NCT03866993

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (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 evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.

Conditions

• Lung Cancer Non-small Cell Stage IV
• Squamous Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	AK105	IV infusion
DRUG	Paclitaxel	IV infusion
DRUG	Carboplatin	IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2018-12-20
• Primary completion: 2020-10-08
• Completion: 2022-01-14
• First posted: 2019-03-07
• Last updated: 2024-04-03

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study