NCT05692999

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,166 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Metastatic Non-squamous Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab 200 mg Q6W	Pembrolizumab 200mg Q6W
DRUG	Pemetrexed 500 mg/m^2 Q3W	Pemetrexed 500 mg/m\^2 Q3W
DRUG	Pembrolizumab 200 mg Q3W or 400 mg Q6W	Pembrolizumab 200 mg Q3W or 400 mg Q6W

Timeline

• Start date: 2023-03-20
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2023-01-20
• Last updated: 2025-06-25

Locations

37 sites across 3 countries: Belgium, France, Spain