Maintenance Pembrolizumab at Usual or Low doSE in Non-squamous Lung Cancer: a Non-inferiority Study

Pulse is a randomized non-inferiority phase III clinical trial assessing a new mode of immunotherapy administration based on increased interval time between 2 infusions as maintenance treatment in Pulse arm compared with the conventional administration in Control arm. In both treatment arms, pembrolizumab alone or combined with pemetrexed is allowed as maintenance treatment. Indeed : In Pulse arm : Pembrolizumab 200 mg will be administered to patients every 6 weeks (Q6W) plus, in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W). In control arm : Pembrolizumab 200 mg will be administered to patients every 3 weeks (Q3W) or 400 mg every 6 weeks plus,in the absence of contra-indication pemetrexed 500 mg/m\^2 will be administered every 3 weeks (Q3W).

NCT Number	NCT05692999
Lead Sponsor	Gustave Roussy, Cancer Campus, Grand Paris
Conditions	Metastatic Non-squamous Lung Cancer
Enrollment	1,166 participants
Start Date	2023-03-20
Primary Completion	2029-01 (estimated)
Study Completion	2029-01 (estimated)
Updated on ClinicalTrials.gov	2025-06-25