Phase 3 Clinical Study of AK112 for NSCLC Patients

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

322

Participants

Timeline

Start Date

January 25, 2022

Primary Completion Date

June 28, 2024

Study Completion Date

November 2, 2025

Conditions
Non-Squamous Non-small Cell Lung Cancer
Interventions
DRUG

Ivonescimab (SMT112 or AK112) Injection

Subjects will receive Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, Ivonescimab (SMT112 or AK112) Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

DRUG

Placebo Injection

Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Trial Locations (1)

510000

Sun Yat-sen University Cancer Center, Guangzhou

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Akeso

INDUSTRY