Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
Keychain 008
Clinical summary
Summary
This trial consists of two parts: the Induction and Maintenance phase. All patients eligible to participate in this trial will receive intravenous administration of Pembrolizumab and chemotherapy drugs (carboplatin and paclitaxel or nab-paclitaxel) on Day 1 of 4 x 21 day cycles. People eligible to participate in the Maintenance phase will either receive intravenous administration of Pembrolizumab on Day 1 of each 21 day cycle and orally administered Olaparib twice daily, or Pembrolizumab and an orally administered placebo. Maintenance will continue for up to 31 cycles.
Conditions
This trial is treating people with Metastatic Squamous Non-Small-Cell Lung Cancer
Eligibility
Inclusion
- Have a histologically or cytologically confirmed diagnosis squamous NSCLC.
- Have Stage IV squamous NSCLC.
- Have measurable disease based on RECIST 1.1.
- Have not received prior systemic treatment for their advanced/metastatic NSCLC.
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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.
- Male participants must refrain from donating sperm during the treatment period and for 180 days afterwards.
Exclusion
- Has non-squamous 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 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.
- 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.
Inclusion
- You are able to swallow medication by mouth.
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
- NCT03976362 *
- MK-7339-008 KEYLYNK-008 2018-004721-88 7339-008
Trial sponsor
Merck
Scientific Title
A Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance Olaparib in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
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