Clinical Trial: NCT03789604
A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer
Status:
COMPLETEDPhase:
Phase 3| Lead Sponsor: | CStone Pharmaceuticals |
| Information Provided By: | CStone Pharmaceuticals |
| Last Update Posted: | 2026-08-18 |
Study Overview
Brief 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).
Official Title
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
Conditions
Non Small Cell Lung Cancer
Intervention / Treatment
- Biological: CS1001 monoclonal antibody
- Biological: CS1001 placebo
Other Study ID Numbers
- CS1001-302
Start Date (Actual)
2018-12-13
Primary Completion Date (Actual)
2023-05-15
Study Completion Date (Actual)
2026-07-01
Enrollment (Actual)
479
Study Type
Interventional
Phase
Phase 3
| Lead Sponsor: | CStone Pharmaceuticals |
| Information Provided By: | CStone Pharmaceuticals |
| Last Update Posted: | 2026-08-18 |
Study Overview
Brief 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).
Official Title
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
Conditions
Non Small Cell Lung Cancer
Intervention / Treatment
- Biological: CS1001 monoclonal antibody
- Biological: CS1001 placebo
Other Study ID Numbers
- CS1001-302
Start Date (Actual)
2018-12-13
Primary Completion Date (Actual)
2023-05-15
Study Completion Date (Actual)
2026-07-01
Enrollment (Actual)
479
Study Type
Interventional
Phase
Phase 3