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PEmbRolizumab verSus chEmotherapy and pEmbrolizumab in Non-small-cell Lung Cancers (NSCLC) With PDL1 ≥ 50 %

Study acronym: PERSEE
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record status
This record was last updated September 17, 2025 (before its estimated December 22, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv10
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 292 to confirmed 349
    • Study sites: 31 to 29
    v9
  3. Primary endpoint revised
    • Study sites: 28 to 31
    • Secondary endpoints revised (15)
    v8
  4. Site details revised at 14 of 28 sitesv7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Dec 16, 2025 to Dec 22, 2025
    • Start date changed from estimate of Dec 16, 2020 to Dec 22, 2020
    • Site details revised at 28 of 28 sites
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Start date: Nov 16, 2020 to Dec 16, 2020
    • Primary and study completion dates: Nov 16, 2025 to Dec 16, 2025
    • Eligibility criteria shortened, about 32 words
    • Study sites revised (28)
    v4
  3. Primary and study completion dates: Oct 27, 2025 to Nov 16, 2025
    • Start date: Oct 27, 2020 to Nov 16, 2020
    • Site contacts updated at 1 of 28 sites
    v3
  4. Re-verified, no change to tracked fieldsv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PERSEE is a French national phase 3 academic study comparing the chemotherapy-pembrolizumab combination to pembrolizumab alone as a first-line treatment for advanced NSCLC molecularly defined by a PDL1 expression ≥ 50% of tumour cells and no EGFR mutations or ALK rearrangement. The main hypothesis is the superiority of the chemo-immunotherapy combination over mono-immunotherapy in terms of progression-free survival evaluated by an independent review committee. One of the anticipated benefits of using the chemotherapy-pembrolizumab combination starting from the first line setting for NSCLC patients with PD L1 ≥ 50% is a reduced risk of early progression, which is known to occur with pembrolizumab monotherapy, and therefore, a better PFS.
Trial Details
NCT Number NCT04547504
Lead Sponsor University Hospital, Brest
Collaborators: Groupe Francais De Pneumo-Cancerologie
Conditions
(from sponsor)		 Non-small-cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 349 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov