[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05715229":3,"trial-entities:NCT05715229":249,"trial-summary:NCT05715229":255},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":65,"secondary_outcomes":70,"sex":91,"minimum_age":92,"maximum_age":93,"healthy_volunteers":94,"eligibility_criteria":95,"std_ages":99,"locations":102,"central_contacts":140,"overall_officials":146,"references":150,"see_also_links":242},"NCT05715229","Pro2022-0016","Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy","A Multicenter Phase II Randomized Trial Of Immunotherapy Versus Chemotherapy Guided By Circulating Tumor DNA-Based Molecular Response On Patients With Metastatic NSCLC","RECRUITING","2027-04-28","2026-02","2026-02-18","2023-09-29","Hackensack Meridian Health","OTHER",true,"This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.","Subjects will be randomized 2:1 and patients in both arms will begin treatment with nivolumab 360 mg intravenously every 3 weeks and ipilimumab 1 mg\u002Fkg intravenously every 6 weeks. At five weeks of treatment, subjects will have ctDNA response evaluation with Guardant360 Response assay. At the next cycle of treatment (+\u002F- 2 days), patients in the larger arm will receive treatment based on the Guardant360 Response assay results, as described below. Subjects will undergo ctDNA evaluation with Guardant360 Response assay 6- week post-randomization and at the time of progression. Response to therapy will be assessed by interval imaging with CT scan of the chest\u002Fabdomen\u002Fpelvis (and MRI brain if applicable) with response evaluated by irRECIST criteria every 12 weeks until disease progression.",[19],"Carcinoma, Non-Small-Cell Lung",[21,22,23,24],"Advanced Non Small Cell Lung Cancer (NSCLC)","Metastatic NSCLC","circulating tumor DNA (ctDNA)","G360","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},108,"ESTIMATED",[33,42,47,53,59],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":40},"DRUG","Nivolumab","Immunotherapy",[38,39],"Arm A","Arm B",[41],"Opdivo",{"type":34,"name":43,"description":36,"armGroupLabels":44,"otherNames":45},"Ipilimumab",[38,39],[46],"Yervoy",{"type":34,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Carboplatin","Chemotherapy",[38],[52],"Paraplatin",{"type":34,"name":54,"description":49,"armGroupLabels":55,"otherNames":56},"Paclitaxel",[38],[57,58],"Taxol","Paxel",{"type":34,"name":60,"description":49,"armGroupLabels":61,"otherNames":62},"Pemetrexed",[38],[63,64],"Alimta","Pemfexy",[66],{"measure":67,"description":68,"timeFrame":69},"Progression Free Survival (PFS)","To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.","Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months",[71,75,79,83,87],{"measure":72,"description":73,"timeFrame":74},"Progression Free Survival on Subsequent line of therapy (PFS2)","To compare progression free survival on subsequent line of therapy (PFS2) between patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results","Duration of time from randomization to second objective disease progression, or death from any cause, whichever first, up to 36 months",{"measure":76,"description":77,"timeFrame":78},"Overall Survival","To compare overall survival (OS) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results","Duration of time from first treatment to time of death, up to 36 months",{"measure":80,"description":81,"timeFrame":82},"Objective Response Rate","To compare objective response rate (ORR) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on treatment-ctDNA results.","Duration of time between the date of first treatment and the date of objectively documented progression per irRECIST or the date of initiation of palliative local therapy or the date of subsequent anti-cancer therapy, whichever occurs first, up to 36 mo",{"measure":84,"description":85,"timeFrame":86},"Duration of Response","To compare duration of response (DOR) in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.","Duration of time between the date of first confirmed response to the date of the first documented tumor progression (per irRECIST), or death due to any cause, whichever occurs first, up to 36 months",{"measure":88,"description":89,"timeFrame":90},"Safety and Tolerability","Serious adverse events will be summarized by treatment group as number and percentages. Overall summary of SAEs by grade (any grade, grade 3-4, grade 5) will be reported. Overall summary of drug-related SAEs by worst CTC grade (any grade, grade 3-4, grade 5) will be reported.","All analyses will be conducted using the 30-day safety window","ALL","18 Years",null,false,{"inclusion":96,"exclusion":97,"raw_text":98},[],[],"Inclusion Criteria:\n\n1. Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC\n2. Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.\n3. Patients will require a baseline Guardant360 CDx test prior to enrollment\n4. Patients willing to undergo serial ctDNA testing as required by protocol\n5. Patients will be over the age of 18\n6. Life expectancy ≥12 weeks\n7. Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.\n8. Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization\n9. ECOG Performance Score ≤2\n10. Adequate organ function\n11. Hemoglobin \\> 9 g\u002FdL\n12. Platelets \\> 100,000mm3 or 100 x 109\u002FL\n13. AST, ALT \\\u003C 2.5 x ULN with no liver metastases or \\\u003C 5x ULN with the presence of liver metastases\n14. Total bilirubin \\\u003C 1.5 x ULN if no liver metastases or \\\u003C 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n15. Absolute neutrophil count (ANC) \\> 1500 cells\u002Fmm3\n16. Creatinine ≤ 1.5 x ULN OR calculated creatinine clearance ≥ 60ml\u002Fmin calculated by Cockcroft and Gault's equation\n17. Willing to use highly effective contraceptive measures if child-bearing potential or if the patient's sexual partner is a woman of childbearing potential: a. Female subjects should be using a highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to starting of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening: i. Post-menopausal is defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. 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 LH and FSH levels in the the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not a tubal ligation b. Male subjects should be willing to use barrier contraception\n\nExclusion Criteria:\n\n1. Patients under the age of 18\n2. Inability to provide informed consent by either the patient or the authorized representative\n3. Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)\n4. Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline\n5. Subjects with untreated CNS metastases are excluded.\n6. Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.\n7. Subjects with carcinomatous meningitis\n8. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization\n9. Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical\u002Fdysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be needed during the study period.\n10. Other active malignancy requiring concurrent intervention.\n11. Subjects with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n12. Subjects with a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroids \\> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.\n13. Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n14. Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:\n\n    1. Uncontrolled hypertension, which is defined as systolic blood pressure \\> 160 mm Hg or diastolic blood pressure \\> 100 mm Hg despite optimal medical management.\n    2. Active coronary artery disease, including unstable all newly diagnosed angina within 3 months of study enrollment.\n    3. Myocardial infarction in the past 6 months.\n    4. History of congenital long QT syndrome.\n    5. History of clinically significant arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or torsade de pointes.\n    6. Uncontrolled heart failure, defined as class III of 4 by the New York Heart Association functional classification.\n    7. History of a current diagnosis of myocarditis.\n15. the Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results.\n16. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection\n17. Subjects with Grade 2 peripheral neuropathy\n18. Life expectancy \\\u003C12 weeks",[100,101],"ADULT","OLDER_ADULT",[103,113,125],{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":109,"geoPoint":110},"Lombardi Comprehensive Cancer Center, Georgetown University","NOT_YET_RECRUITING","Washington D.C.","District of Columbia","20007","United States",{"lat":111,"lon":112},38.89511,-77.03637,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":109,"contacts":118,"geoPoint":122},"John Theurer Cancer Center, Hackensack Meridian Health","Hackensack","New Jersey","07410",[119],{"role":120,"phone":121},"CONTACT","551-996-2000",{"lat":123,"lon":124},40.88593,-74.04347,{"facility":126,"status":105,"city":127,"state":116,"zip":128,"country":109,"contacts":129,"geoPoint":137},"Jersey Shore University Medical Center","Neptune City","07753",[130,133],{"name":131,"role":120,"email":132},"Walter Elliot","Walter.Elliott@hmhn.org",{"name":134,"role":120,"phone":135,"email":136},"Suzanne Kosky","551-996-3986","Suzanne.Kosky@hmhn.org",{"lat":138,"lon":139},40.20011,-74.02792,[141,145],{"name":142,"role":120,"phone":143,"email":144},"Lauren Finaldi","551-996-5228","Lauren.Finaldi@hmhn.org",{"name":134,"role":120,"phone":135,"email":136},[147],{"name":148,"affiliation":13,"role":149},"Martin Gutierrez, MD","PRINCIPAL_INVESTIGATOR",[151,155,158,161,164,167,170,173,176,179,182,185,188,191,194,197,200,203,206,209,212,215,218,221,224,227,230,233,236,239],{"pmid":152,"type":153,"citation":154},"29330207","BACKGROUND","Goldberg SB, Narayan A, Kole AJ, Decker RH, Teysir J, Carriero NJ, Lee A, Nemati R, Nath SK, Mane SM, Deng Y, Sukumar N, Zelterman D, Boffa DJ, Politi K, Gettinger SN, Wilson LD, Herbst RS, Patel AA. 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Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158\u002F2159-8290.CD-20-0047. Epub 2020 Aug 14.",{"pmid":225,"type":153,"citation":226},"35121950","Bratman SV, Yang SYC, Iafolla MAJ, Liu Z, Hansen AR, Bedard PL, Lheureux S, Spreafico A, Razak AA, Shchegrova S, Louie M, Billings P, Zimmermann B, Sethi H, Aleshin A, Torti D, Marsh K, Eagles J, Cirlan I, Hanna Y, Clouthier DL, Lien SC, Ohashi PS, Xu W, Siu LL, Pugh TJ. Personalized circulating tumor DNA analysis as a predictive biomarker in solid tumor patients treated with pembrolizumab. Nat Cancer. 2020 Sep;1(9):873-881. doi: 10.1038\u002Fs43018-020-0096-5. Epub 2020 Aug 3.",{"pmid":228,"type":153,"citation":229},"34994642","Weber S, van der Leest P, Donker HC, Schlange T, Timens W, Tamminga M, Hasenleithner SO, Graf R, Moser T, Spiegl B, Yaspo ML, Terstappen LWMM, Sidorenkov G, Hiltermann TJN, Speicher MR, Schuuring E, Heitzer E, Groen HJM. Dynamic Changes of Circulating Tumor DNA Predict Clinical Outcome in Patients With Advanced Non-Small-Cell Lung Cancer Treated With Immune Checkpoint Inhibitors. JCO Precis Oncol. 2021 Nov;5:1540-1553. doi: 10.1200\u002FPO.21.00182.",{"pmid":231,"type":153,"citation":232},"26703802","Kruglyak KM, Lin E, Ong FS. Next-Generation Sequencing and Applications to the Diagnosis and Treatment of Lung Cancer. Adv Exp Med Biol. 2016;890:123-36. doi: 10.1007\u002F978-3-319-24932-2_7.",{"pmid":234,"type":153,"citation":235},"30988079","Leighl NB, Page RD, Raymond VM, Daniel DB, Divers SG, Reckamp KL, Villalona-Calero MA, Dix D, Odegaard JI, Lanman RB, Papadimitrakopoulou VA. Clinical Utility of Comprehensive Cell-free DNA Analysis to Identify Genomic Biomarkers in Patients with Newly Diagnosed Metastatic Non-small Cell Lung Cancer. Clin Cancer Res. 2019 Aug 1;25(15):4691-4700. doi: 10.1158\u002F1078-0432.CCR-19-0624. Epub 2019 Apr 15.",{"pmid":237,"type":153,"citation":238},"17720276","Rajeswaran A, Trojan A, Burnand B, Giannelli M. Efficacy and side effects of cisplatin- and carboplatin-based doublet chemotherapeutic regimens versus non-platinum-based doublet chemotherapeutic regimens as first line treatment of metastatic non-small cell lung carcinoma: a systematic review of randomized controlled trials. Lung Cancer. 2008 Jan;59(1):1-11. doi: 10.1016\u002Fj.lungcan.2007.07.012. Epub 2007 Aug 27.",{"pmid":240,"type":153,"citation":241},"19934295","Wolchok JD, Hoos A, O'Day S, Weber JS, Hamid O, Lebbe C, Maio M, Binder M, Bohnsack O, Nichol G, Humphrey R, Hodi FS. Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res. 2009 Dec 1;15(23):7412-20. doi: 10.1158\u002F1078-0432.CCR-09-1624. Epub 2009 Nov 24.",[243,246],{"label":244,"url":245},"National Library of Medicine (US). 2021 Aug 16 - . Identifier NCT00527735; Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC);","https:\u002F\u002Fclinicaltrials.gov\u002Fct2\u002Fshow\u002FNCT00527735?term=00527735&draw=2&rank=1",{"label":247,"url":248},"How do OPDIVO® (nivolumab) and YERVOY® (ipilimumab) team up to fight cancer differently than chemotherapy","https:\u002F\u002Fwww.opdivo.com\u002Fabout-opdivo\u002Fhow-the-combination-works-combinationtherapy",{"nct_id":4,"conditions":250,"biomarkers":252},[251],"Lung Non-Small Cell Carcinoma",[253,254],"Circulating Tumor-Derived DNA Negative","Programmed Cell Death 1 Ligand 1",{"nct_id":4,"found":15,"summary":256,"prompt_version":266},{"design":257,"status":258,"heading":259,"summary":260,"follow_up":261,"word_count":262,"commitments":263,"compensation":264,"drugs_mentioned":265},"This study will enroll 108 participants and involves a 2:1 randomization, meaning more participants will be in one treatment group. Participants will start with immunotherapy, and then some will have their treatment adjusted based on ctDNA test results.","completed","Immunotherapy and Chemotherapy for Advanced Non-Small Cell Lung Cancer","This study is for people with newly diagnosed, advanced non-small cell lung cancer (NSCLC) that has spread (Stage IV). It aims to understand if a blood test called circulating tumor DNA (ctDNA) can help doctors decide whether you need only immunotherapy (Nivolumab and Ipilimumab) or if you also need chemotherapy (Carboplatin, Paclitaxel, or Pemetrexed). You must have a certain level of PD-L1 (a protein on cancer cells) and be willing to have regular ctDNA blood tests. The main goal is to see how long people live without their cancer getting worse (Progression Free Survival) for up to 36 months.","Your Progression Free Survival will be measured for up to 36 months.",99,"You will receive intravenous (IV) treatments of Nivolumab and Ipilimumab, and potentially chemotherapy. You will also have regular ctDNA blood tests and CT scans every 12 weeks to check your cancer.","Not stated in the trial record.",[35,43,48,54,60],"v2"]