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

Summit Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: Ivonescimab Injection; Biological: Pembrolizumab Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05899608

SMT112-3003

Details and patient eligibility

About

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.

Enrollment: 1,080 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,080 participants in 2 patient groups

Arm A - Ivonescimab and chemotherapy

Experimental group

Description:

Subject will receive ivonescimab and chemotherapy

Treatment:

Biological: Ivonescimab Injection

Arm B - Pembrolizumab and chemotherapy

Active Comparator group

Description:

Subject will receive pembrolizumab and chemotherapy

Treatment:

Biological: Pembrolizumab Injection