Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer With a High Tumor Burden

This is a randomized, open-label, multicenter, phase III trial. Patients with squamous or non-squamous non-small-cell lung cancer (NSCLC) UICC 9th Stage IV, a high PD-L1 expression level (PD-L1 ≥ 50%) and a high tumor burden (baseline tumor size (BTS) ≥ 50 mm), eligible for 1st-line treatment with platinum and immunotherapy, will be enrolled in this trial. The patients will receive immuno-monotherapy (tislelizumab or pembrolizumab) or immunotherapy plus platinum-based doublet chemotherapy (squamous NSCLC: tislelizumab + carboplatin + (nab-) paclitaxel with tislelizumab maintenance; non-squamous NSCLC: tislelizumab + cis-/carboplatin + pemetrexed with tislelizumab maintenance) for a maximum of 24 months, with a subsequent follow-up phase until end of study (26 months after last patient in or until all patients have finished a 90-days safety follow-up) or preliminary termination or death. Standard of care tumor assessments will be performed and recorded according to RECIST version 1.1., at baseline/screening, throughout the treatment phase (initially after 6 weeks, thereafter each 12 ± 2 weeks), at end of treatment and during follow up.