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

NCT04547504 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: 29BRC20.0159_GFPC01-2020GFPC 01-2020
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Non-small-cell Lung Cancer

Keywords

Non-small-cell lung cancer; PDL1≥50%; advanced stage; Pembrolizumab; Chemotherapy-pembrolizumab combination

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) according to RECIST 1.1 assessed by blinded inependant centra review (BICR)

  Time from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, according to RECIST 1.1 assessed by blinded inependant centra review (BICR)

  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

Secondary Outcomes (15)

• Progression-free survival according to RECIST 1.1 evaluated by investigators

  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

• Progression-free survival according to iRECIST assessed by blinded inependant centra review (BICR)

  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

• Objective Response Rate (ORR)

  From date of first treatment administration until the date of first documented progression or death or the introduction of a new treatment, whichever came first, assessed up to 60 months

• Overall survival (OS)

  From date of randomization until the date of death from any cause assessed up to 60 months

• Duration of treatment (DOT)

  From date of the first treatment administration until the date of last treatment administration, up to 60 months

Other Outcomes (6)

• Early progression rate

  Up to 6 weeks from the first day of treatment

• Following of the quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Cancer patients.

  Up to 60 months

• Following of the quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire of Lung Cancer patients.

  Up to 60 months

Study Arms (2)

Pembrolizumab

ACTIVE COMPARATOR

Pembrolizumab

Drug: Pembrolizumab

Chemotherapy-Pembrolizumab

ACTIVE COMPARATOR

Chemotherapy and Pembrolizumab

Drug: Pembrolizumab and Chemotherapy drugs

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

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.

Chemotherapy-Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older at diagnosis.
• Histologically or cytologically confirmed NSCLC.
• Stage IV NSCLC. Unresectable and non-eligible to radiotherapy stage III NSCLC are permitted.
• For non-squamous NSCLCs and non-smoking squamous NSCLCs, no known activating mutations of EGFR and no ALK or ROS-1 rearrangements.
• PD-L1 expression on ≥ 50 % of tumor cells, which will be determined locally.
• No prior systemic treatment for lung cancer. Patients who received adjuvant therapy are eligible if the adjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
• Palliative radiotherapy completed within one day before randomization (stereotaxic or not) is authorized.
• At least 1 target lesion in a non-irradiated area, measurable according to RECIST v1.1.
• An Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.
• Life expectancy \>12 weeks.
• No history of other malignant tumor during the previous 5 years, except for adequately treated carcinomas (in situ cervical carcinoma, basal cell carcinoma, squamous cell skin carcinoma) and low grade localized prostate cancer (Gleason \<6).
• Adequate organ function, as demonstrated by laboratory results within 7 days prior to the first administration of study treatment:
• Normal hepatic function: bilirubin ≤1.5 x upper limit of normal (ULN), alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) ≤2.5 x ULN or ≤5 x ULN in case of liver metastases
• Normal renal function: calculated creatinine clearance (CrCl, using local formula) of at least 60 mL/min for cisplatin or 45 ml/mn for carboplatin
• Normal hematological function: absolute neutrophil count ≥1.5 giga/L and/or platelets ≥100 giga/L, hemoglobin ≥8 g/dL

You may not qualify if:

• NSCLC with expression of PD-L1 \<50%.
• NSCLC with known activating mutation of EGFR or ALK or ROS-1 translocation.
• Neuroendocrine tumor. In cases of mixed tumors, if small cell elements are present, the patient is ineligible.
• Any previous treatment with immunotherapy regardless of the line of treatment.
• Before the first dose of study treatment:
• Has received prior systemic treatment for metastatic disease (chemotherapy or targeted therapy).
• Had major surgery \<3 weeks prior to first dose.
• Received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study treatment.
• Uncontrolled and untreated superior cava syndrome.
• Untreated and unstable symptomatic brain metastases.
• Leptomeningeal disease.
• Serious concurrent conditions during the previous 6 months (severe or unstable angina pectoris, coronary or peripheral artery bypass graft of \<6 months, class 3 or 4 congestive heart failure, ischemic stroke, grade ≥2 peripheral neuropathy, psychiatric or neurological disorders that may interfere with the patient's understanding of the study or with his/her informed consent.
• Severe or non controlled systemic diseases deemed incompatible with the protocol.
• Other previous or concomitant cancers, with the exception of basal cell carcinoma, squamous cell skin carcinoma, in situ cervical carcinoma treated, and low grade localized prostate cancer (Gleason score \<6) if appropriately treated, unless the initial tumor has been diagnosed and definitively treated \>5 years prior to the study, with no signs of relapse.
• Psychological, family, social, or geographical factors that may interfere with the monitoring of the patient as defined by the protocol.

Sponsors & Collaborators

• University Hospital, Brest: lead
• Groupe Francais De Pneumo-Cancerologie: collaborator

Study Sites (29)

CH du Pays d'Aix

Aix-en-Provence, 13616, France

Location

CHU AMIENS - Hôpital Sud

Amiens, 80054, France

Location

Chu Angers

Angers, 49033, France

Location

CHRU de Brest

Brest, 29609, France

Location

Centre de lutte contre le cancer - Centre François Baclesse

Caen, 14000, France

Location

Centre Hospitalier Métropole Savoie

Chambéry, 73000, France

Location

CH Intercommunal de Créteil

Créteil, 94010, France

Location

CH La Roche Sur Yon - CHD Les Oudairies

La Roche-sur-Yon, 85000, France

Location

Chu Dupuytren

Limoges, 87042, France

Location

CH de Lorient - Hôpital du Scorff

Lorient, 56100, France

Location

Centre Léon Berard

Lyon, 69008, France

Location

Institut Paoli-Calmette

Marseille, 13000, France

Location

Hôpital Européen Marseille

Marseille, 13003, France

Location

CHU MARSEILLE_ Hopital Nord

Marseille, 13915, France

Location

CH MEAUX

Meaux, 77108, France

Location

APHP - Hôpital Cochin

Paris, 75014, France

Location

CHU Bordeaux - Hôpital du Haut Levêque

Pessac, 33604, France

Location

CH d'Annecy-genevois

Pringy, 74374, France

Location

Centre Hospitalier de Cornouaille

Quimper, 29000, France

Location

CHU RENNES - Hôpital Pontchailloux

Rennes, 35033, France

Location

CHU ROUEN - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Saint Aubin Les Elbeuf

Saint-Aubin-lès-Elbeuf, 76503, France

Location

CH La Réunion - Site Félix Guyon

Saint-Denis, 97400, France

Location

CHU La Réunion - Groupe Hospitalier Sud

Saint-Pierre, 97410, France

Location

SAINT-PRIEST EN JAREZ - Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, 42271, France

Location

Institut de Cancérologie Strasbourg Europe

Strasbourg, 67200, France

Location

Hôpital d'Instruction des Armées Toulon - Saint Anne

Toulon, 83041, France

Location

Ch Villefranche Sur Saone

Villefranche-sur-Saône, 69655, France

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Related Publications (1)

• Descourt R, Chouaid C, Perol M, Besse B, Greillier L, Bylicki O, Ricordel C, Guisier F, Gervais R, Schott R, Auliac JB, Robinet G, Decroisette C. First-line pembrolizumab with or without platinum doublet chemotherapy in non-small-cell lung cancer patients with PD-L1 expression >/=50. Future Oncol. 2021 Aug;17(23):3007-3016. doi: 10.2217/fon-2020-1202. Epub 2021 Jun 22.

  PMID: 34156285 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Renaud DESCOURT, MD

  Institut de Cancérologie, CHU Brest, Hôpital Morvan

  PRINCIPAL INVESTIGATOR

• Chantal DECROISETTE, MD

  Medical Oncology, Centre Léon Bérard, Lyon

  PRINCIPAL INVESTIGATOR

• Christos CHOUAID, MD, PhD

  Service de pneumologie, CH intercommunal de Créteil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A national, multicenter, phase III, prospective, open label, 1:1 randomized, interventional study

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 14, 2020
• Study Start: December 22, 2020
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (29)