NCT05990127

A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer

A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS < 1% Non-small Cell Lung Cancer (NSCLC)

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 642 (estimated)
• Sponsor: Akeso · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, phase III clinical study to compare the efficacy and safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS \< 1%.

Conditions

• Locally Advanced or Metastatic NSCLC

Interventions

Type	Name	Description
DRUG	AK104	AK104 IV, q3w
DRUG	Tislelizumab	Tislelizumab IV, q3w
DRUG	carboplatin	carboplatin IV, q3w
DRUG	Pemetrexed	Pemetrexed IV, q3w (for Nonsquamous NSCLC)
DRUG	Paclitaxel	Paclitaxel IV, q3w (for squamous NSCLC)

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-08-05
• Completion: 2026-11-28
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

62 sites across 1 country: China