Trials / Active Not Recruiting
Active Not RecruitingNCT04205812
Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung Cancer
A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 583 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of platinum-based chemotherapy with or without INCMGA00012 in participants with metastatic squamous and nonsquamous non-small cell lung cancer (NSCLC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Retifanlimab | INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
| DRUG | Placebo | Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles. |
| DRUG | Pemetrexed | Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle. |
| DRUG | Cisplatin | Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| DRUG | Carboplatin | Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| DRUG | Paclitaxel | Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles. |
| DRUG | nab-Paclitaxel | nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles. |
Timeline
- Start date
- 2020-09-11
- Primary completion
- 2023-12-15
- Completion
- 2026-08-28
- First posted
- 2019-12-19
- Last updated
- 2026-03-31
- Results posted
- 2025-02-06
Locations
140 sites across 17 countries: United States, Brazil, Bulgaria, China, Czechia, Georgia, Hungary, Malaysia, Philippines, Poland, Romania, Russia, Serbia, South Africa, Turkey (Türkiye), Ukraine, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04205812. Inclusion in this directory is not an endorsement.