[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-non-squamous-non-small-cell-lung-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-non-squamous-non-small-cell-lung-cancer":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,67,135,158],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100600553","phase-2-trial-investigating-visugromab-in-combination-with-immunochemotherapy-in-1l-treatment-of-participants-with-metastatic-nsclc-100600553",false,"NCT07098988","Trial Investigating Visugromab in Combination With Immunochemotherapy in 1L Treatment of Participants With Metastatic NSCLC","A Ph2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo, in Combination With Pembrolizumab, Pemetrexed, and Carboplatin, in 1L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-01)","Main Inclusion Criteria:\n\n* Histologically confirmed, newly diagnosed stage IV non-squamous NSCLC.\n* Demonstrated absence of actionable mutations (e.g., EGFR, ALK, among others) that suggest\u002Frequire treatment with available targeted agent.\n* Measurable disease determined by the local site Investigator\u002Fradiology by their assessment per RECIST v1.1.\n* Have not received prior systemic treatment for advanced\u002Fmetastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant\u002Fneoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease and did not contain any PD 1\u002FPD L1 directed CPI therapy.\n* Availability of locally determined PD L1 TPS, determined with a test validated for this purpose, from a tumor tissue biopsy obtained after any potential prior systemic treatment for this disease. Participants with PD-L1 TPS ≥ 50% can only be enrolled in case CPI monotherapy is not clinically indicated.\n* Availability of a tissue\u002Fhistological biopsy for translational research investigations and Informed Consent Form (ICF) for biopsy release for translational research signed by participant. The biopsy has to be obtained after any potential prior systemic treatment for this disease and be available for shipment. A cytological sample is not accepted.\n* Age ≥ 18 years on the day of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Adequate organ function (bone marrow, hepatic, renal function and coagulation).\n\nMain Exclusion Criteria:\n\n* Presence of predominantly squamous cell histology or predominantly neuroendocrine histology NSCLC (mixed tumors will be categorized by the predominant cell type) or presence of small cell lung cancer elements (ineligibility independent of percentage).\n* Any acute or chronic major tissue injury that may require maintained GDF 15 function for tissue protection as per Investigator assessment (diagnosed with myocardial infarction, or liver, kidney or other major organ failure, all within \\\u003C 3 months prior to planned treatment start).\n* Major surgery (defined as a surgery which requires general anesthetic and\u002For involves opening of body cavities), within 4 weeks of the first dose of study drug.\n* Received potentially curative radiation therapy to the lung that is \\> 30 Gy within 6 months prior to the first dose of study drug.\n* Received or completed any focal radiotherapy for symptoms within 28 days of the first dose of study drug.\n* Expected to require any other form of antineoplastic therapy while on trial.\n* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and\u002For gastrointestinal obstruction.\n* Known history of prior malignancy with the exception that the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n* Known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and\u002For carcinomatous meningitis. Participants with CNS involvement may be enrolled with mandatory regular imaging of the brain under protocol-defined conditions.\n* Have one of the following cardiovascular risk factors: myocardial infarction in the past 3 months before planned treatment start; uncontrolled heart failure; uncontrolled ventricular arrhythmia; QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex; peri\u002Fmyocarditis in the past 3 months before planned treatment start; history of ischemic stroke in the past 3 months before planned treatment start.\n* Any active autoimmune that has required systemic treatment in the past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.\n* Has interstitial lung disease or a history of non-infectious pneumonitis that required systemic steroids or current pneumonitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial.","ALL","18 Years",{"count":19,"type":20},107,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is an exploratory, signal finding, randomized, placebo-controlled, blinded, multi-center Phase 2b trial of the anti GDF-15 antibody Visugromab (CTL-002) versus Placebo, combined with Immunochemotherapy (ICT: Pembrolizumab, Pemetrexed, Carboplatin) in the first-line treatment of participants with newly diagnosed metastatic non-squamous NSCLC. The trial consists of 3 Parts, a non-randomized Safety-run-in part (Part A) and the subsequent randomized Ph2b trial with 2 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).",[26,27],"Metastatic Non-Squamous Non-Small Cell Lung Cancer","Adult Solid Tumor",[29,30,31],"CTL-002","Visugromab","GDF-15","RECRUITING","2026-06-30",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-08-01",{"date":40,"type":20},"2031-03-31",{"name":42,"class":43},"CatalYm GmbH","INDUSTRY",40,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100611921","phase-2-trial-investigating-visugromab-and-nivolumab-with-or-without-docetaxel-in-2l-treatment-of-participants-with-metastatic-nsclc-100611921","NCT07246863","Trial Investigating Visugromab and Nivolumab With or Without Docetaxel in 2L Treatment of Participants With Metastatic NSCLC","Ph 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab and Nivolumab With or Without Docetaxel Versus Docetaxel in 2L Treatment of Participants With Metastatic NSCLC (GDFATHER-NSCLC-02)","Main Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed diagnosis of stage IV non-squamous NSCLC.\n* Participants must have demonstrated absence of actionable mutations (e.g. EGFR, ALK, among others) that suggest\u002Frequire treatment with available targeted agent.\n* Participants must have failed one line of prior systemic treatment for metastatic NSCLC containing an approved anti PD (L)1 checkpoint inhibitor (CPI). The minimum treatment duration on this regimen must have been 12 weeks exposure for the CPI with no documented progression in this period. Failure of the prior line of systemic treatment for metastatic NSCLC must have occurred under ongoing CPI treatment. Discontinuation of the prior CPI and line of treatment due to AEs, or any other reason than progression\u002Frelapse does not permit enrollment.\n* Participants must have measurable disease determined by the local site Investigator by their assessment per RECIST v1.1.\n* Participants must have life expectancy of at least 3 months as assessed by the Investigator.\n* Participants must have ECOG performance status ≤1.\n\nMain Exclusion Criteria:\n\n* Participants must not have received more than one line of prior systemic treatment for advanced\u002Fmetastatic NSCLC.\n* Participants must not have a prior malignancy requiring treatment.\n* Participants must not have a known or detected clinically active central nervous system (CNS) involvement by NSCLC or other tumors, e.g., with symptomatic metastases and\u002For carcinomatous meningitis\n* Participants must not have any active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).\n* Participants must not have interstitial lung disease or a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis.",{"count":53,"type":20},131,[23],"This is an exploratory, signal-finding, randomized, placebo-controlled, blinded, multi-center phase 2b trial of the anti-GDF-15 antibody Visugromab (CTL-002) at two different dose levels plus Nivolumab with Docetaxel versus Visugromab at the higher dose plus Nivolumab with placebo versus double-placebo with Docetaxel, in participants that receive second-line treatment for non-squamous NSCLC after failure of prior first-line treatment including a CPI (checkpoint inhibitor).\n\nThe trial consists of 3 Parts: an open-label Safety Run-in part (Part A) followed by a subsequent randomized phase 2b part with 4 treatment arms. After the treatment of 15 participants with visugromab at the expansion dose, an interim safety and preliminary efficacy analysis will be conducted (Part B), followed by the treatment of the remaining participants (Part C).",[26,27],[29,30,31],"2026-06-08",{"date":60,"type":36},"2026-06-09",{"date":62,"type":36},"2025-10-07",{"date":64,"type":20},"2031-10-01",{"name":42,"class":43},25,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100551713","phase-2-efficacy--safety-of-olvimulogene-nanivacirepvec--platinum-doublet--physicians-choice-of-immune-checkpoint-inhibitor-compared-to-docetaxel-in-nscl-cancer-100551713","NCT06463665","Efficacy & Safety of Olvimulogene Nanivacirepvec & Platinum-doublet + Physician's Choice of Immune Checkpoint Inhibitor Compared to Docetaxel in NSCL Cancer","A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance","VIRO-25","Inclusion Criteria:\n\n* Male or female 18 years or older.\n* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1.\n* Have histologically or cytologically confirmed advanced or metastatic NSCLC.\n* Histologically confirmed Stage III or IV squamous or nonsquamous \\[American Joint Committee on Cancer (AJCC) 8th edition\\].\n* Received at least 2 cycles and maximum of 6 cycles of front-line platinum-based chemotherapy with ICI-based therapy, regardless of PD-L1 expression.\n* Reached first disease progression by radiological assessment while receiving front-line or maintenance ICI.\n* At least one measurable target tumor lesion anywhere except the brain per RECIST 1.1 by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan.\n* Have adequate renal, hepatic, bone marrow function as well as adequate coagulation tests \\[International Normalized Ratio (INR)\\] and adequate immune function by lymphocyte count.\n* Women of child-bearing potential must have a negative serum pregnancy test prior to initiating study dosing.\n* Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests.\n\nExclusion Criteria:\n\n* Active and untreated urinary tract infection, pneumonia, or other systemic infections.\n* Current symptomatic central nervous system (CNS) metastasis.\n* Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the Investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n* Persistent toxicities \\[Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3\\] caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities.\n* Required the use of additional immunosuppression other than corticosteroids for the management of an adverse event or have experienced recurrence of an adverse event if re-challenged, or currently require maintenance doses of \\>10 mg prednisone or equivalent per day.\n* Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, tecovirimat, or other agents with known anti-vaccinia activities).\n* Underwent major surgery within 4 weeks, or have insufficient recovery from surgical-related trauma or wound healing, prior to the planned first dose of treatment in either Arm.\n* Have received prior virus-based gene therapy or therapy with cytolytic virus of any type.\n* Vaccination against smallpox or monkeypox within 1 year of study therapy.\n* Any non-oncology vaccine therapy used for prevention of infectious diseases, such as seasonal (influenza) vaccinations, corona virus disease (COVID) vaccination or other vaccines, within 2 weeks of the planned first dose of study drug.\n* Clinically significant skin disease as assessed by the Investigator (e.g., severe eczema, psoriasis, or any unresolved skin injury or ulcer).\n* Known hypersensitivity to carboplatin, cisplatin, paclitaxel or nab-paclitaxel, docetaxel, or any of the constituents of Olvi-Vec (i.e., gentamicin).\n* Had severe hypersensitivity (CTCAE Grade ≥ 3) to ICI and\u002For any of its excipients previously.\n* Dementia or altered mental status that would prohibit informed consent, and\u002For psychiatric illness\u002Fsocial situations that might interfere or limit compliance with study requirements.",{"count":76,"type":20},142,[23],"This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.",[80,81,82,83,84,85,86,87],"Advanced Non-squamous Non-small-cell Lung Cancer","Advanced Squamous Non-Small Cell Lung Carcinoma","Metastatic Non-squamous Non Small Cell Lung Cancer","Metastatic Squamous Non-Small Cell Lung Carcinoma","Non-small Cell Lung Cancer","Non-small Cell Lung Cancer Stage III","Non-small Cell Lung Cancer Stage IV","Non-small Cell Lung Cancer Recurrent",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124],"Olvi-Vec","virotherapy","viral therapy","immunotherapy","immunochemotherapy","combination therapy","vaccinia virus","platinum-doublet chemotherapy","pembrolizumab","nivolumab","cemiplimab","atezolizumab","durvalumab","anti-PD-1","anti-PD-L1","carboplatin","cisplatin","docetaxel","neoplasms by site","neoplasms","carcinoma","Neoplasms by Histologic type","Antineoplastic Agents, Phytogenic","Antineoplastic Agents","Antimitotic Agents","Molecular Mechanisms of Pharmacological Action","Immune Checkpoint Inhibitors","NSCLC","NSCL cancer","chemoimmunotherapy","ICI","platinum resensitization","platinum resistant","chemoresistance","resensitize","olvimulogene nanivacirepvec","2026-06-02",{"date":127,"type":36},"2026-06-04",{"date":129,"type":36},"2024-09-26",{"date":131,"type":20},"2029-07",{"name":133,"class":43},"Genelux Corporation",15,{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":157},"100548086","phase-3-jab-21822-combined-with-jab-3312-compared-soc-in-the-first-line-for-treatment-of-advanced-non-small-cell-lung-cancer-with-kras-pg12c-mutation-100548086","NCT06416410","JAB-21822 Combined With JAB-3312 Compared SOC in the First Line for Treatment of Advanced Non-small Cell Lung Cancer With KRAS p.G12C Mutation","An Open-label, Randomized, Positive Control, Multicenter Phase III Clinical Study. Evaluating JAB-21822 Combined With JAB-3312 Compared Tislelizumab Combined With Pemetrexed + Carboplatin in the First Line for Treatment of Advanced Non-squamous Non-small Cell Lung Cancer With KRAS p.G12C Mutation","Inclusion Criteria:\n\n* A signed written informed consent is required before performing any study-related operations\n* Age greater than or equal to 18 years old\n* Histologically or cytologically confirmed locally advanced\u002Fmetastatic, unresectable non-squamous NSCLC with KRAS p. G12C mutation confirmed by the central lab\n* No history of systemic anticancer therapy to the local advanced\u002Fmetastatic disease\n* Expected survival period greater than or equal to 3 months\n* Having at least one target lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Previous (≤2 years) or current solid tumors or hematologic tumors of other pathological types\n* Carry other driver gene mutations with available target therapy, or carry other KRAS mutations\n* Subjects with untreated central nervous system (CNS) metastases were excluded;\n* Uncontrolled pleural effusion, pericardial effusion, and ascites\n* Subjects with impaired heart function or clinically significant heart disease",{"count":143,"type":20},392,[145],"PHASE3","This Phase 3 study will evaluate the efficacy of JAB-21822+JAB-3312 versus tislelizumab (PD-1 Ab) combined with pemetrexed+carboplatin as the first line treatment in subjects with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC).",[80,82],"2025-04-03",{"date":150,"type":36},"2025-04-04",{"date":152,"type":36},"2024-08-07",{"date":154,"type":20},"2027-02-28",{"name":156,"class":43},"Allist Pharmaceuticals, Inc.",37,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":183},"100518291","phase-2-efficacy-and-safety-of-nab-paclitaxel-lenvatinib-pembrolizumab-as-second-line-treatment-in-advanced-nsclc-patients-100518291","NCT06028633","Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients","Efficacy and Safety of Albumin-bound Paclitaxel-Lenvatinib-Pembrolizumab in Advanced Nonsquamous NSCLC Patients After Progression to First-line Anti-PD-1\u002FL1 Inhibitor With Platinum-doublet Chemotherapy","Inclusion criteria\n\n1. Male\u002Ffemale participants who are at least 18 years of age on the day of signing informed consent (ICF) with histologically confirmed diagnosis of metastatic nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study.\n2. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n3. Male participants are eligible to participate the study if they agree to the following during the intervention period and for at least 180 days after the last dose of study intervention:\n\n   Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must agree to use contraception unless confirmed to be azoospermia (vasectomized or secondary to medical cause) as:\n\n   A. Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP) who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n\n   B. Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.\n\n   C. Please note that 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed D. Refrain from donating sperm for at least 120 days after the last dose of Lenvatinib.\n4. Female participant is eligible to participate if she is not pregnant or not breastfeeding, and at least one of the following conditions applies:\n\n   A. Not a woman of childbearing potential (WOCBP).\n\n   B. A WOCBP who agrees to follow the contraceptive method that is highly effective (with a failure rate of \\\u003C1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the treatment period and for at least 120 days after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib, study treatment, and agrees not to donate eggs (ova, oocytes) to others or freeze\u002Fstore these for her own use for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n\n   C. A WOCBP must have negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention.\n\n   D. If a urine test cannot be confirmed as negative (i.e., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n   E. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n5. Participants must have progressed on treatment with an anti-PD-1\u002FL1 mAb administered in combination with platinum doublet chemotherapy concomitantly as first line treatment. Participants who have received Anti-PD-1\u002FPD-L1(either as monotherapy or in combination with chemotherapy) as initial treatment at early-stage or locally advanced NSCLC should NOT be enrolled in this study. Anti-PD-1\u002FPD-L1 treatment progression is defined by meeting all of the following criteria:\n\n   A. Has received at least 2 doses of an approved anti-PD-1\u002FL1 mAb\n\n   B. Has demonstrated disease progression after anti-PD-1\u002FL1 as defined by RECIST v1.1. The initial evidence of PD is to be confirmed by a second assessment no less than 4 weeks from the date of the first documented disease progression, in the absence of rapid clinical progression. Eligible participants should have at least 2 pre-study images as confirmed evidence of PD (assessed by investigator) on treatment of anti-PD-1\u002FL1 mAb before the study intervention.\n\n   C. Progressive disease has been documented within 12 weeks from the last dose of anti-PD-1\u002FL1 mAb,\n6. Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as primary therapy. Subjects who have failed directed therapy are not eligible for the study.\n7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n8. Have measurable disease (at least 1 measurable lesion by CT or MRI) based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.\n9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.\n10. Have a life expectancy of at least 3 months and adequate organ function as defined in the following table.\n11. Have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150\u002F90mmHg and no change in antihypertensive medications within 1 week before treatment initiation.\n\nExclusion Criteria:\n\n1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment initiation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n2. Has received prior therapy at any stage of disease with any anti-VEGF-TKIs (i.e. Bevacizumab, Lenvatinib, Anlotinib, Apatinib, etc.) as monotherapy or in combination with an anti-PD-1\u002FL1 inhibitor.\n3. Has received prior Paclitaxel, Docetaxel or Albumin-paclitaxel as monotherapy or in combination with other therapies at any stage of disease.\n4. Has received prior radiotherapy within 2 weeks of start of study intervention or has received lung radiation therapy \\>30 Gy within 6 months before the first dose of study intervention. Participants 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.\n5. Has had major surgery within 3 weeks prior to first dose of study interventions.\n\n   Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.\n6. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n7. Has radiographic evidence of major blood vessel invasion\u002Finfiltration. In the chest, major blood vessels include the main pulmonary artery, the left and right pulmonary arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the aorta.\n\n   Note: The degree of proximity to major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage\u002Fnecrosis following lenvatinib therapy.\n8. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n9. Has urine protein ≥1 g\u002F24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg\u002FdL) on urine dipstick testing or urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria.\n10. Has a LVEF below the institutional (or local laboratory) normal range, as determined by echocardiogram (ECHO). OR has Prolongation of QTcF interval to \\>480 ms according to ECG.\n11. Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib\n12. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n13. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n14. Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n\n    Note: Medically controlled arrhythmia would be permitted.\n15. 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 to the first dose of study drug.\n16. Has a known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of disease recurrence for 3 years since initiation of that therapy. Note: The requirement for no evidence of disease for 3 years does not apply to the NSCLC for which a participant is enrolled in the study. This time requirement also does not apply to participants who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.\n17. Has known active CNS metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention.\n18. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n19. Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n20. Has an active infection requiring systemic therapy.\n21. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n22. Has a sensitivity to any of the excipients contained in Albumin-paclitaxel and\u002For Lenvatinib.\n23. Has a known history of Human Immunodeficiency Virus (HIV) infection.\n24. Has active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA) or Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.\n\n    Note: Hepatitis B and C screening tests are not required unless:\n    * Known history of HBV and HCV infection\n    * As mandated by local health authority\n25. Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n26. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n27. Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n28. Has had an allogenic tissue\u002Fsolid organ transplant.","75 Years",{"count":167,"type":20},28,[23],"The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression to first-line anti-PD-1\u002FL1 inhibitor with platinum-doublet chemotherapy. All participants will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.",[80,171,82],"Recurrent Non-Squamous Non-Small Cell Lung Cancer","NOT_YET_RECRUITING","2023-09-10",{"date":175,"type":36},"2023-09-13",{"date":177,"type":20},"2023-10",{"date":179,"type":20},"2026-10",{"name":181,"class":182},"Peking University First Hospital","OTHER",1]