[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nsclc-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nsclc-stage-iii":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,48,76,104,129,150,172,200,225,254,276],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100558524","phase-2-phase-ii-efficacy-study-of-repotrectinib-in-frail-andor-elderly-patients-with-ros1-rearranged-advanced-nsclc-100558524",false,"NCT06552234","Phase II Efficacy Study of Repotrectinib in Frail and\u002For Elderly Patients With ROS1-rearranged Advanced NSCLC","Open-label Phase II Efficacy Study of Repotrectinib in Frail (PS ≥2) and\u002For Elderly Patients With ROS1-rearranged Advanced NSCLC","REPOROS","Inclusion Criteria:\n\n* Eligible patients are defined as patients with\n\n  * Eastern Cooperative Oncology Group (ECOG) PS ≥ 2 at the time of inclusion and\u002For\n  * Age ≥ 70 years\n* Age ≥ 18 years\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an ROS1 gene rearrangement as by any nucleic acid-based diagnostic testing method (e.g., next-generation sequencing \\[NGS\\], Sanger sequencing, reverse transcription-polymerase chain reaction), Break-apart fluorescence in situ hybridization (FISH) or Immunohistochemistry (IHC) (confirmed by NGS or qPCR test).\n* Willing and able to provide written institutional review board (IRB)\u002Finstitutional ethics committee-approved Informed Consent.\n* At least 1 measurable target lesion according to RECIST (v1.1). CNS-only measurable disease as defined by RECIST (v1.1) is allowed.\n* Prior cytotoxic chemotherapy for advanced or metastatic disease is allowed. At the time of starting treatment with repotrectinib, at least 14 days or 5 half-lives (whichever is shorter) must have elapsed after discontinuation of prior cytotoxic chemotherapy (or at least 42 days for prior nitrosoureas, mitomycin C, and liposomal doxorubicin) and all side effects from prior treatments must have resolved to grade ≤ \\_1 (CTCAE Version 5.0 with the exception of alopecia.\n* Prior immunotherapy (e.g., anti-PD-1, anti-PDL1, anti-TIM3, anti-OX40) is allowed. At the time of starting treatment with repotrectinib, at least 14 days must have elapsed after discontinuation of prior immunotherapy treatment and all immune-related side effects from prior treatments must have resolved to grade ≤ \\_1.\n* No prior ROS1 TKI is allowed for the TKI naïve cohort.\n* Prior ROS1 TKI is allowed for the TKI pretreated cohort (max 30% of patients). At least 7 days or 5 half-lives (whichever is shorter) must have elapsed since completion of treatment with the last ROS1i prior to starting treatment with repotrectinib for subjects enrolling into the TKI-pretreated expansion cohorts. All side effects from prior treatments with ROS1i must have resolved to grade ≤ \\_1 prior to starting treatment with repotrectinib.\n\n  * Prior ROS1i allowed include crizotinib, ceritinib, lorlatinib, brigatinib, entrectinib, ensartinib, cabozantinib.\n* Subjects with symptomatic CNS metastases and\u002For asymptomatic leptomeningeal carcinomatosis are eligible.\n* Life expectancy ≥3 months\n* Subject affiliated to an appropriate social security system\n* Adequate hematologic and end-organ function, defined by the following laboratory\n\n  * ANC ≥ 1500 \u002Fmm3 without granulocyte colony-stimulating factor support\n  * Lymphocyte count ≥ 500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3 without transfusion\n  * Hemoglobin ≥ 9.0 g\u002FdL. Patients may be transfused to meet this criterion.\n  * INR or aPTT ≤ 1.5, upper limit of normal (ULN)\n  * This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be receiving a stable dose.\n  * ASAT, ALAT, and alkaline phosphatase ≤ 2.5xULN, with the following exceptions:\n  * Patients with documented liver metastases: ASAT and\u002For ALAT ≤ 5xULN\n  * Patients with documented liver or bone metastases: alkaline phosphatase \\\u003C 5xULN\n  * Serum bilirubin ≤1.25xULN\n  * Patients with known Gilbert disease who have serum bilirubin level ≤ 3xULN may be enrolled.\n  * Calculated creatinine clearance (CRCL) ≥ 45 mL\u002Fmin\n* Adequate method of contraception during the treatment period\n\n  * For Females:\n\nAll women of childbearing potential (WOCBP) must agree to avoid pregnancy during the study and must use a highly effective method of contraception during study treatment with repotrectinib and for at least 2 months following the final dose.\n\nHighly effective contraceptive methods consist of prior sterilization, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), injectable or implantable contraceptives and abstinence.\n\nHormonal contraception must begin 7 days prior to the first dose of study treatment.\n\nDue to a potential loss of effectiveness of hormonal contraceptives caused by interaction with study intervention, if WOCBP use hormonal contraceptives (including oral hormonal contraceptives), they must use either another form of non-hormonal highly effective contraception or a reliable barrier method.\n\nFemale subjects must refrain from egg donation from screening through at least 2 months after the last dose of study drug.\n\n* For Males:\n\nMale participants with WOCBP partners must use latex condoms during treatment with repotrectinib and for 4 months following the final dose even if the participant has undergone a successful vasectomy or if the partner is pregnant or breastfeeding.\n\nMale subjects must refrain from sperm donation from screening through at least 4 months after the last dose of study drug\n\nExclusion Criteria:\n\n* Malignancies other than NSCLC within 2 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS ≥ 90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous-cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\n* Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[HBcAb\\] and absence of HBsAg) are eligible only if they are negative for HBV DNA. Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR is negative for HCV RNA.\n* Active tuberculosis\n* Severe infections within 2 weeks prior to inclusion, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to inclusion, unstable arrhythmias, or unstable angina\n* Major surgical procedure other than for diagnosis within 28 days prior to inclusion or anticipation of need for a major surgical procedure during the course of the study\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* Patients with illnesses or conditions that interfere with their capacity to understand follow and\u002For comply with study procedures.\n* Concurrent participation in any therapeutic clinical trial\n* Patient deprived of liberty or placed under the authority of a tutor or a curator\n* Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","ROS1 rearrangements are rare, accounting for only 1-2% of NSCLC cases, but have been associated with response to ROS1 inhibitors, such as crizotinib and entrectinib. However, many patients develop resistance to the tyrosine-kinase inhibitors (TKIs), creating a need for new treatments.\n\nRepotrectinib is a new-generation TKI designed against ROS1 or NTRK rearranged malignancies (Drilon 2018). Early phase clinical data support activity of repotrectinib in patients with NSCLC harboring such gene rearrangements (TRIDENT-1 study), but there are limited evidence in frail populations, such as poor performance status patients and\u002For elderly patients, who are classically excluded from clinical trials or underrepresented.\n\nThe present study aims to assess the activity and tolerability of repotrectinib in frail (PS ≥2) and\u002For elderly patients with ROS1-rearranged advanced NSCLC.",[27,28],"NSCLC Stage IV","NSCLC, Stage III",[30,31,32,33,34],"tyrosine-kinase inhibitors","Frail patients","Elderly patients","ROS1 rearrangements","resistance","RECRUITING","2026-06-15",{"date":38,"type":39},"2026-06-16","ACTUAL",{"date":41,"type":39},"2024-10-01",{"date":43,"type":21},"2031-09",{"name":45,"class":46},"Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer","OTHER",20,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100637461","phase-2-shr-1701-for-induction-and-consolidation-therapy-in-unresectable-stage-iii-non-small-cell-lung-cancer-100637461","NCT07619911","SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer","SHR-1701 for Induction and Consolidation Therapy in Unresectable Stage III Non-Small Cell Lung Cancer: A Randomized, Phase II Clinical Trial","Inclusion Criteria:\n\n* Age ≥18 years, male or female.\n* Baseline ECOG performance status 0-1.\n* Histologically or cytologically confirmed unresectable stage III NSCLC\n* Life expectancy ≥3 months\n* No prior anti-tumor therapy\n* No known EGFR\u002FALK\u002FROS1 sensitive mutations\n* At least one measurable lesion according to RECIST v1.1\n* Adequate organ function\n* Signed informed consent\n\nExclusion Criteria:\n\n* Mixed small-cell and non-small-cell lung cancer histology\n* Known EGFR\u002FALK\u002FROS1 mutations\n* Prior systemic anti-cancer therapy within 4 weeks\n* Active autoimmune disease requiring systemic treatment\n* Active infection including uncontrolled HBV, HCV or HIV infection\n* Significant cardiovascular disease\n* Uncontrolled hypertension\n* Pregnancy or breastfeeding\n* Participation in another interventional clinical trial",{"count":56,"type":21},84,[24],"This randomized phase II exploratory clinical study aims to evaluate the efficacy and safety of SHR-1701 in patients with unresectable stage III non-small cell lung cancer (NSCLC). A total of 84 eligible patients will be randomized 1:1 into an induction immunotherapy group or a consolidation immunotherapy group. Group A will receive SHR-1701 combined with platinum-based chemotherapy as induction therapy followed by concurrent chemoradiotherapy (cCRT) and subsequent SHR-1701 consolidation therapy, while Group B will receive standard cCRT followed by SHR-1701 consolidation therapy. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety outcomes.",[60,61,62],"NSCLC Stage III","SHR-1701","Chemoradiotherapy",[64,61,65],"NSCLC","chemoradiotherapy","NOT_YET_RECRUITING","2026-05-27",{"date":69,"type":39},"2026-06-02",{"date":71,"type":21},"2026-07",{"date":73,"type":21},"2030-12",{"name":75,"class":46},"Fudan University",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100407443","phase-3-personalized-escalation-of-consolidation-treatment-following-chemoradiotherapy-and-immunotherapy-in-stage-iii-nsclc-in-stage-iii-nsclc-100407443","NCT04585490","Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC in Stage III NSCLC","Personalized Escalation of Consolidation Treatment Following Chemoradiotherapy and Immunotherapy in Stage III NSCLC","Inclusion Criteria:\n\n1. Histologically- or cytologically-documented NSCLC presenting with locally-advanced, unresectable stage III disease (Version 8 of AJCC Staging Manual) or NSCLC with locoregional recurrence after previous definitive treatment.\n2. For stage III or recurrent disease, must have completed platinum-based chemotherapy and radiation therapy to all known tumor sites (60 Gy +\u002F- 10%). Must not have known progression of disease.\n3. Must be receiving consolidation durvalumab following completion of radiation and chemotherapy, and less than 32 weeks has elapsed from their first dose of durvalumab. (Patients may sign consent for study before start of durvalumab, but confirm eligibility and enroll only after first dose of durvalumab is received).\n4. Able to potentially receive further consolidation chemotherapy plus durvalumab and tremelimumab, but not be currently intended to receive additional systemic consolidation chemotherapy apart from this durvalumab.\n5. Pre-treatment tumor tissue or tumor DNA sample is believed to be available for analysis\n6. Aged 18 years or older\n7. Weight \\> 30kg\n8. Life expectancy ≥ 12 weeks\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n10. Absolute neutrophil count \\> 1.0 x 109\u002FL (1000\u002Fmm3)\n11. Platelets \\> 75 x 109\u002FL (100,000\u002Fmm3)\n12. Hemoglobin ≥ 9.0 g\u002FdL (5.59 mmol\u002FL)\n13. Measured creatinine clearance \\> 40 mL\u002Fmin, by either 24 hour urine collection or the Cockcroft Gault formula\n\n    Males:\n\n    Mass(kg) x (140-Age) \u002F 72 x serum creatinine (mg\u002FdL)\n\n    Females:\n\n    Mass(kg) x (140-Age) x 0.85 \u002F 72 x serum creatinine (mg\u002FdL)\n14. Serum bilirubin ≤ 1.5 x upper limit of normal (ULN). This will not apply to subjects with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of hemolysis or hepatic pathology) who will be allowed in consultation with their physician.\n15. aspartate aminotransferase (AST) (SGOT)\u002FAlanine Aminotransferase (ALT) (SGPT) ≤ 2.5 x institutional upper limit of normal (ULN) unless liver metastases are present, in which case it must be ≤ 5 x ULN\n16. Ability to understand and the willingness to sign the written IRB approved informed consent document.\n\nExclusion Criteria:\n\nInvolvement in the planning and\u002For conduct of the study\n\n2\\. Previous enrollment or randomization in the present study\n\n3\\. Received Investigational product as part of another clinical study\n\n4\\. Mixed small cell and non small cell lung cancer histology\n\n5\\. History of another primary malignancy and currently undergoing active treatment.\n\nException: May participate if receiving adjuvant endocrine therapy for breast or prostate cancer.\n\n6\\. Current or prior use of immunosuppressive medication within 14 days before enrollment, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.\n\n7\\. Any unresolved toxicity CTCAE \\> Grade 2 from the prior chemoradiation therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.\n\n* Subjects with Grade ≥ 2 neuropathy will be evaluated on a case by case basis after consultation with the Protocol Director \u002F Principal Investigator\n* Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by treatment with durvalumab may be included (ie, hearing loss) only after consultation with the Protocol Director \u002F Principal Investigator.\n\n  8\\. Any prior Grade ≥ 3 immune related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE \\> Grade 1) that may limit subject from continuing durvalumab during the study\n\n  9\\. Recent major surgery within 4 weeks prior to entry into the study (excluding the placement of vascular access) that would prevent administration of study drug.\n\n  10\\. Active or prior documented autoimmune or inflammatory disorders which is likely to limit the subjects ability to continue durvalumab on the study (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \\[granulomatosis with polyangiitis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis; etc\\]). Those with history of autoimmune or inflammatory disorders who are currently tolerating durvalumab may be eligible to participate with approval from the PI. The following are also exceptions to this criterion:\n  1. Vitiligo or alopecia\n  2. Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\n  3. Chronic skin condition not requiring systemic therapy\n  4. Celiac disease controlled by diet alone\n\n     11\\. History of primary immunodeficiency\n\n     12\\. History of organ transplant requiring therapeutic immunosuppression\n\n     13\\. History of hypersensitivity to carboplatin, pemetrexed, paclitaxel, or nab-paclitaxel that is likely to prevent re-administration of these agents\n\n     14\\. Active infection including but not limited to:\n* Grade 3 or higher clinically significant infection\n* Active known Hepatitis B \\[known positive results for HBV surface antigen (HBsAg) within 2 months prior to enrollment\\]. EXCEPTION: Subjects with a past or resolved HBV infection, defined as the presence of hepatitis B core antibody (anti-HBc) and absence of HBsAg are eligible\n* Active known Hepatitis C (HCV). EXCEPTION: Subjects positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA\n* Active known tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n* Active known HIV infection\n\n  15\\. Receipt of live attenuated vaccine within 30 days prior to the first dose of concurrent chemotherapy and durvalumab. Note: Subjects, if enrolled, should not receive live vaccine through 30 days after the last dose of chemotherapy concurrent with durvalumab.\n\n  16\\. Uncontrolled intercurrent illness, including but not limited to:\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Uncontrolled hypertension\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Interstitial lung disease\n  * Serious chronic gastrointestinal conditions associated with diarrhea\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.\n\n    17\\. Female subjects who are pregnant or breast feeding; or subjects of reproductive potential of any gender who are not employing or who do not agree to employ an effective method of birth control prior to trial enrollment.ollment.",{"count":84,"type":21},48,[86],"PHASE3","The purpose of this study is to test whether or not number of circulating cancer cells detected in the blood can be decreased the by combining the standard treatment (durvalumab) with Tremelimumab and additional chemotherapy",[89,28,90],"Non Small Cell Lung Cancer","Nsclc",[92,93],"durvalumab","tremelimumab","2026-04-28",{"date":96,"type":39},"2026-05-04",{"date":98,"type":39},"2021-08-25",{"date":100,"type":21},"2028-04",{"name":102,"class":46},"Maximilian Diehn",1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":103},"100624541","phase-2-efficacy-of-anti-ctla-4-antibody-combined-with-sintilimab-and-chemotherapy-as-neoadjuvant-therapy-for-resectable-stage-ii-iii-non-small-cell-lung-cancer-100624541","NCT07410975","Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer","Efficacy of Anti-CTLA-4 Antibody Combined With Sintilimab and Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III Non-Small Cell Lung Cancer: A Phase II, Single-Arm Clinical Study","INCLUSION CRITERIA\n\n1. The patient shall sign the informed consent.\n2. Age ≥ 18 years.\n3. Histologically or cytologically confirmed non-small-cell lung cancer (NSCLC).\n4. No prior anticancer therapy, including (but not limited to) chemotherapy, immunotherapy or radiotherapy. Traditional Chinese medicine given for anticancer intent is permitted provided it was discontinued ≥ 2 weeks before first dose.\n5. Investigator-assessed resectable Stage II-IIIB (N3 excluded) NSCLC per AJCC 9th.\n6. Non-squamous NSCLC: no EGFR mutation, ALK rearrangement or any other driver mutation with an approved targeted agent. Squamous NSCLC: no known EGFR mutation, ALK rearrangement or other actionable driver mutation.\n7. PD-L1 expression negative (22C3 or E1L3N).\n8. ECOG performance status 0 or 1.\n9. Adequate organ function within 7 days before first dose:\n\n   * Haemoglobin ≥ 90 g\u002FL (no transfusion within 28 days)\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL\n   * Platelet count ≥ 100 × 10⁹\u002FL (no platelet transfusion or IL-11 within 14 days)\n   * Creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault)\n   * Total bilirubin ≤ 1.5 × ULN (≤ 2.5 × ULN in Gilbert's syndrome or hepatic metastases)\n   * ALT and AST ≤ 3 × ULN\n   * INR or aPTT ≤ 1.5 × ULN\n   * FEV\\> 2L, FEV1\\> 1L, FEV1\u002FFVC ≥ 70%, DLCO ≥ 70% predicted; or Investigator determination that pulmonary reserve is adequate for planned surgery.\n10. Fertile female must have a negative serum pregnancy test within 7 days before first dose.\n11. Fertile female and male patients with female partners of childbearing potential must use a highly effective contraceptive method (annual failure rate \\\u003C 1 %) from 7 days before first dose until 24 weeks after the last dose.\n\nEXCLUSION CRITERIA\n\n1. Major thoracic or abdominal surgery within 28 days before first dose or incomplete recovery from previous surgery.\n2. Participants who were systemically treated with corticosteroids (prednisone or other corticosteroids \\>10 mg\u002Fday) or other immunosuppressive agents for ≥ 7 consecutive days within 14 days before first dose. Except for inhaled or topical corticosteroids, or corticosteroid therapy at physiological replacement doses for adrenal insufficiency; short- courses (\\\u003C7 days) corticosteroid use is permitted for the prevention or treatment of non-autoimmune conditions;\n3. Participants who received live vaccines (including live attenuated vaccines) within 28 days before first dose.\n4. Current or prior interstitial pneumonia or pulmonary diseases requiring systemic glucocorticoids.\n5. Presence of any active autoimmune disease or history of autoimmune disease. Except in the following cases: Type 1 diabetes, stable hypothyroidism under hormone replacement therapy, psoriasis or vitiligo not requiring systemic treatment.\n6. Other malignancy within 5 years before first dose, except for tumors assessed by the investigator as cured.\n7. Uncontrolled comorbidities, including:\n\n   * Active hepatitis B (HBsAg positive and HBV DNA \\> 500 IU\u002FmL or \\> 2000 copies\u002FmL) or hepatitis C (HCV antibody and HCV RNA positive). Subjects with HBV DNA ≤ 500 IU\u002FmL who agree to antiviral prophylaxis are eligible.\n   * Known HIV infection or history of AIDS.\n   * Active tuberculosis.\n   * Active infection requiring systemic antibiotics for \\> 7 days within 28 days before first dose.\n   * Clinically significant cardiovascular disease: cerebrovascular accident within 6 months, symptomatic heart failure (NYHA class II-IV), unstable angina or myocardial infarction within 6 months, risk of QTc prolongation or arrhythmia.\n   * Urine protein qualitative≥ 2+, and 24-hour urine protein test \\> 1g\n8. History of allogeneic haematopoietic stem-cell or solid-organ transplantation.\n9. Hypersensitivity to antibody therapies (≥ grade 3 NCI-CTCAE v6.0), history of anaphylaxis, uncontrolled asthma, or significant drug allergies.\n10. Pregnancy or lactation.\n11. Other conditions that may affect the safety or compliance of drug therapy in this study include, but are not limited to, psychiatric disorders, uncontrolled large serosal cavity effusions, or moderate to large serosal cavity effusions requiring repeated drainage (recurring within 2 weeks after intervention), such as pleural effusion, pericardial effusion, or ascites cachexia.",{"count":112,"type":21},54,[24],"This study aims to evaluate the major pathologic response (MPR) rate of neoadjuvant therapy with sintilimab (PD-1 inhibitor) + IBI310 (anti-CTLA-4 antibody) + chemotherapy, and to assess the efficacy of this treatment strategy in patients with PD-L1-negative stage II - IIIB (excluding N3) NSCLC (according to AJCC 9th) scheduled for surgery.",[116,60],"NSCLC Stage II",[118,64,119],"CTLA-4","neoadjuvant","2026-02-06",{"date":122,"type":39},"2026-02-13",{"date":124,"type":39},"2026-01-10",{"date":126,"type":21},"2030-01-10",{"name":128,"class":46},"Shanghai Pulmonary Hospital, Shanghai, China",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":137,"briefSummary":139,"conditions":140,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":147,"locationsCount":149},"100588752","pilot-for-the-precision-exercise-regimen-for-cancer-care-percc-study-100588752","NCT06945484","PILOT for The Precision Exercise Regimen for Cancer Care (PERCC) Study","PILOT PERCC","Inclusion Criteria:\n\n* Ages 18 and older at time of diagnosis\n* Patient diagnosed with stage II and III non-small cell lung cancer (NSCLC)\n* Patient receives either neoadjuvant chemotherapy or immunotherapy and surgery\n* Patient able to follow direction and complete questionnaires in English or Spanish\n* Patient agrees to complete the PERCC intervention\n\nExclusion Criteria:\n\n* Morbidly obese (BMI \\>40 kg\u002Fm2 ) or anorexic (BMI \\\u003C17.5 kg\u002Fm2 )\n* Abnormalities on screening physical exam per study physicians or physical therapist to contraindicate participation in exercise program compliance\n* Alcohol or drug abuse, significant mental or emotional problems that would interfere with compliance (assessed by NCCN Distress Thermometer)\n* Patient scheduled to receive single modality cancer treatment (unimodal therapy), scheduled to begin treatment within 2 weeks of the pre-treatment clinic visit, or for whom treatment has already started",{"count":47,"type":21},[138],"NA","This study is designed to evaluate whether a precision exercise regimen is feasible to implement within cancer populations, specifically stage II-III primary lung cancer patients receiving multimodal therapy, and delivered through telehealth.",[116,28],"2026-01-30",{"date":143,"type":39},"2026-02-03",{"date":145,"type":39},"2025-11-21",{"date":73,"type":21},{"name":148,"class":46},"University of Utah",2,{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100611032","phase-2-ensartinib-after-chemoradiotherapy-in-stage-iii-alk-mutated-nsclc-100611032","NCT07235306","Ensartinib After Chemoradiotherapy in Stage III ALK-Mutated NSCLC","Ensartinib for the Treatment of Patients With ALK-Mutated Stage III Unresectable NSCLC: A Multicenter, Randomized Controlled, Double-blind Clinical Study","Inclusion Criteria:\n\n* Male or female aged at least 18 years\n* Histologically or cytologically confirmed Stage III unresectable non-small cell lung cancer (NSCLC) with curative treatment intent\n* ALK mutations assessed by FISH, IHC, or NGS\n* ECOG Performance Status of 0 or 1\n* Completion of platinum-based concurrent or sequential chemoradiotherapy as per protocol requirements\n* Chemoradiotherapy must have been completed ≤ 6 weeks prior to randomization\n* No disease progression during or after chemoradiotherapy\n* Life expectancy \\> 12 weeks\n* Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment\n* Signed informed consent form obtained from the patient or their legally authorized representative\n* Male and female patients of childbearing potential agree to use highly effective contraception methods from before entering the trial, throughout the study, and until 8 weeks after discontinuation of study treatment\n\nExclusion Criteria:\n\n* Mixed histology of small cell and non-small cell lung cancer\n* Symptomatic pneumonitis following chemoradiotherapy that has not resolved to ≤ Grade 1 (per CTCAE criteria) prior to randomization;\n* Any unresolved toxicity from prior chemoradiotherapy with toxicity ≥ Grade 2 (according to CTCAE criteria);\n* Poor cardiac function, including but not limited to any of the following:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec (obtained from 3 ECGs);\n  * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG;\n  * Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or concomitant use of any known drugs that prolong the QT interval and may lead to Torsades de Pointes;\n* Inadequate bone marrow reserve or organ function;\n* History of other malignant malignancies, except for adequately treated non-melanoma skin cancer or malignant lentigo, cured carcinoma in situ, or other solid tumors cured \\> 5 years ago with no evidence of disease and considered by the treating physician to have a low risk of recurrence;\n* Severe or uncontrolled systemic diseases: including uncontrolled hypertension and active bleeding tendency; or active infections, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV);\n* Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of ensartinib;\n* Any prior chemotherapy, radiotherapy, immunotherapy, or investigational drug therapy beyond the definitive treatment for locally advanced disease;\n* Prior treatment with any ALK tyrosine kinase inhibitor (ALK-TKI);\n* Major surgery within 4 weeks prior to the first dose of study drug;\n* Current use of medications known to be strong inducers of CYP3A4 (which cannot be discontinued at least 3 weeks prior to the first dose of study drug);\n* Known hypersensitivity to ensartinib or any excipient in this product;\n* Pregnant or lactating women;\n* History of definite neurological or psychiatric disorders, including epilepsy or dementia;\n* Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation in the study.",{"count":158,"type":21},45,[24],"The PACIFIC study established the standard of care for immunotherapy consolidation after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC). However, its benefit is limited in patients with driver gene mutations. The LAURA study established a new paradigm of targeted consolidation therapy after CRT for patients with EGFR mutations. Although retrospective data support the efficacy of ALK-TKIs, no randomized controlled trial (RCT) has clearly demonstrated the value of ALK-TKI maintenance therapy after CRT. This study adopts a multicenter, randomized, double-blind, placebo-controlled design aimed at evaluating the efficacy and safety of ensartinib in patients with ALK-positive unresectable stage III NSCLC.",[60,162,62,163],"Ensartinib","ALK","2025-11-17",{"date":166,"type":39},"2025-11-19",{"date":168,"type":21},"2025-12-01",{"date":170,"type":21},"2031-12-31",{"name":128,"class":46},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":179,"minAge":180,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":187,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":103},"100555447","a-study-on-the-efficacy-of-androgen-deprivation-therapy-combined-with-anti-pd-1-therapy-in-advanced-lung-cancer-100555447","NCT06512207","A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer","A Clinical Investigation on the Efficacy of Leuprorelin Acetate (Androgen Deprivation Therapy) Combined With Sintilimab (Anti-PD-1) in Advanced Lung Cancer","3.Inclusion Criteria:\n\n1. Male patients aged ≥60 years.\n2. ECOG performance status score of 0 \\~1.\n3. Expected survival time of more than 3 months.\n4. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.\n5. Patients who have not previously received any anti-PD-1 treatment.\n6. Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.\n7. At least one tumor lesion meeting the following criteria:\n\n   * No prior local treatments such as radiotherapy\n   * Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).\n   * Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).\n   * If only one measurable lesion, no prior local treatments such as radiotherapy.\n8. Ability to understand and voluntarily sign a written informed consent form.\n9. Willingness to follow the study protocol and follow-up examinations.\n\nExclusion Criteria:\n\n* Exclusion of cases that do not meet the inclusion criteria","MALE","60 Years",{"count":182,"type":21},80,[138],"Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.",[28,186],"NSCLC, Stage IV",[188,189,64,190],"Androgen Deprivation Therapy （ADT）","Leuprorelin acetate","PD-1 inhibitor","2025-09-02",{"date":193,"type":39},"2025-09-09",{"date":195,"type":39},"2023-12-03",{"date":197,"type":21},"2026-06",{"name":199,"class":46},"Jinzhou Medical University",{"id":201,"slug":202,"hasResults":11,"nctId":203,"briefTitle":204,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":206,"targetDuration":208,"studyType":209,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100412731","lung-cancer-registry-100412731","NCT04654364","Lung Cancer Registry","Inclusion Criteria:\n\n* stage III A-C and IV A-B NSCLC\n* limited disease (LD) and extensive disease (ED) SCLC)\n* patients ≥ 18 years\n\nExclusion Criteria:\n\n\\- Due to the non-interventional design of the registry there are no specific exclusion criteria.",{"count":207,"type":21},500,"5 Years","OBSERVATIONAL","Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.\n\nThis malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.\n\nDespite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.",[212,27,28,213,214],"Lung Cancer","SCLC, Extensive Stage","SCLC, Limited Stage","2025-04-09",{"date":217,"type":39},"2025-04-10",{"date":219,"type":39},"2020-08-18",{"date":221,"type":21},"2030-08",{"name":223,"class":46},"Arbeitsgemeinschaft medikamentoese Tumortherapie",3,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":232,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":234,"conditions":235,"keywords":238,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":253},"100551999","a-study-to-describe-the-diagnostic-and-therapeutic-path-of-patients-with-nsclc-in-early-stage-and-locally-advanced-100551999","NCT06467383","A Study to Describe the Diagnostic and Therapeutic Path of Patients with NSCLC in Early Stage and Locally Advanced","Key-Early","Inclusion Criteria:\n\n1. Patients with stage I-III NSCLC who have received curative surgery or radiotherapy between January 2018 and June 2019 with available follow-up through January 2021\n2. Adult patients (aged ≥ 18 years) at the moment of diagnosis\n3. Patients (or their legally acceptable representatives) must have signed and dated the Informed Consent form; privacy Form (ICF). In case of deceased or untraceable patient the investigator before collecting data shall demonstrate and report all necessary measures adopted to contact the patient.\n\nExclusion Criteria:\n\n1. Patients without availability of medical charts or information required\n2. Enrollment in studies imposing a specific patient's management strategy which does not correspond to the site's normal clinical practice.",{"count":233,"type":21},600,"This is a non-interventional, retrospective observational study to improve knowledge regarding the diagnosis and treatments of patients who have\u002Fhad non-small cell lung cancer (NSCLC), either early stage (stage I-II).",[236,64,28,237],"Non-small Cell Lung Cancer","NSCLC, Stage I",[239,240,241,242],"NSCLC early stage","NSCLC locally advanced","retrospective observational study","Real-World Evidence","2025-01-13",{"date":245,"type":39},"2025-01-14",{"date":247,"type":39},"2024-06-25",{"date":249,"type":21},"2025-06-24",{"name":251,"class":252},"MSD Italia S.r.l.","INDUSTRY",25,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":209,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":149},"100414727","using-microbiome-to-predict-durvalumab-toxicity-in-post--concurrent-chemoradiation-therapy-ccrt-nsclc-patients-100414727","NCT04680377","Using Microbiome to Predict Durvalumab Toxicity in Post- Concurrent Chemoradiation Therapy (CCRT) NSCLC Patients","Using Microbiome to Predict Durvalumab Toxicity in Post-CCRT NSCLC Patients (Microdurva)","Microdurva","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* Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n* Life expectancy ≥12 weeks\n* Males and females age ≥ 18 years\n* Allowable type and amount of prior therapy:\n\nParticipants must have received two or more cycles of platinum-based chemotherapy (containing etoposide, vinblastine, vinorelbine, a taxane \\[paclitaxel or docetaxel\\], or pemetrexed) concurrently with definitive radiation therapy (54-66 Gy)\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status = 0 or 1\n* Body weight \\>30 kg (66.14 lbs)\n* Participants must have histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease\n* Participants must have not progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Adequate organ function based on laboratory results\n* Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use an acceptable form of contraception for the duration of study participation, and for the time specified following completion of therapy\n\nExclusion Criteria:\n\n* Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or if the participant is in the follow-up period of an interventional study\n* Participation in another clinical study with an investigational product during the last 4 weeks prior to enrollment on this study\n* Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment\n* Mixed small cell and non-small cell lung cancer histology\n* Participants who receive sequential chemoradiation therapy for locally advanced NSCLC\n* Participants with locally advanced NSCLC who have progressed whilst definitive platinum based, concurrent chemoradiation therapy\n* Receipt of any investigational drug within 4 weeks prior to the first dose of durvalumab; and in the case of monoclonal antibodies (not immunotherapy) 6 weeks prior to the first dose of durvalumab\n* Participants who have received prior anti-programmed death (PD)-1, anti- programmed death ligand (PD-L)1 or anti- cytotoxic T-lymphocyte-associated protein (CTLA)-4\n* Participants who have received prior immunotherapy\n* Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product (IP). Note: Participants, if enrolled, should not receive live vaccine whilst receiving durvalumab and up to 30 days after the last dose of IP\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab\n* Any unresolved toxicity CTCAE ≥ Grade 2 from the prior chemoradiation \u002F anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria\n* Any grade pneumonitis from prior chemoradiation therapy\n* Active infection\n* Recent major surgery within 28 days prior to the first dose of study therapy\n* Active or prior documented autoimmune or inflammatory disorders\n* History of primary immunodeficiency\n* History of another primary malignancy\n* History of allogenic organ transplantation\u002Forgan transplant that requires therapeutic immunosuppression\n* History of leptomeningeal carcinomatosis\n* Participants with active ventricular arrhythmia requiring medication\n* Uncontrolled intercurrent illness\n* Participants who have progressed following definitive, platinum-based, concurrent chemoradiation therapy\n* Known allergy or hypersensitivity to durvalumab or any of durvalumab's excipients\n* Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the patient to give written informed consent",{"count":263,"type":21},44,"This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer participants who will receive durvalumab can predict treatment toxicity.",[28,266],"Locally Advanced Lung Carcinoma","2024-05-06",{"date":269,"type":39},"2024-05-08",{"date":271,"type":39},"2021-04-12",{"date":273,"type":21},"2026-12",{"name":275,"class":46},"Jun Zhang, MD, PhD",{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":22,"phases":286,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":103},"100465706","phase-2-efficacy-and-safety-of-anti-pd-1pd-l1-treatment---uv1-vaccination-in-patients-with-non-small-cell-lung-cancer-100465706","NCT05344209","Efficacy and Safety of Anti-PD-1\u002FPD-L1 Treatment +\u002F- UV1 Vaccination in Patients With Non-small Cell Lung Cancer","A Randomized Phase II, Open-label, Multicenter Study Investigating Efficacy and Safety of Pembrolizumab +\u002F- UV1 Vaccination as First Line Treatment in Patients With Inoperable Advanced or Metastatic Non-small Cell Lung Cancer","LUNGVAC","Inclusion Criteria:\n\n* Histologically confirmed NSCLC stage IIIB\u002FIIIC or IV not amenable for curative treatment, with PD-L1 ≥ 50% measured by a validated method, and eligible for pembrolizumab monotherapy in the first-line setting\n* At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline according to RECIST 1.1\n* Subjects who received previous neo-adjuvant or adjuvant systemic therapy (other than immunotherapies) will be eligible if neo-adjuvant or adjuvant therapy was completed at least 12 months prior to the development of metastatic disease. Last dose of neoadjuvant or adjuvant therapy must be more than 12 months prior to enrollment\u002Frandomization\n* Available unstained archived tumour tissue sample in sufficient quantity to allow for analyses. At least fifteen unstained slides or a tumour block (preferred)\n* Male and female age ≥ 18 years at time of signing the ICF\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function as defined below\n* Haemoglobin ≥9.0 g\u002FdL\n* Absolute neutrophil count (ANC) 1.5 x (\\> 1500 per mm3)\n* Platelet count ≥100 x 109\u002FL (\\>75,000 per mm3)\n* Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN).\n* AST (SGOT)\u002FALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN\n* Measured creatinine clearance (CL) \\>40 mL\u002Fmin or Calculated creatinine CL \\>40 mL\u002Fmin by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:\n\nMales:\n\nCreatinine CL (mL\u002Fmin) = Weight (kg) x (140 - Age) 72 x serum creatinine (mg\u002FdL)\n\nFemales:\n\nCreatinine CL (mL\u002Fmin)\n\n= Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg\u002FdL)\n\n* Written informed consent obtained prior to any study specific procedure\n\nExclusion Criteria:\n\n* Previous treatment with a PD-1 or PD-L1 inhibitor, including pembrolizumab or any other agent targeting immune checkpoints\n* Previous malignancy (except non-melanoma skin cancer and the following in situ cancers: bladder, gastric, esophageal, colon, endometrial, cervical, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry\n* Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and\u002For corticosteroids (prednisone \\>10 mg or equivalent). Surgery, radiation and\u002For corticosteroids (any dose \\>10 mg prednisone equivalent) must have been completed ≥ 2 weeks prior to registration\n* Known history of leptomeningeal carcinomatosis\n* Uncontrolled seizures.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of pembrolizumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg\u002Fday of prednisone, or an equivalent corticosteroid. Steroid premedication given as prophylaxis for imaging contrast allergy should not be counted for this criterion\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome) within the past 2 years. Subjects with vitiligo, alopecia, Grave's disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded\n* History of primary immunodeficiency\n* History of allogeneic organ transplant\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent\n* Active infection including tuberculosis (clinical evaluation including: physical examination findings, radiographic findings, positive PPD test, etc.), hepatitis B (known positive HBV surface antigen \\[HBsAg\\] result), hepatitis C, or human immunodeficiency virus (positive HIV 1\u002F2 antibodies as defined by a positive ELISA test). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. HIV testing is not required in the absence of clinical suspicion\n* Pregnant or lactating women\n* Live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving pembrolizumab\n* Any condition that, in the opinion of the investigator, would interfere with the evaluation of study treatment or interpretation of patient safety or study results\n* History of allergy or hypersensitivity to any of the active substances or excipients in the study drug\n* Involvement in the planning and\u002For conduct of the study (investigator staff and\u002For staff at the study site)\n* Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements",{"count":285,"type":21},138,[24],"A Randomized, Multicenter Study Investigating Efficacy and Safety of anti-PD-1\u002FPD-L1-treatment +\u002F- UV1 vaccination as first line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer. The objective of the phase 2 study is to induce a meaningful Progression-Free Survival (PFS) benefit in patients with stage IIIB\u002FIIIC or stage IV NSCLC by treating with anti-PD-1\u002FPD-L1 treatment and UV1 vaccination versus anti-PD-1\u002FPD-L1 treatment alone.",[289,27,28],"Oncology","2023-11-08",{"date":292,"type":39},"2023-11-09",{"date":294,"type":39},"2022-08-12",{"date":296,"type":21},"2027-07-01",{"name":298,"class":46},"Vestre Viken Hospital Trust"]