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Active Not RecruitingPhase 3NCT05899608
Official study title

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

Study summary

This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedIvonescimab Injection and Pembrolizumab Injection

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 3

Interventional

Where is it offered?260 U.S. locations

Locations may change over time.

Who runs it?Summit Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Summit Therapeutics
Interventions being studied
Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Treatment approach
Immunotherapy→Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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
Reasons someone may not be able to joinExclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Banner University Medical CenterPhoenix, Arizona
  • TMC HealthcareTucson, Arizona
  • Genesis Cancer and Blood InstituteHot Springs, Arkansas
  • University of ArkansasLittle Rock, Arkansas
  • LA Cancer NetworkAnaheim, California
  • The Oncology Institute of Hope & InnovationCerritos, California
  • University of Southern California (USC)Los Angeles, California
  • Cedar Sinai Medical CenterLos Angeles, California
  • Valkyrie Clinical TrialsLos Angeles, California
  • Sutter Institute for Medical ResearchSacramento, California
  • UC Davis Medical CenterSacramento, California
  • University of California Los Angeles (UCLA)Santa Monica, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2026. Always confirm current availability with the study team.

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