[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-non-small-cell-lung-nsclc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-non-small-cell-lung-nsclc":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,43,85,113,133,161,184,207],{"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":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643034","vortioxetine-for-cognitive-function-in-alk-positive-nsclc-treated-with-lorlatinib-100643034",false,"NCT07633626","Vortioxetine for Cognitive Function in ALK-positive NSCLC Treated With Lorlatinib","Potential Effect of Vortioxetine on Cognitive Functioning of Patients With ALK-positive Non-Small Cell Lung Cancer Treated With Lorlatinib","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of ALK\u002FROS1-positive non-small cell lung cancer (NSCLC), stage IIIB\u002FIV.\n* Currently receiving lorlatinib as part of the standard therapeutic regimen.\n* Documented neurocognitive adverse events (NAEs) attributable to lorlatinib.\n* Age \\>= 18 years.\n* ECOG performance status 0-2.\n* Ability to understand and sign informed consent.\n* Expected survival \\>= 6 months.\n* Planned initiation of vortioxetine as part of standard care.\n* Ability to complete neuropsychological tests and questionnaires in Spanish.\n\nExclusion Criteria:\n\n* Prior diagnosis of major cognitive impairment unrelated to cancer treatment.\n* Current use of another antidepressant that cannot be discontinued.\n* Uncontrolled major psychiatric disorder.\n* History of uncontrolled epilepsy or recent seizures.\n* Severe hepatic or renal impairment.\n* Known hypersensitivity to vortioxetine.\n* Participation in another clinical trial within the past 30 days.\n* Inability to provide informed consent.\n* Life expectancy \\\u003C 3 months.\n* Contraindications to vortioxetine (e.g., concomitant MAOI use).\n* Prior vortioxetine use.\n* Severe psychiatric disorders or significant cognitive impairment unrelated to lorlatinib.","ALL","18 Years",{"count":19,"type":20},24,"ESTIMATED","OBSERVATIONAL","This observational study evaluates whether vortioxetine - an antidepressant medication with cognitive-enhancing properties - can reduce the neurological and cognitive side effects associated with lorlatinib treatment in patients with non-small cell lung cancer (NSCLC) harboring ALK or ROS1 gene rearrangements.\n\nLorlatinib is a highly effective third-generation tyrosine kinase inhibitor, but it causes neuropsychological adverse events (NAEs) in approximately 42% of patients, including cognitive impairment, mood changes, and speech disturbances. Vortioxetine has demonstrated cognitive improvement in depressed patients and in preclinical models of androgen deprivation therapy-induced cognitive impairment.\n\nTwenty-four adult patients with ALK\u002FROS1-positive NSCLC receiving lorlatinib as standard care and prescribed vortioxetine (10-20 mg\u002Fday) for NAE management will be enrolled. Comprehensive neuropsychological assessments and quality-of-life questionnaires will be conducted at baseline, week 6, week 12, and month 6 to document changes in cognitive function, depressive symptoms, and quality of life.",[24,25,26,27,28,29],"Advanced ALK\u002FROS1-positive NSCLC","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Adenocarcinoma","ALK-positive Non-small Cell Lung Cancer (NSCLC)","Cognitive Dysfunction","Depression","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-08","ACTUAL",{"date":36,"type":34},"2026-03-10",{"date":38,"type":20},"2027-11-10",{"name":40,"class":41},"Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":65,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":76,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100630545","phase-2-symbiotic-lung-10-a-study-to-learn-about-pf-08634404-alone-or-in-combination-in-early-stage-or-locally-advanced-nsclc-100630545","NCT07489066","Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Adequate organ function\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his\u002Fher practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.\n* Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.\n* Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.\n\nExclusion Criteria:\n\n* Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.\n* Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n\n  * Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n  * Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":51,"type":20},120,"INTERVENTIONAL",[54],"PHASE2","This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.\n\nThe study is seeking participants who:\n\n* Are aged 18 years or older\n* Have either:\n\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.\n  * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.\n* Be in good physical condition and have healthy organs based on medical tests.\n* Do not have known actionable changes in DNA\n\nThe study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:\n\n* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.\n* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.\n* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.\n\nAll treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[57,58,59,60,25,61,62,63,64],"Carcinoma","Non-Small-Cell Lung","Lung Cancer (NSCLC)","Lung Neoplasms","Lung Disease","Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer, Non-squamous","Non-small Cell Lung Cancer, Squamous",[66,67,68,69,70,71,72,73,74,75],"early stage non small cell lung cancer","NSCLC","adjuvant NSCLC","locally advanced non small cell lung cancer","resectable NSCLC","unresectable NSCLC","neoadjuvant NSCLC","consolidation NSCLC","squamous NSCLC","non-squamous NSCLC",{"date":33,"type":34},{"date":78,"type":20},"2026-06-01",{"date":80,"type":20},"2031-07-30",{"name":82,"class":83},"Pfizer","INDUSTRY",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":52,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100610052","phase-3-symbiotic-lung-01--a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100610052","NCT07222566","Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Expected survival ≥12 weeks\n\nExclusion Criteria:\n\n* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C 1 cm are permitted.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Previous systemic anti-tumor therapy including:\n\n  1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n  2. Previous treatment with immunotherapy\n  3. Prior radiotherapy \\> 30 Gy to the lung \\\u003C 6 months of first dose of study intervention\n  4. Palliative local therapy \\\u003C 2 weeks before the first dose of study intervention;\n  5. Non-specific immunomodulatory therapy \\\u003C 2 weeks before the first dose.\n  6. Prior systemic anti-angiogenic therapy\n* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n* Prior and concomitant therapy:\n\n  1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \\\u003C 10 days to the first dose.\n  2. chronic antiplatelet therapy \\\u003C7 days to randomization.\n  3. live or attenuated live vaccine \\\u003C 4 weeks to the first dose.\n  4. current high-dose systemic corticosteroids.\n  5. prohibited concomitant medication(s) \\\u003C 21 days to the first dose.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":93,"type":20},1410,[95],"PHASE3","This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.\n* Is not a candidate for complete surgical resection or curative chemoradiotherapy.\n* Do not have known actionable genomic alterations\n* Be treatment naïve for advanced or metastatic disease\n\nParticipants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.\n\nEach participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:\n\n* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.\n* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.\n\nParticipants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.\n\nThe study will include regular visits for:\n\n* Treatment and health checks: while participant continues receiving treatment.\n* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.",[98,62,99,25,100,101],"Advanced Non-Small Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","Metastatic Non Small Cell Lung Cancer","Lung Cancer",[75,74,103,104],"metastatic (Stage IV) squamous or non-squamous NSCLC","Advanced or Metastatic Non-Small Cell Lung Cancer","2026-06-03",{"date":31,"type":34},{"date":108,"type":34},"2026-01-06",{"date":110,"type":20},"2032-08-26",{"name":82,"class":83},346,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":42},"100580125","prospective-cohort-study-evaluating-18fdg-pet-ct-for-the-early-prediction-of-the-efficacy-of-immunotherapy-associated-or-not-with-chemotherapy-in-patients-with-locally-advanced-or-metastatic-non-small-cell-broncho-pulmonary-carcinoma-100580125","NCT06833229","Prospective Cohort Study Evaluating 18FDG PET-CT for the Early Prediction of the Efficacy of Immunotherapy Associated or Not With Chemotherapy in Patients With Locally Advanced or Metastatic Non-Small Cell Broncho-Pulmonary Carcinoma","FDG Immun Comb","Inclusion Criteria:\n\n* Age greater than or equal to 18 years,\n* Patients with histologically proven, metastatic or locally advanced NSCLC, with indication for immunotherapy (Nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab), in combination or not with chemotherapy molecules (carboplatin, cisplatin, pemetrexed, paclitaxel or nab-paclitaxel), validated by a Multidisciplinary Team and prescribed within the scope of their Marketed Authorization, whatever the line of treatment treatment line,\n* ECOG 0 to 3,\n* The patient's understanding of the protocol and the note of non-opposition, with oral agreement,\n* Patient has not objected to the use of his or her data for medical research. research,\n* Patient has social security coverage.\n\nExclusion Criteria:\n\n* Age under 18,\n* Contraindication to 18FDG PET-CT examinations: severe claustrophobia, unbalanced diabetes at the time of the first PET-CT scan (fasting capillary glucose ≥ 11 mmol),\n* Hemoglobin less than 7 g\u002FdL at inclusion. If the patient has a respiratory or or cardiovascular pathology, hemoglobin must not be less than 9.0 g\u002FdL,\n* Any participation in other biomedical studies involving the drug, medical devices or medical devices or imaging techniques is prohibited, with the exception of biomedical studies,\n* Refusal to participate in the present study,\n* Contraindication (e.g. hypersensitivity to the active substance or to one of the excipients of immunotherapy or chemotherapy treatments...).\n* Vulnerable persons are defined in article L1121-5 to -8:\n\n  * Pregnant women, parturients and nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons hospitalized without consent under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of the provisions of article L. 1121-8,\n  * and persons admitted to a health or social establishment for purposes other than research purposes,\n  * adults who are the subject of a legal protection measure, or who are unable to exercise their non opposition",{"count":121,"type":20},200,"The hypothesis of this prospective observational pilot study of diagnostic diagnostic performance is that, for patients with NSCLC treated with immunotherapy associated or not with chemotherapy, certain metabolic biomarkers on 18FDG PET scans allow early identification of treatment response (or lack of response to treatment) and optimize prediction of tumor response compared with current standards.",[25],"2026-05-27",{"date":126,"type":34},"2026-05-29",{"date":128,"type":34},"2022-01-27",{"date":130,"type":20},"2031-01-27",{"name":132,"class":41},"Centre Antoine Lacassagne",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":52,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":42},"100640654","phase-2-intermittent-hypoxic-training-as-neoadjuvant-therapy-for-lung-squamous-cell-carcinoma-100640654","NCT07618793","Intermittent Hypoxic Training as Neoadjuvant Therapy for Lung Squamous Cell Carcinoma","Study on the Novel Application of Intermittent Hypoxic Training in Neoadjuvant Therapy for Lung Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Age between 18 and 75 years old (inclusive), regardless of sex.\n2. Diagnosed with histologically confirmed stage II-IIIA (according to the AJCC 8th edition staging system) squamous cell lung carcinoma.\n3. The primary tumor is evaluated by a multidisciplinary team (MDT) and deemed completely resectable.\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n5. Life expectancy of at least 6 months.\n6. Adequate organ, bone marrow, and coagulation functions, meeting the following laboratory criteria within 7 days prior to enrollment:\n\n   * Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL;\n   * Platelet count \\>= 100 x 10\\^9\u002FL;\n   * Hemoglobin \\>= 90 g\u002FL;\n   * Total bilirubin \\\u003C= 1.5 x upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \\\u003C= 2.5 x ULN;\n   * Serum creatinine \\\u003C= 1.5 x ULN, or creatinine clearance \\>= 50 mL\u002Fmin;\n   * International normalized ratio (INR) and activated partial thromboplastin time (APTT) \\\u003C= 1.5 x ULN.\n7. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for at least 6 months after the last dose. Male participants must agree to use effective contraception during the study and for at least 6 months after the last dose.\n8. Participant understands the study protocol, voluntarily participates, and signs the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n1. Histologically confirmed small cell lung cancer, adeno-squamous carcinoma, large cell neuroendocrine carcinoma, or adenocarcinoma (including components of these types).\n2. Patients with driver gene mutations that have approved targeted therapies available (e.g., EGFR mutations, ALK rearrangements, ROS1 fusions, etc.).\n3. Prior systemic antitumor therapy for lung cancer, including chemotherapy, radiotherapy, immunotherapy, targeted therapy, or definitive surgical resection.\n4. Active, known, or suspected autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune hepatitis), or a history of autoimmune disease within the past 2 years.\n5. History of other malignant tumors within the past 5 years, except for adequately treated cured skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ (e.g., cervical carcinoma in situ).\n6. Severe cardiovascular or cerebrovascular diseases, including but not limited to:\n\n   * Myocardial infarction or unstable angina within the past 6 months;\n   * New York Heart Association (NYHA) Class III or IV congestive heart failure;\n   * Clinically significant ventricular arrhythmia or poorly controlled symptomatic arrhythmia;\n   * Stroke or transient ischemic attack (TIA) within the past 6 months.\n7. Poorly controlled hypertension (systolic blood pressure \\>= 160 mmHg and\u002For diastolic blood pressure \\>= 100 mmHg despite standard antihypertensive therapy).\n8. Chronic obstructive pulmonary disease (COPD) or other respiratory diseases with severe lung function impairment (e.g., FEV1 \\\u003C 50% predicted value, or requiring long-term home oxygen therapy).\n9. Active infections requiring systemic intravenous anti-infective treatment within 2 weeks prior to enrollment (e.g., severe pneumonia, bacteremia), or active tuberculosis infection.\n10. Known history of human immunodeficiency virus (HIV) infection, or active Hepatitis B (HBV DNA \\>= 500 IU\u002FmL or copy number above detection limit) or active Hepatitis C (HCV RNA positive).\n11. History of interstitial lung disease (ILD), drug-induced pneumonitis, radiation pneumonitis requiring steroid treatment, or evidence of active pneumonitis.\n12. Severe claustrophobia, severe high-altitude sickness history, or other medical\u002Fpsychological conditions that prevent compliance with intermittent hypoxic training (IHT) using the FLY-2265 low oxygen system.\n13. Pregnant or breastfeeding women.\n14. Any other medical condition, clinical laboratory abnormality, or social circumstance that, in the opinion of the investigator, may compromise participant safety, interfere with the evaluation of study interventions, or affect compliance with study procedures.","75 Years",{"count":142,"type":20},60,[54],"The goal of this clinical trial is to learn if adding intermittent hypoxic training (IHT) to standard neoadjuvant chemo-immunotherapy can increase the pathologic complete response (pCR) rate in patients aged 18 to 75 of both sexes with resectable stage II-IIIA lung squamous cell carcinoma. The main questions it aims to answer are:Can the addition of IHT to standard neoadjuvant chemo-immunotherapy significantly improve the pathologic complete response (pCR) rate compared to standard therapy alone? Is IHT safe and well-tolerated in this perioperative setting, and can it improve 2-year recurrence-free survival (RFS) without increasing complications? Researchers will compare the experimental group (standard neoadjuvant chemo-immunotherapy combined with IHT) to the control group (standard neoadjuvant chemo-immunotherapy alone) to see if the combination safely enhances anti-tumor immune responses, improves tumor regression, and extends long-term survival. Participants will:Receive standard neoadjuvant chemo-immunotherapy for 4 cycles (21 days per cycle), consisting of nab-paclitaxel, carboplatin, and pembrolizumab. Undergo Intermittent Hypoxic Training (IHT) if randomized to the experimental group, using the FLY-2265 low oxygen system (13% $FiO\\_2$ for 5 minutes followed by 21% $FiO\\_2$ for 5 minutes per cycle; 10 cycles per session, twice daily) for 7 consecutive days starting on Day 1 of each chemo-immunotherapy cycle. Undergo surgery (VATS lobectomy and systematic lymph node dissection) 3 to 4 weeks after the completion of the 4th cycle, provided that the disease has not progressed. Complete regular post-operative follow-up visits (including chest CT scans, brain MRIs, bone scans, tumor markers, and peripheral blood immune monitoring) for up to 5 years to evaluate long-term outcomes.",[146,25],"Lung Squamous Cell Carcinoma",[146,148,149,150,62,151],"Intermittent Hypoxic Training","Neoadjuvant Chemoimmunotherapy","CD8-Positive T-Lymphocytes","Pathologic Complete Response","NOT_YET_RECRUITING","2026-05-25",{"date":78,"type":34},{"date":156,"type":20},"2026-06",{"date":158,"type":20},"2028-12",{"name":160,"class":41},"zhang yi",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":52,"phases":171,"briefSummary":172,"conditions":173,"keywords":174,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},"100574370","phase-3-this-is-a-study-to-learn-about-how-the-combination-of-the-study-medicines-sigvotatug-vedotin-plus-pembrolizumab-works-in-people-with-non-small-cell-lung-cancer-with-high-levels-of-pd-l1-100574370","NCT06758401","This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.","AN OPEN-LABEL, RANDOMIZED, CONTROLLED PHASE 3 STUDY OF SIGVOTATUG VEDOTIN IN COMBINATION WITH PEMBROLIZUMAB COMPARED WITH PEMBROLIZUMAB MONOTHERAPY AS FIRST-LINE TREATMENT IN PARTICIPANTS WITH PD-L1 HIGH (≥50% OF TUMOR CELLS EXPRESSING PD-L1), LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC NON-SMALL CELL LUNG CANCER (BE6A LUNG-02)","Be6A Lung-02","Inclusion Criteria:\n\n1. Participants must meet the following criteria:\n\n   1. Have pathologically confirmed Stage IIIB or IIIC NSCLC and not be a candidate for surgical resection or definitive chemoradiation, or Stage IV NSCLC per the AJCC Staging Manual (Version 8.0) and the UICC Staging System (Eighth edition).\n   2. Participants with non-squamous histology must have documented negative test results for EGFR, ALK, and ROS1 AGAs and no known AGAs in NTRK, BRAF, RET, MET, or other AGAs with approved front-line therapies per local standard of care.\n   3. Large cell neuroendocrine carcinoma is excluded.\n   4. Candidate for treatment with pembrolizumab monotherapy per local guidelines.\n2. Tumor has PD-L1 expression in ≥50% of tumor cells (TPS ≥50%) as determined by local testing\n3. Measurable disease based on RECIST v1.1 per investigator.\n4. Resolution of acute effects of any prior therapy to either baseline severity or NCI CTCAE Grade 1 or less (except for AEs not constituting a safety risk in the investigator's judgment), unless otherwise excluded.\n\nExclusion Criteria:\n\n1. Life expectancy of \\\u003C3 months in the opinion of the investigator.\n2. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n3. Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n4. Known or suspected hypersensitivity, intolerance, or contraindication to any excipient contained in the drug formulation of sigvotatug vedotin or pembrolizumab.\n5. Participants with any of the following respiratory conditions:\n\n   1. Evidence of noninfectious or drug-induced ILD or pneumonitis\n   2. Known DLCO (adjusted for hemoglobin) \\\u003C50% predicted.\n   3. Grade ≥3 pulmonary disease unrelated to underlying malignancy\n6. Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C0.5 cm are permitted.\n7. Major surgery (defined as a surgery requiring inpatient hospitalization of at least 48 hours) within 21 days or minor surgery within 7 days prior to first dose of study intervention.\n8. Receipt of a live vaccine within 30 days prior to first dose of study intervention.\n9. Pre-existing peripheral neuropathy Grade ≥2 per NCI CTCAE v5.0.\n10. Uncontrolled diabetes mellitus, defined as HbA1c ≥8.0% or HbA1c between 7.0% and 8.0% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.\n11. Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, required a high-dose steroid taper (≥0.5 mg\u002Fkg prednisone or equivalent per day) for \\>2 weeks, or required treatment with systemic immunosuppressive therapy.\n12. History of autoimmune disease that has required systemic treatment in the past 2 years\n13. Participants with prior solid organ or bone marrow transplantation.\n14. Currently receiving a high-dose steroid (\\>10 mg prednisone or equivalent per day) or other immune suppressant or has a condition requiring a chronic high-dose steroid or immune suppressant.\n15. Prior and concomitant therapy:\n\n    1. Any prior treatment with MMAE-derived drugs or IB6 targeting agents.\n    2. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n\n       * (Neo)adjuvant anti-PD-(L)1 is allowed if recurrence or progression occurred ≥9 months after the last dose.\n       * Other (neo)adjuvant or definitive therapy is allowed if recurrence or progression occurred ≥6 months after the last dose.\n    3. Prior radiotherapy to the lung within 6 months of first dose of study intervention, referencing the last date radiotherapy was received.\n    4. Chemotherapy, biologics, and\u002For other antitumor treatment with immunotherapy not specifically prohibited that is completed less than 4 weeks prior to first dose of study intervention, or 2 weeks for palliative radiotherapy.\n    5. Any prior therapy with an immune-oncology agent directed to a stimulatory or co-inhibitory T-cell receptor\n16. History of or current ongoing infection, including participants positive for active HIV, HBV, or HCV.\n17. Severe uncontrolled cardiac or cerebrovascular condition within the previous 6 months",{"count":170,"type":20},714,[95],"The purpose of the study is to compare how the new combination treatment (Sigvotatug Vedotin plus pembrolizumab) works compared to pembrolizumab alone in patients with non-small cell lung cancer (NSCLC) with high levels of PD-L1. This is a protein that acts as a kind of \"brake\" to keep the body's immune responses under control.\n\nThe study is seeking for participants who:\n\n* Are confirmed to have NSCLC (Stage 3 or 4).\n* Have PD-L1 levels in more than 50% of the cancer cells.\n\nAll participants in this study will receive pembrolizumab at the study clinic once every 6 weeks as an intravenous (IV) infusion (give directly into a vein). In addition, half of the participants will also receive Sigvotatug Vedotin once every 2 weeks as an IV infusion in addition to receiving pembrolizumab.\n\nParticipants may receive pembrolizumab for up to about two years. Those participants taking Sigvotatug Vedotin can continue until their NSCLC is no longer responding. The study team will monitorsee how each participant is doing with the study treatment during regular visits at the clinic.",[62,99,25],[101,99,62],"2026-04-17",{"date":177,"type":34},"2026-04-20",{"date":179,"type":34},"2025-07-23",{"date":181,"type":20},"2029-03-01",{"name":82,"class":83},329,{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":52,"phases":193,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":42},"100634323","iparomlimab-and-tuvonralimab-plus-chemotherapy-before-surgery-for-stage-iii-lung-cancer-100634323","NCT07538193","Iparomlimab and Tuvonralimab Plus Chemotherapy Before Surgery for Stage III Lung Cancer","A Study of Iparomlimab and Tuvonralimab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable Stage III-N2b Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Voluntarily join the study and sign the Informed Consent Form (ICF).\n2. ≥18 years old, male or female.\n3. Histologically or cytologically confirmed T\\\u003Csub\\>any\\\u003C\u002Fsub\\>N2b stage NSCLC (American Joint Committee on Cancer \\[AJCC\\] 9th edition). Lymph node status must be confirmed by endobronchial ultrasound (EBUS\u002FEUS) or mediastinoscopy for mediastinal lymph nodes. For left-sided stations 5\u002F6 lymph nodes, parasternal mediastinoscopy is recommended to confirm lymph node status; if mediastinoscopy is not performed, station 5\u002F6 lymph node status is diagnosed based on imaging diagnostic criteria.\n4. Based on MDT assessment (which must include a thoracic surgeon specialized in oncology), the primary NSCLC is deemed to be completely resectable (R0).\n5. At least one measurable lesion as assessed by the investigator per RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n7. Adequate organ function meeting the following requirements (no use of any blood components, cell growth factors, etc., within 14 days before the first dose):\n\n   1. Absolute neutrophil count ≥1.5×10⁹\u002FL;\n   2. Platelet count ≥100×10⁹\u002FL;\n   3. Hemoglobin ≥90 g\u002FL;\n   4. Serum creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance (CLcr) ≥40 mL\u002Fmin calculated by the Cockcroft-Gault formula;\n   5. Total bilirubin ≤1.5×ULN (patients with Gilbert's syndrome may have ≤3×ULN);\n   6. AST and ALT ≤3×ULN;\n   7. International normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN, unless the subject is receiving anticoagulant therapy;\n   8. Left ventricular ejection fraction (LVEF) ≥50%.\n8. For female patients of non-surgical sterilized or childbearing potential, must agree to use a medically accepted contraceptive method (e.g., intrauterine device, contraceptive pills, or condoms) during the study treatment period and for 3 months after the study treatment period ends; female patients of childbearing potential who are not surgically sterilized must have a negative serum or urine HCG test within 72 hours before the first dose; and must be non-lactating; for male patients with partners of childbearing potential, must agree to use effective contraception during the trial and for 3 months after the last dose of Iparomlimab\u002FTuvonralimab.\n\nExclusion Criteria:\n\n1. Known presence of EGFR or ALK positive mutations.\n2. History of or concurrent other malignancy within the past 5 years (excluding adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery).\n3. Prior receipt of any anti-tumor therapy for the current lung cancer (e.g., radiotherapy, chemotherapy, targeted therapy, ablation, or other systemic or local anti-tumor therapies).\n4. Current use of immunosuppressants or systemic hormone therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) and continued use within 2 weeks before enrollment (Note: Inhaled or topical corticosteroids and adrenal replacement steroids are permitted in the absence of active autoimmune disease).\n5. Any active autoimmune disease or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, pulmonary fibrosis, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism.\n\n   1. Subjects with hypothyroidism controlled by hormone replacement therapy alone are eligible;\n   2. Subjects with skin diseases not requiring systemic treatment such as vitiligo, psoriasis, alopecia, type 1 diabetes, or childhood asthma that has completely resolved and requires no intervention in adulthood are eligible;\n   3. Patients with asthma requiring medical intervention with steroids are not eligible.\n6. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation).\n7. Congenital or acquired immunodeficiency (e.g., HIV-infected individuals).\n8. Uncontrolled active hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\] test at screening with concurrent HBV-DNA test value above the upper limit of normal of the research center's laboratory; subjects with HBV-DNA \\\u003C500 IU\u002FmL measured within 28 days before study drug administration and who have received standard local antiviral therapy for at least 4 weeks and are willing to continue antiviral therapy during the study may be enrolled). Subjects with active hepatitis C (defined as positive hepatitis C virus antibody \\[HCsAb\\] test at screening and positive HCV-RNA).\n9. History of severe allergic reactions to other monoclonal antibodies.\n10. Vaccination with live vaccine within 30 days before the first dose of study treatment (continuing until 90 days after the last dose of study treatment). Note: Live vaccines include but are not limited to measles, mumps, rubella, varicella\u002Fzoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Inactivated seasonal influenza vaccines, inactivated COVID-19 vaccines, etc., are permitted.\n11. Clinically significant cardiovascular or cerebrovascular diseases, including but not limited to:\n\n    1. Myocardial infarction or unstable angina pectoris within 6 months before the first dose;\n    2. Stroke or transient ischemic attack within 6 months before the first dose;\n    3. Hypertension not controlled with optimal antihypertensive therapy (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg);\n    4. Clinically significant arrhythmia that has been stable for ≥14 days before the first dose may be enrolled;\n    5. Congestive heart failure (New York Heart Association \\[NYHA\\] functional class III-IV);\n    6. Myocarditis.\n12. Systemic infection or other severe infection requiring intravenous antibiotics for \\>7 days within 2 weeks before the first study treatment, or unexplained fever \\>38.5°C during screening or before enrollment (fever due to tumor causes as judged by the investigator is excluded).\n13. Any other condition that, in the investigator's judgment, might affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases (including mental illness) requiring concomitant treatment, severe laboratory abnormalities, or family or social factors, which could affect patient safety.",{"count":192,"type":20},28,[194],"NA","Background: For patients with resectable stage III-N2b non-small cell lung cancer (NSCLC), optimal perioperative treatment strategies remain an area of active investigation. Iparomlimab and tuvonralimab (QL1706) is a novel bifunctional antibody combination targeting PD-1 and CTLA-4, designed to enhance anti-tumor immunity.\n\nObjective: This phase II, single-arm, multicenter study aims to evaluate the efficacy and safety of neoadjuvant iparomlimab and tuvonralimab (QL1706) in combination with platinum-based chemotherapy in patients with resectable stage III-N2b NSCLC.\n\nStudy Design and Methods: A total of 28 patients will be enrolled across approximately 4 centers in China. Eligible patients (aged ≥18 years, ECOG PS 0-1) with histologically or cytologically confirmed, resectable stage III-N2b NSCLC (AJCC 9th edition) will receive three cycles of neoadjuvant therapy every three weeks. Patients with non-squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg\u002Fkg) plus pemetrexed (500 mg\u002Fm²) and carboplatin (AUC 5). Patients with squamous carcinoma will receive iparomlimab and tuvonralimab (5 mg\u002Fkg) plus nab-paclitaxel (260 mg\u002Fm²) and carboplatin (AUC 5). Surgical resection will be performed within 6 weeks following completion of neoadjuvant therapy. Subsequent adjuvant treatment is at the discretion of the investigator.\n\nKey Eligibility Criteria: Key inclusion criteria include pathologically confirmed T\\\u003Csub\\>any\\\u003C\u002Fsub\\>N2b disease with mediastinal nodal status confirmed by EBUS\u002FEUS or mediastinoscopy, and the determination by multidisciplinary team (MDT) assessment that the tumor is completely resectable (R0). Key exclusion criteria include known EGFR or ALK positive mutations, prior anti-cancer therapy for current lung cancer, active autoimmune disease, or uncontrolled hepatitis B or C.\n\nStudy Endpoints: The primary endpoint is the pathological complete response (pCR) rate. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), R0 resection rate, event-free survival (EFS), overall survival (OS), impact on surgical outcomes, and safety. Exploratory endpoints involve biomarker analysis including ctDNA.\n\nSample Size Rationale: Assuming a null hypothesis pCR rate (P0) of 8.8% (based on historical data) and an expected pCR rate (P1) of 28%, with a two-sided α of 5% and 80% power, 24 patients are required. Factoring in a 15% inoperable rate, the total sample size is 28 patients.\n\nStatistical Analysis: The primary endpoint, pCR rate, and other binary endpoints will be summarized with frequencies, percentages, and their 95% confidence intervals calculated using the Clopper-Pearson method. Time-to-event endpoints (EFS, OS) will be analyzed using the Kaplan-Meier method. Safety data will be summarized descriptively.\n\nClinical Trial Information: This study is sponsored by The Second Affiliated Hospital of Air Force Medical University, PLA. The Principal Investigator is Dr. Yan Xiaolong.",[25,197,198],"Neoplasm Staging","Lymphatic Metastasis","2026-04-15",{"date":177,"type":34},{"date":202,"type":20},"2026-05",{"date":204,"type":20},"2029-12",{"name":206,"class":41},"Tang-Du Hospital",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":52,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":4},"100603389","phase-3-primary-radiotherapy-in-metastatic-lung-cancer-100603389","NCT07135882","Primary Radiotherapy In MEtastatic Lung Cancer","A Randomised Phase III Trial of Up-front Radiotherapy Before Standard-of-care Systemic Therapy in Advanced Lung Cancer","PRIME-Lung","Inclusion Criteria:\n\n* Newly diagnosed metastatic (stage IV) NSCLC, not amenable to curative surgery or curative radiotherapy\n* Histologically or cytologically documented NSCLC\n* EGFR\u002FALK\u002FROS1 Wild-type\n* Primary suitable for radiotherapy and not requiring immediate palliative thoracic irradiation\n* Investigator deemed appropriate for SoC systemic therapy\n* Metastases in up to 3 organ systems\n\nExclusion Criteria:\n\n* Medically unfit for systemic therapy\n* EGFR\u002FALK\u002FROS1 mutation positive or actionable driver mutation with intention to use available targeted drug therapy\n* Has had previous thoracic radiotherapy of \\> 36Gy within the 6 months prior to randomisation.\n* Has been diagnosed and\u002For treated additional malignancy within 2 years prior to randomisation with the exception of: Curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, curatively treated early-stage cervical cancer, breast cancer or prostate cancer with no evidence of active disease and not on active therapy. Other exceptions may be considered following consultation with the principal investigator\n* Has a history of (non-infectious) pneumonitis or current pneumonitis that requires active corticosteroids with a dose equivalent of prednisolone \\> 10mg\u002Fd.\n* A known diagnosis of fibrotic interstitial lung disease\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Uncontrolled brain metastasis not amenable to debulking surgery or stereotactic radiotherapy\n* Has an active autoimmune disease that has required systemic treatment within last year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed",{"count":216,"type":20},420,[95],"Lung cancer has the highest mortality rate of all cancers in Australia and is an area of unmet need. It starts in the lung (the primary tumour), and then spreads (metastasise) to other organs. The PRIME-Lung clinical trial will investigate if radiotherapy to the primary lung tumour, in addition to standard drug therapies, for patients with metastatic lung cancer will lead to less spread of cancer, prolong life, improve patient well-being and be cost-effective for the health care system.",[25],[62,60,101,221,222,223],"Clinical reseach","Radiation Therapy","Advanced lung cancer","2025-08-15",{"date":226,"type":34},"2025-08-22",{"date":228,"type":20},"2026-01-01",{"date":230,"type":20},"2033-01-01",{"name":232,"class":41},"Trans Tasman Radiation Oncology Group"]