Actively Recruiting
Phase III Global Study Comparing Rilvegostomig and Pembrolizumab with Chemotherapy for First-Line Treatment of Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer with PD-L1 Expression
Led by AstraZeneca · Updated on 2026-07-14
1160
Participants Needed
287
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.
CONDITIONS
Brief Title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Locally Advanced or Metastatic Non-Squamous NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed non-squamous NSCLC
- Stage III B/C or IV NSCLC not suitable for curative treatment
- Tumors expressing PD-L1 at 1% or higher
- No sensitizing EGFR mutations or ALK and ROS1 rearrangements
- No other actionable driver mutations with approved first-line therapies
- At least one measurable lesion not previously irradiated
- Adequate organ and bone marrow function
You will not qualify if you...
- Small cell or neuroendocrine histology components
- Brain metastases unless stable, asymptomatic, and off steroids or anticonvulsants for at least 7 days
- Prior systemic therapy for NSCLC except certain adjuvant/neoadjuvant treatments with progression after 12 months
- Prior treatment with anti-TIGIT or anti-PD-1/PD-L1 agents
- History of other primary malignancies unless treated curatively with no active disease for 2 years
- Active or prior autoimmune or inflammatory disorders requiring systemic immunosuppressive treatment
- Active primary immunodeficiency or infectious diseases
- Active tuberculosis infection
Research Team
A
AstraZeneca Clinical Study Information Center
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here