drugset / Trial / NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

NCT05633667

Phase 2 Active not recruiting 192 enrolled Gilead Sciences Arcus Biosciences, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-16
Primary completion
2029-09
Completion
2029-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule Intravenous
Comparator Cisplatin Other / unclassified Intravenous
Comparator Docetaxel Small molecule Intravenous
Subject Domvanalimab Monoclonal antibody Intravenous
Subject Etrumadenant Small molecule Oral
Comparator Nivolumab Monoclonal antibody Intravenous
Comparator Paclitaxel Small molecule Intravenous
Subject Pemetrexed Small molecule Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody Intravenous
Subject Zimberelimab Monoclonal antibody Intravenous