NCT03866980

A Study of Anti-PD-1 AK105 in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer

A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Pemetrexed vs Placebo Combined With Carboplatin and Pemetrexed as First-line Therapy in Patients With Metastatic Nonsquamous Non-small Cell Lung Cancer

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III , randomized, double-blinded, multicenter clinical study to compare efficacy and safety of AK105 (Anti-PD1 antibody) combined with Carboplatin and Pemetrexed vs Placebo combined with Carboplatin and Pemetrexed as first-line therapy in patients with EGFR and ALK wild type metastatic nonsquamous non-small cell lung cancer.

Conditions

• Lung Cancer Non-small Cell Stage IV

Interventions

Type	Name	Description
BIOLOGICAL	AK105	IV infusion
DRUG	carboplatin	IV infusion
DRUG	pemetrexed	IV infusion
DRUG	placebo	IV infusion
DRUG	Anlotinib	PO

Timeline

• Start date: 2018-11-27
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2019-03-07
• Last updated: 2024-04-03

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study