Trials / Recruiting
RecruitingNCT06692738
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (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 Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (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 first-line (1L) treatment for patients with squamous metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rilvegostomig | Administered intravenously (IV) on Day 1 of each 21-day cycle |
| DRUG | Pembrolizumab | Administered intravenously (IV) on Day 1 of each 21-day cycle |
| DRUG | Carboplatin | Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| DRUG | Paclitaxel | Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles |
| DRUG | Nab-paclitaxel | Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles |
Timeline
- Start date
- 2024-11-18
- Primary completion
- 2029-02-05
- Completion
- 2029-10-08
- First posted
- 2024-11-18
- Last updated
- 2026-03-31
Locations
300 sites across 26 countries: United States, Argentina, Australia, Austria, 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 NCT06692738. Inclusion in this directory is not an endorsement.