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Phase 3 Study of Pembrolizumab with or without Maintenance Olaparib in First-Line Metastatic Squamous NSCLC
EU CTIS ID: 2023-508449-41-00
What this study is testing
1. To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to progression-free survival (PFS) assessed according to RECIST 1.1 (Section 4.2.1.1) by blinded independent central review (BICR). 2. To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus placebo with respect to overall survival (OS).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Have a histologically or cytologically confirmed diagnosis squamous non-small cell lung cancer (NSCLC).
- Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
- Have Stage IV squamous NSCLC.
- Have measurable disease based on RECIST 1.1.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- 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 receive study intervention(s). Submission of another tumor specimen may be required prior to enrolling the participant, if adequate tumor tissue was not provided the first time.
You likely can't join if
- Has non-squamous histology NSCLC.
- 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 a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
See the full eligibility criteria
- Have a histologically or cytologically confirmed diagnosis squamous non-small cell lung cancer (NSCLC).
- Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
- Have Stage IV squamous NSCLC.
- Have measurable disease based on RECIST 1.1.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
- 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 receive study intervention(s). 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 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 a life expectancy of at least 3 months.
- Has 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.
- Has non-squamous histology NSCLC.
- 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 a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a known hypersensitivity to any components or excipients of carboplatin, paclitaxel or nab-paclitaxel, or olaparib.
- Has a severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- United Kingdom
- Taiwan
- New Zealand
- Canada
- Russian Federation
- Turkey
- Mexico
- Argentina
- Korea, Republic of
- Australia
- Brazil
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; United Kingdom; Taiwan; New Zealand; Canada; Russian Federation and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.