Study of Novel Treatment Combinations in Patients With Lung Cancer
Trial Parameters
Brief Summary
The goal of this platform clinical trial is to test how well novel treatment combinations work in participants with lung cancer. Substudy-01 will compare the different novel combinations versus standard of care in participants with metastatic (cancer that has spread) non-small-cell lung cancer (NSCLC) who have not been treated before. Substudy-02 will compare the different novel combination versus standard of care in participants with cancer that has progressed after receiving previous treatment for metastatic NSCLC. Substudy-03 will compare the different novel combinations versus standard of care in participants with resectable stage II-III NSCLC. The primary objectives of this study are: Substudy-01 and Substudy-02: To evaluate the objective response rate (ORR) assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Substudy-03: To evaluate the efficacy of treatment combinations based on complete pathological response (pCR) rate.
Eligibility Criteria
Key Inclusion Criteria: All Substudies: * Histologically or cytologically documented non-small-cell lung cancer (NSCLC). * No known actionable genomic alterations for which targeted therapies are available. * Eastern cooperative oncology group (ECOG) performance status score of 0 or 1. * Measurable disease per response evaluation criteria in solid tumors. * Adequate hematologic and end-organ function. * Individuals of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception. Substudy 01: All Experimental arms * Stage IV NSCLC. * For individuals with nonsquamous histology: Epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) alteration negative. * PD-L1 status by central confirmation. * No prior systemic treatment for metastatic NSCLC. Substudy 02: All Experimental arms * Stage IV NSCLC. * In individuals with nonsquamous histology and actionable EGFR, ALK, or other known genomic alterations must have rece