AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer
NCT05904379 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 233
Last updated 2026-03-09
Summary
This trial is a Phase Ib/II 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 safety and efficacy of AK112 and AK104 with or without chemotherapy in subjects with advanced NSCLC.
Conditions
- Advanced Non-small-cell Lung Cancer
Interventions
- DRUG
-
AK112
Subjects receive AK112 intravenously.
- DRUG
-
AK104
Subjects receive AK104 intravenously.
- DRUG
-
Subjects receive carboplatin intravenously.
- DRUG
-
Subjects receive paclitaxel intravenously.
- DRUG
-
pemetrexed
Subjects receive pemetrexed intravenously.
- DRUG
-
Subjects receive docetaxel intravenously.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-07-13
- Primary Completion
- 2026-06-30
- Completion
- 2027-01-31
Countries
- China
Study Locations
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