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.

Full description

This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently

Enrollment: 1,600 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) or Tumor Cells (TC) 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. pericardium, 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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1,600 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