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