Status:

RECRUITING

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

Lead Sponsor:

Summit Therapeutics

Conditions:

Non-Small Cell Lung Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

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 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

Key Trial Info

Start Date :

February 27 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2029

Estimated Enrollment :

780 Patients enrolled

Trial Details

Trial ID

NCT06767514

Start Date

February 27 2025

End Date

June 1 2029

Last Update

February 24 2026

Active Locations (202)

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Page 1 of 51 (202 locations)

1

Clinical Study Site

Chandler, Arizona, United States, 85224

2

Clinical Study Site

Phoenix, Arizona, United States, 85006

3

Clinical Study Site

Hot Springs, Arkansas, United States, 71913

4

Clinical Study Site

Cerritos, California, United States, 90703