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

NCT05692999 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1166

Last updated 2025-06-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Principal Investigators

  • Benjamin BESSE · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • Belgium
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05692999 on ClinicalTrials.gov