Trials / Active Not Recruiting
Active Not RecruitingNCT05499390
AK112 in Advanced Non-Small Cell Lung Cancer
A Randomized Controlled, Multi-center Phase III Clinical Trial of AK112 Versus Pembrolizumab as First-line Treatment for PD-L1-Positive Locally-Advanced or Metastatic Non-Small Cell Lung Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 398 (actual)
- Sponsor
- Akeso · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or IV 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 comparing Pembrolizumab in subjects with advanced NSCLC whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AK112 | Subjects receive AK112 intravenously. |
| DRUG | Pembrolizumab | Subjects receive Pembrolizumab intravenously. |
Timeline
- Start date
- 2022-11-09
- Primary completion
- 2024-01-29
- Completion
- 2026-12-31
- First posted
- 2022-08-12
- Last updated
- 2026-03-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05499390. Inclusion in this directory is not an endorsement.