OncRef

Clinical Trial: NCT05840016

AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 3

Lead Sponsor:Akeso
Information Provided By:Akeso
Last Update Posted:2025-05-02

Study Overview

Brief Summary

This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.

Official Title

A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer

Conditions

Advanced Squamous Non Small Cell Lung Cancer

Intervention / Treatment

  • Drug: AK112, Carboplatin, Paxlitaxel
  • Drug: Tislelizumab, Carboplatin, Paxlitaxel

Other Study ID Numbers

  • AK112-306

Start Date (Actual)

2023-08-17

Primary Completion Date (Actual)

2025-02-28

Study Completion Date (Estimated)

2026-12-31

Enrollment (Actual)

532

Study Type

Interventional

Phase

Phase 3