squamous NSCLC
Conditions
Interventions
Induction Phase (4 Cycles)
All participants will receive the study intervention (pembrolizumab + carboplatin/taxane-based chemotherapy) in a nonrandomized Induction Phase:
- Pembrolizumab 200 mg IV ev
Sponsors
MSD K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have a histologically or cytologically confirmed diagnosis squamous NSCLC. 2. Have Stage IV squamous NSCLC. 3. Have measurable disease based on RECIST 1.1. 4. Have not received prior systemic treatment for their advanced/metastatic NSCLC. 5. Have provided archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated. 6. 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 7. Have a life expectancy of at least 3 months. 8. Has adequate organ function. 9. Participants who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 180 days following the last dose of pembrolizumab and olaparib or at least 180 days following the last dose of cytotoxic chemotherapy.
Exclusion criteria
Exclusion criteria: 1. Has non-squamous 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 metastases and/or carcinomatous meningitis. 4. Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib. 5. Has a severe hypersensitivity (>=Grade 3) to pembrolizumab and/or any of its excipients. 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 or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention. 8. Has known history of human immunodeficiency virus (HIV) infection. No HIV testing is required unless mandated by local health authority. 9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Progression-free Survival (PFS) - Overall Survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Adverse events (AEs), Study intervention discontinuations due to AEs - Change from baseline (at randomization) and the time to true deterioration (TTD) in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) and QLQ Lung Cancer Module 13 (LC13) scales/items. | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactMSDJRCT inquiry mailbox
MSD K.K.
Outcome results
None listed