Advanced Non-Small Cell Lung Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : pembrolizumab+MK-4280, pembrolizumab+lenvatinib, pembrolizumab+MK1308
INN of investigational material : pembrolizumab, MK-4280, lenvatinib, MK-1308
Thera
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Has a histologically- or cytologically-confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v 8) NSCLC and has not had prior systemic therapy for advanced disease 2) Has confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1- (ROS1-), or B isoform of rapidly accelerated fibrosarcoma- (B-Raf-) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR mutations, B-Raf mutations, ALK gene rearrangements, and ROS1 gene rearrangements) 3) Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology 4) Male participants must agree to use contraception during the treatment period and for >=120 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom 5) Female participants eligible to participate if not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow contraceptive guidance during the treatment period and for >=120 days after the last dose of study treatment 6) Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated 7) Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 8) Has adequate organ function
Exclusion criteria
Exclusion criteria: 1) Has significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability, significant cardiovascular impairment, or a left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram 2) Prolongation of QTc interval to >480 milliseconds (ms) 3) Has symptomatic ascites or pleural effusion 4) Has had an allogenic tissue/solid organ transplant 5) WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment 6) Has not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy, or has had major surgery within 3 weeks prior to first dose of study intervention 7) Has preexisting gastrointestinal or non-gastrointestinal fistula, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib 8) Radiographic evidence of major blood vessel invasion/infiltration 9) Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug 10) Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC 11) Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation 12) Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection) 13) Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor 14) Has received previous treatment with another agent targeting the Lymphocyte-activation gene 3 (LAG-3) receptor 15) Has received previous treatment with another agent targeting vascular endothelial growth factor (VEGF) or the VEGF receptor 16) Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization 17) Has received prior radiotherapy within 2 weeks of start of study treatment or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention 18) Has received a live or live-attenuated vaccine within 30 days before the first dose of study treatment 19) 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 treatment. 20) 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 the first dose of study treatment 21) Has a known additional malignancy that is progressing or has required active treatment within the past 3 years 22) Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis 23) Has severe hypersensitivity (>=Grade 3) to pembrolizumab, favezelimab, or lenvatinib and/or any of its excipients 24) Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease mo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - objective response rate (ORR): Participants who have a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by local site. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy - PFS: Time from randomization to the first documented disease progression per RECIST 1.1 as assessed by local site or death, whichever occurs first. - OS: Time from randomization to death due to any cause. - Number of Participants Experiencing Adverse Events (AEs). - Number of Participants Discontinuing Study Drug due to AEs. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed