Study of Novel Treatment Combinations in Patients With Lung Cancer
NCT05633667 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2026-03-17
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.
Conditions
- Lung Cancer
- Advanced or Metastatic Non-Small-Cell Lung Cancer
- Resectable Non-Small-Cell Lung Cancer
Interventions
- DRUG
-
Zimberelimab (ZIM)
Administered intravenously
- DRUG
-
Domvanalimab (DOM)
Administered intravenously
- DRUG
-
Sacituzumab govitecan-hziy (SG)
Administered intravenously
- DRUG
-
Etrumadenant (ETRUMA)
Administered orally
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Pemetrexed
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
- DRUG
-
Administered intravenously
Sponsors & Collaborators
-
Arcus Biosciences, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Gilead Study Director · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-16
- Primary Completion
- 2029-09-30
- Completion
- 2029-09-30
- FDA Drug
- Yes
Countries
- United States
- Brazil
- Hong Kong
- Israel
- South Korea
- Taiwan
- Turkey (Türkiye)
- United Kingdom
Study Locations
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