NCT05633667

Study of Novel Treatment Combinations in Patients With Lung Cancer

A Phase 2 Platform Study Evaluating the Safety and Efficacy of Novel Treatment Combinations in Patients With Lung Cancer (VELOCITY-Lung)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Zimberelimab (ZIM)	Administered intravenously
DRUG	Domvanalimab (DOM)	Administered intravenously
DRUG	Sacituzumab govitecan-hziy (SG)	Administered intravenously
DRUG	Etrumadenant (ETRUMA)	Administered orally
DRUG	Carboplatin	Administered intravenously
DRUG	Cisplatin	Administered intravenously
DRUG	Pemetrexed	Administered intravenously
DRUG	Paclitaxel	Administered intravenously
DRUG	Nab-paclitaxel	Administered intravenously
DRUG	Docetaxel	Administered intravenously
DRUG	Nivolumab	Administered intravenously

Timeline

• Start date: 2023-03-16
• Primary completion: 2029-09-01
• Completion: 2029-09-01
• First posted: 2022-12-01
• Last updated: 2026-03-17

Locations

100 sites across 8 countries: United States, Brazil, Hong Kong, Israel, South Korea, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study