[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-non-small-cell-lung-cancer":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,88,114,149,194,222,250,280,313,338,362,397,421,453,475,505,528,549,577,600],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":32,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100607241","phase-3-study-to-evaluate-efficacy-and-safety-of-firmonertinib-compared-with-investigators-choice-of-egfr-inhibitor-as-first-line-treatment-in-participants-who-have-locally-advanced-or-metastatic-nsclc-with-egfr-p-loop-and-alpha-c-helix-compressing-pacc-uncommon-mutations-100607241",false,"NCT07185997","Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and\u002For adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.","ALL","18 Years",{"count":19,"type":20},480,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.",[26,27,28,29,30,31],"Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74],"Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","NSCLC","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","Lung neoplasms","EGFR","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","G719X","S768I","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P\u002FS","R776C\u002FH","G724S","E736K","I740_K745dup","N771G","K757M\u002FR","V769L\u002FM","RECRUITING","2026-07-01",{"date":78,"type":79},"2026-07-02","ACTUAL",{"date":81,"type":79},"2025-12-17",{"date":83,"type":20},"2030-12",{"name":85,"class":86},"ArriVent BioPharma, Inc.","INDUSTRY",78,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100532707","phase-3-lunar-2-ttfields-with-pembrolizumab--platinum-based-chemotherapy-for-metastatic-nsclc-100532707","NCT06216301","LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC","LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer","LUNAR-2","Inclusion Criteria\n\n* ≥22 years of age in the USA\n\n  ≥18 years of age outside of the USA.\n* Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \\[AJCC\\] criteria) non-squamous or squamous NSCLC.\n* Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.\n* Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease.\n* ECOG Performance Status (PS) of 0-1.\n* Adequate hematologic and end-organ function\n\n  o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding\n* If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception\n* All subjects must sign written informed consent.\n\nExclusion Criteria:\n\nAll individuals meeting any of the following exclusion criteria will be excluded from study participation:\n\n* Mixed small cell and NSCLC histology.\n* EGFR sensitizing mutation and\u002For ALK translocation, and\u002For ROS1 and\u002For RET targetable gene rearrangement, and\u002For METex14 skipping mutation, and\u002For NTRK1\u002F2 gene fusion and\u002For BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available.\n* Has received systemic therapy for metastatic disease.\n* Had major surgery \\\u003C3 weeks prior to randomization\n* Received radiation therapy to the lung that is \\> 30 Gy within 6 months of randomization.\n* Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Is expected to require any other form of antineoplastic therapy while on study.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has symptomatic Central Nervous System (CNS) metastases and\u002For carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 days prior to randomization.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.\n* Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization.\n* Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization.\n* Concurrent treatment with other experimental treatments for NSCLC while in the study.\n* Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin\u002Fcarboplatin, pemetrexed\u002Fpaclitaxel\u002Fnab-paclitaxel) .\n* Pregnant or breastfeeding\n* Admitted to an institution by administrative or court order.",{"count":97,"type":20},734,[23],"This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.",[101],"Metastatic Non-small Cell Lung Cancer",[42,103],"Metastatic","2026-06-24",{"date":106,"type":79},"2026-06-25",{"date":108,"type":79},"2024-07-31",{"date":110,"type":20},"2028-10",{"name":112,"class":86},"NovoCure GmbH",98,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":127,"conditions":128,"keywords":136,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":148},"100520749","phase-1-safety-and-efficacy-of-obx-115-in-advanced-solid-tumors-100520749","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.",{"count":123,"type":20},208,[125,126],"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.",[129,130,131,132,133,134,135],"Tumor Skin","Metastatic Melanoma","Melanoma","Lung Cancer","Metastatic Lung Cancer","Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer",[137,138,139,131,132],"Adoptive cell therapy","Tumor Infiltrating Lymphocytes","TIL",{"date":141,"type":79},"2026-06-29",{"date":143,"type":79},"2023-10-25",{"date":145,"type":20},"2029-06-30",{"name":147,"class":86},"Obsidian Therapeutics, Inc.",10,{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":159,"briefSummary":160,"conditions":161,"keywords":162,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"100409639","phase-2-autologous-ln-145-in-patients-with-metastatic-non-small-cell-lung-cancer-100409639","NCT04614103","Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer","A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (TIL or LN-145) in Patients With Metastatic Non-Small-Cell Lung Cancer","Inclusion Criteria:\n\n* Patients who are over 70 years of age may be allowed to enroll after discussion with the Medical Monitor.\n* Have historically or pathologically confirmed diagnosis of metastatic Stage IV NSCLC without EGFR, ALK, or ROS1 genomic alterations.\n* For patients who have actionable mutations (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate health authority approved targeted therapy is required.\n* Patients must have documented radiographic disease progression on or after the first-line therapy, including concurrent or sequential ICI and platinum-based chemotherapy ± bevacizumab. No more than 1 prior line is allowed if ICI and platinum-based chemotherapy were administered concurrently and no more than 2 prior lines are allowed for sequential administration of platinum-based chemotherapy and ICI as 2 separate lines.\n* LN-145 manufacture is allowed for patients who have residual resectable disease after completion of the platinum-based chemotherapy component of the front-line ICI and platinum-based chemotherapy combination and meet all eligibility criteria except documented disease progression. These patients must intend to receive TIL therapy after disease progression\n* Prior systemic therapy in the adjuvant or neoadjuvant setting, or as part of definitive chemoradiotherapy, will count as a line of therapy if the patient had disease progression during or within 12 months after the completion of such therapy.\n* At least 1 resectable lesion for TIL production and at least one remaining measurable lesion, as defined by RECIST v1.1\n* Have adequate organ function\n* LVEF \\> 45%, NYHA Class 1\n* Have adequate pulmonary function\n* ECOG performance status of 0 or 1\n* Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy\n\nExclusion Criteria:\n\n* Patients who have EGFR, ALK or ROS1 driver mutations\n* Patients who have symptomatic, untreated brain metastases.\n* Patients who have had allogeneic organ transplant or prior cell therapy within the past 20 years\n* Patients who have any form of primary immunodeficiency\n* Patients who are on systemic steroid therapy ≥ 10 mg\u002Fday of prednisone or equivalent.\n* Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment\n* Patients who have had another primary malignancy within the previous 3 years\n* Participation in another interventional clinical study within 21 days","70 Years",{"count":158,"type":20},170,[126],"This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer",[135],[163,164,165,166,138,139,167,134,42,168,48,169,170,133,135,171,172,173,174,175,176,177,178,179,180,181,182,183,184],"LN-145","Cell Therapy","Autologous Adoptive Cell Therapy","Cellular Immuno-therapy","IL-2","Second line Lung Cancer","Carcinoma","Lung Disease","Metastatic NSCLC","Lung Carcinoma","PD-L1","Stage IV Lung Cancer","Stage IV Non-Small Cell Lung Cancer","Stage IV NSCLC","Systemic Therapy","2nd line therapy","Second line therapy","CPI","Immune checkpoint inhibitor (ICI)","NSCLC Recurrent","Recurrent Lung Cancer","Recurrent Lung Carcinoma",{"date":186,"type":79},"2026-06-26",{"date":188,"type":79},"2021-05-07",{"date":190,"type":20},"2031-12",{"name":192,"class":86},"Iovance Biotherapeutics, Inc.",71,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":206,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":221},"100601865","phase-1-mov19-bbz-car-t-cells-in-fra-cancers-100601865","NCT07116057","MOv19-BBz CAR T Cells in FRa+ Cancers","Phase I Clinical Trial of Autologous Folate Receptor-Alpha Redirected T Cells in Patients With FRa+ Cancers","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Documentation of tumor FRa expression by IHC at the Hospital of the University of Pennsylvania (≥ 10% of tumor cells). Subjects must have archived tumor tissue available.\n3. Disease-specific criteria:\n\n   a. NSCLC Patients: i. Metastatic or recurrent lung adenocarcinoma with cytologically or pathologically confirmed malignant pleural effusion.\n\n   ii. Failure of at least one prior line of standard of care therapy for advanced stage disease.\n4. Patients must have evidence of active disease as defined by RECIST 1.1 criteria\n5. Patients with asymptomatic CNS metastases that have been treated (and are off steroids for the treatment of CNS disease) are allowed. They must meet the following criteria\n\n   1. No concurrent treatment for the CNS disease\n   2. No progression of CNS metastasis on MRI at screening\n   3. No evidence of leptomeningeal disease or cord compression\n6. Adequate organ function defined as:\n\n   1. Serum creatinine ≤ 1.5 mg\u002Fdl or creatinine clearance ≥ 30 cc\u002Fmin; Patient must not be on dialysis\n   2. ALT\u002FAST ≤ 3x upper limit of normal range\n   3. Serum total bilirubin ≤ 1.5 mg\u002Fdl, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤ 3.0 mg\u002Fdl)\n   4. Must have a minimum level of pulmonary reserve defined as \\\u003C Grade 1 dyspnea and pulse oxygen \\> 92% on room air\n   5. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO or MUGA\n7. Male or female age ≥ 18 years\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status that is either 0 or 1\n9. Subjects must be a possible clinical candidate for standard of care treatment with a commercial checkpoint inhibitor, as per physician-investigator assessment.\n\nExclusion Criteria:\n\n1. Any clinically significant pleural effusion that cannot be drained with standard approaches.\n2. Patients with significant lung disease as follows:\n\n   1. Patients with radiographic evidence of greater than lobar lymphangitic pulmonary involvement, greater than lobar bronchial wall thickening suggestive of peribronchial lymphatic disease extension, and\u002For evidence of extensive bilateral parenchymal metastatic burden.Note: \"Greater than lobar\" = \"in more than 1 lobe\".\n   2. Patients with radiographic and\u002For clinical evidence of active radiation pneumonitis.\n   3. Patients with radiographic evidence of underlying interstitial lung disease, including evidence of unresolved drug toxicity from any agent (e.g. chemotherapy, targeted agents, amiodarone, nitrofurantoin, etc.).\n   4. Patients with radiographic evidence of significant pleural effusion that is not readily amenable to minimally invasive drainage.\n3. Active hepatitis B or hepatitis C infection\n4. Any other active, uncontrolled infection\n5. Class III\u002FIV cardiovascular disability according to the New York Heart Association Classification\n6. Active invasive cancer, other than the proposed cancer included in this protocol, within 2 years prior to eligibility confirmation by a physician-investigator. \\[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\\].\n7. Dependence on systemic steroids or immunosuppressant medications.\n8. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods\n9. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone daily. Patients with autoimmune neurologic diseases (such as MS) will be excluded.\n10. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)",{"count":148,"type":20},[125],"This is a Phase I open-label clinical trial to assess the safety, feasibility, and preliminary efficacy of intrapleural administration of MOv19-BBz CAR T cells in patients with FRa+ cancers. This study will be initiated in patients with metastatic or recurrent non-small cell lung cancer (NSCLC) only. Subjects will receive a single dose of MOv19-BBz CAR T cells via intrapleural infusion following lymphodepleting chemotherapy. Subjects without an existing intra-pleural catheter will have a temporary pleural catheter placed for the study. Subjects may initiate treatment with commercial checkpoint inhibitors per routine care beginning at least 28 days after receiving MOv19-BBz CAR T cells.",[135,205],"Recurrent Lung Non-Small Cell Carcinoma",[42,207,208,209,210],"CAR T cells","FRa+","lung cancer","lung adenocarcinoma","2026-06-16",{"date":213,"type":79},"2026-06-18",{"date":215,"type":79},"2025-10-07",{"date":217,"type":20},"2040-10",{"name":219,"class":220},"University of Pennsylvania","OTHER",1,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":21,"phases":231,"briefSummary":232,"conditions":233,"keywords":234,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":249},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":230,"type":20},626,[126,23],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[41,40],[235,236,42,40,237,238,239],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS","2026-06-05",{"date":242,"type":79},"2026-06-08",{"date":244,"type":79},"2020-12-02",{"date":246,"type":20},"2032-06-09",{"name":248,"class":86},"Mirati Therapeutics Inc.",770,{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":265,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":279},"100610052","phase-3-symbiotic-lung-01--a-study-to-learn-about-the-study-medicine-called-pf-08634404-in-combination-with-chemotherapy-in-adult-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100610052","NCT07222566","Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer","AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER","Inclusion Criteria:\n\n* 18 years of age or older at screening.\n* Have pathologically confirmed locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV)squamous or non-squamous NSCLC and not be a candidate for complete surgical resection and curative concurrent\u002Fsequential chemoradiotherapy (according to the 9th edition of the Union for International Cancer Control and American Joint Committee on Cancer lung cancer Tumor, lymph nodes, metastasis (TNM) staging system).\n* Have tumor tissue available, either paraffin block or slides from a core, excisional or fine needle biopsy\n* PD-L1 status available based on local testing results\n* Measurable disease based on RECIST v1.1 per investigator.\n* Eastern Cooperative Oncology Group performance status (ECOG) score of 0 or 1\n* Expected survival ≥12 weeks\n\nExclusion Criteria:\n\n* Participants with known actionable genomic alteration (AGAs), including estimated glomerular filtration rate (EGFR), anaplastic lymphoma kinase (ALK), Repressor of Silencing 1 (ROS1), neurotrophic tyrosine receptor kinase (NTRK), v-raf murine sarcoma viral oncogene homolog B1 (BRAF), rearranged during transfection (RET), and mesenchymal-epithelial transition (MET), for which there are available first-line therapies per local standard-of-care (SOC) are ineligible. Documented negative results for EGFR, ALK, and ROS1 AGAs are required for participants with non-squamous histology.\n* Known active CNS lesions are excluded. Participants with definitively treated brain metastases (surgery and\u002For radiotherapy) may be eligible. Clinically inactive brain metastases of longest diameter \\\u003C 1 cm are permitted.\n* Participants with clinically significant risk of hemorrhage or fistula are excluded.\n* Participants with any history of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy.\n* Unresolved toxicities from prior anti-tumor therapy, that did not recover to NCI CTCAE v5.0 Grade 0 or 1.\n* Known to have a history of a severe allergy to any component of the study intervention, or a history of severe allergic reaction to chimeric or humanized antibody.\n* History of allogeneic organ \u002F hematopoietic stem cell transplantation.\n* Participants with any of the following respiratory conditions:\n* Evidence of noninfectious or drug-induced interstitial lung disease (ILD) or pneumonitis\n* Grade ≥3 pulmonary disease unrelated to underlying malignancy\n* History of uncontrolled comorbidities within 6 months prior to the first dose including uncontrolled cardiac and cerebrovascular conditions, hypertension, diabetes, significant vascular disease or arterial\u002Fsevere venous thromboembolic events.\n* Major surgery \\\u003C 4 weeks or minor surgery \\\u003C 3 days prior to first dose of study intervention.\n* History of severe bleeding tendency or coagulation dysfunction\n* History of esophageal varices, severe ulcers, unhealed wounds, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months prior to the first dose.\n* Participants with acute, chronic or symptomatic infections including participants positive for active HIV, hepatitis B virus (HBV), or Hepatitis C virus (HCV).\n* Participants with history of immunodeficiency\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior (in the past 5 years) or laboratory abnormality that may increase the risk of study participation or make the participant inappropriate for the study.\n* Previous systemic anti-tumor therapy including:\n\n  1. Prior systemic therapy, including anti-PD-(L)1 therapy, for locally advanced, unresectable, or metastatic NSCLC.\n  2. Previous treatment with immunotherapy\n  3. Prior radiotherapy \\> 30 Gy to the lung \\\u003C 6 months of first dose of study intervention\n  4. Palliative local therapy \\\u003C 2 weeks before the first dose of study intervention;\n  5. Non-specific immunomodulatory therapy \\\u003C 2 weeks before the first dose.\n  6. Prior systemic anti-angiogenic therapy\n* Prior immune-related AE that led to anti-PD-(L)1 treatment discontinuation, adverse events from prior immunotherapy not improved to Grade 1 before screening, or required treatment with systemic immunosuppressive therapy.\n* Prior and concomitant therapy:\n\n  1. therapeutic oral or parenteral anticoagulants or thrombolytic agents \\\u003C 10 days to the first dose.\n  2. chronic antiplatelet therapy \\\u003C7 days to randomization.\n  3. live or attenuated live vaccine \\\u003C 4 weeks to the first dose.\n  4. current high-dose systemic corticosteroids.\n  5. prohibited concomitant medication(s) \\\u003C 21 days to the first dose.\n* Breastfeeding participants, participants of childbearing potential, and male participants who are unwilling to follow contraceptive measures.",{"count":258,"type":20},1410,[23],"This study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body.\n\nTo join the study, participants must meet the following conditions:\n\n* Be 18 years or older.\n* Have locally advanced (Stage IIIB\u002FIIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC.\n* Is not a candidate for complete surgical resection or curative chemoradiotherapy.\n* Do not have known actionable genomic alterations\n* Be treatment naïve for advanced or metastatic disease\n\nParticipants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2.\n\nEach participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion:\n\n* Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor.\n* Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor.\n\nParticipants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects.\n\nThe study will include regular visits for:\n\n* Treatment and health checks: while participant continues receiving treatment.\n* Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.",[41,262,263,264,135,132],"Non-Small Cell Lung Cancer","Carcinoma, Non-Small-Cell Lung","Carcinoma, Non-Small-Cell Lung (NSCLC)",[266,267,268,269],"non-squamous NSCLC","squamous NSCLC","metastatic (Stage IV) squamous or non-squamous NSCLC","Advanced or Metastatic Non-Small Cell Lung Cancer","2026-06-03",{"date":272,"type":79},"2026-06-04",{"date":274,"type":79},"2026-01-06",{"date":276,"type":20},"2032-08-26",{"name":278,"class":86},"Pfizer",346,{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":301,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":221},"100521172","phase-1-a-study-of-therapeutic-drug-monitoring-based-atezolizumab-dosing-100521172","NCT06066138","A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","* INCLUSION CRITERIA:\n* Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab, either alone or in combination with other FDA-approved drug(s), for example, TMB-high, PDL-1 positive, or other disease states that respond to PD(L)-1 inhibitors. Regimens with atezolizumab alone or in combination with agents that have previously demonstrated safety in published clinical trials may be used. An LIP may be either an MD, DO, PA, or NP and must be qualified for oncologic management per institutional practice.\n* Age \\>=18 years old.\n* Measurable disease per RECIST 1.1 criteria.\n* ECOG performance status of 0-2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,200\u002Fmicroliter\n  * Hemoglobin \\>9.0 g\u002FdL\n  * Platelets \\>=75,000\u002Fmicroliter\n  * Total bilirubin \\\u003C= 1.5 mg\u002FdL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg\u002FdL\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=2.5 X institutional upper limit of normal (ULN)\n  * Creatinine Clearance (CrCl) \\>=30 mL\u002Fmin\u002F1.73 m\\^2 (calculated using the Cockcroft-Gault formula).\n  * Serum albumin \\> 3 g\u002FdL\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 5 months after the last dose of the atezolizumab (restriction period). NOTE: abstinence, defined as no vaginal heterosexual intercourse within 6 months prior to the treatment initiation and willingness to continue abstinence for restriction period is also acceptable.\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 5 months after the last dose of the atezolizumab.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 5 months after atezolizumab treatment discontinuation.\n* Participants with history of human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and have undetectable viral load.\n* Participants with history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy, if indicated, and have undetectable HBV viral load.\n* Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load.\n* Participants with history of treated brain metastases must have follow-up brain imaging after central nervous system (CNS)-directed therapy with no evidence of progression.\n* Participants 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.\n* All participants must have the ability to understand and willingness to sign a written informed consent.\n\nEXCLUSION CRITERIA:\n\nParticipants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation.\n\n* Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation. NOTE: Physiologic doses of systemic steroids (\\\u003C= 10 mg prednisone or equivalent) or local (e.g., topical, nasal, intraarticular, inhaled) steroid use is permitted.\n* Prior treatment with CD137 agonists\n* Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation.\n* History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.\n  * Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:\n\n    * Rash must cover less than 10% of body surface area (BSA)\n    * Disease is well controlled at screening and only requiring low potency topical steroids\n    * No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within 12 months prior to study treatment initiation.\n* Persisting toxicity related to prior therapy of Grade \\>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible. NOTE: alopecia and sensory neuropathy Grade \\\u003C= 2 are acceptable.\n* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Active tuberculosis at screening\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident (https:\u002F\u002Fwww.heart.org\u002Fen\u002Fhealth-topics\u002Fheart-failure\u002Fwhat-isheart-failure\u002Fclasses-of-heart-failure), unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.\n* Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).\n* Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.","120 Years",{"count":289,"type":20},30,[125],"Background:\n\nA type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects.\n\nObjective:\n\nTo test different doses and timing of atezolizumab for people with cancer.\n\nEligibility:\n\nPeople aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor.\n\nAtezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care.\n\nThe first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later.\n\nFor the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change.\n\nResearchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months.\n\nStudy treatment may last up to 2 years.",[293,294,295,135,296,297,298,299,300,130],"Locally Advanced Alveolar Soft Part Sarcoma","Metastatic Alveolar Soft Part Sarcoma","Locally Advanced Non Small Cell Lung Cancer","Locally Advanced Small Cell Lung Cancer","Metastatic Small Cell Lung Cancer","Locally Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma","Locally Advanced Melanoma",[173,302,303,304],"PD-1","Tecentriq","Immunotherapy",{"date":272,"type":79},{"date":307,"type":79},"2025-11-04",{"date":309,"type":20},"2028-01-31",{"name":311,"class":312},"National Cancer Institute (NCI)","NIH",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":322,"briefSummary":323,"conditions":324,"keywords":325,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100394034","phase-2-osimertinib-alone-or-with-chemotherapy-for-egfr-mutant-lung-cancers-100394034","NCT04410796","Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers","A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib","Inclusion Criteria: Inital\n\n* Age ≥ 18 years\n* Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution\n* Somatic activating mutation in EGFR in pre-treatment tumor biopsy\u002F cytology from pleural fluid or cfDNA\n* Either have not started a prior EGFR TKI therapy or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy \\> 6 months prior to study start is acceptable)\n* Measurable (RECIST 1.1) indicator lesion not previously irradiated with measurable disease determined per treating investigator. If a patient has already started on osimertinib there must be available pre-osimertinib baseline tumor assessments , or tumor assessments within +7 days of Osimertinib start, to be utilized for RECIST 1.1 assessment.\n* Karnofsky performance status (KPS)≥70%,\n* Ability to swallow oral medications\n* Adequate organ function (use of G-CSF and\u002For transfusion to meet these criteria are not allowed)\n\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Platelets ≥ 150,000mm\\^3 or 150 x 10\\^9\u002FL\n  * AST, ALT ≤ 2.5 x ULN with no liver metastases or \\\u003C 5x ULN with the presence of liver metastases\n  * Total bilirubin ≤ 1.5 x ULN if no liver metastases or \\\u003C 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  * Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm\\^3\n  * Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin calculated by Cockcroft and Gault equation\n  * Creatinine clearance ≥ 60 mL\u002Fmin calculated by Cockcroft and Gault equation\n* Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential:\n\n  * Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing through 6 weeks after discontinuing the study drug if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n  * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n  * Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution\n  * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n  * Male subjects should be willing to use barrier contraception and avoid sperm donation prior to the start of dosing through 4 months of discontinuing the study drug\n\nExclusion Criteria: Initial\n\n* Pregnant or lactating women\n* Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.\n* Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.\n* Any evidence of clinically significant interstitial lung disease\n* Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater\n* Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any medications, herbal supplements and\u002For ingestion of foods with known inducer effects on CYP3A4.\n* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy- related neuropathy\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial\n* active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n* Screening for chronic conditions is not required.\n* In patients with resolved or chronic hepatitis B infection (inactive carrier state) or active controlled HBV infection on treatment with osimertinib\n\n  * Recommend monthly monitoring of ALT\u002FAST, HBV DNA levels and HBsAg (if negative at baseline)\n  * Where liver signs and symptoms of viral reactivation appear (HBV DNA levels exceeding 10-fold from baseline or ≥100 IU\u002Fml (if baseline HBV DNA levels are undetectable) or conversion of HBsAg negative to positive):\n  * Expert hepatologist\u002Fspecialist oversight of the patient is required\n  * Consider interruption or discontinuation of study treatment, based on riskbenefit assessment\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec where QT interval is corrected for heart rate using Frederica's formula (QTcF).\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n  * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum\u002FPlasma potassium \\\u003CLLN, Serum\u002FPlasma Magnesium \\\u003CLLN; Serum\u002FPlasma Calcium \\\u003CLLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.If concomitant medication can not be discontinued, please notify and confirm with MSK PI prior to enrollment.\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n* History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n\nInclusion Criteria: Randomization\n\n* Patients with detectable plasma EGFR mutations at C2D1\n* Karnofsky performance status (KPS) ≥ 70%\n* Adequate organ function\n\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Platelets ≥ 100,000mm\\^3 or 100 x 10\\^9\u002FL\n  * Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin\n  * AST, ALT ≤ 3x ULN with no liver metastases or ≤ 5x ULN with the presence of liver metastases\n  * Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  * Absolute neutrophil count (ANC) ≥ 1500 cells\u002Fmm3Must have at least stable disease per RECIST 1.1 assessment prior to initiating chemotherapy at C4D1\n  * Eligibility testing (KPS, bloodwork) should be tested at C3D1. If the subject's evaluation does not meet eligibility criteria, any result obtained between C3 and C4 can be used\n\nPlease note: All 'Initial' Exclusion Criteria must be re-confirmed prior to randomization, except for the cardiac criteria related to the ECG. The ECG does not need to be repeated for patients screening for Randomization.",{"count":321,"type":20},571,[126],"This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.",[101],[326,43,327,328],"EGFR-Mutant Lung Cancers","Osimertinib Plus Chemotherapy","20-011","2026-06-01",{"date":270,"type":79},{"date":332,"type":79},"2020-05-28",{"date":334,"type":20},"2027-05",{"name":336,"class":220},"Memorial Sloan Kettering Cancer Center",18,{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":21,"phases":347,"briefSummary":348,"conditions":349,"keywords":350,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":359,"locationsCount":361},"100572295","phase-2-reduced-ct--anti-pd-1-as-first-line-tx-in-vulnerable-older-adults-wadv-50-pd-l1-non-small-cell-lung-cancer-nsclc-100572295","NCT06731413","Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w\u002FAdv \u003C50% PD-L1 Non-Small Cell Lung Cancer (NSCLC)","Phase 2 Study to Evaluate Reduced Dose Chemotherapy in Combination With Anti-PD-1 Therapy as First Line Treatment in Vulnerable or Older Adults (Vulnerable or Age ≥70) With Advanced PD-L1 TPS \u003C50% Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) (either squamous or non- squamous)\n* Stage IIIB, IIIC or IV disease OR have recurrent disease and not be candidates for curative treatment such as combined chemo-radiation\n* No previous line of treatment in the recurrent or metastatic setting. Neoadjuvant or adjuvant treatment more than 6 months before enrollment is acceptable.\n* Age 70 or meeting frailty definition or above at the date of signing informed consent\n* Absence of driver mutations that have first line Food and Drug Administration (FDA) approved targeted therapy (biomarker testing is optional for squamous cell)\n* PD-L1 tumor proportion score (TPS) of less than 50%\n* Eastern Cooperative Oncology Group (ECOG) PS of 0-3\n* Have measurable disease based on RECIST 1.1 as determined by the local site investigator\u002Fradiology assessment\n* Absolute neutrophil count (ANC) ≥ 1,000\u002FμL\n* Platelets ≥ 75,000\u002FμL\n* Hemoglobin (Hgb) ≥ 8.0 g\u002FdL (transfusion permitted)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate amino transferase (AST)serum glutamic-oxaloacetic transaminase (SGOT) \u002Falanine aminotransferase (ALT)serum glutamic-pyruvic transaminase (SGPT) ≤ 5.0 × institutional ULN\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Participants with life expectancy of less than 3 months at the time of enrollment\n* Has active autoimmune disease that has required systemic treatment in past 2 years (ie, with use of disease modifying agents, or immunosuppressive drugs)\n* Diagnosis of interstitial lung disease\n* Creatinine clearance of \\\u003C30 mL\u002Fmin\n* Symptomatic, untreated central nervous system (CNS) disease or leptomeningeal disease. Patients with asymptomatic or treated CNS disease are eligible\n* Required ongoing use of immunosuppressive medication, including steroids, with the following allowable exceptions:\n\n  * Doses less than or equal to the equivalent of prednisone 10 mg daily\n  * Short courses of steroids that are discontinued prior to enrollment\n  * Inhaled, intranasal and\u002For topical steroids\n  * Dexamethasone taper for treating vasogenic edema associated with CNS disease",{"count":346,"type":20},40,[126],"Evaluate frequency of adverse events that lead to chemotherapy discontinuation in vulnerable older adults with recurrent\u002Fmetastatic PD-L1 TPS\\\u003C50% NSCLC patients who receive reduced dose chemotherapy in combination with immunotherapy.",[262,42,41,135],[351],"Non-Small Cell Lung Cancer, NSCLC","2026-05-29",{"date":354,"type":79},"2026-06-02",{"date":356,"type":79},"2025-02-11",{"date":358,"type":20},"2033-07-30",{"name":360,"class":220},"Virginia Commonwealth University",2,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":370,"enrollmentInfo":371,"targetDuration":4,"studyType":21,"phases":373,"briefSummary":374,"conditions":375,"keywords":376,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100548193","phase-3-a-study-to-investigate-the-efficacy-and-safety-of-dato-dxd-with-or-without-osimertinib-compared-with-platinum-based-doublet-chemotherapy-in-participants-with-egfr-mutated-locally-advanced-or-metastatic-non-small-cell-lung-cancer-100548193","NCT06417814","A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer","A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants With EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer Whose Disease Has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)","TROPION-Lung15","Inclusion Criteria:\n\n* Histologically or cytologically confirmed non-squamous NSCLC.\n* Must have evidence of documented pre-existing EGFRm information (EGFRm known to be associated with (epidermal growth factor receptor \\[EGFR\\] tyrosine kinase inhibitor \\[TKis\\] sensitivity \\[Ex19del, L858R, G719X, S768I, or L861Q\\], either alone or in combination with other EGFR mutations, which may include T790M).\n* Documented extra-cranial radiologic progression on prior osimertinib monotherapy (as most recent line of treatment) in the adjuvant, locally advanced, or metastatic setting.\n* Less than or equal to (\\\u003C=2) prior lines of EGFR TKIs (osimertinib is the only permitted prior third generation EGFR TKI).\n* At least one lesion, not previously irradiated, that qualifies as a RECIST v1.1 TL at baseline and can be accurately measured at baseline.\n* World Health Organization (WHO)\u002FEastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Adequate bone marrow reserve and organ function within 7 days before randomization.\n\nExclusion Criteria:\n\n* Use of chemotherapy, vascular endothelial growth factor inhibitor, immunotherapy or any anti-cancer therapy in the metastatic setting. Platinum-based chemotherapy in non-metastatic setting within 12 months prior to randomization.\n* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before the first dose of study intervention.\n* Any evidence of severe or uncontrolled systemic diseases, including, but not limited to active bleeding diseases, active infection, active ILD\u002Fpneumonitis, cardiac disease.\n* Has significant third-space fluid retention (example \\[eg.\\], ascites or pleural effusion) as judged by the investigator and is not amenable for required repeated drainage.\n* History of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids or drug-induced ILD, has current ILD\u002Fpneumonitis, or has suspected ILD\u002Fpneumonitis that cannot be ruled out by imaging at screening.\n* Has severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.\n* Unstable spinal cord compression and\u002For unstable brain metastases.\n* Participants with symptomatic brain metastases (including leptomeningeal involvement).\n* Clinically significant corneal disease.\n* Uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals, suspected infections or inability to rule out infections. Use of systemic antibiotics within 14 days of randomization.\n* Has known human immunodeficiency virus (HIV) infection that is not well controlled.","130 Years",{"count":372,"type":20},744,[23],"This study will assess the effect of Dato-DXd in combination with osimertinib or Dato-DXd monotherapy versus platinum-based doublet chemotherapy in terms of progression-free survival (PFS).",[101],[377,378,379,380,236,381,382,43,383,384,385,386],"Epidermal growth factor receptor gene mutation","Standard of Care","Locally, advanced carcinoma","Metastatic carcinoma","Dato-dxd","Datopotamab deruxtecan","Tagrisso","Pemetrexed","Carboplatin","Cisplatin","2026-05-13",{"date":389,"type":79},"2026-05-14",{"date":391,"type":79},"2024-10-04",{"date":393,"type":20},"2028-09-27",{"name":395,"class":86},"AstraZeneca",303,{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":21,"phases":406,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":420},"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":405,"type":20},350,[125],"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.",[409,40,42,235,133,410],"Non-small Cell Lung Cancer","Advanced Lung Carcinoma","2026-05-04",{"date":413,"type":79},"2026-05-05",{"date":415,"type":79},"2024-05-22",{"date":417,"type":20},"2031-09",{"name":419,"class":86},"TheRas, Inc., d\u002Fb\u002Fa BBOT (BridgeBio Oncology Therapeutics)",35,{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":21,"phases":430,"briefSummary":431,"conditions":432,"keywords":436,"overallStatus":443,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":451,"locationsCount":4},"100628445","phase-1-an-open-label-single-arm-dose-escalation-phase-i-study-evaluating-the-safety-tolerability-and-preliminary-efficacy-of-edb-102-in-patients-with-egfr-l858r-mutant-third-generation-tki-resistant-advanced-non-small-cell-lung-cancer-with-liver-metastases-100628445","NCT07461727","An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases","Inclusion Criteria:\n\n1. Age ≥18 and ≤75 years, any sex.\n2. Histologically or cytologically confirmed, unresectable locally advanced or metastatic (stage IV) non-small cell lung cancer (NSCLC)\n3. Prior treatment with at least one third-generation EGFR-TKI (e.g., osimertinib) with radiologically confirmed disease progression according to RECIST 1.1 or intolerance, and no concomitant anticancer therapy during this period.\n4. Availability of tumor tissue obtained after progression on third-generation EGFR-TKI, with EGFR L858R mutation confirmed in the post-progression tumor tissue or blood sample by central laboratory- or study site-validated methods (e.g., WES or RNAseq).\n5. At least one measurable hepatic lesion per RECIST 1.1, confirmed by biopsy, with the EGFR L858R mutation verified in the lesion by central laboratory- or study site-validated methods (e.g., WES or RNAseq).\n6. ECOG performance status of 0 or 1.\n7. Adequate organ and bone marrow function: a) Hematologic: within 14 days prior to enrollment and without recent transfusion or growth factor therapy: ANC ≥1.5×10⁹\u002FL, Hb ≥90 g\u002FL, PLT ≥75×10⁹\u002FL, WBC \\>3.0×10⁹\u002FL. b) Hepatic: TBIL ≤1.5×ULN, ALT ≤5×ULN, AST ≤5×ULN. c) Renal: serum creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL\u002Fmin. d) Coagulation: PT ≤1.5×ULN, APTT ≤1.5×ULN, INR ≤1.5×ULN.\n8. Ability and willingness to provide written informed consent, comply with study procedures, and cooperate with study personnel.\n\nExclusion Criteria:\n\n1. Prior exposure to any gene-editing therapies (e.g., CRISPR, TALEN, ZFN)\n2. Receipt of chemotherapy, radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy, or other anticancer agents within 4 weeks prior to the first dose of study drug. For oral fluoropyrimidines or small-molecule targeted agents, the washout period is 2 weeks or 5 half-lives of the drug, whichever is longer\n3. Receipt of any investigational, unapproved therapy within 4 weeks prior to the first dose of study drug.\n4. Presence of other known driver gene alterations conferring TKI resistance, excluding EGFR mutations, unless these occur as co-mutations, including: Bypass pathway activation: High-level MET amplification: detected by WES (gene copy number \\>5) or FISH (MET\u002FCEP7 ratio ≥2.0). High-level HER2 amplification: detected by ISH (gene copy number ≥6 per nucleus, HER2\u002FCEP17 ratio ≥2.0). Other acquired resistance driver mutations: Newly emerged confirmed resistance mutations, e.g., KRAS or BRAF-V600E. Activating mutations in PI3K\u002FAKT\u002FmTOR pathway genes (e.g., PIK3CA). Loss of primary EGFR mutation: absence of the original EGFR L858R mutation in post-resistance tumor tissue.\n5. Known allergy or adverse reaction to any lipid nanoparticle (LNP) components.\n6. Uncontrolled hypertension (systolic BP \\>150 mmHg and\u002For diastolic BP \\>100 mmHg despite regular antihypertensive therapy) or history of hypertensive crisis or hypertensive encephalopathy.\n7. Liver disease, including cirrhosis, hepatitis, or history of hepatitis B or C infection.\n8. Unstable angina or acute myocardial infarction, or history of these events within the past 6 months.\n9. History of malignancy within the past 5 years, except for treated basal cell carcinoma, cutaneous squamous cell carcinoma, cervical cancer, or gastrointestinal cancers.\n10. Pregnant, breastfeeding, positive pregnancy test, or unwillingness to use contraception in premenopausal women. Women are considered postmenopausal if amenorrheic for ≥2 years. Male patients unwilling to use contraception during the study are also excluded.\n11. Leptomeningeal, brainstem, or spinal metastases, or active CNS metastases with compression. Subjects with previously treated brain metastases may participate if clinically stable ≥4 weeks prior to first study drug administration and off corticosteroids for ≥14 days.\n12. Any condition deemed by the investigator to make the subject unsuitable for participation in the study.","65 Years",{"count":429,"type":20},15,[125],"The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of EDB-102 Injection in patients with advanced non-small cell lung cancer (NSCLC) who have liver metastases. The study specifically targets patients harboring the EGFR-L858R mutation who have disease progression after treatment with third-generation EGFR tyrosine kinase inhibitors (TKIs, e.g., osimertinib).\n\nEDB-102 is a novel in vivo gene-editing therapy. It consists of CRISPR-Cas9 mRNA and a single-guide RNA (sgRNA) encapsulated in lipid nanoparticles (LNPs). The drug is designed to specifically identify and disrupt the mutant EGFR-L858R gene in tumor cells, thereby inhibiting tumor growth. Due to the liver-targeting properties of the LNP carrier, this therapy is particularly aimed at patients with liver metastases.\n\nThis is a Phase I, open-label, dose-escalation study. Participants will receive a single intravenous (IV) infusion of EDB-102. The study will follow a \"3+3\" design to determine the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D). Participants will be monitored for adverse events, and tumor biopsies will be collected to assess the gene-editing efficiency of the drug.",[262,101,433,434,435],"Liver Metastases","EGFR Gene Mutation","EGFR L858R",[437,438,435,439,440,441,442],"EDB-102","CRISPR-Cas9","Lipid Nanoparticles (LNP)","In vivo Gene Editing","TKI Resistance","Osimertinib Resistance","NOT_YET_RECRUITING","2026-03-05",{"date":446,"type":79},"2026-03-10",{"date":448,"type":20},"2026-02-10",{"date":450,"type":20},"2029-01-31",{"name":452,"class":220},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":459,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":443,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":4},"100583887","phase-2-this-study-is-comparing-morning-vs-random-scheduling-of-standard-of-care-pembrolizumab-checkpoint-inhibitor-immunotherapy-infusions-in-patients-with-metastatic-non-small-cell-lung-cancer-100583887","NCT06882174","This Study is Comparing Morning vs Random Scheduling of Standard of Care Pembrolizumab Checkpoint Inhibitor Immunotherapy Infusions in Patients With Metastatic Non-small Cell Lung Cancer","Timing of Immunotherapy for the Modulation of Efficacy: a Pilot Study in Metastatic Non-Small Cell Lung Cancer","TIME-NSCLC","Inclusion Criteria:\n\n1. Patients with histologic diagnosis mNSCLC with PDL1 staining ≥ 50% on standard of care IHC testing\n2. Patients must be eligible for treatment with standard-of-care pembrolizumab\n3. Patients must be 18 years of age or older.\n4. Patients must be capable of providing consent to enrolment and willing to comply with study, treatment and follow-up.\n5. Patients with a performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Oken et al., 1982) will be eligible for enrolment\n6. Women of childbearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 7 days prior to the first dose of pembrolizumab. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.\n7. Patients of childbearing \u002F reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n8. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n9. The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.0\n* Platelet count \\>100\n* Hemoglobin \\>90 mg\u002FdL\n\nRenal:\n\no Serum creatinine \\\u003C3x upper limited of normal (ULN)\n\nHepatic:\n\n* Total serum bilirubin \\\u003C2x ULN\n* AST and ALT \\\u003C3x ULN\n\nCoagulation:\n\no International Normalized Ratio (INR) \\\u003C1.5x ULN (unless patient is receiving anticoagulant therapy and if PT or PTT is within therapeutic range of intended use of anticoagulants)\n\nExclusion Criteria:\n\n1. Concurrent therapy with systemic therapy other than pembrolizumab (such as chemotherapy, targeted therapy, other checkpoint inhibitors, or hormonal therapy).\n2. Treatment plan includes local therapy such as radiation or surgery.\n3. Untreated symptomatic brain metastases, or previously treated brain metastases requiring corticosteroids for symptom control. Patients with untreated asymptomatic brain metastases, where all lesions are \\\u003C 2cm in size with no vasogenic edema, are eligible.\n4. Presence of leptomeningeal disease.\n5. Known history of human immunodeficiency virus (HIV), active Hepatitis B or Hepatitis C. Testing for HIV, HBV or HCV is not mandatory for enrolment to study but may occur at the discretion of the investigator.\n6. Active autoimmune disease that has required systemic treatment in past 12 months (i.e. with use of disease modifying agents, requiring \\>10mg prednisone or equivalent or other immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n7. Participant unwilling to agree to their treatment times being scheduled as per study protocol during the study treatment period (Cycles 1-6).",{"count":462,"type":20},58,[126],"This clinical trial is comparing morning infusions of the study drug (pembrolizumab) to random infusion scheduling for patients with non-small cell lung cancer.\n\nParticipants will be randomized to either the Intervention (Morning Group) where Infusion start times are restricted between 0800 AM and 1000 AM or to the Control (Standard of Care) group where scheduling will occur as standard of care scheduling, in which infusions are scheduled without respect to a specific time of day.\n\nThere are past studies that suggest the timing of treatment may influence immune response and outcomes. This idea is called chronotherapy. Chronotherapy explores the notion that the timing of drug administration in relation to the body's internal clock can optimize treatment effectiveness. The timing of the infusions for the morning group was therefore, chosen based on data from these past studies that looked at circadian variation in immune system function with the intent to focus on similar infusion windows.\n\nThe aim of this study is to provide confirmation that the intervention is possible to achieve and use these results to design a larger study. Circadian timing of drug administration, if effective, would represent an intervention that could improve survival outcomes at no additional cost or apparent increase in toxicity, which is truly rare in oncology.\n\nParticipants are asked to participate in the study intervention for 18 weeks (6 cycles of pembrolizumab), after which participants would continue with ad hoc scheduling as per standard of care.",[135],"2025-12-02",{"date":468,"type":79},"2025-12-08",{"date":470,"type":20},"2026-05",{"date":472,"type":20},"2028-07",{"name":474,"class":220},"AHS Cancer Control Alberta",{"id":476,"slug":477,"hasResults":11,"nctId":478,"briefTitle":479,"officialTitle":480,"acronym":481,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":483,"enrollmentInfo":484,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":221},"100460624","phase-3-standard-maintenance-therapy-smt-vs-local-consolidative-radiation-therapy-and-smt-in-om-nsclc-100460624","NCT05278052","Standard Maintenance Therapy (SMT) vs Local Consolidative Radiation Therapy and SMT in OM-NSCLC","Standard Maintenance Therapy Versus Local Consolidative Radiation Therapy and Standard Maintenance Therapy in 1-5 Sites of Oligometastatic Non-small Cell Lung Cancer (NSCLC): A Phase III Randomized Controlled Trial","TARGET-02","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Patients with ECOG performance status of 0-2\n3. Patients with pathologically proven diagnosis of NSCLC\n4. Patients with 1-5 sites of metastatic disease not including the primary tumor and regional nodes (less than or equal to 3 metastatic lesions in one organ will be eligible and 4 or more metastatic lesions in one organ will be ineligible)\n5. Patients who have received standard duration of systemic therapy (4 - 6 cycles) without progression of the disease\n6. Patients suitable for definitive therapy to the primary disease\n7. All the Oligometastases lesions should be radiologically visible and suitable for ablative doses of radiation in accordance with the dose fractionation regimens specified in the protocol.\n8. Patients who have received ablative radiation therapy or surgery or RFA for metastatic sites at presentation or during systemic therapy will be eligible provided the total number of oligometastatic sites at the time of study entry (treated site included) is less than or equal to five.\n9. Patients who have received palliative RT for symptomatic bony metastases or RFA will also be eligible provided the treated site is under control on imaging. If not controlled, could be eligible for study if further ablative doses of radiation can be delivered according to the treating physician.\n10. Patients who underwent surgical decompression, or stabilization followed by palliative radiation therapy for bony metastases will be eligible in the study provided the treated site is under control on imaging and patient has less than 5 sites of metastases at the time of study entry.\n11. Adequate end organ function CBC\u002Fdifferential obtained within 15 days prior to registration on study, with adequate bone marrow function defined as follows:\n\n    * Absolute neutrophil count (ANC) ≥ 500 cells\u002Fmm3;\n    * Platelets ≥ 50,000 cells\u002Fmm3;\n    * Hemoglobin ≥ 8.0 g\u002Fdl (Use of transfusion or other intervention to achieve Hgb ≥ 8.0 g\u002Fdl is acceptable);\n12. For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration;\n13. Patients willing for written informed consent and must be willing to comply with the specified follow up schedule\n\nExclusion Criteria:\n\n1. Patients with progressive disease after initial standard systemic therapy\n2. Patients with oncogene driver mutations\n3. Patients with more than 5 sites of oligo metastases\n4. Patients with metastatic lesion size of more than 5 cm\n5. Patients with more than three metastatic lesion in one organ\n6. Patients not suitable for definitive radiation therapy to primary disease\n7. Patients not suitable for ablative radiation therapy to metastatic sites\n8. Patients with malignant peritoneal disease\n9. Patients with malignant pleural effusion\n10. Leptomeningeal disease\n11. Brain metastases in the brain stem\n12. Clinical or radiological evidence of spinal cord compression or metastases within 2 mm of spinal cord on MRI\n13. Severe, active co-morbidity defined as follows:\n\n    * Unstable angina and\u002For congestive heart failure requiring hospitalization within the last 6 months;\n    * Transmural myocardial infarction within the last 6 months;\n    * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;\n14. Patients with prior history of radiation therapy to thorax\n15. Patients with previous history of malignancy within last 3 years from the date of diagnosis\n16. Pregnancy","99 Years",{"count":485,"type":20},190,[23],"Standard Maintenance Therapy versus Local Consolidative Radiation Therapy and standard maintenance therapy in 1-5 sites of OligoMetastatic Non-small cell lung cancer (NSCLC): A Phase III Randomized Controlled Trial",[489,135],"Oligometastatic Disease",[491,492,42,493,494],"Local Consolidative Radiation Therapy","Oligometastatic disease","Maintenance therapy","SABR","2025-09-03",{"date":497,"type":79},"2025-09-10",{"date":499,"type":79},"2020-04-20",{"date":501,"type":20},"2028-04-20",{"name":503,"class":504},"Tata Memorial Hospital","OTHER_GOV",{"id":506,"slug":507,"hasResults":11,"nctId":508,"briefTitle":509,"officialTitle":510,"acronym":4,"eligibilityCriteria":511,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":21,"phases":514,"briefSummary":515,"conditions":516,"keywords":517,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":527},"100582432","phase-1-a-study-of-cd8-t-cell-imaging-during-treatment-in-people-with-non-small-cell-lung-cancer-100582432","NCT06863233","A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer","Assessment of Patients Immune Response After Treatment With Engineered Tumor Infiltrating Lymphocyte Therapy Incorporating CD8 PET Imaging","Inclusion Criteria:\n\n* Patient must be 18 years of age or older at the time of signing the informed consent.\n* Patient has a histologically confirmed diagnosis of metastatic non-small cell lung cancer\n* Patient is enrolled in the engineered TIL cell therapy protocol OBX115-23-01, but has not received the treatment yet.\n* Men and women of child-producing potential, use of effective double barrier contraceptive methods during the study, up to 30 days after the last administration of the investigational product.\n* Patient or legally authorized representative provided signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Patient or legally authorized representative provided written authorization for use and disclosure of protected health information.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with a history of splenectomy or significant splenic dysfunction (e.g., as evidenced by splenomegaly or a history of recurrent infections due to impaired immune function)",{"count":513,"type":20},5,[125],"The purpose of this study to learn whether PET\u002FCT (positron emission tomography\u002Fcomputed tomography) scans using an imaging agent (radiotracer) called zirconium Zr 89 crefmirlimab berdoxam is a safe and effective way to identify CD8+ T cells",[132,134,135],[132,134,135,336,518],"24-369","2025-08-11",{"date":521,"type":79},"2025-08-12",{"date":523,"type":79},"2025-03-03",{"date":525,"type":20},"2028-03-03",{"name":336,"class":220},7,{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":532,"acronym":533,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":537,"phases":4,"briefSummary":538,"conditions":539,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":221},"100514963","pilot-study-of-the-contribution-of-fractional-exhaled-nitric-oxide-as-a-prognostic-marker-of-response-to-anti-pd-l1-immunotherapy-in-non-small-cell-lung-cancer-100514963","NCT05985330","Pilot Study of the Contribution of Fractional Exhaled Nitric Oxide as a Prognostic Marker of Response to Anti-PD-L1 Immunotherapy in Non-small Cell Lung Cancer","FENOTYPE","Inclusion Criteria:\n\n* Patients with metastatic NSCLC\n* Patient not previously treated\n* PD-L1 tumor expression \\> 50%, to be treated with immunotherapy alone after validation by a multidisciplinary consultation meeting.\n* Patients over 18 years of age\n* Patient having given his\u002Fher non-opposition\n* Patient who speaks and reads French\n\nExclusion Criteria:\n\n* Patients previously treated for NSCLC\n* Patient with oncogene addiction or a first-line targetable rearrangement\n* Patient not suitable for immunotherapy alone\n* Patient having received corticosteroid treatment in the 15 days prior to FeNO.\n* Patient on inhaled corticosteroid at time of inclusion.\n* Blood eosinophilia \\> 500 \u002Fmm3\n* Patient on 24-hour oxygen therapy\n* Contraindication to immunotherapy\n* Inability to perform FeNO measurement manoeuvres\n* Pregnant, parturient or breast-feeding women\n* Person under judicial protection (curatorship, guardianship)\n* Person subject to limited judicial protection\n* Adult unable to express their non-opposition\n* Patient refusing to participate in the study",{"count":536,"type":20},56,"OBSERVATIONAL","Based on the use of the patient's natural defences, immunotherapy mobilizes the immune system to recognize and destroy cancer cells, and it has revolutionized the treatment of lung cancer.\n\nHowever, the effectiveness of immunotherapy varies from patient to patient. At present, we have no weak markers to predict with certainty the efficacy of immunotherapy treatment in a given individual.\n\nCurrent scientific data identifies a number of molecules produced by the cancer cells and their environment which can be detected by various means (blood tests, breath analysis, etc.).\n\nThe aim of this study is to understand whether the amount of nitric oxide (NO) present in the breath is a more accurate predictor of response to immunotherapy.\n\nParticipation in this study involves breath testing (to measure FeNO (Fractional exhaled Nitric Oxide)) before receiving the first infusion of immunotherapy, and at the follow-up visit after the 4th course of immunotherapy.",[101],"2025-06-19",{"date":542,"type":79},"2025-06-25",{"date":544,"type":79},"2023-09-26",{"date":546,"type":20},"2027-09",{"name":548,"class":220},"Centre Hospitalier Universitaire Dijon",{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":553,"acronym":554,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":537,"phases":4,"briefSummary":558,"conditions":559,"keywords":564,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":221},"100593615","feasibility-study-of-tissue-and-blood-collection-in-oncogene-addicted-and-neoadjuvantly-treated-non-small-cell-lung-cancer-100593615","NCT07008742","Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer","FeStival","Inclusion Criteria (Cohort 1):\n\n1. Age \\>\u002F= 18.\n2. Histologically confirmed locally advanced or metastatic NSCLC\n3. ECOG performance score 0-2\n4. Tier 1 ASCO\u002FAMP NSCLC oncogenic variant identified through routine clinical methods, e.g. EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2, NTRK\n5. Planned to commence targeted therapy (any line of therapy)\n\n   o This includes bispecific antibodies (e.g. amivantamab), and antibody-drug conjugates (e.g. trastuzumab-deruxtecan)\n6. Regular follow-up and monitoring for cancer recurrence per standard of care planned at the enrolling site\n7. Provided written informed consent to participate in the study\n\nInclusion Criteria (Cohort 2)\n\n1. Age \\>\u002F= 18.\n2. Histologically confirmed stage II\u002FIII operable NSCLC\n3. Planned to undergo neoadjuvant CPI-based therapy\n4. Provided written informed consent to participate in the study\n\nExclusion Criteria:\n\n• Patient too medically unstable to commit to sampling required for the study",{"count":557,"type":20},100,"This study aims to determine if it is feasible to collect samples of blood and viable lung cancer tissue in patients with either:\n\n* Stage IV mutation-driven NSCLC\n* Stage II-III NSCLC undergoing neoadjuvant immunotherapy prior to surgery\n\nViable tissue has been defined by the collaborating pathology department as the presence of viable tumour cells, in accordance with recommendations from the International Association or the Study of Lung Cancer.\n\nIn patients with stage IV NSCLC, obtaining adequate samples of viable tissue for advanced testing can be challenging, as sites of cancer that are accessible by biopsy are often small, and contain few viable cancer cells. If obtained, however, viable blood and tissue specimens can be utilised for genetic and other analyses aimed at identifying cancer markers that may offer prognostic information, or that may potentially lead to development of therapies that target these markers in the future.\n\nIn patients with stage II-III NSCLC, the use of immunotherapy prior to surgery has been shown to affect the proportion of viable tumour tissue at the time of surgery, although this needs to be further studied. There is a need to better understand the genetic basis of these tumours to improve response rates to immunotherapy prior to surgery.\n\nThe study will be open for four years in total. The first three years will consist of recruitment and participant follow up, and the fourth year will consist of follow up only. Data analysis will occur in the fifth year when the study is closed.",[560,561,134,135,562,563],"Oncogene-addicted Non Small Cell Lung Cancer","Early-stage Operable Non Small Cell Lung Cancer","Locally Advanced NSCLC - Non-Small Cell Lung Cancer","Stage 2\u002F3 Operable Non Small Cell Lung Cancer",[565,566,567],"tissue","blood","feasibility study","2025-06-13",{"date":570,"type":79},"2025-06-15",{"date":572,"type":79},"2025-06-04",{"date":574,"type":20},"2029-06-01",{"name":576,"class":220},"Royal Marsden NHS Foundation Trust",{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":21,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":598,"locationsCount":221},"100556328","phase-3-stereotactic-body-radiotherapy-for-oligo-progression-metastatic-non-small-cell-lung-cancer-100556328","NCT06523673","Stereotactic Body Radiotherapy for Oligo-Progression Metastatic Non-Small Cell Lung Cancer","Stereotactic Body Radiotherapy (SBRT) for Oligo-Progression During First-Line Chemotherapy in Metastatic Non-Small Cell Lung Cancer (OPPRESS):A Randomized, Controlled, Open-label, Multi-Center Phase 3 Study","OPPRESS","Inclusion Criteria:\n\n* Age ≥ 18 years. Gender is not limited.\n* Histologically and\u002For cytologically confirmed stage IV metastatic NSCLC.\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2.\n* Patients who had prior first-line chemotherapy with clinical benefit lasting for ≥3 months.\n* Driver gene-negative NSCLC patients with oligo-progression during first-line chemotherapy combined with Immune Checkpoint Inhibitors (ICI). Driver gene-positive NSCLC patients, such as epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) fusion positivity, are allowed to enroll if oligo-progression occurred during treatment with first-line chemotherapy combined with bevacizumab ± ICI after failure of Tyrosine Kinase Inhibitor (TKI) therapy.\n* Progressive sites were assessed as ≤5 according to RECIST v1.1 criteria combined with positron emission tomography \u002F computertomography (PET\u002FCT), and all were located extracranially. Progressive lymph node lesions are counted by region, with each lymph node region amenable to concurrent SBRT (which may contain multiple progressive lymph nodes) counted as 1 progressive site.\n* All progressive sites should be visible on radiologic imaging and assessed as suitable for SBRT treatment by a radiotherapist.\n* Intracranial progressive lesions and symptomatic lesions can be treated with palliative radiotherapy and local therapy prior to enrollment and are not counted within the oligo-progressive sites.\n* Expected survival time greater than 3 months.\n* Comprehensive examination completed within 28 days prior to enrollment in the study and a complete blood count\u002Fdifferential, collected within 15 days, showing that the patient has normal internal organ function and normal bone marrow function.\n* Negative serum or urine pregnancy test in females of childbearing age within 14 days prior to study enrollment.\n* Patients are willing to provide written informed consent and must be willing to adhere to the prescribed follow-up schedule.\n\nExclusion Criteria:\n\n* Currently participating in an interventional clinical study treatment that may affect this study, or have been treated with another investigational drug or investigational device that may affect this study within 4 weeks prior to first treatment.\n* Pregnant or lactating women.\n* Progression sites deemed unsuitable for SBRT treatment as assessed by radiotherapy specialists.\n* Presence of untreated intracranial metastases or symptomatic progressive sites.\n* History of malignancy other than NSCLC or untreated primary malignancy within the past 3 years.\n* Serious active comorbidities that would interfere with treatment in this study.\n* History or evidence of disease that could interfere with the results of the trial, prevent the subject from participating in the study throughout, abnormal values of treatment or laboratory tests, or other conditions that, in the opinion of the investigator, make enrollment inappropriate.",{"count":586,"type":20},104,[23],"The goal of this clinical trial is to learn if Stereotactic Body Radiotherapy (SBRT) can treat the oligo-progressive metastatic non-small cell lung cancer (NSCLC) after first-line chemotherapy. The main questions it aims to answer are:\n\nDoes SBRT improve progression-free survival in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy? Does SBRT improve overall survival and quality of life in oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy?\n\nResearchers will compare SBRT in combination with standard of care (SOC) and SOC only to see if SBRT works to treat oligo-progressive metastatic non-small cell lung cancer after first-line chemotherapy.\n\nParticipants will:\n\nTake SBRT in combination with SOC or SOC only. Visit the clinic for checkups and tests as required by the study. Keep a diary of their symptoms and complete the quality of life assessment questionnaire.",[40,590,591],"NSCLC Stage IV","OligoProgressive Metastatic Disease","2024-08-28",{"date":594,"type":79},"2024-08-30",{"date":596,"type":20},"2024-09",{"date":546,"type":20},{"name":599,"class":220},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":601,"slug":602,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":4,"eligibilityCriteria":606,"healthyVolunteers":11,"sex":16,"minAge":607,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":21,"phases":610,"briefSummary":612,"conditions":613,"keywords":614,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":221},"100549008","the-impact-of-probiotic-on-survival-and-treatment-response-in-metastatic-non-small-cell-lung-cancer-patients-100549008","NCT06428422","The Impact of Probiotic on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients","The Impact of Bifidobacterium Lactis Supplementation on Survival and Treatment Response in Metastatic Non-small Cell Lung Cancer Patients Receiving Immunotherapy (Nivolumab)","Inclusion Criteria:\n\n* Volunteering to participate in the study.\n* Histologically confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC).\n* Patients must be in an advanced stage (incurable with surgery or radiotherapy) or have metastatic disease (Stage IV).\n* Male or female patients aged \\>18 years.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status less than 2.\n* Laboratory findings must confirm adequate bone marrow function, indicated by:\n\nWhite Blood Cell (WBC) count \\> 2,000\u002Fmm³, Neutrophil count \\> 1,500\u002Fmm³,Platelet count \\> 100,000\u002Fmm³\n\nExclusion Criteria:\n\n* Previously received treatment with any of the following antibody blockers: anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4.\n* Currently taking probiotic supplements or consuming probiotic bacteria-supported yogurt and similar food supplements.\n* Antibiotic utilization within the past month\n* Active interstitial lung disease or a history of interstitial lung disease requiring systemic steroid treatment.\n* A condition requiring systemic corticosteroids (greater than 10 mg of prednisone daily or equivalent) or who have received immunosuppressive treatment within 14 days prior to the first dose of the study.\n* Presence of uncontrolled adrenal insufficiency.\n* Pregnancy or breastfeeding.\n* Severe congestive heart failure (Class III or higher according to the New York Heart Association Functional Classification) or a history of myocarditis.\n* Uncontrolled cardiac arrhythmia that developed within six months prior to the start of the study.","19 Years","90 Years",{"count":557,"type":20},[611],"NA","The aim of this study is to evaluate the effect of a probiotic supplement containing Bifidobacterium animalis lactis BL-04 on the clinical effectiveness of immunotherapy in patients diagnosed with metastatic non-small cell lung cancer who are receiving immunotherapy.",[101],[615,209,616,617,618],"immunotherapy","probiotics","Bifidobacterium animalis","microbiota","2024-08-14",{"date":621,"type":79},"2024-08-16",{"date":623,"type":79},"2024-08-12",{"date":625,"type":20},"2026-12-20",{"name":627,"class":220},"Necmettin Erbakan University"]