NCT03789604

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

A Multi-Center, Randomized, Double-Blind, Phase III Study of Platinum-Containing Chemotherapy With or Without CS1001 in Stage IV Non-Small Cell Lung Cancer Subjects

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: CStone Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, phase III study to evaluate the efficacy and safety of CS1001 in combination with platinum-containing chemotherapy versus placebo in combination with chemotherapy in first-line treatment-naive subjects with stage IV non-small cell lung cancer (NSCLC).

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CS1001 monoclonal antibody	Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle
BIOLOGICAL	CS1001 placebo	Participant will receive CS1001 placebo 1200 mg by intravenous infusion every 3 weeks, for up to 24 months; Drug Carboplatin on Day 1 of each 21-day cycle; Drug Pemetrexed on Day 1 of each 21-day cycle; Drug Paclitaxel on Day 1 of each 21-day cycle

Timeline

• Start date: 2018-12-13
• Primary completion: 2023-05-15
• Completion: 2027-06-30
• First posted: 2018-12-28
• Last updated: 2025-07-24

Locations

1 site across 1 country: China