[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-nsclc---non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-nsclc---non-small-cell-lung-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,50,72,104,134,156,182],{"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":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100643366","phase-2-olomorasib--pembrolizumab-kras-g12c-mutant-pd-l1-tps-1-49-locally-advanced-or-metastatic-nsclc-100643366",false,"NCT07639242","Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC","Olomorasib Plus Pembrolizumab as First-Line Treatment for KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)","In order to participate in this study a subject must meet all of the eligibility criteria outlined below. Eligibility must be maintained up until the point at which the subject receives treatment for the subject to be considered eligible for treatment.\n\nInclusion Criteria:\n\nIn order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.\n\nWritten informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n\n* Age ≥ 18 years at the time of consent.\n* Eastern Cooperative Oncology Group performance status (ECOG) of 0-2\n* Subjects must have previously untreated, Stage IIIB-IIIC or Stage IV Non-Small Cell Lung Cancer (NSCLC) not amenable to curative intent treatment.\n* Measurable disease according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1 within 28 days prior to treatment\n* Known KRAS G12C mutation identified on tumor tissue or circulating tumor DNA (ctDNA) as determined by molecular testing performed in a CLIA, CAP or other similarly certified laboratory per local guidelines.\n* Subjects must have a known PD-L1 tumor proportion score (TPS) of 1-49% as determined by an IHC assay in a CLIA, CAP, or other similarly certified laboratory as per local guidelines\n\nExclusion Criteria:\n\n• Subject has a serious pre-existing medical condition(s) that, in the judgment of the Investigator, would preclude participation in this study, including interstitial lung disease (ILD) or severe dyspnea at rest and uncontrolled disease-related pericardial effusion or pleural effusion.","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This clinical trial evaluates the combination of olomorasib and pembrolizumab as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a Kirsten Rat Sarcoma Virus (KRAS) G12C mutation and a programmed death-ligand (PD-L1) score between 1% and 49%. The main goal of the study is to determine how long patients live without their cancer worsening after starting treatment, also known as progression-free survival (PFS). Additional goals include evaluating how many patients experience tumor shrinkage or disappearance, how long responses to treatment last, overall survival, and the safety and side effects of the treatment combination. Furthermore, how well the treatment works in patients whose cancer has spread to the brain, outcomes in patients with a lower Eastern Cooperative Oncology Group performance status (ECOG), and whether certain tumor or blood-based biomarkers are associated with treatment response or side effects, if enough patient data is available for analysis.",[26,27,28,29],"Lung Cancer","Lung Cancer (NSCLC)","Locally Advanced NSCLC","Metastatic NSCLC - Non-Small Cell Lung Cancer",[31,32,33,34,35,36],"olomorasib","pembrolizumab","KRAS G12C+mutant","Kirsten Rat Sarcoma Virus G12C+ mutant","programmed death-ligand","PD-L1","NOT_YET_RECRUITING","2026-06-30",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":20},"2026-06",{"date":45,"type":20},"2030-06-21",{"name":47,"class":48},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100578620","phase-2-ctdna-guided-curb-for-opd-mnsclc-on-tki-curb-tki-100578620","NCT06813664","ctDNA-Guided CURB for OPD mNSCLC on TKI (CURB-TKI)","Consolidative Use of Radiotherapy to Block Oligoprogression in Patients With Metastatic Non-Small-Cell Lung Cancer on Tyrosine Kinase Inhibitor","CURB-TKI","Inclusion Criteria:\n\n1. Age 18 or older.\n2. Able to do most daily activities (ECOG 0-2).\n3. Able and willing to sign an informed consent form to join the study.\n4. Metastatic non-small cell lung cancer (NSCLC) with either an EGFR mutation or ALK rearrangement confirmed by imaging and biopsy.\n5. Eligible for second-line therapy or targeted treatment (TKI) if in Group B.\n6. Willing to give a blood sample for ctDNA analysis.\n7. No limit to how many metastatic sites, but up to 5 progressive lesions that do not require immediate treatment.\n8. Prior radiation therapy near progressive lesions is allowed if applicable.\n9. Cancer lesions must be treatable with specific radiotherapy methods (like SBRT or ablative therapy).\n10. Oligoprogressive disease is evaluated independently for each lesion using specific criteria.\n11. Stable brain metastases allowed if asymptomatic and do not require corticosteroids.\n12. Prior treatment with radiation for oligoprogressive lesions is allowed as long as they remain asymptomatic and re-treatment is possible.\n13. Prior non-stereotactic radiation for palliative purposes is allowed, and if the lesion later progresses but is still asymptomatic and does not require immediate therapy, it can count towards the 5 oligoprogressive lesions.\n14. Able and willing to complete quality of life and health utility questionnaires in English, French, or Spanish.\n15. Accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. More than 5 extracranial sites of progressive disease.\n2. Pregnant.\n3. Leptomeningeal disease.\n4. Serious health issues that prevent radiotherapy, like ataxia-telangiectasia or scleroderma.\n5. Prior radiation therapy near the progressive lesion that would prevent treatment with SBRT due to exceeding limits of healthy tissue tolerance.\n6. Any psychological, social, or geographic issues that could make it difficult to comply with the study.\n7. Any other condition that the investigator believes makes participation in the study inappropriate.",{"count":19,"type":20},[23],"This is an open-label, prospective single arm Phase II trial that investigates the role of ablative stereotactic body radiation therapy (SBRT) in oncogene driven metastatic non-small cell lung cancer (mNSCLC) patients with oligoprogressive disease (OPD) on targeted therapy (TKI) followed by circulating tumor DNA (ctDNA) analysis for tailoring targeted therapies.",[29,62],"OligoProgressive Metastatic Disease","2026-05-21",{"date":65,"type":41},"2026-05-22",{"date":67,"type":20},"2026-06-01",{"date":69,"type":20},"2028-04-01",{"name":71,"class":48},"University Health Network, Toronto",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100594486","phase-2-reduced-dose-carboplatin-doublet-chemotherapy--cemiplimab-vs-cemiplimab-monotherapy-in-treatment-naive-older-and-frail-patients-with-metastatic-nsclc-with-pd-l1-50-100594486","NCT07020065","Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 \u003C50%","Reduced-dose Carboplatin-doublet-chemotherapy + Cemiplimab vs Cemiplimab Monotherapy in Treatment Naive Older and Frail Patients With Metastatic NSCLC With PD-L1 \u003C50% A Multicentre Randomized Open-label Phase II Trial","Inclusion Criteria:\n\n* Informed Consent as documented by signature\n* Histologically or cytologically confirmed NSCLC. Mixed histology with small-cell component is not allowed.\n* Metastatic or advanced or recurrent NSCLC without a curative-intent treatment option (surgery or chemo-radiotherapy).\n* PD-L1 \\\u003C50% by local testing (SP 142 excluded)\n* ≥70 years\n* ECOG 0-2\n* G8 screening score of ≤14 and\u002For ineligible for full-dose chemotherapy, defined as doses of carboplatin AUC 5, pemetrexed 500 mg\u002Fm2, paclitaxel 175 mg\u002Fm2, gemcitabine 1200 mg\u002Fm2 (as per Investigator)\n* Life expectancy ≥6 months\n* Patients with a prior malignancy (except NSCLC, see EC 7.2.2 and 7.2.3) and treated with curative intent are eligible if all treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and\u002For no late recurrence, after consultation with CI.\n* Patients with asymptomatic untreated or symptomatic treated CNS metastases are eligible if corticosteroid dose \\\u003C10 mg prednisolone equivalent\u002Fday for at least 7 days\n* Patients must be suitable to receive reduced-dose carboplatin-doublet chemotherapy in combination with immunotherapy including adequate bone marrow, renal and hepatic function as follows:\n\n  * Hemoglobin ≥90 g\u002FL, neutrophils ≥1.5 G\u002FL, Thrombocytes ≥100G\u002FL\n  * Creatinine clearance (Cockroft-Gault) ≥30 mL\u002Fmin\n  * ASAT\u002FALAT ≤2xULN, Bilirubin ≤1.5xULN (≤3xULN for patients with Gilbert's disease),\n* Men agree not to donate sperm or father a child during trial treatment and until 6 months after the last dose of trial treatment\n\nExclusion Criteria:\n\n* Actionable genomic alteration for 1L treatment (EGFR, ALK, ROS1, RET, NTRK, MET Exon14 skipping). Testing is required for any NSQ-NSCLC or patients with SCC and a smoking history of ≤10py.\n* Prior systemic treatment for metastatic NSCLC.\n* Prior chemotherapy and\u002For immunotherapy in curative-intent treatment for locally advanced NSCLC in the past 6 months.\n* Oligometastatic treatment concept with induction systemic therapy and planned LAT to all lesions.\n* High tumor burden with a risk of rapid critical progression, as judged by the Investigator. Careful patient selection is important in order to prevent that patients in the comparator arm are not eligible for receiving add-on reduced-dose chemotherapy anymore if primary progression occurs (e.g., pericardial infiltration, high liver metastasis load etc).\n* Active, treatment-requiring auto-immune disease in the past 2 years other than vitiligo, alopecia, hypothyroidism, type 1 diabetes or diet-controlled celiac disease.\n* History of pneumonitis in the past 5 years.\n* Systemic corticosteroid treatment ≥10 mg\u002Fday of prednisolone-equivalent or any other systemic immunosuppressive medication within 7 days prior to first dose of study intervention (except as needed for chemotherapy premedication or for physiologic corticosteroid replacement)\n* Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first dose of study medication\n* Uncontrolled infection with HIV, hepatitis B or hepatitis C infection\n* Receipt of a live vaccine within 4 weeks of start of study medication\n* Receipt of COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study medication\n* Organ transplant","70 Years",{"count":81,"type":20},156,[23],"Metastatic non-small cell lung cancer is often treated with a combination of chemotherapy and immunotherapy. In patients over the age of 70, some are already in poor health and frail, requiring assistance with daily activities, for example. Older and\u002For frail individuals often do not tolerate standard-dose chemotherapy well, and their risk of side effects is higher than that of younger patients.\n\nFor this reason, the SAKK 18\u002F24 study is investigating how effective and safe chemotherapy is in patients over 70 years of age when the chemotherapy drugs are administered at lower doses than usual. The aim of the study is to find a potentially effective and well-tolerated treatment for older people with metastatic non-small cell lung cancer.",[29],[86,87,88,89,90,91,92,93],"Reduced-dose chemotherapy","Cemiplimab","carboplatin","metastatic NSCLC","PD-L1 \u003C50%","Non-Small Cell Lung Cancer","older and frail patients","phase II","RECRUITING","2026-04-10",{"date":97,"type":41},"2026-04-15",{"date":95,"type":41},{"date":100,"type":20},"2030-09",{"name":102,"class":48},"Swiss Cancer Institute",17,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},"100604448","phase-2-magnesium-supplementation-in-advanced-non-small-cell-lung-cancer-nsclc-100604448","NCT07149649","Magnesium Supplementation in Advanced Non-small Cell Lung Cancer (NSCLC)","Magnesium Supplementation in Addition to Standard Chemo-immunotherapy in Patients With Locally Advanced Unresectable Stage III or Metastatic Stage IV Non-small Cell Lung Cancer (NSCLC). A Double-blind Randomized Multicenter Phase II\u002FIII Study.","Inclusion Criteria:\n\n* Written informed consent according to Swiss law and ICH GCP E6 regulations before registration and prior to any trial specific procedures;\n* Histologically or cytologically confirmed diagnosis of NSCLC (adeno-, squamous-, large cell carcinoma or NSCLC not otherwise specified);\n* Patients planned for systemic first-line therapy with a combination of a carboplatin-based doublet chemotherapy and a PD-1 \u002F PD-L1 targeting immune checkpoint inhibitor;\n* Patients not eligible for immune checkpoint inhibitor monotherapy irrespective of PD-L1 expression;\n* Locally advanced unresectable stage III or metastatic stage IV disease (defined as TNM, according to 8th edition) not eligible for curative surgery and\u002For definitive (curative intended) chemoradiotherapy;\n* No sensitizing EGFR mutation, METex14 skipping mutation, BRAF V600E mutation, ALK\u002FROS1\u002FRET, NTRK1\u002F2 gene rearrangements, HER2 mutations, amplifications detected in primary tumor or metastases;\n* Have not received prior systemic treatment for their metastatic NSCLC. Patients who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for nonmetastatic disease are eligible if the therapy was completed at least 12 months prior to the diagnosis of metastatic disease;\n* Patients with treated and stable CNS metastases are eligible, provided they meet the following criteria:\n\n  * No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed\n  * No stereotactic radiation or whole-brain radiation within 14 days prior to registration.\n* Patients with known HIV-infection, who are at low risk of AIDS-related outcomes, are eligible, provided they meet the following criteria:\n\n  * CD4+ T-cell counts are ≥ 350 cells\u002FųL\n  * No history of AIDS-defining opportunistic infection within past 12 months\n  * Patients have been on antiretroviral therapy (ART) for \\> 4 weeks before registration and have a HIV viral load \\\u003C 400 copies\u002FmL;\n* Patients with a prior malignancy and treated with curative intention are eligible if the treatment of that malignancy was completed at least 2 years before registration and the patient has no evidence of disease at registration. Less than 2 years is acceptable for malignancies with low risk of recurrence and\u002For no late recurrence;\n* Measurable disease per RECIST v1.134);\n* Age ≥ 18 years;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1;\n* Adequate bone marrow function as per local guidelines;\n* Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert's disease ≤ 3.0 x ULN), AST and ALT ≤ 2.5 x ULN, or ≤ 5 x ULN under the assumption that abnormal values are a result of NSCLC;\n* Adequate renal function defined by stable estimated glomerular filtration rate (eGFR) ≥ 45 mL\u002Fmin\u002F1.73 m2 (according to CKD-EPI formula);\n* Women of childbearing potential must use highly effective contraception (see chapter 9.4), are not pregnant or lactating and agree not to become pregnant during trial treatment and until 6 months after the last dose of investigational drug. A negative pregnancy test before inclusion into the trial is required for all women of childbearing potential.\n* Men agree not to donate sperm or to father a child during trial treatment and until 6 months after the last dose of investigational drug.\n\nExclusion Criteria:\n\n* Plasma magnesium concentration \\\u003C 0.4 mmol\u002Fl or \\> 1.2 mmol\u002FL\n* Treatment with any anti-cancer therapy within 21 days prior to registration (excluding hormonal therapy or anti-cancer surgery). Any previous anti-cancer therapy must have been administered with curative intent;\n* Treatment with radiotherapy within 14 days prior to registration (except for local pain control);\n* Patients planned for cisplatin-based chemo-immunotherapy;\n* Treatment with any other experimental drug within 28 days of registration;\n* Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV), unstable angina pectoris, history of myocardial infarction within the last six months, serious arrhythmias requiring medication (with exception of atrial fibrillation or paroxysmal supraventricular tachycardia);\n* Atrioventricular (AV) block of any degree unless being treated with cardiac pacemakers;\n* Bradycardia \\\u003C40\u002Fmin at steady state;\n* Active chronic Hepatitis C or Hepatitis B infection or any uncontrolled active systemic infection, needing antibiotic treatment within 14 days before registration;\n* Known history of tuberculosis, known history of relevant primary immunodeficiency, known history of allogeneic organ transplant, receipt of live attenuated vaccine within 28 days prior to registration;\n* Diagnosis of myasthenia gravis;\n* Concomitant or prior use of immunosuppressive medication within 28 days before registration, with the exceptions of:\n\n  * intranasal and inhaled corticosteroids\n  * systemic corticosteroids ≤ 10 mg\u002Fday of prednisone, or a dose equivalent corticosteroid,\n  * premedication for chemotherapy;\n* Prior treatment with peroral or intravenous magnesium 14 days prior to registration;\n* Patient not willing to stop the use of peroral magnesium treatment including over the counter or lifestyle products;\n* Any concomitant drugs contraindicated for use with the trial drug according to the approved product information;\n* Known hypersensitivity to any of the trial drugs;\n* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.",{"count":112,"type":20},230,[23,114],"PHASE3","This study investigates whether adding magnesium to the standard chemo-immunotherapy for advanced non-small cell lung cancer (NSCLC) can improve treatment outcomes. Magnesium is important for immune function, and low levels during chemotherapy are common. Participants are randomly assigned to receive either magnesium or a placebo, both as infusions and tablets. Neither the participants nor the doctors know who receives which treatment. The study compares the two groups to see if magnesium helps and how well it is tolerated.",[29],[118,119,120,91,121,122,123,124],"Magnesium supplementation","Magnesium aspartate hydrochloride","Placebo","phase II\u002Fphase III","unresectable stage III NSCLC","metastatic stage IV NSCLC","double-blind randomized","2026-03-25",{"date":127,"type":41},"2026-03-27",{"date":129,"type":20},"2026-07",{"date":131,"type":20},"2035-03-31",{"name":102,"class":48},11,{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":49},"100623132","phase-2-phase-ii-trial-of-amivantamab-plus-monochemotherapy-in-platinum-unfit-nsclc-patients-with-egfr-exon20-insertion-mutations-100623132","NCT07392658","Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations.","AMICUTE","Inclusion Criteria:\n\n* Written informed consent;\n* Male or female patient aged ≥18 years;\n* Histologically or cytologically confirmed stage IV or recurrent non-squamous NSCLC harboring EGFR exon20 insertion mutation;\n* No prior systemic treatment;\n* Unfit for platinum-based chemotherapy; Unfit for platinum is defined by a glomerular filtration rate (GFR) value less than 50 ml\u002Fmin\u002FBSA (body surface area) 1.73 m2 (or a CCR value of \\\u003C50 ml\u002Fmin) or age 80 years, presence of neurological disorders or hypersensitivity to platinum.\n* At least one radiological measurable disease according to RECIST criteria version 1.1;\n* Patients with brain metastases are eligible if they are asymptomatic and stable (i.e. without evidence of progression by imaging for at least two weeks prior to the first dose of trial treatment and without deterioration of any neurologic symptoms);\n* Performance status 0-2 (ECOG PS);\n* Patient compliance to trial procedures;\n* Adequate bone marrow function (ANC ≥ 1.5x109\u002FL, platelets ≥75x109\u002FL, haemoglobin \\>9 g\u002Fdl);\n* Adequate liver function (Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits, transaminases no more than 3xULN\u002F\\\u003C5xULN in presence of liver metastases);\n* Normal level of alkaline phosphatase and Serum creatinine \\\u003C1.5 x ULN and creatinine clearance \\>45 mL\u002Fmin as measured or calculated; refer to Appendix --Cockcroft-Gault Formula for Estimated creatinine clearance 12 Patients should be using adequate contraceptive measures, should not be breastfeeding, until 7 months after the last dose, and must have a negative pregnancy test (serum or urine) prior to first dose of study drug (within 72 hours) and must agree to further serum or urine pregnancy tests during the study; or female patients must have an evidence of non-childbearing potential by fulfilling one of the following criteria at screening: Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments; Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.\n\nA participant must be either of the following:\n\n* Not of childbearing potential\n* Of child-bearing potential and practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given\n* Of childbearing potential and practicing 2 methods of contraception, including 1 highly effective user independent method and a second method (examples of highly effective methods of contraception are in section 9.6: Contraceptive Guidance and Collection of Pregnancy Information).\n\nA participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.\n\nA participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person during the study and for 6 months after receiving the last dose of study treatment. A participant who is sexually active with a partner of childbearing potential must agree to use a condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository and their partner must also be practicing a highly effective method of contraception (ie, established use of oral, injected, or implanted hormonal methods of contraception; placement of an intrauterine device \\[IUD\\] or intrauterine hormone-releasing system \\[IUS\\]).\n\nIf the participant is vasectomized, they must still use a condom (with or without spermicide) for prevention of passage of exposure through ejaculation, but their partner is not required to use contraception.\n\nA participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 6 months after receiving the last dose of study treatment.\n\nNote: If the childbearing potential changes after start of the study (eg, participant of childbearing potential who is not heterosexually active becomes active, premenarchal participant experiences menarche) the participant must begin birth control, as described above.\n\nExclusion Criteria:\n\n* Uncontrolled infectious liver disease;\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg) Note: participants with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n* Positive hepatitis C antibody (anti-HCV). Note: participants with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n* Participant is positive for human immunodeficiency virus (HIV), with 1 or more of the following:\n\nReceiving ART that may interfere with study treatment (consult sponsor for review of medication prior to enrollment) CD4 count \\\u003C350 at screening AIDS-defining opportunistic infection within 6 months of start of screening Not agreeing to start ART and be on ART\\>4 weeks plus having HIV viral load \\\u003C400 copies\u002FmL at end of 4-week period (to ensure ART is tolerated and HIV controlled).\n\n-Participant has active cardiovascular disease including, but not limited to: A medical history of deep vein thrombosis or pulmonary embolism within 1 month prior to randomization or any of the following within 6 months prior to randomization: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary\u002Fperipheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated thrombus, incidental or asymptomatic pulmonary embolism, are not exclusionary.\n\n* Uncontrolled (persistent) hypertension: systolic blood pressure \\>160 mm Hg; diastolic blood pressure \\>100 mm Hg.\n* Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class; refer to Appendix 6: New York Heart Association Criteria) within 6 months of randomization.\n* Participant has an uncontrolled illness, including but not limited to:\n\nUncontrolled diabetes Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \\[participants will be required to complete antibiotics 1 week prior to starting study treatment\\] or diagnosed or suspected viral infection.\n\nActive bleeding diathesis Impaired oxygenation requiring continuous oxygen supplementation Psychiatric illness, social situation, or any other circumstances that would limit compliance with study requirements Any ophthalmologic condition that is clinically unstable\n\n* Absence of measurable lesions;\n* Concomitant radiotherapy;\n* Previous treatment with any EGFR Exon20ins-targeted TKIs;\n* Symptomatic or immediately requiring therapy for brain metastases or carcinomatous meningitis. Subjects with asymptomatic and stable or treated brain metastases may participate;\n* Participant has concurrent or prior malignancy other than the disease under study. The following exceptions require consultation with the Medical Monitor:\n\n  1. Non-muscle invasive bladder cancer (NMIBC) treated within the last 24 months that is considered completely cured.\n  2. Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.\n  3. Non-invasive cervical cancer treated within the last 24 months that is considered completely cured.\n* Participant had major surgery excluding placement of vascular access or tumor biopsy, or had significant traumatic injury within 4 weeks before randomization, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.\n\nNote: Participants with planned surgical procedures to be conducted under local anesthesia may participate.\n\n* History of extensive disseminated\u002Fbilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis;\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV);\n* Pregnancy or lactating female;\n* Other serious illness or medical condition potentially interfering with the study.","99 Years",{"count":143,"type":20},33,[23],"To assess safety and efficacy of amivantamab plus monochemotherapy in terms of ORR, PFS and OS in subjects with EGFR exon20 insertion mutations metastatic non-small cell lung cancer unfit for platinum-based chemotherapy.",[29],"2026-02-05",{"date":149,"type":41},"2026-02-06",{"date":151,"type":41},"2025-12-02",{"date":153,"type":20},"2028-10",{"name":155,"class":48},"Fondazione Ricerca Traslazionale",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":166,"studyType":167,"phases":4,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":49},"100620914","large-granular-lymphocytes-in-mnsclc-treated-with-nivolumab-100620914","NCT07363811","Large Granular Lymphocytes in mNSCLC Treated With Nivolumab","Large Granular Lymphocytes as a Prognostic Factor in Metastatic Non-small Cell Lung Cancer Treated With Nivolumab","Inclusion Criteria:\n\n* Histological and staging diagnosis of metastatic non-small cell lung cancer\n* ECOG performance score between 0 and 2\n* No contraindications for nivolumab\n\nExclusion Criteria:\n\n* Patients diagnosed with mNSCLC who received nivolumab as adjuvant or perioperative therapy\n* Those with a second primary malignancy undergoing active treatment\n* Those who have not signed the informed consent form\n* Those with additional hematological malignancies such as leukemia, lymphoma, or myelodysplastic syndrome\n* Those who have undergone palliative or curative radiotherapy within the last three months\n* Those with active viral\u002Fbacterial infections before nivolumab treatment\n* Patients who have used steroids in the last three months","90 Years",{"count":165,"type":20},50,"24 Months","OBSERVATIONAL","Large granular lymphocytes (LGLs), which constitute 10-15% of peripheral blood mononuclear cells, are large lymphocytes with a round nucleus, large cytoplasm, and azurophilic granules in the cytoplasm.\n\nMost normal LGLs in peripheral blood are natural killer (NK) cells, but some are T lymphocytes. These cells cannot be measured by a standard complete blood count (CBC) test. These cells, which can be detected by peripheral smear, are expressed numerically and as a percentage relative to other cells. The aim of this study is to determine the relationship between the percentage of LGLs at baseline and at three months and the response and clinical parameters in participants with metastatic non-small cell lung cancer treated with nivolumab in second-line therapy.",[29],[171,172],"Large granular lymphocyte","Nivolumab","2026-01-23",{"date":175,"type":41},"2026-01-26",{"date":177,"type":41},"2025-07-01",{"date":179,"type":20},"2027-06-01",{"name":181,"class":48},"Necmettin Erbakan University",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":197,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":210},"100505273","phase-2-a-study-of-combining-cabozantinib-and-atezolizumab-for-advancedmetastatic-nsclc-cabatezo-1-100505273","NCT05859217","A Study of Combining Cabozantinib and Atezolizumab for Advanced\u002FMetastatic NSCLC (Cabatezo-1)","A Multi-center Phase II Study of Combining Cabozantinib and Atezolizumab as the 1st Line Therapy for PD-L1 Negative Advanced\u002FMetastatic NSCLC (Cabatezo-1)","Cabatezo-1","INCLUSION CRITERIA:\n\n* Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Males and females age ≥ 18 years\n* ECOG Performance Status 0 - 1\n* Pathologically confirmed advanced\u002Fmetastatic NSCLC, with PD-L1\\\u003C1% based on IHC using 22C3 antibody\n* At least one target lesion that can be assessed by RECIST 1.1\n* For candidates who are not qualified for upfront FDA-approved targeted therapy, must be systemic treatment naïve (local palliative RT more than 4 weeks prior is allowed)\n* For candidates who are qualified for upfront FDA-approved targeted therapy (e.g. having sensitizing mutations in EGFR, ALK and BRAF, etc.), treatment must have failed and received at least one line of ONLY FDA-approved targeted therapy\n* Availability of a representative tumor specimen for correlative research. Optional but highly recommended: willing to undergo tumor tissue biopsy only if deemed safe and feasible by the investigator.\n* Recovery to baseline or ≤ Grade 1 CTCAE v5 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and\u002For stable on supportive therapy.\n* Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment. Female participants are considered to be of childbearing potential unless one of the following criteria is met: documented permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes. In addition, females \\\u003C 55 years-of-age must have a serum follicle stimulating (FSH) level \\> 40 mIU\u002FmL to confirm menopause). Note: Documentation may include review of medical records, medical examinations, or medical history interview by study site.\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence or to use two forms of adequate contraception (hormonal AND barrier method of birth control) prior to study entry, for the duration of study participation and for 6 months following completion of therapy.\n* Men of child-bearing potential must not father a child or donate sperm while on this study and for 6 months after the last study treatment.\n* Adequate organ function\n* Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy, have a CD4 count \\>200\u002FuL, and have an undetectable viral load. They must agree to continue on such anti-retroviral therapy per local standard treatment guideline\n* Negative HBV and HCV tests at screening, with the following exception:\n\n  * For HBV: DNA must be \\\u003C 500 IU\u002FmL (or must be \\\u003C 2500 copy\u002FmL if copy\u002FmL is the only unit available in the study site; if the normal ranges of the study sites are different, the positive standard must not be met), and have received anti-HBV therapy for at least 14 days prior to the first dose of study treatment (treatment in accordance with local standard of care, e.g., entecavir) and are willing to receive antiviral therapy throughout the study if indicated;\n  * For HCV (with positive HCV RNA): must receive anti-viral therapy in accordance with the local standard treatment guideline and hepatic function resolve to CTCAE Grade ≤1\n\nEXCLUSION CRITERIA:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other investigational agents while participating in this study\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Patients harboring targetable mutations (e.g., EGFR, ALK and BRAF, etc.) who have not had at least one frontline targeted therapy fail, or have received other systemic therapies (e.g. chemotherapy, immunotherapy, etc.)\n* Patients with carcinomatous meningitis (leptomeningeal metastasis)\n* Undergone major surgery within 2 weeks prior to the start of study regimen, or has not achieved complete wound healing\n* Presence of another cancer with disease manifestations or therapy that could adversely affect participant safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results. Otherwise, patients can be considered eligible, for example, locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n* Prior treatment with cabozantinib and\u002For atezolizumab.\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* Receipt of any type of cytotoxic, biologic or other systemic anticancer therapy (including investigational) within 4 weeks before first dose of study treatment\n* Radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before first dose of study treatment. Participants with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and\u002For surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible participants must be neurologically asymptomatic and with corticosteroid no more than 10mg prednisone or equivalent at the time of first dose of study treatment.\n* Concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel). Allowed anticoagulants are the following:\n\n  * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n  * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors such as rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* Live, attenuated vaccines (e.g., FluMist) are prohibited within 4 weeks prior to initiation of study treatment, during treatment with atezolizumab, and for 5 months after the last dose of atezolizumab.\n* The participant has uncontrolled, significant cardiovascular disorders\n* Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of study treatment\n* Lesions invading or encasing any major blood vessels.\n* Other clinically significant disorders that would preclude safe study participation\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose of study treatment. Participants must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Participants with clinically relevant ongoing complications from prior surgery are not eligible\n* Pregnant or lactating females.\n* Inability to swallow tablets or unwillingness or inability to receive IV administration.\n* Previously identified allergy or hypersensitivity to Chinese hamster ovary cell products, or components of the study treatment formulations or history of severe infusion-related reactions to monoclonal antibodies.\n* Uncontrolled tumor-related pain\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters (e.g., PleurX) are allowed.\n* Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, calcium \\> 12 mg\u002FdL or corrected serum calcium \\> ULN)\n* Active or history of autoimmune disease or immune deficiency (see Appendix I), including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis.\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results",{"count":191,"type":20},40,[23],"NSCLC patients with low expression level of PD-L1, esp. those with its level less than 1%, do not derive much benefit from anti-PD-1\u002FL1 therapy (e.g. atezoilzumab). In this study, investigators hypothesize that the combination of cabozantinib (a multi-kinase inhibitor) and atezolizumab will result in better therapeutic value.",[26,195,29,196],"NSCLC Stage IV","Advanced NSCLC",[198,199,200],"Cancer immunotherapy","anti-angiogenesis","Investigator-initiated clinical trial","2024-05-06",{"date":203,"type":41},"2024-05-08",{"date":205,"type":20},"2024-12",{"date":207,"type":20},"2028-06",{"name":209,"class":48},"Jun Zhang, MD, PhD",4]