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 Nab-paclitaxel Small molecule — Intravenous
Comparator Nivolumab Monoclonal antibody — Intravenous
Subject Paclitaxel Small molecule — Intravenous
Subject Pemetrexed Small molecule — Intravenous
Subject Sacituzumab Govitecan Monoclonal antibody — Intravenous
Subject Zimberelimab Monoclonal antibody — Intravenous