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

Study acronym: Pulse
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 30 to 37v5
  2. Study sites: 1 to 30v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2023 to Mar 20, 2023
    • Site details revised
    v3
  4. Start date: Jan 2023 to Mar 2023
    • Site contact updated
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05692999
Lead Sponsor Gustave Roussy, Cancer Campus, Grand Paris
Conditions
(from sponsor)		 Metastatic Non-squamous Lung Cancer
Enrollment 1,166 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov