Trials / Recruiting
RecruitingNCT06627647
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Non-squamous NSCLC
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 878 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with non-squamous mNSCLC whose tumors express PD-L1.
Detailed description
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with non-squamous mNSCLC whose tumors express PD-L1 (TC ≥ 1%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilvegostomig | Administered as one intravenously (IV) on Day 1 of each 21-day cycle |
| DRUG | Pembrolizumab | Administered as one intravenously (IV) on Day 1 of each 21-day cycle |
| DRUG | Carboplatin | Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| DRUG | Cisplatin | Administered as one intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| DRUG | Pemetrexed | Administered as one intravenously (IV) on Day 1 of each 21-day cycle |
Timeline
- Start date
- 2024-11-27
- Primary completion
- 2029-05-10
- Completion
- 2030-03-25
- First posted
- 2024-10-04
- Last updated
- 2026-03-27
Locations
282 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Vietnam
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06627647. Inclusion in this directory is not an endorsement.