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NCT06767514PHASE3RECRUITING

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

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

Sponsor: Summit Therapeutics

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Non-Small Cell Lung Cancer
Interventions
Ivonescimab Injection, Pembrolizumab Injection
Enrollment
780 participants
Primary completion
Apr 2028
Study completion
Jun 2029
First posted
Jan 2025
Last updated
Feb 2026

Primary Endpoints (CT.gov)

Overall Survival (OS)

Time frame: Up to approximately 36 months

Progression free survival (PFS)

Time frame: Up to approximately 36 months

Secondary Endpoints

Objective response rate (ORR)

Disease control rate ( DCR)

Duration of response (DoR)

Eligibility 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 enrolle

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov