[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fundación GECP\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":239},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,77,105,131,159,186,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100549255","phase-3-study-of-treatment-with-sacituzumab-and-zimberelimab-for-patients-with-lung-cancer-confined-to-the-chest-and-previously-operated-on-who-were-not-disease-free-100549255",false,"NCT06431633","Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free.","A Phase III Clinical Trial of Adjuvant Treatment With Sacituzumab and Zimberelimab for Stage IB-IIIA-IIIB(N2) Previously Resected (R0) Non-small Cell Lung Cancer Patients That Did Not Achieve Pathological Complete Response After Neoadjuvant treatment_ARIAN","ARIAN","Inclusion Criteria:\n\n* 1\\. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed.\n* 2\\. Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA or IIIB (N2) according to pathological criteria (pTNM) and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology\n* 3\\. Complete surgical resection (R0) of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide. Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station\n* 4\\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study except if R0 resection can be confirmed.\n* 5\\. Only patients that do not achieve pathological complete response (pCR) seen in the surgical piece after neoadjuvant therapy are eligible.\n* 6\\. Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.\n* 7\\. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible.\n* 8\\. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery.\n* 9\\. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* 10\\. Patients aged ≥ 18 years.\n* 11\\. PDL1 value analysed locally (hospital must be able to provide this value before randomization)\n* 12\\. PET-CT and brain CT before randomization to confirm the absence of distant disease.\n* 13\\. Adequate hematologic and organ function\n* 14.All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.\n* 15.For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception\n* 16\\. For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception\n* 17\\. Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs.\n* 18.Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug.\n* 19.Patient capable of proper therapeutic compliance and accessible for correct follow-up\n* 20\\. Patients with a life expectancy of at least more than 12 weeks\n\nExclusion Criteria:\n\n* 1\\. Patients with a history of other malignant diseases, with the exception of the following:\n\n  * properly treated non-melanotic skin cancer\n  * cancer in situ treated with curative intent or other malignancies treated with curative intent and without signs of disease for a period of\\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease.\n* 2.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus or spine\n* 3\\. Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusion in this trial.\n* 4\\. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study.\n* 5\\. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma\n* 6\\. Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of randomization.\n* 7\\. Patients that received live attenuated vaccines within 30 days prior to randomization\n* 8\\. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments\n* 9\\. 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* 10\\. Patients who have suffered untreated and \u002F or uncontrolled cardiovascular disorders and \u002F or who have symptomatic cardiac dysfunction\n* 11\\. Pregnant or breastfeeding women\n* 12\\. Patients in whom R0 resection cannot be confirmed.\n* 13\\. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* 14.Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n* 15\\. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patients with a history of HBV or HCV, patients with detectable viral loads will be excluded.\n* 16\\. History of allergy or hypersensitivity to any of the study drug components\n* 17\\. Pleural or pericardial effusion, both will be considered indicative of metastatic disease unless proven otherwise. Patients with pleural effusion not visible on chest-X-ray or too small to perform diagnostic puncture safely may be included.\n* 18\\. Have known history of HIV-1 or 2 with detectable viral load OR taking medications that may interfere with SN-38 metabolism.\n* 19.Severe infections within 4 weeks prior to be included in the study, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n* 20.Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.\n* 21\\. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder; any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement; or prior pneumonectomy.\n* 22\\. Treatment with systemic immunosuppressive medications\n* 23.Patients with uncontrolled comorbidities that may affect the clinical trial compliance.\n* 24.Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.","ALL","18 Years",{"count":20,"type":21},129,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Open-label, phase III, randomized, stratified (PDL1- vs PDL1+), 3 arms, multicenter clinical trial.\n\n129 resected patients (43 per arm) with stage from IB to IIIA and IIIB (N2) non-small cell lung cancer that do not achieve pathologic complete response (pCR) after neoadjuvant treatment.\n\nThis clinical trial has 3 arms of treatment. ARM 1: Observation 10 months, ARM 2: treatment with immunotherapy (Zimberelimab) for 13 cycles and ARM 3: treatment with Sacituzumab Govitecan and Zimberelimab for 8 cycles and Zimberelimab monotherapy for 5 cycles.\n\nThe primary objective is to evaluate the disease-free survival (DFS): defined as the length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.\n\nPatient accrual is expected to be completed within 2 years, treatment is planned to extend during 1 years and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded.",[27,28,29],"Lung Diseases","Carcinoma, Non-Small-Cell Lung","Resectable Lung Non-Small Cell Carcinoma","RECRUITING","2026-05-14",{"date":33,"type":34},"2026-05-18","ACTUAL",{"date":36,"type":34},"2025-02-04",{"date":38,"type":21},"2031-11-30",{"name":40,"class":41},"Fundación GECP","OTHER",32,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100611589","phase-2-study-of-tarlatamab-as-maintenance-treatment-after-chemo-radiotherapy-for-limited-stage-sclc-patients-100611589","NCT07242547","Study of Tarlatamab as Maintenance Treatment After Chemo-radiotherapy for Limited Stage SCLC Patients","A Phase II Clinical Trial of Tarlatamab as Maintenance Treatment After Sequential Chemo-radiotherapy for Limited Stage SCLC Patients Not Eligible for Concurrent Chemo-radiotherapy","MERLIN","Inclusion Criteria:\n\n* Histologically or cytologically documented new diagnosis of LS-SCLC by histology or cytology from brushing, washing, or needle aspiration. Mixed tumors are not eligible.\n* Patients who:\n\n  1. were treated with sequential chemo-radiotherapy\n  2. were treated only with chemotherapy\n* Have at least one lesion that meets criteria for being measurable or non-measurable, as defined by RECIST 1.1.\n* Has completed chemo-radiation or chemotherapy alone without progression of disease per RECIST v1.1\n* Be male or female ≥18 years of age inclusive, on the day of signing informed consent.\n* Have a life expectancy of at least 3 months from the study start.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 within 7 days prior to the first dose of study intervention.\n* Toxicities attributed to chemo-radiotherapy treatment have to be resolved to grade ≤1, unless otherwise specified.\n* No clinically significant electrocardiogram (ECG) findings\n* Correct pulmonary function without oxygen supplementation\n* Have voluntarily agreed to participate by giving written consent for the study prior to any specific protocol procedures.\n* Have adequate organ function (hematological and biochemistry parameters).\n\nExclusion Criteria:\n\n* Patients expected to require any other form of radiation therapy for LS-SCLC as concurrent radiotherapy.\n* Extensive-stage SCLC (ES-SCLC) or any previous diagnosis of transformed non-small cell lung cancer. Mixed tumors (SCLC-NSCLC) are not eligible.\n* Has known history of, or active, neurologic paraneoplastic syndrome of autoimmune nature.\n* Has had major surgery within 4 weeks prior to first dose of study interventions.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Has known history of a second malignancy other than SCLC, unless potentially curative treatment has been completed with no evidence of malignancy for at least 3 years since the initiation of that therapy.\n* Uncontrolled intercurrent active infection at the time of enrollment requiring systemic therapy.\n* Evidence of interstitial lung disease or active, non-infectious pneumonitis.\n* History of solid organ transplantation.\n* Myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association \\>class II) within 6 months prior to first dose of study treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV) infection.\n* Has a known history of Hepatitis B or known active Hepatitis C virus infection.\n* Has a known history of active tuberculosis.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention.\n* Female subjects of childbearing potential unwilling to use protocol specified method of contraception during treatment and for an additional 60 days after the last dose of study treatment.\n* Female subjects who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.\n* Female subjects planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.\n* Female subjects of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.\n* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence or use contraception during treatment and for an additional 60 days after the last dose of study treatment.\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.\n* Subject has known sensitivity to any of the products or components to be administered during dosing.",{"count":52,"type":21},37,[54],"PHASE2","This is an open-label, phase II, exploratory and multi-centre clinical trial. 37 Limited stage SCLC patients not eligible for concurrent chemo-radiotherapy will be enroll.\n\nPatients will be enrolled in the trial after receiving sequential chemo-radiotherapy, if there is no progression disease, patients will be treated with maintenance Tarlatamab.\n\nPatients will receive maintenance with Tarlatamab IV until disease progression unacceptable toxicity, patient or physician decision to discontinue or death.\n\nThe primary objective is to evaluate the Progression free survival (PFS).\n\nPatient accrual is expected to be completed within 2 years. Treatment and follow-up are expected to extend the study duration to a total of 5 years. Patients will be followed for 2 years after enrollment. The study will end once survival follow-up has concluded.",[57,58,59,60],"Limited-stage Small-cell Lung Cancer","Carcinoma, Small Cell Lung","Respiratory Tract Neoplasms","Thoracic Neoplasms",[62,63,64,65,66,67],"Non small cell lung cancer","Tarlatamab","Maintenance treatment","Antineoplastic Agents","Chemo-radiotherapy","Immunotherapy","2026-04-29",{"date":70,"type":34},"2026-05-05",{"date":72,"type":21},"2026-05-28",{"date":74,"type":21},"2030-06-01",{"name":40,"class":41},20,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":98,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":76},"100611992","phase-2-study-for-evaluating-the-safety-and-feasibility-of-fecal-microbiota-transplant-in-stage-ii-iii-nsclc-patients-using-ici-responders-as-donors-migrant-100611992","NCT07247786","Study for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant in Stage II-III NSCLC Patients Using ICI Responders as Donors (MIGRANT)","Phase II Randomized Clinical Trial for Evaluating the Safety and Feasibility of Fecal Microbiota Transplant (FMT) in Stage II-III Non-small Cell Lung Cancer (NSCLC) Patients, Using Immune Checkpoint Inhibitors (ICI) Responders as Donors.","MIGRANT","Inclusion Criteria:\n\n* Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIA, IIB, IIIA or IIIB (only T3N2) disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)\n* PET scan and brain CT or MRI at baseline to confirm the absence of distant disease\n* ECOG (Performance status) 0-1\n* Adequate hematologic and organ function.\n* All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention\n* Adequate lung function: Forced Espiratoy Volumen in 1 second (FEV1) \\>50% of normal volume and Difusion Capacity of the Lungs for Carbon Monoxide (DLCO) \\>40% of normal value\n* Patients aged ≥ 18 years at the time of study entry\n* Body weight \\> 30Kg (for durvalumab monotherapy)\n* PDL1 analyzed (value in %)\n* For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective forms of contraception that results in a low failure rate (\\\u003C 1% per year) when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.\n* For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception that results in a low failure rate when used consistently and correctly, and to continue its use for 6 months after the last dose of trial treatment.\n* Oral contraception should always be combined with an additional contraceptive method because of a potential interaction with the study drugs. The same rules are valid for male patients involved in this clinical study if they have a partner of childbirth potential. Male patients must always use a condom.\n* Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.\n* Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Presence of at least one measurable lesion by CT-SCAN, as defined by RECIST v1.1.\n* Patients with a life expectancy ≥12 weeks.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act in the US, European Union \\[EU\\] Data Privacy Directive in the EU) obtained from the patient\u002Flegal representative prior to performing any protocol-related procedures, including screening evaluations\n\nExclusion Criteria:\n\n* Patients with known sensitizing mutation or an amplification in the epidermal growth factor receptor (EGFR) gene or any variety of alterations of ALK oncogene.\n* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.\n* Weight loss \\>10% within the previous 3 months.\n* Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.\n* Patients with other active malignancy requiring concurrent intervention and\u002For concurrent treatment with other investigational drugs or anti-cancer therapy\n* History of active primary immunodeficiency\n* History of another primary malignancy.\n* Active or prior documented autoimmune or inflammatory disorders.\n* Patients with a condition requiring systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.\n* Pleural or pericardial effusion.\n* Patients who have experienced untreated and\u002For uncontrolled cardiovascular conditions and\u002For have symptomatic cardiac dysfunction.\n* Positive test for HIV.\n* Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.\n* Patients with history of allergy to study drug components\u002Fexcipients.\n* Active tuberculosis.\n* Severe infections within 4 weeks prior to be included in the study.\n* Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* Patients with medical, mental, neurological or psychological condition which in the opinion of the investigator would not permit the patient to understand the patient information sheet or comply with study procedures.\n* Treatment with any other investigational agent with therapeutic intent within 28 days prior to initiation of study treatment.\n* Patients with uncontrolled comorbidities that may affect the clinical trial compliance.\n* Women who are pregnant or in the breastfeeding period or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.\n* Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.\n* Patients must be informed that they are not allowed to donate blood during the treatment period of this clinical trial.\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.\n* Receipt of a live attenuated vaccine within 30 days prior to the first dose of investigational product (IP).\n* Concurrent enrollment in another clinical study, except in cases where the study is observational (non-interventional) or the patient is in the follow-up phase of a previous interventional study.",{"count":86,"type":21},68,[54],"This is a randomized, phase II, multi-centre clinical trial.\n\nSample size: 68 patients (Experimental Arm (Durvalumab + chemotherapy + FMT capsules): 34 patients, Control Arm (Durvalumab + chemotherapy): 34 patients)\n\nPopulation: Patients with stage IIA, IIB, IIIA and IIIB (only T3N2) non-small cell lung cancer\n\nIn the Experimental arm, patients will receive Fecal Microbiota Transplant. Once done, the patient will start neoadjuvant treatment with Durvalumab + Chemotherapy .\n\nIn the Control arm, patients will receive neoadjuvant treatment with Durvalumab + Chemotherapy.\n\nAfter neoadjuvant\u002Finduction treatment every patient will be evaluated to decide if the patient is a candidate for surgery or not. Patients that are R0 after surgery will receive Adjuvant treatment with Durvalumab.\n\nThe primary objective is to evaluate the pathological Complete Response (pCR) rate.\n\nThe total trial duration will be 6.5 years approximately.",[90,91],"Non Small Cell Lung Cancer","Respiratory Tract Neoplasm",[62,93,94,95,96,97],"Fecal microbiota transplant","Inmune checkpoint inhibitor responder","Neoadjuvant treatment","Adjuvant treatment","Durvalumab","NOT_YET_RECRUITING",{"date":70,"type":34},{"date":101,"type":21},"2026-09-15",{"date":103,"type":21},"2031-12-30",{"name":40,"class":41},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":76},"100469844","phase-2-clinical-trial-of-amg510-in-stage-iii-unresectable-nsclc-kras-pg12c-patients-and-ineligible-for-chemo-radiotherapy-100469844","NCT05398094","Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy","Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy","MERIT-lung","Inclusion Criteria:\n\n* 1\\. Male or female, aged ≤ 80 years old\n* 2\\. ECOG performance status of 0-1\n* 3\\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.\n* 4\\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.\n* 5\\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.\n* 6\\. Having a life expectancy ≥ 12 weeks\n* 7\\. Patients must be ineligible for concurrent chemo-radiotherapy because of:\n\n  1. Tumor size ≥ 5 cm and lymph node N2 involvement\n  2. The target lesion has to be bulky disease and\u002For more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function\n  3. Interstitial Lung diseases\n  4. Prior treatment with thoracic radiotherapy for any reason\n  5. Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront\n* 8\\. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease\n* 9\\. PET-CT positive mediastinic adenopathies must be histologically confirmed. Mediastinic involvement could be considered without histological test when no margin can be distinguished in the lymph node mass.\n* 10\\. Brain CT or MRI is mandatory\n* 11\\. Patients with at least 1 measurable lesion, as defined by RECIST v1.1.\n* 12\\. Adequate hematologic and organ function.\n* 13\\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.\n* 14\\. Willingness and ability to comply with scheduled visits and study procedures\n* 15\\. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment).\n* 16\\. For female patients of childbearing potential, agreement (by patient and\u002For partner) to usea highly effective form(s) of contraception that results in a low failure rate (\\\u003C 1% per year)when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib). No hormonal methods and preferably barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.\n* 17\\. For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception that results in a low failure rate \\[\\\u003C 1% per year\\] when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib).\n* 18\\. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrollment.\n* 19\\. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.\n\nExclusion Criteria:\n\n* 1\\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations\n* 2\\. Weight loss \\>10% within the previous 3 months\n* 3\\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0\n* 4\\. Major surgery within 28 days of study day 1\n* 5\\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication\n* 6\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina\n* 7\\. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \\> 470ms\n* 8\\. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia\n* 9\\. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization\n* 10\\. Patients with any concomitant and uncontrolled medical disorder\n* 11\\. Patients with vena cava syndrome\n* 12\\. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastaticdisease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray pleural effusion or too small to be safely punctured could be included.\n* 13\\. Prior treatment with anti-neoplasic drugs\n* 14\\. Malignancies other than NSCLC within 3 years prior to enrollment\n* 15\\. Women who are pregnant, lactating, or intending to become pregnant during the study.\n* 16\\. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.\n* 17\\. Patients with active hepatitis B or hepatitis C.\n* 18\\. Active tuberculosis.\n* 19\\. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* 20\\. Patients with illnesses or conditions that interfere with their capacity to understand follow and\u002For comply with study procedures.\n* 21\\. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug\n* 22\\. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study\n* 23\\. Use of strong inducers of CYP3A4 within 14 days of half-lives (whichever is longer) prior to study day 1\n* 24\\. Use of proton pump inhibitors within 14 days to study day",{"count":114,"type":21},19,[54],"Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.",[118,119],"Non-small Cell Lung Cancer Stage III","KRAS P.G12C",[121,122,66,123],"Sotorasib","Unresectable","Lung cancer",{"date":125,"type":34},"2026-04-30",{"date":127,"type":34},"2022-03-21",{"date":129,"type":21},"2028-12-31",{"name":40,"class":41},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100452129","pathological-response-after-neoadjuvant-treatment-on-nsclc-100452129","NCT05167487","Pathological Response After Neoadjuvant Treatment on NSCLC","Retrospective Observational Study of Resectable Stage IIIA Non-small Cell Lung Cancer Patients: Pathological Response After Neoadjuvant Treatment and Patient Outcomes","PLANET","Inclusion Criteria:\n\n* Patients with resectable stage IIIA disease (according to American Joint Committee on Cancer \\[AJCC\\] lung cancer edition 7 or 8) who were included in the Tumor Thoracic Registry data base and in stage IIIA clinical trials which the sponsor is Fundación GECP.\n* Patients with histologically N2 involvement confirmed\n* Patients diagnosed as stage IIIA from 2010 and 2017\n* Patients who have received neoadjuvant platinum-based treatment and surgery\n* Age ≥ 18 years at time of study entry\n* PET \u002FTC at diagnosis\n\nExclusion Criteria:\n\n* Patients who received chemoradiotherapy neoadjuvant treatment\n* Patients who were not resected after neoadjuvant treatment\n* Patients who were diagnosed after June 2017",{"count":140,"type":21},150,"OBSERVATIONAL","This is a non-interventional, observational, multicenter and retrospective study. Being limited to the collection of patient data already filled in the Tumor Thoracic Registry data base and the data from stage IIIA clinical trials case report forms.",[144],"Stage IIIA Non-small Cell Lung Cancer",[146,147,148,62,149],"Neoadjuvant Treatment","Observational study","Resectable IIIA patients","Pathological response","2026-02-04",{"date":152,"type":34},"2026-02-06",{"date":154,"type":34},"2021-12-13",{"date":156,"type":21},"2028-12-01",{"name":40,"class":41},17,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":141,"phases":4,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},"100564824","study-of-antitumor-immune-response-after-ccrt-and-io-treatment-in-non-resectable-iii-stage-nsclc-patients-100564824","NCT06634199","Study of Antitumor Immune Response After cCRT and IO Treatment in Non-resectable III Stage NSCLC Patients","Study of Antitumor Immune Response Generated After Concurrent Chemo-radiotherapy (cCRT) and IO Treatment in Non-resectable Stage IIIA\u002FB and IIIC NSCLC Patients Treated in Real World.","SIENNA","Inclusion Criteria:\n\n* Patients with histologically- or cytologically- documented NSCLC who present unresectable stage IIIA-IIIB-IIIC disease, according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology).\n* ECOG 0-1.\n* PDL1\\>1%.\n* Age ≥ 18 years at time of study\n* Patients without progression after cCRT, that are going to receive IO treatment (Durvalumab) for 12 months as subsequent treatment as per standard clinical practice\n* Patient capable of proper therapeutic compliance and accessible for correct follow-up.\n* Patients must have signed, dated and IRB\u002FEC-approved written informed consent form in accordance with regulatory and institutional guidelines.\n\nExclusion Criteria:\n\n* Patients who refuse to sign and date an IRB\u002FIEC-approved written informed consent form.\n* No possibility of venipuncture\n* Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.",{"count":168,"type":21},50,"Observational, multicenter, one-arm, non-comparative study. Data will be recorded in a retrospectively manner. The study will be based on secondary data collected from patient clinical chart completed by the doctor during routine visits. The primary objective is describe the antitumor immune response generated in the context of IO (immunotherapy) treatment after cCRT in patients with unresectable NSCLC treated in real world.",[118,171],"PDL1 Gene Mutation",[173,174,175,176],"Lung Cancer","Chemo radiotherapy","ctDNA","Inmunotherapy","2026-01-26",{"date":179,"type":34},"2026-01-28",{"date":181,"type":34},"2024-10-03",{"date":183,"type":21},"2027-11-04",{"name":40,"class":41},22,{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":192,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":196,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100604740","phase-2-neoadjuvant-treatment-with-atezolizumab-and-atezolizumab-as-maintenance-for-the-treatment-of-stage-iii-non-small-cell-lung-cancer-nsclc-100604740","NCT07153445","Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)","Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy","ATHENEA","Inclusion Criteria:\n\n* Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)\n* Confirm the absence of distant disease\n* ECOG (Performance status) 0-1\n* Adequate hematologic and organ function\n* All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention\n* Adequate lung function\n* Patients aged \\> 18 years\n* For female patients of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form(s) of contraception\n* For male patients with female partners of childbearing potential, agreement (by patient and\u002For partner) to use a highly effective form of contraception\n* Oral contraception should always be combined with an additional contraceptive method\n* Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.\n* Patient capable of proper therapeutic compliance and accessible for correct follow-up\n\nExclusion Criteria:\n\n* Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.\n* Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.\n* Weight loss \\>10% within the previous 3 months.\n* Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.\n* Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment\n* Pleural or pericardial effusion\n* Known hypersensitivity or allergy to atezolizumab formulation.\n* History of autoimmune disease or lung disease\n* Positive test for human immunodeficiency viruses (HIV)\n* Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.\n* Active tuberculosis.\n* Symptomatic neuropathy grade \\> 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0\n* Severe infections within 4 weeks prior to be included in the study",{"count":195,"type":21},97,[54],"This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.\n\nThe treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant\u002Finduction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.\n\nDepending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.",[90,199,200],"Stage IIIA Lung Cancer","Stage IIIB Lung Cancer",[62,202,203,96],"Atezolizumab","Non-resected lung cancer","2025-11-17",{"date":206,"type":34},"2025-11-19",{"date":208,"type":34},"2025-07-08",{"date":210,"type":21},"2035-05-02",{"name":40,"class":41},21,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":229,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":234,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":238,"locationsCount":76},"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":222,"type":21},63,[54],"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.",[226,27,227,228,59,60],"Non Small Cell Lung Cancer Metastatic","Stage IV Non-small Cell Lung Cancer","Stage III Non-small Cell Lung Cancer",[230,231,232,233],"Cemiplimab","ctDNA levels","Chemotherapy","Non-resectable non-small cell lung cancer",{"date":206,"type":34},{"date":236,"type":34},"2025-07-29",{"date":103,"type":21},{"name":40,"class":41},""]