NCT04547504 (PERSEE) is a Phase 3 clinical trial of Pembrolizumab in Non-small-cell Lung Cancer, sponsored by University Hospital, Brest.

Who is sponsoring NCT04547504?

NCT04547504 is sponsored by University Hospital, Brest.

What drugs are being tested in NCT04547504?

Interventions in NCT04547504: Pembrolizumab, Pembrolizumab and Chemotherapy drugs.

What condition does NCT04547504 study?

NCT04547504 studies Non-small-cell Lung Cancer.

Is NCT04547504 still recruiting?

NCT04547504 is currently active, enrolled. Last updated 17 September 2025.

Last reviewed 2025-09-17 · How we verify

NCT04547504: PERSEE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 17 September 2025

What this trial tests

Phase 3 trial testing Pembrolizumab in Non-small-cell Lung Cancer in 349 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

22 December 2020

Primary endpoint
22 December 2025

22 December 2025

Quick facts

Lead sponsor	University Hospital, Brest
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	349
Start date	22 December 2020
Primary completion	22 December 2025
Estimated completion	22 December 2025
Sites	29 locations across France

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →
Pembrolizumab and Chemotherapy drugs — full drug profile →

Conditions studied

Non-small-cell Lung Cancer — all drugs for Non-small-cell Lung Cancer →

Sponsor

University Hospital, Brest

Who can join

18 and older, any sex, with Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting nucleotide metabolism: a promising approach to enhance cancer immunotherapy.
Wu HL, Gong Y, Ji P, Xie YF, et al · · 2022 · cited 123× · PMID 35477416 · DOI 10.1186/s13045-022-01263-x
Association of the advanced lung cancer inflammation index (ALI) with immune checkpoint inhibitor efficacy in patients with advanced non-small-cell lung cancer.
Mountzios G, Samantas E, Senghas K, Zervas E, et al · · 2021 · cited 75× · PMID 34481329 · DOI 10.1016/j.esmoop.2021.100254
Durable responders in advanced NSCLC with elevated TMB and treated with 1L immune checkpoint inhibitor: a real-world outcomes analysis.
Huang RSP, Carbone DP, Li G, Schrock A, et al · · 2023 · cited 25× · PMID 36650021 · DOI 10.1136/jitc-2022-005801
Association between the baseline tumor size and outcomes of patients with non-small cell lung cancer treated with first-line immune checkpoint inhibitor monotherapy or in combination with chemotherapy.
Uehara Y, Hakozaki T, Kitadai R, Narita K, et al · · 2022 · cited 17× · PMID 35280320 · DOI 10.21037/tlcr-21-815
First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression ≥50.
Descourt R, Chouaid C, Pérol M, Besse B, et al · · 2021 · cited 14× · PMID 34156285 · DOI 10.2217/fon-2020-1202
First-line treatment options for advanced non-small cell lung cancer patients with PD-L1 ≥ 50%: a systematic review and network meta-analysis.
He M, Zheng T, Zhang X, Peng Y, et al · · 2022 · cited 13× · PMID 34657171 · DOI 10.1007/s00262-021-03089-x
Real-world multicentre cohort of first-line pembrolizumab alone or in combination with platinum-based chemotherapy in non-small cell lung cancer PD-L1 ≥ 50.
Pons-Tostivint E, Hulo P, Guardiolle V, Bodot L, et al · · 2023 · cited 12× · PMID 36690799 · DOI 10.1007/s00262-022-03359-2
ICI plus chemotherapy prolonged survival over ICI alone in patients with previously treated advanced NSCLC.
Mao S, Zhou F, Liu Y, Yang S, et al · · 2022 · cited 10× · PMID 34097116 · DOI 10.1007/s00262-021-02974-9

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
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NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
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NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Non-small-cell Lung Cancer

Currently open trials in the same condition.

NCT06245837 — Treatment and Biomarker Testing Patterns,Treatment Outcomes in a/m NSCLC With and Without Actionable Genomic Alterations · active not recruiting
NCT06141226 — Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Che · Phase 2 · recruiting
NCT04849481 — The Research Plan of Taiwan Precision Medicine · recruiting
NCT04181788 — Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies · Phase 1, PHASE2 · active not recruiting

Other University Hospital, Brest trials

Trials by the same sponsor.

NCT07526688 — Aerobic Physical Activity and Orofacial Myofascial Pain · NA · not yet recruiting
NCT07487155 — Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Dis · NA · not yet recruiting
NCT07417605 — Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiatio · not yet recruiting
NCT07302074 — Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations a · NA · recruiting
NCT06441773 — Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated W · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04547504 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
Last refreshed: 17 September 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04547504.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing