OncRef

Clinical Trial: NCT05184712

Phase 3 Clinical Study of AK112 for NSCLC Patients

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Akeso
Information Provided By:Akeso
Last Update Posted:2026-03-04

Study Overview

Brief Summary

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment

Official Title

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 Combined With Pemetrexed and Carboplatin Versus Placebo Combined With Pemetrexed and Carboplatin in Patients With Locally Advanced or Metastatic EGFR-mutant Non-squamous NSCLC Who Have Failed Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR-TKIs)

Conditions

Non-Squamous Non-small Cell Lung Cancer

Intervention / Treatment

  • Drug: Ivonescimab (SMT112 or AK112) Injection
  • Drug: Placebo Injection

Other Study ID Numbers

  • AK112-301
  • HARMONi-A

Start Date (Actual)

2022-01-25

Primary Completion Date (Actual)

2023-03-10

Study Completion Date (Estimated)

2026-09

Enrollment (Actual)

322

Study Type

Interventional

Phase

Phase 3