| Titre |
A Randomized Phase 3 Study of the Combination of Pembrolizumab Plus Epacadostat Alone or With Platinum-based Chemotherapy Versus Pembrolizumab Plus Platinum-based Chemotherapy Plus Placebo as First-Line Treatment in Patients With Metastatic Non-Small Cell Lung Cancer |
| Protocole ID |
MK-3475-715/KEYNOTE-715-05 |
| ClinicalTrials.gov ID |
NCT03322566 |
| Type(s) de cancer |
Poumon non à petites cellules |
| Phase |
Phase III |
| Stade |
Métastatique |
| Type étude |
Traitement |
| Médicament |
Epacadostat, Pembrolizumab, Chimio |
| Institution |
CIUSSS DE L'OUEST-DE-L'ILE-DE-MONTREAL
 CENTRE HOSPITALIER DE ST. MARY
3830 av. Lacombe, Montréal, QC, H3T 1M5
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Adrian Langleben
|
| Coordonnateur(trice) |
Dora Bartulovic
514-345-3511 poste 3378
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
Histologically or cytologically confirmed diagnosis of stage IV NSCLC without epidermal growth factor receptor (EGFR)-sensitizing mutation, ROS1 and/or anaplastic lymphoma kinase (ALK) translocation
-
Measurable disease based on RECIST 1.1
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Life expectancy of at least 3 months.
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
-
Adequate organ function per protocol-defined criteria.
-
Provide tumor tissue sample.
|
| Critètes d'exclusion |
-
Known untreated central nervous system metastases and/or carcinomatous meningitis
-
History of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease.
-
Symptomatic ascites or pleural effusion.
-
Known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.
-
Active autoimmune disease that has required systemic treatment in past 2 years.
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Has had an allogeneic tissue/solid organ transplant.
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Has a known history of human immunodeficiency virus (HIV) infection. HIV testing is not required unless mandated by the local health authority.
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Has known history of or is positive for active Hepatitis B (HBsAg reactive) or has active Hepatitis C (HCV RNA). Note: Testing must be performed to determine eligibility.
-
History or presence of an abnormal electrocardiogram (ECG) that, in the Investigator's opinion, is clinically meaningful.
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Use of protocol-defined prior/concomitant therapy.
|
Groupe d'étude en oncologie du Québec