| Titre |
A Phase 3 Study of Pembrolizumab in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants With Metastatic Nonsquamous Non-Small-Cell Lung Cancer |
| Protocole ID |
MK-7339-006 |
| ClinicalTrials.gov ID |
NCT03976323 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Métastatique |
| Type étude |
Traitement |
| Médicament |
Pembrolizumab avec Pemetrexed/Platine (Carboplatine ou Cisplatine) suivi de Pembrolizumab et Olaparib en maintien vs Pemetrexed en maintien |
| Institution |
CISSS DE LA MONTEREGIE-CENTRE
 HOPITAL CHARLES-LE MOYNE
3120 boulevard Taschereau, Greenfield Park, QC, J4V2H1
|
| Ville |
Greenfield Park |
| Investigateur(trice) principal(e) |
Dre Flávia De Angelis
|
| Coordonnateur(trice) |
Stéphanie Bonin
450-466-5000 poste 7691
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- 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.
- 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.
|
| Critètes d'exclusion |
- 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.
|
Groupe d'étude en oncologie du Québec