A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)
Gilead Sciences
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. * F…
Interventions
- DrugZimberelimab (ZIM)
Administered intravenously
- DrugDomvanalimab (DOM)
Administered intravenously
- DrugSacituzumab govitecan-hziy (SG)
Administered intravenously
- DrugEtrumadenant (ETRUMA)
Administered orally
- DrugCarboplatin
Administered intravenously
- DrugCisplatin
Administered intravenously
- DrugPemetrexed
Administered intravenously
Locations (100)
- Arizona Oncology Associates,Substudy-01Tucson, Arizona
- Arizona Oncology Associates,Substudy-02Tucson, Arizona
- Rocky Mountain Cancer Center,Substudy-01Denver, Colorado
- Rocky Mountain Cancer Center,Substudy-02Denver, Colorado
- Fort Wayne Medical Oncology and Hematology, Inc.,Substudy-03Fort Wayne, Indiana
- Baptist Health Lexington,Substudy-03Lexington, Kentucky