Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC

This study is testing ivonescimab combined with chemotherapy against pembrolizumab combined with chemotherapy for people with metastatic (cancer that has spread) non-small cell lung cancer (NSCLC). Researchers want to see if ivonescimab can help people live longer and prevent their cancer from growing or spreading for a longer time. To join, you must be at least 18 years old, have metastatic NSCLC, and a good general health status (ECOG performance status of 0 or 1). Your doctor will also check your PD-L1 expression levels. The study aims to enroll about 1600 participants.

Study design
This is a Phase 3, randomized, double-blind study, meaning participants are assigned to a treatment group by chance and neither you nor your doctor will know which treatment you are receiving. It plans to enroll about 1600 participants.
What's involved
You will receive either ivonescimab or pembrolizumab, both given as an intravenous (IV) injection, along with chemotherapy. The trial record does not specify the number of visits or specific procedures.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants for overall survival for approximately 4 years and for progression-free survival for approximately 3 years.

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NCT05899608

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

Recruiting
PHASE3Ages 18+InterventionalTreatment
Summit Therapeutics
~1,600 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Ivonescimab InjectionPembrolizumab Injection

At a glance

Recruiting sites
19 of 260 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over approximately 4 years
+1 more outcome measured
Non-Small Cell Lung Cancer
260 sites across 72 states
Spain19
Japan18
Italy16
France15
Florida13
Turkey (Türkiye)12
Mexico11
California10
  • Indu Lal · STUDY_DIRECTOR · Summit Therapeutics, Inc.

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Eligibility criteria

Inclusion

Age ≥ 18 years old at the time of enrollment
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Expected life expectancy ≥ 3 months
Metastatic (Stage IV) NSCLC
Histologically or cytologically confirmed squamous or non-squamous NSCLC
Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
At least one measurable noncerebral lesion according to RECIST 1.1
No prior systemic treatment for metastatic NSCLC

Exclusion

Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.
For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
Has received any prior therapy for NSCLC in the metastatic setting
Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
  • Overall Survival (OS)approximately 4 years

    Overall Survival (OS) in the ITT population

  • Progression Free Survival (PFS)approximately 3 years

    Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1