[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-lung-cancer":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,52,102,175,201,230,254,283,312,341,364,391,417,438,462,491,520,543],{"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":26,"conditions":27,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100520749","phase-1-safety-and-efficacy-of-obx-115-in-advanced-solid-tumors-100520749",false,"NCT06060613","Safety and Efficacy of OBX-115 in Advanced Solid Tumors","A Phase 1\u002F2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors","Agni-01","Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing the informed consent.\n2. Participant has a histologically confirmed diagnosis of advanced\u002Fmetastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).\n3. Cohort and indication specific criteria as follows:\n\n   1. Phase 1 and Phase 2 Cohort 1 (enrollment complete):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n   2. Phase 1 and Phase 2 Cohort 2 (recruiting):\n\n      * Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and\u002For an approved targeted therapy for known molecular abnormalities if applicable to their disease).\n      * Participant must not have been exposed to any second line cytotoxic chemotherapy if they have already received cytotoxic chemotherapy in the first line setting.\n   3. Phase 2 Cohort 3 (recruiting):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1\u002FPD-L1 blocking antibody.\n      * Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF\u002FMEK inhibitor that was given as the most recent line of therapy.\n   4. Phase 2 Cohort 4 (recruiting):\n\n      * Participants with frontline unresectable or metastatic melanoma.\n      * Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)\u002Fprogrammed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression.) Neoadjuvant\u002FAdjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1\u002FPD-L1 blocking antibody given as adjuvant treatment (primary ICI resistant) are not eligible.\n4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.\n5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.\n7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\]).\n8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.\n9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and\u002For abstinence requirements.\n10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.\n11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).\n2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.\n3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.\n4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.\n5. Participant has any form of primary or acquired immunodeficiency.\n6. Participant has a history of hypersensitivity to any component of the study intervention.\n7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).\n8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.\n9. Participant requires systemic steroid therapy of greater than10 mg\u002Fday of prednisone or equivalent.\n10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).\n11. Participant has evidence of positive infectious disease screening and\u002For any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.","ALL","18 Years",{"count":20,"type":21},208,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.",[28,29,30,31,32,33,34],"Tumor Skin","Metastatic Melanoma","Melanoma","Lung Cancer","Metastatic Lung Cancer","Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[36,37,38,30,31],"Adoptive cell therapy","Tumor Infiltrating Lymphocytes","TIL","RECRUITING","2026-06-24",{"date":42,"type":43},"2026-06-29","ACTUAL",{"date":45,"type":43},"2023-10-25",{"date":47,"type":21},"2029-06-30",{"name":49,"class":50},"Obsidian Therapeutics, Inc.","INDUSTRY",10,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":74,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100564176","phase-1-open-label-study-of-bbo-10203-in-subjects-with-advanced-solid-tumors-100564176","NCT06625775","Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study)","Inclusion Criteria:\n\n* Locally advanced and unresectable or metastatic HER2-positive advanced breast cancer (aBC), HR-positive\u002FHER2-negative advanced breast cancer, KRAS mutant advanced colorectal cancer (aCRC), or KRAS mutant advanced non-small cell lung cancer (aNSCLC)\n* Measurable disease by RECIST v1.1 (except for HR-positive HER2-negative aBC where evaluable bone-only disease is permitted)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n* Adequate LVEF assessed by ECHO or MUGA (BBO-10203 + Trastuzumab cohorts only)\n* Stable brain metastases\n* Patients with HER2-positive aBC: Must have had at least 2 prior lines of anti-HER2-directed therapy. Only 1 prior line is acceptable where there is no other regionally available standard of care (SoC)\n* Monotherapy Cohort patients with HR-positive, HER2-negative aBC, KRAS mutant aCRC or aNSCLC: Must have progression on, or disease recurrence after at least one line of SOC treatment or in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from SoC therapy\n* BBO-10203 + Fulvestrant combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, must have been treated with a CDK4\u002F6i\n* BBO-10203 + Fulvestrant + ribociclib combination cohort patients with HR-positive, HER2-negative aBC: confirmed PIK3CA mutation, no prior systemic therapy in the aBC setting permitted\n* BBO-10203 + FOLFOX + Bevacizumab combination cohort patients with KRAS mutant aCRC: One prior line of irinotecan-containing therapy for locally advanced or metastatic CRC is allowed but not required\n\nExclusion Criteria:\n\n* Patients with KRAS mutant aCRC who have KRAS G12R mutation, BRAFV600E mutation, HER2amp, or dMMR\u002FMSI-H tumors\n* Patients with KRAS mutant aNSCLC who have KRAS G12R mutation, or tumors with other targetable driver mutations (eg, EGFR, anaplastic lymphoma kinase, ROS1\u002FBRAF\u002FRET\u002FMET\u002FEGFR exon20 insertion\u002FNTRK\u002FHER2)\n* Patients with untreated and\u002For non-stable brain metastases\n\nOther inclusion\u002Fexclusion criteria are specified in the protocol",{"count":60,"type":21},392,[24],"First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.",[64,65,66,67,68,69,32,70,71,72,73],"Solid Tumor, Adult","Metastatic Breast Cancer","Advanced Breast Cancer","HER2 Mutation-Related Tumors","HER2-positive Metastatic Breast Cancer","KRAS Mutant Metastatic Colorectal Cancer","Metastatic Colorectal Cancer","Advanced Lung Cancer","HR-positive, HER2-negative Advanced Breast Cancer","HER2-positive Advanced Breast Cancer",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"BREAKER-101","BridgeBio Oncology Therapeutics","BBOT","Phase1","Phase 1a\u002F1b","Trastuzumab","Breast","Colorectal","Non-Small Cell Lung Cancer","CRC","NSCLC","Metastatic Cancer","Advanced Cancer","HER2-positive","HR-positive","HR-positive, HER2-negative","HER2-negative","2026-06-18",{"date":94,"type":43},"2026-06-23",{"date":96,"type":43},"2024-10-29",{"date":98,"type":21},"2028-11",{"name":100,"class":50},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",40,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":144,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":174},"100499720","phase-1-phase-12-trial-of-s241656-in-selected-rasmapk-mutation--positive-malignancies-100499720","NCT05786924","Phase 1\u002F2 Trial of S241656 in Selected RAS\u002FMAPK Mutation- Positive Malignancies","A Phase 1\u002F2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination With Other Anti-Cancer Therapies in Patients With KRAS, BRAF and Other Selected RAS\u002FMAPK Mutation-Positive Malignancies","Key Inclusion Criteria:\n\n* Life expectancy of ≥ 12 weeks in the opinion of the investigator.\n* Histologically or cytologically confirmed recurrent locally advanced (unresectable) or metastatic solid tumors with documented RAS or RAF mutations or alterations.\n* Adequate bone marrow and organ function.\n* Recovered from toxicity to prior anti-cancer therapy.\n\nPart 1 Dose Escalation cohort ONLY:\n\n* Part 1A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C, HRAS, NRAS, BRAF or CRAF (RAF1) mutations or alterations\n* Part 1B: Advanced\u002Fmetastatic GI tumors (e.g., PDAC, CRC, and BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1C: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1D: Colorectal adenocarcinoma with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 1E: Other advanced\u002Fmetastatic non-GI, non-NSCLC solid tumors with KRAS, HRAS, NRAS, BRAF, CRAF (RAF1) mutations or alterations\n\nPart 2 Dose Optimization and Expansion cohorts ONLY:\n\n* Part 2A: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations and\u002For BRAF mutations\n* Part 2A1: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C mutations\n* Part 2A2: Advanced\u002Fmetastatic NSCLC with BRAF mutations\n* Part 2A3: Advanced\u002Fmetastatic NSCLC with KRAS non-G12C or BRAF mutations or alterations and active CNS metastatic disease\n* Part 2A4: Advanced\u002Fmetastatic NSCLC with a KRAS G12C mutation\n* Part 2B1: Advanced\u002Fmetastatic PDAC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B2: Advanced\u002Fmetastatic CRC with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n* Part 2B3: Advanced\u002Fmetastatic BTC (adenocarcinoma) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations or alterations\n\nKey Exclusion Criteria:\n\n* Cancer that has a known MEK1\u002F2 mutation.\n* Known allergy\u002Fhypersensitivity to excipients of S241656 or to any of the registered IMPs administered in combination.\n* Any contra-indication, to use of any of the combination chemotherapy or anti-EGFR therapy partners administered as part of this trial.\n* Major surgery within 4 weeks of study entry or planned during study.\n* Ongoing anticancer therapy.\n* Ongoing radiation therapy.\n* Uncontrolled or active clinically relevant bacterial, fungal, or specific viral infection requiring systemic therapy.\n* Clinically significant cardiovascular disease.\n* Symptomatic spinal cord compression.\n* Evidence of active malignancy (other than study-specific malignancies) requiring systemic therapy within the next 2 years.\n* History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO.\n* Females who are pregnant or breastfeeding.\n* Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.\n* Prior use of experimental agents that target the KRAS\u002FBRAF\u002FMEK\u002FERK pathway.",{"count":110,"type":21},554,[24,25],"BDTX-4933-101 is a first-in-human, open-label, Phase 1\u002F2 dose escalation, dose optimization and expansion study designed to evaluate the safety and tolerability of S241656 as monotherapy and in combination with other anti-cancer therapies in participants with selected advanced malignancies. The study population for the Dose Escalation part of the study comprises adults with recurrent advanced\u002Fmetastatic non-small cell lung cancer (NSCLC), Gastrointestinal (GI) cancers, and other solid tumors harboring KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (Rapidly Accelerated Fibrosarcoma (RAF1)) mutations or alterations. A dose optimization part in adults with NSCLC may follow the dose escalation phase if the sponsor, in consultation with the safety review committee, decides it is necessary to further characterize the optimal dose. However, the study may also proceed directly to the expansion phase. The study population for the Dose Expansion part of the study comprises adults with advanced\u002Fmetastatic NSCLC with KRAS and\u002For BRAF mutations, and with Pancreatic Ductal AdenoCarcinoma (PDAC), ColoRectal Cancer (CRC), and Biliary Tract Cancer (BTC) with KRAS, HRAS, NRAS, BRAF, and\u002For CRAF (RAF1) mutations and alterations. All patients will self-administer S241656 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.",[114,115,116,117,118,119,120,121,122,32,123,124,85,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143],"Non-small Cell Lung Cancer","Histiocytic Neoplasm","Histiocytosis","BRAF Gene Mutation","BRAF V600E","BRAF V600 Mutation","BRAF Mutation-Related Tumors","BRAF","Metastatic Lung Non-Small Cell Carcinoma","Recurrent Lung Cancer","Recurrent Lung Non-Small Cell Carcinoma","Solid Tumor","Solid Carcinoma","KRAS G12D","KRAS G12V","KRAS Mutation-Related Tumors","NRAS Gene Mutation","Thyroid Cancer","Thyroid Carcinoma","Colorectal Cancer","Colorectal Carcinoma","Recurrent Histiocytic and Dendritic Cell Neoplasm","Brain Metastases","Recurrent NSCLC","KRAS G13C","Acquired Resistance to KRAS G12C Inhibitor","KRAS G12A","KRAS G12F","KRAS G12R","KRAS G13D",[145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163],"BRAF Class I","BRAF Class II","BRAF Class III","KRAS","Intolerant histiocytic neoplasm","BDTX-4933","Phase 1","dose escalation","dose expansion","MAPK","mitogen-activated protein kinase","RAS","RAF","Upstream oncogenic alterations","RAF inhibitor","intracranial disease","CRAF","NRAS","RAF fusions","2026-06-16",{"date":166,"type":43},"2026-06-17",{"date":168,"type":43},"2023-04-18",{"date":170,"type":21},"2028-06",{"name":172,"class":173},"Institut de Recherches Internationales Servier","OTHER",27,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"100642335","phase-2-a-study-evaluating-the-combination-of-immunotherapy-with-radiotherapy-in-non-small-cell-lung-cancer-100642335","NCT07603856","A Study Evaluating The Combination of Immunotherapy With Radiotherapy in Non-Small Cell Lung Cancer","A Randomized Phase II Study of Radiotherapy Plus Immune Checkpoint Inhibitor Therapy Versus Standard of Care Chemotherapy in Patients With Metastatic or Relapsed Non-Small Cell Lung Cancer Previously Treated With Immunotherapy","REVIVE","Inclusion Criteria:\n\n* Disease-Related Criteria\n\n  * Patients must have histologically or cytologically confirmed metastatic or recurrent non-small cell lung cancer (NSCLC) with progression on prior immunotherapy\n  * The patient's disease is eligible for SOC treatment with immunotherapy or chemotherapy.\n  * Patients must have measurable disease per RECIST v1.1, defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter ≥10 mm (or ≥15 mm short axis for lymph nodes) by CT or MRI\n  * Patients must have at least one lesion that meets criteria for hypofractionated ablative RT treatment:\n  * Tumor volume 0.25 cc to 65 cc (approximately ≤5 cm maximal dimension)\n  * Located in sites amenable to ablative RT (see radiotherapy section for specific anatomic criteria)\n  * Note: Tumors \\>65 cc may be partially treated to 65 cc volume\n  * Prior\u002FConcurrent Therapy Criteria\n  * Patients must have received exactly ONE prior line of anti-PD-1 or anti-PD-L1 therapy for non-small cell lung cancer. This therapy may have been given as:\n  * Monotherapy\n  * In combination with chemotherapy\n  * In combination with another immunotherapy such as CTLA-4 inhibition\n  * In combination with a targeted therapy, such as adagrasib\n  * Special Cases for Neoadjuvant\u002FAdjuvant Immunotherapy:\n  * If patient received neoadjuvant, adjuvant, or consolidation anti-PD-1\u002FPD-L1 therapy for Stage I-III disease and progressed ≤365 days from initiation (Cycle 1 Day 1), this counts as the single allowed therapy for advanced disease\n  * If patient progressed \\>365 days from neoadjuvant\u002Fadjuvant therapy initiation, this does NOT count as therapy for advanced disease, and patient must have received subsequent anti-PD-1\u002FPD-L1 therapy for Stage IV or recurrent disease\n  * Patients with the following sensitizing mutations are ineligible, given known poor response to immunotherapy: EGFR, ALK, ROS1, RET, NTRK, HER2.\n  * Patients with the following sensitizing mutations must have previously received at least one of the appropriate targeted therapies, in addition to prior immunotherapy: BRAF, KRAS, MET. Prior targeted therapy for participants with targetable alterations is allowed if all other eligibility criteria is also met.\n* Clinical\u002FLaboratory Criteria\n\n  * Age ≥18 years\n  * ECOG Performance Status 0-2 (see Appendix A)\n  * Participants must be able to safely receive the investigational drug combination and the investigator's choice of standard of care regimens described in Section 5.1 (Agent Administration), per the current FDA-approved package inserts, treating investigator's discretion, and institutional guidelines.\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n  * Because radiation and chemotherapy are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of immunotherapy, radiation, and\u002For chemotherapy administration.\n  * Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with history of (non-infectious) pneumonitis requiring corticosteroids.\n* Patients with evidence of interstitial lung disease.\n* Patients with uncontrolled intercurrent illness.\n* Pregnant women are excluded from this study. Radiation is considered Class X and chemotherapy such as docetaxel are considered Class D agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with radiation, immunotherapy, and chemotherapy breastfeeding should be discontinued if the mother is participating in the study.\n\nRadiation-Specific Exclusions\n\n* Patients who have received prior radiation to any of the planned treatment sites (\\>10% dose overlap)\n* Patients with lesions in locations not amenable to safe ablative RT delivery, including:\n* Esophagus or stomach directly involved by tumor (unless dose constraints can be met)\n* Small bowel or colon directly involved by tumor (unless dose constraints can be met)\n* Spinal cord lesions with \\\u003C3 mm clearance between epidural disease and spinal cord",{"count":184,"type":21},39,[25],"Current clinical trials testing the combination of immunotherapy with radiotherapy.",[83,32],[189,190,191],"Radiotherapy","Chemotherapy","Immunotherapy","2026-06-12",{"date":164,"type":43},{"date":195,"type":21},"2026-12-12",{"date":197,"type":21},"2030-06-25",{"name":199,"class":173},"University of Chicago",1,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":211,"briefSummary":212,"conditions":213,"keywords":218,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":226,"leadSponsor":228,"locationsCount":200},"100639751","phase-2-effects-of-infusion-timing-on-treatment-response-in-solid-tumors-100639751","NCT07630168","Effects of Infusion Timing on Treatment Response in Solid Tumors","Timing of Immunotherapy and Effective Administration (TIMED): Effects of Infusion Timing on Treatment Response in Solid Tumors","TIMED","Inclusion Criteria:\n\nCohort 1A and 1B:\n\n* Participants with metastatic non-small cell lung cancer (NSCLC).\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nCohort 2A and 2B:\n\n* Participants with resectable head and neck squamous cell carcinoma (HNSCC)\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Subject is willing and able to comply with study procedures based on the judgement\n* of the investigator.\n* Age ≥ 18 years at the time of consent.\n\nExclusion Criteria: For All Cohorts (1A,1B, 2A, 2B)\n\n* Subject is currently using steroids (prednisone ≥10 mg or its equivalent) and that cannot be discontinued at least 7 days before starting standard of care treatment.\n* Prior ICI (PD-1\u002FPD-L1\u002FCTLA4) treatment received less than 6 months from the time of screening.\n* Subject is participating in another treatment clinical trial.",{"count":210,"type":21},238,[25],"This study evaluates whether the time of day when immunotherapy is given affects clinical outcomes. It includes patients eligible for PD-1 (programmed cell death protein 1) or PD-L1 (programmed death-ligand 1) inhibitor treatment who have either advanced or metastatic non-small cell lung cancer (NSCLC) or locally advanced, resectable head and neck squamous cell carcinoma (HNSCC).The study tests the hypothesis that outcomes differ based on infusion timing (morning versus afternoon). Patients are divided into two cohorts by disease type: Cohort 1 includes NSCLC and Cohort 2 includes HNSCC. Within each cohort, patients are randomly assigned to receive infusions in the morning or afternoon, using a 2:1 ratio for NSCLC and a 1:1 ratio for HNSCC. All treatment and disease assessments follow standard medical care, and outcomes such as survival and treatment response are collected from medical records. Patients will be followed for up to 2 years.",[31,114,32,214,215,216,217],"Head and Neck Cancer","Metastatic Squamous Cell Carcinoma","Metastatic Head and Neck Cancer","Resectable Head and Neck Squamous-cell Carcinoma",[219,220],"programmed cell death protein 1","programmed death-ligand 1","NOT_YET_RECRUITING","2026-06-01",{"date":224,"type":43},"2026-06-05",{"date":222,"type":21},{"date":227,"type":21},"2033-01-01",{"name":229,"class":173},"UNC Lineberger Comprehensive Cancer Center",{"id":231,"slug":232,"hasResults":11,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100542479","phase-1-open-label-study-of-bbo-8520-in-adult-subjects-with-krasg12c-non-small-cell-lung-cancer-100542479","NCT06343402","Open-label Study of BBO-8520 in Adult Subjects With KRASG12C Non-small Cell Lung Cancer","A Phase 1a\u002F1b Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BBO-8520 in Subjects With Advanced KRASG12C Mutant Non-Small Cell Lung Cancer - The ONKORAS-101 Study","Inclusion Criteria:\n\n* Histologically documented locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS G12C mutation\n* Measurable disease by RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1\n\nExclusion Criteria:\n\n* Patients with malignancy within the last 2 years as specified in the protocol\n* Patients with untreated or unstable brain metastases\n* Patients with known hypersensitivity to BBO-8520 or its excipients\n* For Cohorts 1b and 2b:\n* Patients with a known hypersensitivity to pembrolizumab or its excipients\n* Patients with active autoimmune disease of history of autoimmune disease that might recur\n* Patients with a history of interstitial lung disease\u002Fpneumonitis that required steroids, or current interstitial lung disease\u002Fpneumonitis\n\nOther inclusion\u002Fexclusion criteria may apply",{"count":238,"type":21},350,[24],"A first in human study to evaluate the safety and preliminary antitumor activity of BBO-8520, a KRAS G12C (ON and OFF) inhibitor, as a single agent and in combination with pembrolizumab and BBO-10203 in subjects with locally advanced and unresectable or metastatic non-small cell lung cancer with a KRAS (Kirsten rat sarcoma) G12C mutation.",[114,242,85,243,32,244],"Metastatic Non-Small Cell Lung Cancer","KRAS G12C","Advanced Lung Carcinoma","2026-05-04",{"date":247,"type":43},"2026-05-05",{"date":249,"type":43},"2024-05-22",{"date":251,"type":21},"2031-09",{"name":100,"class":50},35,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":282},"100611634","long-terms-responders-in-metastatic-lung-cancer-better-understanding-for-better-management-lungevity-study-100611634","NCT07243132","Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (Lungevity Study)","Long-Terms Responders in Metastatic Lung Cancer: Better Understanding for Better Management (LUNGEVITY STUDY)","LUNGEVITY","Inclusion Criteria:\n\n* Patient over 18 years old\n* Patients alive after more than three years from diagnosis with stage IV or Stage III NSCLC or SCLC, not treated with cytotoxic chemotherapy at the time of inclusion (the patient may be undergoing imunotherapy, targeted therapy or surveillance).\n* Patients covered by the French National Health Insurance program or with thirdparty-payer health insurance\n\nExclusion Criteria:\n\n* Difficulties for understanding French\n* Patients undergoing treatment with cytotoxic chemotherapy\n* Patients under legal guardianship, under curatorship or tutorship\n* Insufficient cognitive capacity to answer questions\n* Inability to obtain data collection (lost to follow-up, patient's refusal for data collection)\n* Patients refusing the collection of their data (an information sheet will be provided)",{"count":263,"type":21},1000,"OBSERVATIONAL","The goal of this observational study is to identify and describe the clinical characteristics, health status, socio-economic impacts and quality of life of patients alive for three years after diagnosis of metastatic Lung cancer and no longer receiving cytotoxic chemotherapy. The main question is to identify the needs of these patients in terms of health status (impact of cancer treatments, incidence of new diseases, cardiovascular, diabetes, second cancers), socio-economic aspects, quality of life and return to employment.\n\nParticipants will be asked to answer quality of life questionnaires at the time of inclusion and 6 and 12 months after inclusion and then, every year up to 5 years in this study.\n\nThey will be followed regularly, in consultations, according to the usual practices of the physicians in each participating center.",[32,267,268],"Metastatic NSCLC","Metastatic Small Cell Lung Cancer",[270,271,267,272],"long-terms responders","Mestastatic Lung Cancer","Metastatic small cell lung cancer","2026-04-24",{"date":275,"type":43},"2026-04-27",{"date":277,"type":43},"2025-07-02",{"date":279,"type":21},"2031-01-31",{"name":281,"class":173},"GFPC Investigation",46,{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":291,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":296,"conditions":297,"keywords":300,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":200},"100553109","prospective-longitudinal-biocollection-in-thoracic-oncology-including-newly-diagnosed-lung-cancer-patients-100553109","NCT06481813","Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","BREATHE","Inclusion Criteria:\n\nPatients :\n\n* Adult\n* Patient newly diagnosed with NSCLC or CPC\n* Cared for at Nantes University Hospital\n* Affiliated or beneficiaries of a social security scheme or similar\n* Treated with a systemic therapy including chemotherapy and\u002For immunotherapy and\u002For targeted therapy and\u002For therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding).\n* Having agreed to participate in this study by signing the biocollection consent.\n\nHealthy subjects :\n\n* Adult\n* Affiliated or beneficiaries of a social security or similar scheme\n* Who have agreed to participate in this study by signing the Biocollection consent form.\n* No known infectious pathology\n* No known history of cancer\n* No known history of chronic autoimmune disease\n* No background immuno-suppressive treatment\n\nAncillary Study :\n\n-Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination.\n\nExclusion Criteria:\n\nPatients :\n\n* Previous anticancer treatment for Lung cancer\n* Patients who have not consented to participate in the BREATHE collection\n* History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years\n* Inclusion in a therapeutic trial with blinded treatment\n* Patients under guardianship\n* Patients with AME.\n* Pregnant or breast-feeding women\n\nHealthy subjects :\n\n* Person under guardianship\n* Person benefiting from AME (State medical aid)\n* Pregnant or breast-feeding women\n\nAncillary Study :\n\n\\- Pregnant or breast-feeding women",true,{"count":293,"type":21},730,[295],"NA","In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).\n\nIn parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.",[31,298,299,32],"Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma",[301,31,302],"Real-world cohort","Biobank","2026-01-19",{"date":305,"type":43},"2026-01-21",{"date":307,"type":43},"2024-12-10",{"date":309,"type":21},"2034-12-01",{"name":311,"class":173},"Nantes University Hospital",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":264,"phases":4,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":340},"100576177","description-of-neurocognitive-and-psychiatric-disorders-associated-with-targeted-therapies-used-in-the-treatment-of-lung-cancers-with-alkros1-fusion-and-their-impact-on-patients-quality-of-life-construction-of-an-experimental-patient-researcher-collaborative-care-and-research-pathway-100576177","NCT06781905","Description of Neurocognitive and Psychiatric Disorders Associated With Targeted Therapies Used in the Treatment of Lung Cancers With ALK\u002FROS1 Fusion and Their Impact on Patients' Quality of Life: Construction of an Experimental Patient-researcher Collaborative Care and Research Pathway","DRACONIS","Inclusion Criteria:\n\n* Adult patients aged 18 years or older, fluent in French\n* Currently treated with anti-ITK-ALK\u002FROS1 for ALK\u002FROS1-positive lung cancer\n* Identified by the prescribing physician as having complaints with or without associated neurocognitive and\u002For neuropsychiatric disorders related to the treatment.\n\nExclusion Criteria:\n\n* History of neurocognitive and\u002For neuropsychiatric disorders prior to initiation of anti-ITK-ALK\u002FROS1 targeted therapy, excluding disorders associated with anti-ITK-ALK\u002FROS1 or other systemic anticancer treatments\n* Patients with uncontrolled brain metastases or carcinomatous meningitis (requiring symptomatic treatment with corticosteroids progressive or symptomatic)\n* Patients who do not have sufficient proficiency in French to complete questionnaires and\u002For participate in semi-structured interviews\n* Severe, progressive or unstable medical conditions that may interfere with the evaluation variables (uncontrolled epilepsy, acute psychiatric or psychotic disorders, visual hallucinations, acute infection).\n* Consumption of toxic substances that may affect cognitive performance\n* Deafness or blindness that may compromise participant evaluation or participation in tasks and scales\n* Patients who refuse to participate in the study or are unable to express thein non-opposition to participating in the study",{"count":320,"type":21},20,"Targeted cancer therapies have a higher therapeutic index than chemotherapy and are prescribed to tens of thousands of patients in France each year. These treatments modify often ubiquitous signaling pathways involved in neuronal synaptic plasticity, the cellular substrate of cognitive and psychiatric functions. Neurocognitive and psychiatric disorders associated with targeted therapies are poorly described and therefore still poorly understood, although they appear to be clinically more severe than chemobrain (neurocognitive disorders related to chemotherapy).\n\nThe case of patients with metastatic lung cancer with ALK\u002FROS1 fusion is emblematic. These cancers are treated very effectively with oral targeted therapies inhibiting the tyrosine kinase activity of ALK or ROS1 proteins (ITK-ALK\u002FROS1), with survival that can exceed 10 years. However, neurocognitive and psychiatric disorders associated with anti-ITK-ALK\u002FROS1 are reported in 7 to 60% of patients, with a prevalence of about 10% with anti-ITK-ALK\u002FROS1 brigatinib or alectinib and up to 53% with lorlatinib in industrial therapeutic trials. These disorders appear to be particularly frequent and severe with lorlatinib, including cognitive disorders - especially memory - mood disorders such as anxiety, depression and emotional lability, and psychotic disorders. Current therapeutic trials and care pathways are not designed to take into account these side effects related to anti-ITK-ALK\u002FROS1. Their incidence is therefore probably underestimated.\n\nThe DRACONIS project aims to:\n\n(1) describe the complaints +\u002F- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK\u002FROS1 through a rigorous neuropsychological and psychiatric evaluation (i.e. patient phenotyping) and (2) understand the experience of complaints +\u002F- neurocognitive and neuropsychiatric disorders associated with anti-ITK-ALK\u002FROS1 and their consequences on patients' quality of life in a comprehensive approach.\n\nThe DRACONIS project is part of a multidisciplinary and collaborative approach through the establishment of a partnership between researchers, clinicians and representatives of the anti-ITK-ALK\u002FROS1 France Cancer du Poumon patient association. The project is notably monitored by a joint scientific committee composed of researchers, clinicians, patients and patient caregivers.",[32,323],"Metastatic Lung Cancer With ALK\u002FROS1 Fusion",[325,326,327,328,329,330],"Neurocognitive disorders","Targeted therapies","Quality of life","Lung cancer","Collaborative research","Care pathway","2025-12-22",{"date":333,"type":43},"2025-12-30",{"date":335,"type":43},"2025-01-16",{"date":337,"type":21},"2027-05-09",{"name":339,"class":173},"Hospices Civils de Lyon",2,{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":22,"phases":350,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":200},"100614865","phase-1-a-study-to-evaluate-ans014004-in-combination-with-egfr-tki-in-non-small-cell-lung-cancer-100614865","NCT07285148","A Study to Evaluate ANS014004 in Combination With EGFR-TKI in Non-Small Cell Lung Cancer","An Open-label, Multicenter Phase Ib\u002FII Study to Evaluate the Safety, Efficacy and Pharmacokinetic Characteristics of ANS014004 in Combination With EGFR-TKI in Patients With EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female participants ≥18years of age at the time of signing the informed consent form.\n2. Patients with histologically or cytologically confirmed diagnosis of unresectable locally advanced (Stage IIIB and IIIC) or metastatic (Stage IV) NSCLC (according to the lung cancer staging criteria, refer to the eighth edition of the American Joint Committee on Cancer \\[AJCC\\] Lung Cancer Staging).\n3. Have a documented EGFR positive mutation (EGFR classic mutations including ex19del and ex21 L858R, uncommon mutations and ex20 insertion mutations) in tumor tissue samples or pleural fluid or blood samples.\n4. For Phase Ib dose escalation: have disease progression after the existing standard of care or intolerance to the existing standard of care or inappropriate or no effective standard of care is available (standard of care is defined as treatment recommended by the National Comprehensive Cancer Network \\[NCCN\\] guidelines \\[including but not limited to chemotherapy, radiotherapy, targeted therapy based on mutation status, immunotherapy, and surgery\\]). For participants who are considered intolerant to or ineligible for available standard therapy, or for whom effective standard therapy does not exist, the documentation of these reasons is required.\n\n   For Phase Ib dose optimization and Phase II study: have or haven't received prior standard systemic therapy for advanced disease.\n\n   Standard systemic therapy is referred to as (country-specific approved treatment will also be applied):\n   * EGFR classic mutations: EGFR-TKIs alone or in combination (examples, gefitinib and osimertinib with or without chemotherapy) for ex19del and ex21 L858R. Osimertinib or other third-generation EGFR TKI for T790M mutation.\n   * EGFR uncommon mutations: EGFR-TKIs or chemotherapy for uncommon mutations including but not limited to G719X, S768I, L861Q mutations.\n   * EGFR exon 20 activating insertions: chemotherapy with or without amivantamab or country-specific approved EGFR TKIs.\n5. For China only: the presence of MET amplification and\u002For overexpression in tumor tissue samples or pleural fluid or blood samples collected after progression on prior EGFR-TKI treatment, confirmed by a central \u002Flocal laboratory.\n\n   MET amplification is defined as the presence of MET amplification confirmed by nextgeneration sequencing (NGS) technology or mean MET gene copy number (GCN) ≥ 4 per cell or the ratio of MET to chromosome enumerating probe against chromosome 7 (MET\u002FCEP7) ≥2.0 confirmed by fluorescence in situ hybridization (FISH) testing.\n\n   MET overexpression is defined as immunohistochemistry (IHC) ≥ 2+ (local or central lab test results are accepted).\n6. Have at least one measurable target lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n7. ECOG PS ≤ 1.\n8. Life expectancy of ≥12 weeks, in the opinion of the investigator.\n9. Adequate organ function as determined by medical evaluation (within 7 days prior to study treatment) including:\n\n   * Adequate hematologic status, defined as: absolute neutrophil count (ANC) ≥1.5×109\u002FL, hemoglobin ≥90 g\u002FL, platelets ≥75×109\u002FL. Platelet transfusions are not permitted within 3 days, red blood cell transfusions are not permitted within 14 days, hematopoietic growth factors are not permitted within 7 days (14 days for PEGylated granulocyte colony stimulating factor \\[G-CSF\\] or erythropoietin) prior to obtaining these laboratory values.\n   * Adequate hepatic function, defined as: serum TBIL ≤1.5× ULN (in participants with known Gilbert's syndrome, TBIL ≤3× ULN with direct bilirubin ≤1.5× ULN), serum ALT or AST ≤2.5× ULN (or 5.0× ULN for documented liver metastasis).\n   * Adequate renal function, defined as: creatinine clearance ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula or CKD EPI formula \\[Appendix 4 of Section 12.4\\]).\n   * Adequate coagulation profile, defined as (including if receiving anticoagulant therapy):\n\n   prothrombin time (PT)\\\u003C 1.5 × ULN, activated partial thromboplastin time (APTT)\\\u003C 1.5 × ULN. If the participant is on anticoagulant therapy, must be on a stable dose of anticoagulant for at least1month prior to the study treatment.\n10. Female participants should be using adequate contraceptive measures until 90 days after the EOT, should not be breast feeding and must have a negative serum beta human chorionic gonadotropin (β-hCG) pregnancy test within 7 days prior to start of dosing if of childbearing potential; or must have evidence of non-child bearing potential by fulfilling one of the following criteria at screening.\n\n    * Achieved postmenopausal status, refer to NCCN Guidelines for Breast Cancer (2024V3.0) for the detailed definition of menopause.\n    * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n11. Male participants of childbearing potential are required to use adequate contraception (i.e., barrier method of birth control), during their participation in the study and for 90 days following the EOT. Male participants must also refrain from donating sperm during their participation in the study and for 90 days following the last dose of study treatment.\n12. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this study.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Have other known primary driver gene alterations. For example, NSCLC with a targetable alteration in ALK, RET, ROS1, BRAF, KRAS, etc. The investigators should discuss enrollment with the sponsor regarding co-mutations.\n2. Prior treated with hepatocyte growth factor (HGF) targeted therapy or other MET-TKIs (including Type I and Type II), e.g., gulmonertinib, savolitinib, capmatinib, tepotinib, bozitinib, cabozantinib, glenitinib and almonertinib.\n3. Participation in other therapeutic clinical trials within 28 days prior to the first dose of study treatment.\n4. Received anti-tumor therapy (chemotherapy, immunotherapy, hormone therapy, targeted therapy, biological therapy or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, and agonists required to inhibit serum testosterone levels) within 14 days or 5 half-lives (whichever is shorter) of the first dose of study treatment. The following exceptions are:\n\n   * Nitrosourea or mitomycin-C within 6 weeks prior to the first dose of study treatment.\n   * Chinese medicines with anti-tumor indications within 7 days prior to the first dose of study treatment.\n5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment.\n\n   Participants must have recovered from all radiation related toxicity, not requiring corticosteroids.\n6. Major surgery, other than diagnostic surgery, within 4 weeks of the first study treatment or is expected during the study.\n7. Toxicities of prior therapy have not been resolved to Grade ≤1 or to baseline, as evaluated by NCI-CTCAE v5.0. NOTE: Participants with Grade 2 toxicities can be enrolled if the toxicities as stable and do not affect the safety of participating in this study (e.g., alopecia, skin hyperpigmentation, neuropathy).\n8. History of another primary malignancy that has been diagnosed or required therapy within the past 3 years (other than adequately treated local basal cell or squamous cell carcinoma of the skin; or any other cancer in situ currently in complete remission).\n9. Have central nervous system (CNS) metastases that are symptomatic or clinically unstable or require increased steroid dose to manage CNS symptoms within 4 weeks prior to the first dose of study treatment.\n\n   * Participants with symptomatic CNS metastases may participate in the study providing that symptoms are controlled after treatment, clinically stable for at least 4 weeks and have no evidence of new or enlarged brain metastases.\n   * Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression are excluded regardless of clinical stability.\n   * Participants with asymptomatic CNS metastases with a maximum diameter of brain metastases \\\u003C3 cm by imaging (such as MRI) without significant cerebral edema are eligible for the study.\n10. Participants with clinically uncontrollable third-space effusion, including but not limited to pleural effusion, peritoneal effusion or pericardial effusion, are assessed by the investigator to be unsuitable for the study treatment.\n11. Participants receiving unstable or increasing doses of corticosteroids. For participants receiving corticosteroids for endocrine deficiencies or symptoms associated to their disease (excluding CNS disease), the dose must have been stabilized (or reduced) for at least 14 days before the first dose of study treatment.\n12. Have a history of or ongoing severe retinopathy.\n13. Presence of serious cardiovascular or cerebrovascular disease, including but not limited to:\n\n    * Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from triplicate 12-lead electrocardiograms (ECGs).\n    * Symptomatic heart failure per New York Heart Association (NYHA) classification Class II or above.\n    * Baseline left ventricular ejection fraction (LVEF) below institution's lower limit of normal (LLN) or \\\u003C50% if assessed by echocardiography (ECHO) or Multigated Radionuclide Angiography (MUGA).\n    * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.\n    * Presence of any factors that increase the risk of QTc prolongation or the risk of arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of any concomitant medication known to prolong the QT interval within 14 days prior to the first dose of study treatment.\n    * Any of the following within 6 months prior to the first dose of the study treatment: myocardial infarction, severe\u002Funstable angina, coronary artery bypass graft, congestive heart failure, cardiomyopathy, pulmonary embolism, cerebrovascular accident, or transient ischemic attack.\n14. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including but not limited to:\n\n    * Uncontrolled hypertension, defined as a systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg despite medical therapy. Participant with a history of hypertension is allowed if BP is stable and controlled within these limits by antihypertensive treatment.\n    * Previous history of, or presence of clinically symptomatic or at high risk for interstitial lung disease or interstitial pneumonitis, including radiation pneumonitis (i.e., affecting activities of daily living or requiring therapeutic treatment).\n    * Unstable or uncompensated respiratory and renal disease, active bleeding diseases.\n15. Uncontrolled concurrent infection including but not limited to:\n\n    * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n\n      * If hepatitis B surface antigen (HBsAg) is positive, HBV DNA assay should be performed. Participants may be eligible if HBV DNA test value ≤ ULN.\n      * If HCV antibody is positive, HCV ribonucleic acid (RNA) assay should be performed. Participants may be eligible if HCV RNA negative.\n    * Known human immunodeficiency virus (HIV) infection or known history of acquired immunodeficiency syndrome (AIDS).\n    * Syphilis positive.\n    * Active tuberculosis infection.\n    * Onset period of keratitis or ulcerative keratitis.\n    * Other active infections requiring systemic treatment within 14 days prior to the first dose of study treatment.\n16. Unwilling or unable to comply with the requirements of oral drug administration, or presence of gastrointestinal disorders such as refractory nausea and vomiting, any acute or chronic gastrointestinal disorder, inability to swallow the formulation, or prior major bowel resection that may prevent adequate absorption of ANS014004 or PLB1004.\n17. Hypersensitivity to ANS014004, PLB1004 or their excipients, or history of allergic reactions to ANS014004 and PLB1004 with similar chemical or biological structure or similar drugs.\n18. Concomitant use of drugs metabolized by P-glycoprotein (P-gp)\u002Fbreast cancer resistance protein (BCRP) or OCT2\u002FOATP1B1\u002FMATE1, or moderate or strong inducers or inhibitors of P-gp\u002FBCRP or CYP2B6\u002FCYP2C9\u002FCYP2C19\u002FOCT2\u002FOATP1B1\u002FMATE1 within 5 half-lives before the use of the study treatment. For dose escalation part only: concomitant treatment with moderate or strong P-gp\u002FBCRP or CYP2C8\u002FCYP2D6\u002FCYP3A4 inducers or inhibitors within 5 half-lives prior to administration of study treatment.\n19. In receipt of any live attenuated vaccination within 30 days prior to the first dose of study therapy.\n20. Have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.\n21. Have prior or ongoing clinically significant illness, medical condition, surgical history, physical findings, or laboratory abnormality that, in the investigator's opinion, would not be in the best interest of the participant; or that could alter the absorption, distribution, metabolism, or excretion of the study treatment; or impair the assessment of study results.",{"count":349,"type":21},253,[24,25],"Protocol Title\n\nA Study to Evaluate ANS014004 in Combination with EGFR-TKI in Patients with EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer\n\nThe main purpose of this research study is to\n\nFind a safe and tolerable dose of two investigational drugs, ANS014004 and PLB1004, when used together.\n\nLearn how effective this drug combination is at treating a type of lung cancer called \"EGFR mutation-positive non-small cell lung cancer (NSCLC)\" that has spread to other parts of the body (locally advanced or metastatic).\n\nThis study is trying to answer the following questions:\n\nSafety \\& Dosing: What are the side effects of combining ANS014004 and PLB1004? What is the best dose to use that patients can tolerate well?\n\nEffectiveness: Can this combination of drugs help shrink patients' tumors or stop them from growing?\n\nBackground Information\n\nFor patients with advanced lung cancer that has a specific gene change called an \"EGFR mutation,\" targeted therapies known as EGFR-TKIs are a standard treatment. While these treatments often work well at first, most tumors eventually stop responding to the drug (this is called \"acquired resistance\"). The investigational drug ANS014004 is designed to block a protein called MET, which is one of the ways that tumors become resistant to EGFR-TKIs. The researchers believe that by combining ANS014004 with the EGFR-TKI PLB1004, they may be able to prevent or delay resistance, offering patients a more effective and longer-lasting treatment option.\n\nHow will the study be conducted?\n\nThis study is divided into two parts:\n\nPart 1 (Dose Escalation and Optimization): A small number of participants will receive different dose levels of ANS014004 combined with a fixed dose of PLB1004. The goal is to find the safest and most tolerable dose combination.\n\nPart 2 (Phase II Study): Once a recommended dose is identified, more participants will be enrolled to further evaluate how well the drug combination works against the cancer.\n\nThroughout the study, participants' health will be closely monitored, and their tumors will be measured regularly using imaging scans (like CT scans) to see how they respond to the treatment.",[83,353,32,354],"EGFR Mutation","MET Alteration","2025-12-09",{"date":357,"type":43},"2025-12-16",{"date":359,"type":21},"2026-06",{"date":361,"type":21},"2029-12",{"name":363,"class":50},"Beijing Pearl Biotechnology Limited Liability Company",{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":390},"100423194","liquid-biopsy-to-predict-responses-to-first-line-immunotherapy-in-metastatic-non-small-cell-lung-cancer-liberty-lung-100423194","NCT04790682","LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG","LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer","LIBERTYLUNG","Inclusion Criteria:\n\n1. Histologically-proven NSCLC.\n2. Age ≥ 18 years.\n3. Advanced or metastatic stage IV.\n4. Treatment-naïve patient.\n5. Eligibility to first-line treatment with immune checkpoint inhibitor.\n6. Measurable disease according to RECIST 1.1 criteria on CT-Scan.\n7. Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy.\n8. No ALK or EGFR gene alteration.\n9. Availability of tumor tissue for NGS analysis (7 slides).\n10. PS 0 or 1.\n11. Signed informed consent of the patient.\n\nExclusion Criteria:\n\n1. No social security affiliation.\n2. Person under legal protection.\n3. Pregnant and breastfeeding women.\n\nPatients can participate to another clinical trial that is not modifying immunotherapy or immunotherapy\u002Fchemotherapy treatment nor study follow-up ; after investigator's information",{"count":373,"type":21},300,[295],"Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.",[32],[378,379,380],"Lung Cancer NSCLC","metastatic stage","first-line treatment with immunotherapy","2025-09-17",{"date":383,"type":43},"2025-09-18",{"date":385,"type":43},"2021-05-22",{"date":387,"type":21},"2030-06-03",{"name":389,"class":173},"Institut Curie",3,{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":22,"phases":400,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":408,"lastUpdatePostDateStruct":409,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":200},"100528795","phase-2-definitive-radiation-for-high-risk-spine-metastases-100528795","NCT06165419","Definitive Radiation for High-Risk Spine Metastases","A Phase II Study Evaluating Definitive Radiosurgical Decompression in Patients With High-Risk Spinal Metastases","Eligible patients must have:\n\n* Any pathologically proven solid tumor diagnosis not of central nervous system origin with radiographic or pathologic evidence of metastatic disease\n* Metastatic spine involvement documented by imaging\n* Involvement of maximum 3 contiguous vertebral bodies at the index site\n* Intact neurologic function, or only minor neurologic deficits with muscle strength greater or equal to 4 out of 5 with or without steroids\n* An evaluation by an radiation oncology and orthopedic spine\u002Fneurosurgery attending\n* ECOG Performance Status of 0-3\n\nPatients are ineligible if they have:\n\n* An unstable spine defined as a Spinal Instability Neoplastic Score (SINS) greater than 12\n* Had previous surgery or radiation to address the target spinal metastases\n* Radiosensitive tumors (e.g. small cell lung cancer, lymphoma, multiple myeloma, and germ-cell tumors)",{"count":399,"type":21},26,[25],"This study is looking at whether patients with cancer that has aggressively spread to the spine can be treated with stereotactic body radiation therapy only and avoid a large spine surgery",[86,32,65,403,404,405,406,407],"Metastatic Tumor","Metastatic Tumor of Bone","Metastatic Tumor to the Spine","Spine Metastases","Metastasis","2025-05-09",{"date":410,"type":43},"2025-05-14",{"date":412,"type":43},"2023-12-14",{"date":414,"type":21},"2026-05-31",{"name":416,"class":173},"Stony Brook University",{"id":418,"slug":419,"hasResults":11,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":22,"phases":425,"briefSummary":426,"conditions":427,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":429,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":200},"100481072","phase-1-phase-1-trial-of-sync-t---immunotherapy-for-patients-with-advancedmetastatic-solid-tumors-100481072","NCT05544240","Phase 1 Trial of SYNC-T - Immunotherapy for Patients With Advanced\u002FMetastatic Solid Tumors","Phase 1 Trial of SYNC-T - Immunotherapy Regimen Given After Controlled Cellular Lysis for Patients With Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female, aged \\>18 years old at the time of signed informed consent\n2. Provide written informed consent and must be willing to adhere with treatment and follow-up.\n3. Subjects with advanced and\u002For metastatic histologically or cytologically confirmed solid tumor who have not responded or progressed after standard therapies or for whom no further standard therapy exists or standard therapy is not available.\n4. Meet all eligibility criteria\n5. Has undergone a cardiac work-up and received cardiac clearance two months before first treatment\n6. Has halted use of any anticoagulants or other blood thinners (including but not limited to heparin or warfarin) within five (5) days of each treatment.\n7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v5 grade ≤ 1.\n8. Measurable disease by RECIST.\n9. Able to undergo general anesthesia or conscious sedation.\n10. Eastern Cooperative Oncology Group (ECOG) performance status of \\\u003C 3.\n11. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the study.Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must be on stable doses for at least 42 days prior to the cryolysis\n12. In the opinion of the Investigator, there is no other meaningful life-prolonging therapy option available.\n13. Adequate bone marrow, renal, and hepatic function, defined as follows:\n\n    a. Bone marrow function without transfusion 30 days before first dosing: i. Absolute neutrophil count ≥ 1.5 x 109\u002FL; Lymphocyte count of ≥ 1.0 x 109\u002FL; Platelet count ≥ 100 x 109\u002FL; ii. Hemoglobin ≥ 9.0 g\u002FdL b. Renal function: i. Estimated glomerular filtration rate ≥30 mL\u002Fmin\u002F1.73 m2 or creatinine clearance calculated by Cockcroft-Gault equation ≥30 mL\u002F c. Hepatic function: i. Alanine aminotransferase ≤ 3x upper limit of normal (ULN) ii. Aspartate aminotransferase ≤ 3x ULN iii. Total bilirubin ≤ ULN or total bilirubin ≤ 1.5x ULN with direct bilirubin ≤ ULN of the laboratory in subjects with documented Gilbert's Syndrome iv. Patients with liver metastases ≤5x ULN\n14. All clinically relevant toxicities related to prior anticancer therapy must have recovered to Grade ≤1 or baseline (except alopecia or ototoxicity\n15. All subjects with female partners of childbearing potential must use effective contraception throughout study treatment and for 120-150 days (4-5 months) after the last dose of study intervention\n16. Has at least one lesion that is demonstrable on PET\u002FCT, CT, Ultrasound, or MRI and is accessible for injection\n\nExclusion criteria:\n\n1. Has a known additional malignancy that is progressing or has required active treatment in the last 3 years, excluding basal and squamous cell carcinoma\n2. Has undergone major surgery within 28 days prior to enrollment and has not recovered adequately from the toxicities and\u002For complications\n3. Has an active infection (including tuberculosis) requiring systemic therapy\n4. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n5. Has received a live vaccine within 30 days prior to enrollment\n6. 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 treatment\n7. Has tumor volume or disease burden too great to provide for safe and\u002For effective treatment as determined by the Principal Investigator after consultation with Syncromune's Chief Medical Officer\n8. Subjects who have metastases limited to subcutaneous regions (only skin)\n9. Significant cardiac or other medical illness such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia (e.g., New York Heart Association Class 4), or history of previous heart failure.\n10. Malignant pleural effusions or ascites that require immediate intervention\n11. Prior history of autoimmune disease except hypothyroidism\n12. Any primary or acquired immunodeficiency\n13. Active COVID infection or tests positive for COVID day before or day of planned treatment\n14. Known or suspected hepatitis B if active infection (subjects with chronic hepatitis B infection must have an undetectable Hepatitis B virus (HBV) viral load on suppressive therapy, if indicated; positive surface antibody alone is not an exclusion)\n15. Known or suspected hepatitis C infection which has not been treated and cured unless currently on treatment with an undetectable viral load\n16. Prior history of autoimmune disease except hypothyroidism, uncontrolled or unmanaged diabetes, cardiac arrhytmia (unstable or untreated), hypersensitivity, or other illness or disease that in the opinion of the Principal Investigator, with consultation with Syncromune's Chief Medical Officer, makes the subject a poor candidate.Any condition(s) that, in the opinion of the Investigator, would increase the risk for toxicities from study drug, interfere with subject compliance or conduct of this study",{"count":320,"type":21},[24],"SV-101 is intended to overcome the complex and multifactorial nature of the mechanisms mediating tumor immune evasion, by the use of a combination of therapeutic agents that elicit multiple immuno-pharmacologic effects.",[86,65,32,125,428],"Cancer","2025-04-02",{"date":431,"type":43},"2025-04-06",{"date":433,"type":43},"2023-02-01",{"date":435,"type":21},"2025-12-31",{"name":437,"class":173},"Williams Cancer Foundation",{"id":439,"slug":440,"hasResults":11,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":444,"eligibilityCriteria":445,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":22,"phases":447,"briefSummary":448,"conditions":449,"keywords":450,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":340},"100325232","vapor-ablation-for-localized-cancer-lesions-100325232","NCT03514329","Vapor Ablation for Localized Cancer Lesions","Vapor Ablation for Localized Cancer Lesions of the Lung - A Clinical Feasibility Definitive Treatment Study","VAPORIZED","Inclusion Criteria:\n\n1. Age: ≥ 18 years old\n2. Patient has been recommended for ablation or recommended for an alternative to surgery\n3. Non-small cell lung cancer tumor(s) ≤ 2cm (T1aN0, T1bN0) OR Metastatic lung tumor(s) ≤ 2cm\n4. Microscopic proof of malignancy obtained\n5. Location of tumor:\n\n   1. In periphery of lung (outermost 1\u002F3)\n   2. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan\n6. Signed patient informed consent\n\nExclusion Criteria:\n\n1. Centralized tumor (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea)\n2. Carcinoid lung tumors\n3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion\n4. Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) \\\u003C20% predicted, diffusing capacity of the lung for carbon monoxide (DLCO)\\\u003C20% predicted\n5. Requirement for supplemental oxygen (includes at rest or during exercise)\n6. Hospitalization for cardiac disease within the preceding 6 months\n7. Liver enzymes (ALP, ALT, AST) or total bilirubin \\> 1.5 upper limit of normal (ULN)\n8. Serum creatinine \\> 2 mg\u002Fdl\n9. Recent infection (within 30 days)\n10. Currently receiving immunosuppressive medication or prednisone \\> 10 mg\u002Fday (or equivalent)\n11. Pre-existing implants within the airways that impede navigation to the target lesion\n12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception.\n13. Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days post-procedure.\n14. Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives\n15. Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives.",{"count":51,"type":21},[295],"This study is a prospective, single-arm, multi-center, pilot trial of Bronchoscopic Thermal Vapor Ablation for Lung Cancer (BTVA-C) in patients with primary lung cancer or metastatic cancer in the lung. Patients who have consented to participate in this study (enrolled) will be subject to eligibility screening and baseline assessments, prior to undergoing the BTVA-C procedure. Only patients that meet all of the inclusion criteria and none of the exclusion criteria will receive vapor ablation treatment.\n\nPatients will be followed for up to 12 months.",[33,32,31],[33,32,31,451,452],"Vapor Ablation","BTVA","2025-02-24",{"date":455,"type":43},"2025-02-27",{"date":457,"type":21},"2026-09-01",{"date":459,"type":21},"2028-06-30",{"name":461,"class":50},"Uptake Medical Technology, Inc.",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":471,"studyType":264,"phases":4,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":490},"100511010","the-impact-of-radiotherapy-on-oligometastatic-cancer-100511010","NCT05933876","The Impact of Radiotherapy on Oligometastatic Cancer","Stereotactic ABlative Radiotherapy (SABR) in Oligometastatic Cancer (OC): a Radiomics, Multi-omics, and Machine Learning Approach to Clinical Decision-making. the OC-SABR Multicentric Project","Inclusion Criteria:\n\n* Histologic confirmation of primary tumor: breast, prostate, lung, colorectal.\n* 18 years old or older.\n* Up to five metastases located in the bone, lung, node, liver or brain.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Scale 0 or 1.\n\nExclusion Criteria:\n\n* Non-melanoma skin cancer.\n* Previous radiotherapy in the same anatomic location.\n* Presence of vascular collagen disease.\n* Pregnancy or lactation at the time of inclusion.",{"count":470,"type":21},2000,"5 Years","Metastases represent the most threatening challenge in cancer. One of the management strategies for patients with Oligometastatic Cancer (OC) is Stereotactic ABlative Radiotherapy (SABR). However, there are few studies, and there is no defined clinical standard, nor are the radiobiological mechanisms that contribute to treatment response well understood. The focus should be on generating evidence to guide the personalization of radiotherapy beyond solely technological and anatomical precision. This could be achieved by recollecting clinical and biological data from patients that undergo this treatment and analyzing them to ultimately predict, with the help of artificial intelligence, which patients will be the most beneficiary and improve their survival rate.",[407,65,474,70,32],"Metastatic Prostate Cancer",[407,476,477,478,479,480],"Radiosurgery","Metabolomics","Radiomics","Multi-omics","Molecular subtypes","2024-11-14",{"date":483,"type":43},"2024-11-18",{"date":485,"type":43},"2022-12-01",{"date":487,"type":21},"2037-12-31",{"name":489,"class":173},"Institut Investigacio Sanitaria Pere Virgili",21,{"id":492,"slug":493,"hasResults":11,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":22,"phases":501,"briefSummary":502,"conditions":503,"keywords":504,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":200},"100563900","phase-1-pulse-radiotherapy-to-overcome-metastatic-immune-system-evasion-in-lung-cancer-100563900","NCT06622174","Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer","Pulse Radiotherapy to Overcome Metastatic Immune System Evasion in Lung Cancer (PROMISE) - Phase I Trial","PROMISE","Inclusion Criteria:\n\n* Participants must be ≥ 18 years old\n* Ability to provide written informed consent\n* Actively receiving PD(L)-1 inhibitors\n* Progressive disease defined as per RECIST criteria 1.1 on CT metrics as a greater than 20% increase in the sum measurement of lesions, non-target unequivocal progressive disease or a new lesion on CT.\n* Radiological progression to ≥ 5 disease sites. Progression at the primary tumor site should be counted within the total number of progressive lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Patients with brain metastasis are allowed and should be treated as per standard of care\n* All sites of disease can, in the opinion of the investigator, be safely treated and targetable with high-to-intermediate or low dose radiotherapy (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)\n* Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.\n* Patients receiving additional systemic therapy agents such as chemotherapy are eligible, provided the other systemic agents are temporarily halted during radiation treatment.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding individuals are excluded.\n* Medical conditions that would hinder the safe administration of radiotherapy or follow-up.\n* Patients who are ineligible for immunotherapy.\n* Patients with a history of pneumonitis are excluded.\n* Presence of an active autoimmune disease.",{"count":500,"type":21},32,[24],"This phase I study aims to evaluate the safety and effectiveness of adaptive pulsed radiotherapy combined with immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC) resistant to immune checkpoint inhibitors. The primary goal is to assess treatment-related toxicity, while secondary objectives include progression-free survival, overall survival, and quality of life. The study will enroll 32 patients.",[33,32],[505,506,507,508,509,189,510],"Non small cell lung cancer","Metastatic lung cancer","Progressive disease","Polymetastatic","Immunotherapy resistance","Pulse radiotherapy","2024-09-30",{"date":513,"type":43},"2024-10-02",{"date":515,"type":21},"2025-04",{"date":517,"type":21},"2027-08",{"name":519,"class":173},"Houda Bahig",{"id":521,"slug":522,"hasResults":11,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":11,"sex":17,"minAge":527,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":200},"100518554","phase-2-single-drug-chemotherapy-plus-immunotherapy-in-metastatic-non-small-cell-lung-cancer-elderly-patients-100518554","NCT06032052","Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients","Inclusion Criteria:\n\n1. Regardless of sex, age ≥ 65, PS 0-2.\n2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by histology or cytology.\n3. No mutation or fusion of common driving genes, such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).\n\n   (adenocarcinoma requires genetic testing).\n4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).\n5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local treatment).\n6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular area, and measurable tumor lesions.\n7. The estimated survival time is not less than 6 months.\n8. The clinical laboratory criteria within 2 weeks before treatment are as follows: hemoglobin ≥ 110g \u002F L, leukocytes ≥ 4x109 \u002F L, platelet ≥ 100x109 \u002F L, liver and kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit of the normal value.\n9. Informed understanding and voluntary participation in this study, and informed consent has been signed.\n\nExclusion Criteria:\n\n1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).\n2. Have received systemic treatment before.\n3. Previous suffering from other malignant tumors (except stage I non-melanotic skin cancer or cervical carcinoma in situ) or other malignant tumors at the same time.\n4. Other drugs are being tested.\n5. Patients with positive HIV and are receiving antiviral therapy .\n6. Active pulmonary tuberculosis.","65 Years",{"count":529,"type":21},49,[25],"Lung cancer is the cancer with the highest morbidity and mortality among men in the world. The proportion of elderly lung cancer patients in the global lung cancer population is steadily increasing, at the same time, it is also the age group with the highest lung cancer mortality, but there is little evidence for treatment of elderly lung cancer patients. In this study, the investigators set the definition of the elderly to 65 years and older.\n\nThe progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy were higher than those of chemotherapy alone, which established the dominant position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly patients benefit from immunotherapy.\n\nIt is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can not significantly prolong OS, and can not improve the overall health status of patients. Based on the results of this study, single drug chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era of immunotherapy, it is not clear whether single-drug chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.",[533,32],"Elderly Patients","2024-03-13",{"date":536,"type":43},"2024-03-15",{"date":538,"type":43},"2024-02-01",{"date":540,"type":21},"2027-09",{"name":542,"class":173},"Hubei Cancer Hospital",{"id":544,"slug":545,"hasResults":11,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":563,"locationsCount":340},"100477895","phase-2-fecal-microbiota-transplantation-with-immune-checkpoint-inhibitors-in-lung-cancer-100477895","NCT05502913","Fecal Microbiota Transplantation With Immune Checkpoint Inhibitors in Lung Cancer","Fecal Microbiota Transplantation to Improve Efficacy of Immune Checkpoint Inhibitors in Metastatic Lung Cancer","Patient (Recipient) Inclusion Criteria:\n\n1. A histologically confirmed diagnosis of malignancy.\n2. Patients over the age of 18.\n3. Patients planning to be treated with chemotherapy, immune checkpoint inhibitors and\u002For targeted therapy.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2\n5. Able to provide written informed consent.\n\nPatient (Recipient) Exclusion Criteria:\n\n1. Severe or life-threatening food allergy (e.g. nuts, seafood)\n2. Allergy or other contraindication to omeprazole, investigational medicinal product.\n3. Treatment with pre- or probiotics in the four weeks prior to randomization.\n4. Severe immunodeficiency:\n\n   * Systemic chemotherapy \\\u003C30 days from baseline\n   * Known neutropenia with absolute neutrophils \\\u003C1.0x109 cells\u002FµL\n   * Prolonged treatment with corticosteroids (equivalent to prednisone \\>60mg daily for \\>30 days) within 8 weeks of randomization\n5. Swallowing disorder, oral-motor discoordination, inability to swallow capsules\n6. Pregnant or breastfeeding or expecting to conceive or father children within the trial's projected duration, starting from the pre-screening or screening visit through to 120 days after the last dose of trial treatment.\n\nDonor Inclusion Criteria:\n\n1. A histologically confirmed diagnosis of malignancy.\n2. Over the age of 18.\n3. Treated with immune checkpoint inhibitors and with a full response.\n4. Currently attending medical follow-ups\n\nDonor Exclusion Criteria:\n\n1. Has not consumed any antimicrobials within the past 3 months\n2. No prior exposure to HIV or viral hepatitis or suffering from tuberculosis\u002Flatent tuberculosis\n3. No risk factors for blood-borne viruses, including high-risk sexual behavior, use of illicit drugs, any tattoo\u002Fbody piercing\u002Fneedlestick injury\u002Fblood transfusion\u002Facupuncture, all within the past 6 months\n4. No signs or symptoms consistent with Coronavirus disease 19 (COVID-19) or a nose\u002Fthroat and\u002For stool sample with detectable Coronavirus disease 2 (CoV-2)\n5. Has not received a live attenuated vaccine within the past 6 months\n6. No underlying gastrointestinal conditions\u002Fsymptoms (e.g., history of IBD, irritable bowel syndrome (IBS), chronic diarrhea, chronic constipation, coeliac disease, bowel resection or bariatric surgery)\n7. No acute diarrhea\u002Fgastrointestinal symptoms within the 2 weeks prior to donating\n8. No family history of any significant gastrointestinal conditions (e.g., family history of inflammatory bowel disease (IBD) or colorectal cancer)\n9. No history of atopy (e.g., asthma, eosinophilic disorders)\n10. Does not suffer from any systemic autoimmune conditions\n11. Does not start any new treatment regimens within 2 weeks of fecal collection\n12. No neurological or psychiatric conditions or known risk for prion disease\n13. No history of chronic pain syndromes, including chronic fatigue syndrome and fibromyalgia\n14. No history of receiving growth hormone, insulin from cows or clotting factor concentrates\n15. Has not received an experimental drug or vaccine within the past 6 months\n16. No history of travel to tropical countries within the past 6 months",{"count":551,"type":21},80,[25],"Immunotherapy has recently become a main-stream treatment option in cancer care, with improved clinical outcomes in many malignancies, especially that of lung cancer. The long-term benefits of this treatment however are limited. There is therefore a critical need to distinguish predictive biomarkers of response from those of resistance, and to develop synergistic strategies for improved therapeutic response. Strong emerging evidence indicates that the gut microbiome has the ability to influence response to immunotherapy. Unlike tumor genomics, the gut microbiome is modifiable, and thus its modulation to enhance response to immunotherapy is an attractive therapeutic strategy.\n\nWorking hypothesis: Fecal Microbiota Transplant (FMT) treatment in conjunction with standard (chemo-)immunotherapy as a first-line treatment for metastatic lung cancer enhances disease control rate.\n\nThe main objective of this study is to evaluate the safety and efficacy of Fecal Microbiota Transplant (FMT) in altering response to immunotherapy in patients with metastatic lung cancer. The overall goal is to determine microbiome compositional and gene-content changes in patients who respond more efficiently to immunotherapy subsequent to FMT. This understanding may lead to future microbiome-based treatments in combination with immunotherapy to significantly increase lung cancer treatment efficacy. In this prospective clinical and molecular study, we will perform an in-depth analysis of the potential role of FMT in the context of immunotherapy.",[32],[556,506],"Fecal microbiome transplant","2023-09-27",{"date":559,"type":43},"2023-10-02",{"date":561,"type":43},"2023-09-01",{"date":459,"type":21},{"name":564,"class":173},"Soroka University Medical Center"]