Informations générales (source: ClinicalTrials.gov)
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 (NSCLC)
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
juin 2019
décembre 2025
02 août 2025
The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, versus
(vs) pembrolizumab plus maintenance pemetrexed for the treatment of non-squamous 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 version 1.1 (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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HIA BEGIN | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier De Chauny ( Site 1411) - 02300 - Chauny - Aisne - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier de Pau ( Site 1412) - 64000 - Pau - Pyrenees-Atlantiques - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin ( Site 1407) - 63011 - Clermont Ferrand - Puy-de-Dome - France | Contact (sur clinicalTrials) | ||||
| CHU Angers ( Site 1405) - 49100 - Angers - Maine-et-Loire - France | Contact (sur clinicalTrials) | ||||
| CHU Caen ( Site 1406) - 14033 - Caen - Calvados - France | Contact (sur clinicalTrials) | ||||
| CHU de Rouen ( Site 1403) - 76000 - Rouen - Seine-Maritime - France | Contact (sur clinicalTrials) | ||||
| Hopital Robert Schuman ( Site 1402) - 57070 - Vantoux - Moselle - France | Contact (sur clinicalTrials) | ||||
| Institut De Cancerologie De Lorraine ( Site 1409) - 54519 - Vandoeuvre les Nancy - Ain - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
2. Have stage IV nonsquamous NSCLC.
3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma
kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is
not indicated.
4. Have measurable disease based on RECIST 1.1.
5. 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.
6. Have a life expectancy of at least 3 months.
7. 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.
8. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
9. Have adequate organ function.
10. 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.
11. Male participants must refrain from donating sperm, and female participants must
refrain from donating eggs to others or freeze/store for her own use during the
treatment period and for 180 days afterwards.
1. Have a histologically or cytologically confirmed diagnosis nonsquamous NSCLC.
2. Have stage IV nonsquamous NSCLC.
3. Have confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma
kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1)-directed therapy is
not indicated.
4. Have measurable disease based on RECIST 1.1.
5. 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.
6. Have a life expectancy of at least 3 months.
7. 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.
8. Have not received prior systemic treatment for their advanced/metastatic NSCLC.
9. Have adequate organ function.
10. 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.
11. Male participants must refrain from donating sperm, and female participants must
refrain from donating eggs to others or freeze/store for her own use during the
treatment period and for 180 days afterwards.
1. Has predominantly squamous cell histology NSCLC.
2. Has a known additional malignancy that is progressing or has progressed within the
past 3 years requiring active treatment.
3. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.
4. Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its
excipients.
5. Has a known hypersensitivity to any components or excipients of cisplatin,
carboplatin, pemetrexed, or olaparib.
6. Has an active autoimmune disease that has required systemic treatment in past 2
years.
7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid
therapy.
8. Has a known history of human immunodeficiency virus (HIV) infection, a known history
of hepatitis B infection, or known active hepatitis C virus infection.
9. Has interstitial lung disease, or history of pneumonitis requiring systemic steroids
for treatment.
10. Has received prior therapy with olaparib or with any other polyadenosine 5'
diphosphoribose (polyADP ribose) polymerization (PARP) inhibitor.
11. 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).
12. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features
suggestive of MDS/AML.
13. Has history of a second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 2 years.
14. Has completed palliative radiotherapy within 7 days of the first dose. Participants
must have recovered from all radiation-related toxicities and not require
corticosteroids.