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

ID#: NCT05899608

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: October 26, 2023

End Date: December 31, 2028

Contact Information:
Summit Clinical Trial Information
1-833-256-0522
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.
Eligibility:

Inclusion 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) 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 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. heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
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