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

Sponsor
University Hospital, Brest
Study ID
NCT04547504
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Non-small-cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.
  • Pembrolizumab and Chemotherapy drugs — DRUG
    An induction therapy followed by a maintenance therapy. 4 induction cycles every 3 weeks associating, on the first day of each cycle: * Cisplatin 75mg/m² or carboplatin AUC 5mg/mL/min, pemetrexed 500mg/m² and pembrolizumab 200mg for non squamous NSCLC. * Carboplatin AUC 6mg/mL/min, paclitaxel 200mg/m² and pembrolizumab 200mg for squamous NSCLC. After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable: * Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy. * Squamous NSCLC: pembrolizumab monotherapy. For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop. For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.

Study Details

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.

Key Dates

Start date
Dec 22, 2020
Status verified
Sep 2025
Primary completion
Dec 22, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
349 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pembrolizumab
    Pembrolizumab
  • Active Comparator: Chemotherapy-Pembrolizumab
    Chemotherapy and Pembrolizumab

Primary Outcome Measure

Progression-free survival (PFS) according to RECIST 1.1 assessed by blinded inependant centra review (BICR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]

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