NCT04647344

A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer

An Open-label, Multicenter, Phase Ib/II Study of AK104, Combined Chemotherapy as First-line Therapy to Treat Locally Advanced or Metastatic Non-small Cell Lung Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer.

Conditions

• Lung Cancer Non-Small Cell Stage IIIB/IIIC/IV

Interventions

Type	Name	Description
DRUG	AK104 plus Carboplatin and Pemetrexed	Subjects receive AK104 15mg/kg intravenously (IV) plus pemetrexed 500 mg/m\^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV plus pemetrexed 500 mg/m\^2 IV Q3W until progression.
DRUG	AK104 plus Carboplatin and paclitaxel	Subjects receive AK104 15mg/kg intravenously (IV) plus paclitaxel 175 mg/m\^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV IV Q3W until progression.

Timeline

• Start date: 2020-11-24
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2020-11-30
• Last updated: 2024-04-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study