 28 days and corticosteroids \\> 10mg\u002Fday of prednisone or equivalent received within 7 days prior the start of chemotherapy excepted hydrocortisone replacement for adrenal insufficiency or pituitary disease not considered immunosuppressive therapy.\n15. Chronic active infection including tuberculosis, HIV, hepatitis B (HBsAg positive) or C. Patients with a history of cured hepatitis B (anti HBc and absence of negative HBs antigen) are eligible. In case of hepatitis C (anti HCV Ac) patients are eligible if the HCV PCR is negative.\n16. Severe infections (including covid-19 infection) within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n17. History of neoplastic disease less than 3 years old or progressive (except basal cell carcinoma of the skin and carcinoma in situ of the uterus).\n18. History of thoracic radiotherapy.\n19. Live attenuated vaccine received within 28 days of starting chemotherapy\n20. History of organ or bone marrow transplantation.\n21. Major surgery within 4 weeks of starting treatment.\n22. Patient already included in another therapeutic trial.\n23. Positive pregnancy test or breastfeeding woman.\n24. Protected adults (under guardianship or curatorship).\n25. Inability to undergo medical monitoring of the study (for geographical, social and\u002For physical reasons).\n26. Patients unable to understand the study.",{"count":141,"type":20},152,[23],"The use of neoadjuvant immuno-chemotherapy could improve survival outcomes of patients eligible for sequential radio-chemotherapy comparing to the benefit already obtained with maintenance immunotherapy.",[145],"Stage III NSCLC",[29,147,148,121],"NSCLC, Stage III","Unfit or elderly patients",{"date":96,"type":37},{"date":151,"type":37},"2025-11-07",{"date":153,"type":20},"2032-01",{"name":43,"class":44},25,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":171,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100585947","phase-3-tepotinib-vs-standard-treatment-in-patients-with-advanced-met-exon-14-mutated-non-small-cell-lung-cancer-previously-treated-100585947","NCT06908993","Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer Previously Treated","A Randomized Controlled Trial of Tepotinib vs Standard Treatment in Patients With Advanced MET Exon 14 Mutated Non-Small Cell Lung Cancer","COMET","Inclusion Criteria:\n\n1. Informed, written and signed consent:\n\n   * Patients must have signed and dated the written informed consent form approved by the ethics committee in accordance with the legal and institutional framework.\n   * It must have been signed before protocol-related procedures that are not part of normal patient management are performed. Patients should be willing and able to adhere to the schedule of visits, treatment and laboratory tests.\n2. Histologically proven advanced NSCLC.\n3. Presence of a METex14 mutation (based on local testing). Detection of METex14 mutation should be performed on a tissue sample if available. In case no tissue sample is available, detection of METex14 on a liquid biopsy is authorized. The sponsor should be consulted if there is any doubt about the nature of the mutation.\n4. Evidence of disease progression after at least one prior line of treatment including either a platinum-based chemotherapy or an anti-PD(L)1 agent or both.\n5. Has received no more than 2 prior lines of treatment.\n6. ECOG Performance Status 0-3.\n7. Brain metastases are allowed. If immediate local treatment is required, inclusion is possible once the latter is complete.\n8. Stage IIIB or IIIC non irradiable or stage IV (8th classification TNM, UICC 2015)\n9. Age ≥ 18 years.\n10. Adequate biological function:\n\n    * Creatinine clearance ≥ 30 ml\u002Fmin;\n    * Neutrophils ≥ 1500\u002Fmm3;\n    * Platelets ≥100,000\u002Fmm3;\n    * Haemoglobin ≥ 8 g\u002FdL;\n    * Liver enzymes \\\u003C 3x ULN except for patients with liver metastases (\\\u003C 5x ULN);\n    * Total bilirubin ≤ 1.5 x ULN except for patients with proven Gilbert's syndrome (≤ 5 x ULN) or patients with liver metastases (≤ 3.0 ULN).\n11. Protected adults may participate in the study if they are capable of making decisions regarding their medical treatment in accordance with the guardianship judgment.\n12. For women of childbearing potential (including women who have had a tubal ligation), serum pregnancy test must be performed and documented as negative within 14 days prior to C1D1.\n13. Women of childbearing potential must remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the last dose of study drugs. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries or uterus). Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n14. Men with female partners of childbearing potential or pregnant female partners, must remain abstinent or use a condom during the treatment period and for at least 6 months after the last dose of study treatment to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n15. Patient covered by a national health insurance.\n\nExclusion Criteria:\n\n1. Prior treatment with a MET inhibitor (including crizotinib).\n2. Presence of another known driver oncogene alteration (including EGFR, HER2, KRAS, BRAF mutations or ALK, ROS1, RET fusions). In case of detection of any other driver alteration, inclusion should be discussed with the sponsor.\n3. ECOG Performance Status 4.\n4. Known hypersensitivity to tepotinib or its excipients.\n5. History of cancer within 3 years or active cancer except those with a negligible risk of metastasis or death, or those treated curatively. If a patient does not fulfil this criterion but the investigator considers that the benefit\u002Frisk balance is in favour of inclusion in the study, please contact IFCT.\n6. Inability to comply with study or follow-up procedures.\n7. Pregnant, lactating, or breastfeeding women.\n8. Any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that may render the patient at high risk from treatment complications.\n9. History of idiopathic pulmonary fibrosis or active pneumonitis on chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.",{"count":165,"type":20},133,[114],"The hypothesize is that tepotinib is more effective than the investigator's choice of treatment in patients with MET-mutated NSCLC who have progressed after at least one first-line treatment.\n\nThe main benefit concerns patient access to tepotinib. There is currently no access to a new-generation MET TKI in France for METex14 patients, due to lack of comparative data. There are no phase III RCTs underway anywhere in the world. This study is the only opportunity, perhaps the last, to generate comparative data which, if positive, will enable the drug to be reimbursed. With this in mind, the methodology of this study was discussed with the HAS on several occasions beforehand, to ensure that it met their expectations. With a response rate of around 50% and a median progression-free survival of 11 months in previously-treated subjects based on clinical trials data, tepotinib is a key drug for METex14 NSCLC patients, who are generally elderly and frail, and for whom therapeutic options are limited.\n\nThe investigators expect to observe a benefit for patients treated with tepotinib compared to the control arm in terms of PFS, quality of life, objective response rate and duration of response. The overall survival benefit may be compromised by allowing patients in the control arm to cross over to tepotinib once they have progressed. However, the investigators have decided to maintain this crossover and consequently use PFS as the primary endpoint, as there is no clinical equipoise regarding the efficacy of tepotinib in METex14 NSCLC patients. The EMA has already approved tepotinib based on efficacy and safety data from clinical trials, and patients and investigators already consider this treatment as an important therapeutic option. Indeed, both ESMO and ASCO guidelines recommend the use of MET TKIs in these patients. In France, although neither tepotinib nor capmatinib are available, crizotinib, a multi-target TKI also active on MET, can be used off-label. If cross-over to tepotinib was not allowed in this trial, most patients would still benefit from cross-over to a MET TKI by receiving off-label crizotinib, which would in any case lead to a misinterpretation of the OS data. Therefore, the investigators believe it is preferable to control for cross-over and expose progressive patients in the control arm to tepotinib and use PFS as the primary endpoint.\n\nToxicity of MET TKIs is considered as manageable. In the VISION trial, of 313 patients treated with tepotinib (median age: 72 years), 109 (34.8%) experienced grade ≥3 treatment-related adverse events, leading to discontinuation in 46 patients (14.7%). Rates of adverse events (AE) were broadly consistent irrespective of prior therapies. Edema, the most common adverse event of clinical interest (AECI), was reported in 67.1% (grade ≥ 3, 11.2%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and\u002For treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild\u002Fmoderate: hypoalbuminemia, 23.6% (grade ≥ 3, 3.5%); creatinine increase, 22.0% (grade ≥ 3, 1.0%); nausea, 23.3% (grade ≥ 3, 0.6%), diarrhea, 22.4% (grade ≥ 3, 0.3%), decreased appetite (grade ≥ 3, 0.3%), and ALT increase, 14.1% (grade ≥ 3, 2.2%). GI AEs typically occurred early and resolved in the first weeks10,13.\n\nGiven the efficacy of tepotinib, the manageable safety profile, and the oral administration of tepotinib, the investigators anticipate that treatment with tepotinib will be associated with improved quality of life.\n\nTreatments offered in the control group correspond to standard treatments for advanced NSCLC in second line or beyond. In terms of prior lines of treatment, the eligibility criteria of the trial are aligned with the EMA label of tepotinib: \"indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to MET gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and\u002For platinum-based chemotherapy\". The investigators have not included platinum-based chemotherapy as a treatment option in the control arm, considering that patients who are eligible to platinum-based chemotherapy should have received this regimen in first-line, as per ESMO guidelines14. Given the low efficacy of immunotherapy in patients with oncogene addiction, it is unlikely that some patients would receive immunotherapy alone as first-line treatment. Thus, the absence of platinum-based chemotherapy as a treatment choice in the control arm seems reasonable and will reduce the heterogeneity of this arm.",[169,170],"Advanced Non Small Cell Lung Cancer","MET Exon 14 Mutation",[172,170,173],"Tepotinib","Non Small Cell Lung Cancer","2025-12-09",{"date":176,"type":37},"2025-12-17",{"date":174,"type":37},{"date":179,"type":20},"2028-07-15",{"name":43,"class":44},29,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100458875","phase-2-de-escalation-immunotherapy-maintenance-duration-trial-for-stage-iv-lung-cancer-patients-with-disease-control-after-chemo-immunotherapy-induction-100458875","NCT05255302","De-escalation Immunotherapy mAintenance Duration Trial for Stage IV Lung Cancer Patients With Disease Control After Chemo-immunotherapy Induction","A Phase II-III Randomized Trial Evaluating Maintenance Pembrolizumab (± Pemetrexed) Until Progression Versus Observation (± Pemetrexed) After 6 Months of Platinum-based Doublet Chemotherapy Plus Pembrolizumab Induction Treatment in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)","DIAL","Inclusion Criteria:\n\n1. Signed Written Informed Consent:\n\n   * Subjects must have signed and dated an IRB\u002FIEC approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.\n   * Subjects must be willing and able to comply with scheduled visits, treatment schedule, and laboratory testing.\n2. Patients with histologically confirmed metastatic NSCLC (Stage IV accordingly to 8th classification TNM, UICC 2015). A cytologically-proven NSCLC is allowed if a cytoblock has been prepared.\n3. PD-L1 tumor content as assessed locally by the investigator center.\n4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.\n5. Weight loss\\\u003C 10% within 3 months of study entry.\n6. No prior systemic anticancer therapy (including EGFR or ALK inhibitors) given as primary therapy for advanced or metastatic disease.\n7. Age≥ 18 years, \\\u003C75 years\n8. Life expectancy \\> 3 months\n9. Measurable tumor disease by CT or MRI per RECIST 1.1 criteria\n10. The Investigator must confirm prior to enrolment that the patient has adequate tumor tissue available. Tumor biopsy should be exploitable for molecular analysis. If archival tissue is either insufficient or unavailable, the patient may still be eligible upon discussion with IFCT.\n\n    Note: Tumor tissue collected after the patient was diagnosed with metastatic disease is preferred.\n\n    Tumor tissue sample must not be from locations previously radiated. Tumor sample must be 1 block or at least 7 unstained slides of analyzable tissue.\n11. Adequate biological functions:\n\n    Creatinine Clearance ≥ 45 mL\u002Fmin (Cockcroft or MDRD or CKD-epi); neutrophils≥ 1500\u002Fmm3 ; platelets ≥100 000\u002Fmm3 ; Hemoglobin≥ 9g\u002FdL ; AST and ALT\\\u003C 3x ULN, total bilirubin \\\u003C 2xULN (patients with hepatic metastases or Gilbert's syndrome must have AST and ALT ≤ 5 x ULN and a baseline total bilirubin ≤ 2xULN).\n12. Women of childbearing potential (WOCBP) and sexually active should use an efficacious contraception method within the 28 days preceding the first dose and during the 6 months following the last dose of treatment. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of HCG) prior to the start of study drug.\n13. For Male subjects who are sexually active with WOCBP, an efficacious contraception method should be used during the treatment and during the 6 months following the last dose.\n14. Patient has national health insurance coverage.\n\nExclusion Criteria:\n\n1. Small cell lung cancer or tumors with mixed histology including a SCLC component.\n\n   Note : Sarcomatoid histology is allowed. Neuro-endocrine large cell lung cancer with molecular features of small-cell lung cancer (i.e; Rb loss associated with TP53 mutation) will not be eligible. Other neuro-endocrine large cell subtypes, i.e. with adenocarcinoma features (STK11 or K-Ras mutations) will be eligible. In case of doubt, please contact the sponsor.\n2. Known EGFR activating tumor mutation (deletion LREA in exon 19, L858R ou L861X mutations in exon 21, G719A\u002FS mutation in exon 18, exon 20 insertion) or HER2 exon 20 insertion (either tissue or plasma cfDNA mutation).\n3. Known ALK, ROS1, Ret, NTRK, NRG1 gene rearrangement as assessed by immunohistochemistry, FISH or NGS (ADN or ARN) sequencing by local genetics and\u002For pathology laboratory.\n4. Previous or active cancer within the previous 3 years (except for treated carcinoma in situ of the cervix, or basal cell skin cancer treated or not). Patients with a prostate adenocarcinoma history within the previous 3 years could be included in case of localized prostate cancer, with good prognostic factors according to d'Amico classification (≤T2a, score de Gleason ≤ 6 and PSA ≤ 10 (ng\u002Fml)) provided they were treated in a curative way (surgery or radiotherapy, without any chemotherapy).\n5. Superior vena cava syndrome persisting despite VCS stenting.\n6. Radiotherapy needed at initiation of tumour treatment, except bone palliative radiotherapy on a painful or compressive metastasis, respecting 1 week delay between the end of radiotherapy and the beginning of treatment\n7. Symptomatic untreated brain metastasis (without previous whole brain radiotherapy or stereotactic ablative brain radiotherapy or without surgical resection). At least 2 weeks delay between the end of radiotherapy and the beginning of induction immunotherapy treatment should be respected. Asymptomatic brain metastasis, not needing corticosteroids greater than 10 mg prednisone equivalent daily or mannitol infusions, are allowed.\n8. History of previous primary immunodeficiency, organ transplantation needing an immunosuppressive treatment, any immunosuppressive drug within 28 days before randomization date, or history of severe toxicity (grade 3\u002F4) by immune mechanism linked to another immunotherapy treatment.\n9. Systemic treatment with corticosteroids with greater dose than 10 mg prednisone equivalent daily, within 14 days before initiation of the immunotherapy induction. Inhaled, nasal or topic corticosteroids are allowed.\n10. History of active autoimmune disease including but not limited to rheumatoid polyarthritis, myasthenia, autoimmune hepatitis, systemic Lupus, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome with interstitial pulmonary disease, recent Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    Patients with type I diabetes, or hypothyroidism, or immune cutaneous disease (vitiligo, psoriasis, alopecia) or benign rheumatoid polyarthritis not needing any immunosuppressive systemic treatment, or benign sicca syndrome (Sjogren) without interstitial pulmonary disease, or history of past Guillain-Barre syndrome, totally reversible with no sequelae, no systemic immunosuppressive treatment during the last 20 years, are allowed to be included.\n11. Active inflammatory intestinal disease (Crohn disease, Hemorrhagic recto-colitis, coeliac disease) or any serious chronic intestinal disease with uncontrolled diarrhea.\n12. Active uncontrolled infection including tuberculosis, known acute viral hepatitis B and C according to serological tests. Patients with serological sequelae of cured viral hepatitis are allowed to be included. Past primary pulmonary tuberculosis in youth does not consist of a contra-indication. Past tuberculosis disease history does not consist of a contra-indication provided the patient was treated during at least 6 months by anti-tuberculosis antibiotic treatment.\n13. Known HIV infection\n14. Living attenuated vaccine received within the 30 previous days\n15. Previous treatment with anti-PD-1, anti-PD-L1, Anti-CTLA4 or any ICI antibody\n16. Previous treatment with chemotherapy for lung cancer. However, if a patient has a lung adenocarcinoma, previous cisplatin treatment for another cancer type with squamous histology (Head and Neck, bladder) may be allowed provided the sponsor accepts, and provided blood tests are normal (see above).\n17. General serious condition such as congestive uncontrolled cardiac failure, uncontrolled cardiac arrythmia, uncontrolled ischemic cardiac disease (unstable angina or history of myocardial infarction within the previous 6 months), history or stroke within the 6 previous months. Patients with a significant cardiac history, even if controlled, should have a LVEF \\> 50%.\n18. Pre-existing moderate or severe lung interstitial disease as assessed by the diagnosis CT-scan.\n19. Inability to comply with study and\u002For follow-up procedures for family, social, geographic or psychological reasons.\n20. Pregnant, lactating, or breastfeeding women.\n21. Patients deprived of liberty by judicial or administrative decision\n22. Patient who is subject to legal protection or who is unable to express his will","74 Years",{"count":192,"type":20},1360,[23,114],"Immunotherapeutic approaches recently have demonstrated clinical efficacy in several cancer types, including melanoma and NSCLC. As a matter of fact, first registration trials of immune-checkpoints inhibitors (ICI) in second-line settings (pembrolizumab as well as nivolumab or atezolizumab) had stated that ICI could be continued until disease progression or not tolerable toxicity, up to 5 years. This is only for the first-line registration studies that the arbitrary maximal duration of treatment of 2 years was set up by the Companies sponsoring such trials.\n\nThe aim is to study a de-escalation scheme of treatment from 2 years of immunotherapy to 6 months (27-weeks), in patients with controlled disease.",[196],"Metastatic NSCLC",[121,188,29,198],"Immunotherapy duration","2025-03-26",{"date":201,"type":37},"2025-04-01",{"date":203,"type":37},"2022-05-02",{"date":205,"type":20},"2029-06-01",{"name":43,"class":44},44,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":219,"conditions":220,"keywords":224,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":234},"100520171","a-prospective-cohort-study-to-evaluate-molecular-prognostic-factors-and-resistance-mechanisms-to-osimertinib-in-adjuvant-treatment-of-completely-resected-pib-iiia-non-small-cell-lung-carcinoma-with-common-egfr-mutations-l858r-and-del19-100520171","NCT06053099","A Prospective Cohort Study to Evaluate Molecular pRognostic Factors and Resistance Mechanisms to Osimertinib in Adjuvant Treatment of Completely Resected pIB-IIIA Non-small Cell Lung Carcinoma With Common EGFR Mutations (L858R and Del19)","ROSIE","Inclusion Criteria:\n\n1. Signed Informed consent.\n2. Age ≥ 18 years.\n3. Pre-surgical disease evaluation including brain MRI\u002FCT-scan and total body PET-FDG CT-scan prior to surgery.\n4. Histologically complete anatomical resection (R0) of stage pIB-IIIA (pTNM 8th edition) NSCLC.\n5. Presence of a common EGFR mutation (Del19 or L858R).\n6. Archival tumour tissue FFPE blocks from surgery available for centrally molecular analyses.\n7. Patient eligible to receive osimertinib adjuvant therapy in a 3-year intent to treat decision; patients could receive if necessary adjuvant chemotherapy before starting osimertinib treatment.\n8. Patient who is capable, according to the investigator, of complying with the study's requirements and restrictions.\n9. Patient followed in the institution on a regular basis (every 3 to 6 months) according to standard recommendations.\n10. Estimated life expectancy \\> 3 years.\n11. Woman patients who are of childbearing potential are eligible:\n\n    * They must have a negative pregnancy test before the first dose of osimertinib.\n    * They must agree to use effective methods of contraception throughout the course of treatment and should be maintained for 2 months after the end of treatment.\n12. Male subjects who are sexually active with a woman of childbearing potential are eligible if an efficacious contraception method should be used during the treatment and during the 4 months following the last dose.\n\nExclusion Criteria:\n\n1. History of cancer, except for the following situations:\n\n   Patients with history of cancer for more than 3 years are eligible if they have been treated and considered cured. Patients with history of in situ carcinoma of the cervix or non-melanoma skin carcinoma are eligible.\n2. Neoadjuvant anti-cancer treatment (osimertinib and\u002For chemotherapy or other anti-cancer treatment).\n3. Incompletely resected NSCLC (R1 or R2).\n4. Any medical condition that would, according to the investigator's judgment, prevent the patient's participation in the clinical study.\n5. Active infection (e.g. patients receiving treatment for infection) including hepatitis C virus (HCV) and human immunodeficiency virus (HIV), or active uncontrolled hepatitis B infection except for the situations described in APPENDIX I. Screening for chronic conditions is not required.",{"count":216,"type":20},300,[218],"NA","IFCT-2202 ROSIE study aims to incorporate a broad-panel centralized NGS testing at baseline in all patients with completely resected NSCLC with common EGFR mutation after confirmation of an optimal preoperative extension assessment and with a centralized review of the quality of the surgical excision. Furthermore, the IFCT-2202 ROSIE study also aims to study the molecular events associated with relapse on, or after osimertinib exposure, that should result in the opportunity to accede to optimal treatment in case of metastatic relapse.",[173,221,222,223],"EGFR Activating Mutation","EGFR DEL19","EGFR L858R",[121,29,225],"Adjuvant Osimertinib","2024-03-06",{"date":228,"type":37},"2024-03-08",{"date":230,"type":37},"2024-01-22",{"date":232,"type":20},"2031-10",{"name":43,"class":44},36,""]