Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous 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, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.

Enrollment: 400 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 NSCLC
• Tumor Proportion Score (TPS) with PD-L1 expression percent
• 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, or non-squamous NSCLC histology.
• Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
• Has received any prior therapy for NSCLC in the metastatic setting
• Tumor invasion, encasement of organs (e.g. heart, trachea, esophagus), 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

---

400 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