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First-line treatment for metastatic lung cancer patients with high PD-L1 using ivonescimab

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

PHASE3 · Summit Therapeutics · NCT06767514

This study is testing if a new drug called ivonescimab can help adults with advanced lung cancer who have high PD-L1 levels live longer and feel better compared to another treatment called pembrolizumab.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment780 (estimated)
Ages18 Years and up
SexAll
SponsorSummit Therapeutics (industry)
Drugs / interventionsradiation, ivonescimab
Locations202 sites (Chandler, Arizona and 201 other locations)
Trial IDNCT06767514 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) who have high levels of PD-L1 expression. The study aims to assess overall survival and progression-free survival in this patient population. Participants must be adults with confirmed metastatic NSCLC and no prior systemic treatment for their condition. The study will compare the outcomes of ivonescimab to pembrolizumab, another treatment option.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with metastatic NSCLC and high PD-L1 expression.

Not a fit: Patients with small cell lung carcinoma or those who have received prior treatment for metastatic NSCLC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve survival rates for patients with high PD-L1 metastatic NSCLC.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches in treating NSCLC, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Age ≥ 18 years old at the time of enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1
* Expected life expectancy ≥ 3 months
* Metastatic (Stage IV) NSCLC
* Histologically or cytologically confirmed squamous or non-squamous NSCLC
* Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
* At least one measurable noncerebral lesion according to RECIST 1.1
* No prior systemic treatment for metastatic NSCLC.

Exclusion Criteria:

* Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
* Has received any prior therapy for NSCLC in the metastatic setting.
* Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
* Known actionable genomic alterations for which first-line approved therapies are indicated
* Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
* Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
* Active autoimmune or lung disease requiring systemic therapy
* Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
* Severe infection within 4 weeks prior to randomization
* Major surgical procedures or serious trauma within 4 weeks prior to randomization
* History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

Where this trial is running

Chandler, Arizona and 201 other locations

+152 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-Small Cell Lung Cancer

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.