Addition of Platinum-based Chemotherapy to Tislelizumab in PD-L1high Metastatic Non-small Cell Lung Cancer with a High Tumor Burden (HighFive) [without IMPD-Q]

Condition studied

NSCLC, Non-Small Cell Lung Cancer Stage IV

Investigational medicinal product(s)

Every trial of Pemetrexed, Tislelizumab, Paclitaxel and Cisplatin across our registers →

Eligibility

Primary endpoint

The primary efficacy endpoint is the progression-free survival, defined as time from randomization to the date of first objective disease progression (according to RECIST V1.1) or death of any cause, whichever occurs first. It will be assessed in comparison between the two study arms, IO monotherapy vs tislelizumab + platinum-based chemotherapy.

Endpoint detail

Overall survival, defined as time from randomization to death from any cause., Objective response rate, defined as rate of patients with complete response (CR) or partial response (PR) as best response, Duration of response, defined as time from first occurrence of CR or PR as best response to the date of first objective disease progression (according to RECIST V1.1) or death of any cause, whichever occurs first, Disease control rate, defined as rate of patients with CR, PR or stable disease (SD) as best response, Quality of life, assessed per FACT-L at baseline, during treatment and at end of treatment, Explorative comparison: Progression-free and overall survival between tislelizumab monotherapy (in Arm A) vs. tislelizumab plus chemotherapy (Arm B), Safety endpoints include the incidence of serious and severe adverse events (i.e. adverse events grade ≥3 and SAEs), as well as their relatedness to study treatment.