[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-small-cell-lung\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-small-cell-lung":265},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,52,77,116,156,188,215],{"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":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100053459","a-multi-centre-chart-review-study-of-stage-i-iii-non-small-cell-lung-cancer-in-china-100053459",false,"NCT07316062","A Multi-centre Chart Review Study of Stage I-III Non-Small Cell Lung Cancer in China","A Multi-centre Chart Review Study on the Treatment Patterns and Outcomes of Stage I-III Non-Small Cell Lung Cancer in China","MAP","Inclusion Criteria:\n\n* Stage I-III at initial NSCLC diagnosis\n* Aged ≥18 years at first diagnosis of NSCLC\n* Timeframe of NSCLC diagnosis:\n\nFor DE1: diagnosed with NSCLC during the period between May 1st 2025 and December 31st 2025 For DE2: diagnosed with NSCLC during the period between May 1st 2026 and December 31st 2026 For DE3: diagnosed with NSCLC during the period between May 1st 2027 and December 31st 2027\n\nExclusion Criteria:\n\n* NSCLC is not the primary cancer diagnosis\n* Patients with a recent history of other tumor or concurrent other tumor\n* Patients participating in interventional clinical trials at time of initial diagnosis\n* Patients with positive pregnancy status at the time of diagnosis","ALL","18 Years",{"count":20,"type":21},3000,"ESTIMATED","OBSERVATIONAL","This chart review study is proposed in China to understand the treatment patterns, biomarker testing, and clinical outcomes with SOC and some selected regimens among patients diagnosed with stage I-III NSCLC.",[25],"Non-Small-Cell Lung",[27],"NSCLC, chart review","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":32},"2026-04-29",{"date":36,"type":21},"2029-04-30",{"name":38,"class":39},"AstraZeneca","INDUSTRY",1,{"id":42,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":43,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":44,"keywords":45,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":49,"completionDateStruct":50,"leadSponsor":51,"locationsCount":40},"100617241",{"count":20,"type":21},[25],[27],"2026-06-10",{"date":48,"type":32},"2026-06-11",{"date":34,"type":32},{"date":36,"type":21},{"name":38,"class":39},{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":62,"studyType":22,"phases":4,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":40},"100643485","impact-of-radiotherapy-immunotherapy-timing-in-nsclc-brain-metastases-100643485","NCT07638709","Impact of Radiotherapy-Immunotherapy Timing in NSCLC Brain Metastases","Immune Microenvironment-driven Radiotherapy-immunotherapy Combined With Time-series Strategy for NSCLC Brain Metastases: an Exploratory Study Based on a Clinical Cohort.","(RT-ICI)","Inclusion Criteria:\n\n* Age ≥ 18 years; no gender restriction;\n* Histologically or cytologically confirmed NSCLC, with brain metastases confirmed by contrast-enhanced cranial MRI;\n* Scheduled to receive radiotherapy combined with a PD-1\u002FPD-L1 inhibitor, in accordance with real-world clinical treatment plans;\n* Negative for driver gene mutations, or positive for mutations but with documented failure of prior targeted therapy;\n* ECOG Performance Status score of 0-2, with an estimated life expectancy of ≥ 3 months;\n* Voluntarily signs the informed consent form and agrees to cooperate with blood\u002Fimaging data collection and follow-up procedures.\n\nExclusion Criteria:\n\n* History of whole-brain radiotherapy, stereotactic radiotherapy for brain metastases, or brain surgery;\n* Presence of contraindications to MRI or inability to tolerate gadolinium-based contrast agents (e.g., severe hepatic or renal insufficiency);\n* Presence of active autoimmune disease requiring systemic treatment, or requirement for long-term use of high-dose immunosuppressive agents;\n* Pregnant or lactating women;\n* Other circumstances deemed by the investigator to involve severe complications or render the patient unsuitable for enrollment.",{"count":61,"type":21},150,"2 Years","The goal of this observational study is to learn about the effects of the timing of radiation therapy and immunotherapy in adults with non-small cell lung cancer (NSCLC) that has spread to the brain. The main questions it aims to answer are:\n\n1. Does the timing of the two treatments change how long the brain tumor stays stable and how long participants live?\n2. What medical problems do participants have when receiving these treatments at different times?\n3. How does the timing of treatments affect the body's immune system?\n\nResearchers will compare participants who receive radiation and immunotherapy 30 days or less apart to those who receive them more than 30 days apart to see if the timing affects the treatment's success and safety.\n\nParticipants already receiving radiation and immunotherapy as part of their regular medical care will:\n\n1. Allow researchers to collect information about their treatment, health, and medical imaging during regular checkups.\n2. Give a small blood sample during their routine blood draws.\n3. Have standard magnetic resonance imaging (MRI) scans of their brain.",[65,66],"Non Small Cell Lung","Brain Metastasases","NOT_YET_RECRUITING","2026-06-09",{"date":46,"type":32},{"date":71,"type":21},"2026-06-05",{"date":73,"type":21},"2030-06-01",{"name":75,"class":76},"Xiangya Hospital of Central South University","OTHER",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":105,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100628495","phase-1-a-phase-1-study-of-epi-326-in-egfr-mutant-nsclc-and-hnscc-100628495","NCT07462377","A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC","A First-in-Human, Open-label, Multicenter, Phase 1 Study of EPI-326 in Patients With Epidermal Growth Factor Receptor-Mutant Non-small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Participant has a life expectancy \\> 12 weeks at Day 1.\n2. Participant has an ECOG performance status of 0-2.\n3. Participant has pathologically confirmed NSCLC or HNSCC.\n\n   o For NSCLC: the tumor harbors any documented EGFR mutation, insertion, or deletion.\n4. Participant has locally advanced or metastatic NSCLC or HNSCC.\n5. Participant has adequate organ function\n\nExclusion Criteria:\n\n1. Participant has history of uncontrolled illness.\n2. Participant has symptomatic brain metastases.\n3. Participant has a diagnosis of any secondary malignancy within 3 years prior to enrollment, except for those patients treated with curative intent and no evidence of active disease.",{"count":85,"type":21},110,"INTERVENTIONAL",[88],"PHASE1","A phase 1 study to determine the safety, tolerability, PK, PD, and preliminary anti-tumor activity of ascending doses of EPI-326 administered to patients with locally advanced or metastatic HNSCC and to patients with any documented EGFR-mutant locally advanced or metastatic NSCLC.",[91,92,93,94,65,95,96,97,98,99,100,101,102,103,104],"Epidermal Growth Factor","Epidermal Growth Factor Receptor","Epidermal Growth Factor Receptor Gene Mutation","Non Small Cell","Non Small Cell Lung Cancer","Head and Neck","Head and Neck Cancer","Head and Neck Cancers","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Head and Neck Squamous Cell Carcinoma HNSCC","NSCLC (Non-small Cell Lung Cancer)","HNSCC","EGFR",[100,103,93,104,95,106],"NSCLC","2026-06-08",{"date":46,"type":32},{"date":110,"type":32},"2026-03-31",{"date":112,"type":21},"2029-07",{"name":114,"class":39},"EpiBiologics",6,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":86,"phases":125,"briefSummary":127,"conditions":128,"keywords":137,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":155},"100630545","phase-2-symbiotic-lung-10-a-study-to-learn-about-pf-08634404-alone-or-in-combination-in-early-stage-or-locally-advanced-nsclc-100630545","NCT07489066","Symbiotic-Lung-10: A Study to Learn About PF-08634404 Alone or in Combination in Early-stage or Locally Advanced NSCLC","AN INTERVENTIONAL, OPEN-LABEL, PHASE 2 STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF PF-08634404 MONOTHERAPY OR IN COMBINATION IN ADULT PARTICIPANTS WITH EARLY-STAGE RESECTABLE OR LOCALLY ADVANCED UNRESECTABLE NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Adequate organ function\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Part A only: Participants must have newly diagnosed, previously untreated, pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) with disease that is considered resectable, as assessed by a multidisciplinary evaluation, which must include a thoracic surgeon who performs lung cancer surgery as a prominent part of his\u002Fher practice. The participant must be a candidate for neoadjuvant therapy followed by complete surgical resection.\n* Part B only: Participants must have pathologically confirmed early-stage or LA (Stage II or IIIA\u002FB), squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have undergone complete surgical resection. The participant must be considered a candidate for adjuvant therapy and must not have achieved pCR with SOC neoadjuvant chemo-immunotherapy.\n* Part C only: Participants must have pathologically confirmed LA, unresectable (Stage III) squamous or non-squamous NSCLC (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer TNM staging system) and have received ≥ 60 Gy of radiation and ≥ 2 cycles of definitive, platinum-based concurrent chemotherapy and achieved SD or better per RECIST 1.1.\n\nExclusion Criteria:\n\n* Participants with known EGFR and ALK AGAs; documented negative results for EGFR and ALK AGAs are required for participants with non-squamous histology.\n* Participants with CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n\n  * Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n  * Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":124,"type":21},120,[126],"PHASE2","This study is being done to learn more about a new medicine called PF-08634404. The study team wants to understand how well it works when given alone or with chemotherapy. The study is for adults with early stage or locally advanced non-small cell lung cancer (NSCLC) that may or may not be removable with surgery.\n\nThe study is seeking participants who:\n\n* Are aged 18 years or older\n* Have either:\n\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for neoadjuvant therapy, followed by surgical removal of the tumor. Neoadjuvant therapy is a treatment given as a first step to shrink the tumor before surgery.\n  * Early-stage or locally advanced (Stage II or IIIA\u002FB) NSCLC and are a candidate for adjuvant therapy and did not achieve a pathological complete response (pCR) from approved treatment that was administered before surgery. Adjuvant therapy is an additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back. pCR is defined as absence of viable tumor in all surgically removed samples.\n  * Locally advanced (Stage III) NSCLC that may not be removable with surgery, was treated with concurrent chemoradiotherapy (cCRT), and is a candidate for additional treatment, otherwise known as consolidation therapy. cCRT is chemotherapy and radiation given simultaneously.\n* Be in good physical condition and have healthy organs based on medical tests.\n* Do not have known actionable changes in DNA\n\nThe study has 3 parts and each participant will be assigned to one part by their doctor based on their disease diagnosis:\n\n* Part A will test PF-08634404 given with chemotherapy in the neoadjuvant setting, followed by surgery.\n* Part B will test PF-08634404 alone in adults who already were treated with neoadjuvant chemo-immunotherapy, underwent surgery, and did not achieve pCR per tumor tissue pathology analysis. Neoadjuvant chemo-immunotherapy refers to the combination of chemotherapy with immunotherapy per local standard-of-care, given before surgical removal of the tumor.\n* Part C will test PF-08634404 alone in adults with unresectable disease who received cCRT and did not have progressive disease. Progressive disease refers to a condition that grows, spreads, or worsens.\n\nAll treatments will be done at clinical study sites, where a trained medical team will monitor adults during and after each visit.",[129,25,130,131,132,133,134,135,136],"Carcinoma","Lung Cancer (NSCLC)","Lung Neoplasms","Carcinoma, Non-Small-Cell Lung (NSCLC)","Lung Disease","Non-Small Cell Lung Cancer","Non-small Cell Lung Cancer, Non-squamous","Non-small Cell Lung Cancer, Squamous",[138,106,139,140,141,142,143,144,145,146],"early stage non small cell lung cancer","adjuvant NSCLC","locally advanced non small cell lung cancer","resectable NSCLC","unresectable NSCLC","neoadjuvant NSCLC","consolidation NSCLC","squamous NSCLC","non-squamous NSCLC","2026-06-04",{"date":107,"type":32},{"date":150,"type":21},"2026-06-01",{"date":152,"type":21},"2031-07-30",{"name":154,"class":39},"Pfizer",3,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":86,"phases":165,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"100467171","phase-2-phase-2-study-for-the-patient-who-has-diagnosed-with-small-cell-lung-cancer-sclc-or-non-small-cell-lung-cancer-nsclc-or-renal-cell-carcinoma-rcc-and-finished-the-first-line-stand-treatment--need-more-treatment-100467171","NCT05363280","Phase 2 Study for the Patient, Who Has Diagnosed With Small Cell Lung Cancer (SCLC) or Non Small Cell Lung Cancer (NSCLC) or Renal Cell Carcinoma (RCC) and Finished the First Line Stand Treatment , Need More Treatment","A Phase 2 Evaluation of the Safety and Efficacy of Veonetinib (AL8326) in ≥2nd Line Small Cell Lung Cancer (SCLC), Non Small Cell Lung Cancer (NSCLC) and Renal Cell Carcinoma (RCC) Treatment","Major Inclusion Criteria:\n\n1. Male or female, 18 years of age or older\n2. ECOG performance status of 0 or 1\n3. Histologically or cytologically confirmed SCLC \u002FNSCLC\u002FRCC\n4. Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1\n5. Have a life expectancy of at least 3 months\n\nMajor Exclusion Criteria:\n\n1. Serious, non-healing wound, ulcer or bone fracture\n2. Major surgical procedure within 28 days or minor surgical procedure performed within 7 days prior to treatment\n3. Active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels\n4. Clinically significant cardiovascular disease including uncontrolled hypertension; myocardial infarction or unstable angina within 6 months prior to enrollment; New York Heart Association (NYHA) Grade II or greater congestive heart failure serious cardiac arrhythmia requiring medication; and Grade II or greater peripheral vascular disease\n5. Hemoptysis within 3 months prior to enrollment\n6. Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19 within 14 days prior to enrollment and during the study unless there is an emergent or life-threatening medical condition that required it.\n\nMore information available upon request",{"count":164,"type":21},80,[126],"This trial is a Phase II trial designed to evaluate the safety and efficacy of using oral AL8326 , a multi-targeted receptor Tyrosine Kinase Inhibitor( TKI) , to recurrent, advanced, or metastatic small cell lung cancer (SCLC) patients , Non-Small Cell Lung (NSCLC) and Renal Cell Carcinoma patients who need ≥2nd line treatment .",[168,169,170],"Small Cell Lung Cancer","Renal Cell Carcinoma (RCC)","Non-Small Cell Lung",[172,173,174,175,176,177],"Recurrent small cell lung caner","Advanced small cell lung cancer","Metastatic Small lung cancer","≥2nd Line treatment","Non small cell lung cancer","Renal Cell Carcinoma","2026-05-05",{"date":180,"type":32},"2026-05-08",{"date":182,"type":32},"2022-11-01",{"date":184,"type":21},"2028-12",{"name":186,"class":39},"Advenchen Pharmaceuticals, LLC.",7,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":86,"phases":197,"briefSummary":198,"conditions":199,"keywords":202,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":115},"100632897","phase-1-phase-1-study-of-pf-08046033-in-advanced-solid-tumors-100632897","NCT07519655","Phase 1 Study of PF-08046033 in Advanced Solid Tumors","A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.\n2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).\n3. Participants must have measurable disease.\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.\n\nExclusion Criteria:\n\n1. Participants with known clinically active central nervous system (CNS) metastases.\n2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.\n3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.\n4. Untreated clinically significant thromboembolic disease.\n5. Previous exposure to GPNMB-targeted therapy.\n6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.",{"count":196,"type":21},250,[88],"This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.\n\nThe study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.\n\nThe study has two parts:\n\nIn the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.\n\nOnce a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.\n\nParticipants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.",[25,200,201],"Esophageal Cancer","Cutaneous Melanoma",[203,204,205,206],"Lung cancer","Esophageal cancer","Melanoma","Antibody drug conjugate","2026-04-20",{"date":209,"type":32},"2026-04-23",{"date":211,"type":32},"2026-04-08",{"date":213,"type":21},"2029-07-14",{"name":154,"class":39},{"id":216,"slug":217,"hasResults":11,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":86,"phases":225,"briefSummary":226,"conditions":227,"keywords":240,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":264},"100568558","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-a2b395-an-allogeneic-logic-gated-car-t-in-participants-with-solid-tumors-that-express-egfr-and-have-lost-hla-a02-expression-100568558","NCT06682793","A Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated CAR T, in Participants With Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","A Seamless Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of A2B395, an Allogeneic Logic-gated Tmod™ CAR T, in Heterozygous HLA-A*02 Adults With Recurrent Unresectable, Locally Advanced, or Metastatic Solid Tumors That Express EGFR and Have Lost HLA-A*02 Expression","DENALI-1","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n1. Appropriately enrolled in the BASECAMP-1 A2 Biotherapeutics, Inc. study, with tissue demonstrating LOH of HLA-A\\*02 by NGS (whenever possible from the primary site).\n2. Histologically confirmed recurrent unresectable, locally advanced, or metastatic CRC, NSCLC, HNSCC, TNBC, RCC, or other solid tumors with EGFR expression. Measurable disease is required with lesions of ≥1.0 cm by CT.\n3. Received previous required therapy for the appropriate solid tumor disease as described in the protocol\n4. Has adequate organ function as described in the protocol\n5. ECOG performance status of 0 to 1\n6. Life expectancy of ≥3 months\n7. Willing to comply with study schedule of assessments including long-term safety follow-up\n\nKey Exclusion Criteria:\n\n1. Has disease that is suitable for local therapy or able to receive standard of care therapy that is therapeutic and not palliative\n2. Prior allogeneic stem cell transplant\n3. Prior solid organ transplant\n4. Cancer therapy within 3 weeks or 3 half lives of A2B395 infusion\n5. Radiotherapy within 28 days of A2B395 infusion\n6. Unstable angina, arrhythmia, myocardial infarction, or any other significant cardiac disease within the last 6 months\n7. Any new symptomatic pulmonary embolism (PE) or a deep vein thrombosis (DVT) within 3 months of enrollment. Therapeutic dosing of anticoagulants is allowed for history of PE or DVT if greater than 3 months from time of enrollment, and adequately treated\n8. History of interstitial lung disease including drug-induced interstitial lung disease and radiation pneumonitis that requires treatment with prolonged steroids or other immune suppressive agents within 1 year\n9. Requires supplemental home oxygen\n10. Females of childbearing potential who are pregnant or breastfeeding\n11. Subjects, both male and female, of childbearing potential who are not willing to practice birth control from the time of consent through 6 months post infusion of A2B395",{"count":224,"type":21},240,[88,126],"The goal of this study is to test A2B395, an allogeneic logic-gated Tmod™ CAR T-cell product in subjects with solid tumors including colorectal cancer (CRC), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), renal cell carcinoma (RCC) and other solid tumors that express EGFR and have lost HLA-A\\*02 expression.\n\nThe main questions this study aims to answer are:\n\n* Phase 1: What is the recommended dose of A2B395 that is safe for patients\n* Phase 2: Does the recommended dose of A2B395 kill the solid tumor cells and protect the patient's healthy cells\n\nParticipants will be required to perform study procedures and assessments, and will also receive the following study treatments:\n\n* Enrollment in BASECAMP-1 (NCT04981119)\n* Preconditioning lymphodepletion (PCLD) regimen\n* A2B395 Tmod CAR T cells at the assigned dose",[228,229,170,102,230,231,232,233,234,99,103,177,235,236,237,238,239],"Solid Tumor, Adult","Colorectal Cancer","Cancer","Colon Cancer","Rectal Cancer","Lung Cancer","CRC","RCC","Kidney Cancer","Triple Negative Breast Cancer","TNBC","Colorectal Adenocarcinoma",[241,242,243,244,104,245,246,234,247,248,249,250,230,106,251,233,252,235,236,253,254,238],"CAR T Cell","Solid Tumors","Allogeneic","T Cell","HLA-A2","Solid tumors expressing EGFR","Colorectal","Cell Therapy","Gene Therapy","Blocker","Non small Cell Lung Cancer","renal cell carcinoma","Renal cell cancer","Triple negative breast cancer","2025-09-03",{"date":257,"type":32},"2025-09-09",{"date":259,"type":32},"2025-05-22",{"date":261,"type":21},"2030-03-31",{"name":263,"class":39},"A2 Biotherapeutics Inc.",10,"Non-small-cell Lung"]