Etude : MK-7339-006 / KEYLYNK-006

ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.

Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : MK-7339-006 / KEYLYNK-006

Situation thérapeutique : Métastatique ou localement avancé

Traitement : Chimiothérapie / Immunothérapie / Thérapie ciblée

Cadre réglementaire : RIPH2

Dernière MÀJ : 30/06/2021
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase III évaluant l’association du pembrolizumab avec le permetrexed et un sel de platine, suivi d’une phase de maintenance par pembrolizumab + olaparib VS pembrolizumab + permetrexed en traitement de 1ère ligne chez des patients présentant un CBNPC non epidermoïde.

Spécialité : Organes respiratoires et intrathoraciques
Localisation : C34 - Tumeur maligne des bronches et du poumon
Informations complémentaires
Schéma : The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, v.s. pembrolizumab plus maintenance pemetrexed for the treatment of nonsquamous NSCLC. The study's 2 primary hypotheses are: 1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) by blinded independent clinical review (BICR) and 2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS).

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus pemetrexed plus platinum (carboplatin or cisplatin). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance pemetrexed. In the Maintenance Phase, participants receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance pemetrexed until progressive disease (PD), intolerable toxicities, or physician decision.

Phase : III

Stade : Métastatique

Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
- Have stage IV nonsquamous NSCLC.
- Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is not indicated.
- Have measurable disease based on RECIST 1.1.
- Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated.
Note: Adequacy of biopsy specimen for the above analyses must be confirmed by the central laboratory before the participant can start the induction phase. Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
- Have a life expectancy of at least 3 months.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status assessed within 7 days prior to the administration of study intervention.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- Have adequate organ function.
- Male and female participants who are not pregnant and of childbearing potential must follow contraceptive guidance during the treatment period and for 180 days afterwards.
- Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.

Critères de non-inclusion : - Has predominantly squamous cell histology NSCLC.
- Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
- Has a known history of human immunodeficiency virus (HIV) infection, a known history of hepatitis B infection, or known active hepatitis C virus infection.
- Has interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment.
- Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
- Has received prior therapy with an agent directed to programmed cell death ligand 1 (PD-L1), anti PD-L2, or directed to a stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX-40, CD137).
- Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
- Has not completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
Informations relatives au promoteur
Promoteur :
MSD (Merck Sharp & Dohme Corp.)
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
CHU de Caen - Avenue de la Côte de Nacre - 14033 Caen Cedex - 14000 CAEN

Investigateur :

Vincent LEON

Statut de l'essai : CLOS

MAJ : 30/06/2021