NCT05904379

AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

A Phase Ib/II Clinical Trial of AK112 and AK104 With or Without Chemotherapy in Advanced Non-small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 233 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	AK112	Subjects receive AK112 intravenously.
DRUG	AK104	Subjects receive AK104 intravenously.
DRUG	Carboplatin	Subjects receive carboplatin intravenously.
DRUG	paclitaxel	Subjects receive paclitaxel intravenously.
DRUG	pemetrexed	Subjects receive pemetrexed intravenously.
DRUG	Docetaxel	Subjects receive docetaxel intravenously.

Timeline

• Start date: 2023-07-13
• Primary completion: 2026-06-30
• Completion: 2027-01-31
• First posted: 2023-06-15
• Last updated: 2026-03-09

Locations

2 sites across 1 country: China