Actively Recruiting
Phase 3 Study Comparing Ivonescimab Plus Chemotherapy With Pembrolizumab Plus Chemotherapy for First Treatment of Metastatic Non-Small Cell Lung Cancer
Led by Summit Therapeutics · Updated on 2026-04-30
1600
Participants Needed
253
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy as the first treatment for people with metastatic non-small cell lung cancer NSCLC. This Phase 3, randomized, double-blind, multiregional study involves around 1600 patients divided into two groups based on NSCLC histology squamous and non-squamous. The main goals are to assess overall survival and progression-free survival, with additional focus on treatment response and safety. Participants are randomly assigned to receive either ivonescimab or pembrolizumab along with platinum-doublet chemotherapy. Both treatments are given as intravenous injections. The two histology groups will be analyzed separately to understand how each treatment works within these subtypes of NSCLC. This design helps compare the effects of the two treatment combinations. During the study, participants will be monitored for survival and disease progression over several years. Safety assessments include tracking side effects from the start of treatment through 30 to 90 days after the last dose or start of other cancer therapies, with follow-up lasting up to two years. The study includes regular evaluations to measure tumor response and overall health, ensuring comprehensive monitoring throughout the participation period.
CONDITIONS
Brief Title
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected life expectancy of at least 3 months
- Metastatic (Stage IV) non-small cell lung cancer
- Histologically or cytologically confirmed squamous or non-squamous NSCLC
- Recorded measurement of Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression before randomization
- At least one measurable noncerebral lesion according to RECIST 1.1
- No prior systemic treatment for metastatic NSCLC
You will not qualify if you...
- Presence of small cell lung carcinoma
- Known actionable genomic alterations (EGFR, ALK, ROS1, BRAF V600E) or genes with approved first-line therapies
- For non-squamous patients, required driver mutation testing results before randomization
- Prior therapy for metastatic NSCLC
- Tumor invasion or encasement of organs or major blood vessels that significantly increases bleeding risk
Research Team
S
Summit Clinical Trial Information
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