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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAkeso

About this trial

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%.

Eligibility criteria

Qualifiers

The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.

Aged ≥18 years when the subject signed the informed consent.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Life expectancy ≥ 3 months.

Disqualifiers

Histologically confirmed small cell lung cancer (SCLC).

NSCLC with driver gene mutations for approved targeted drug indications.

Active central nervous system (CNS) metastases were present.

Pulmonary radiation therapy > 30 Gy within 6 months prior to first dose.

Trial design

Treatments tested in this trial

  • AK104
  • Tislelizumab
  • carboplatin
  • Pemetrexed
  • Paclitaxel

Treatment groups

642 Participants
are divided into 2 treatment groups

Sponsors and collaborators