Study design and population
tumor
TUMOR, BRAIN METASTASES, DISEASE, METASTATIC DISEASE, ONCOLOGY
Eligible patients from RATIONALE 303 were randomly assigned in a 2:1 ratio to receive either tislelizumab 200 mg every 3 weeks (Q3W) or docetaxel 75 mg/mPatients who were eligible for inclusion in the study were adults aged 18 years or older with locally advanced or metastatic sq‐ or nsq‐NSCLC, confirmed by histological analysis, regardless of tumor PD‐L1 expression, who experienced progressive disease during or after at least one platinum‐containing chemotherapy regimen (with no more than two prior systemic treatment lines) and had Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patients who had treated, stable brain metastases were also included. Exclusion criteria included: prior docetaxel treatment for metastatic disease or prior immune checkpoint inhibitor treatment; known epidermal growth factor receptor (The study adhered to the ethical principles of the Declaration of Helsinki and Good Clinical Practice guidelines, as well as the requirements of the public registration of clinical trials and approved by the relevant Institutional Review Board or Independent Ethics Committee for each study site. Prior to participating in the study, written informed consent was obtained from all participants. Additional information on study design, efficacy, and safety data is reported elsewhere.