A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC MK-7339-008/KEYLYNK-008)

  • STATUS
    Recruiting
  • End date
    Dec 30, 2024
  • participants needed
    735
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 25 July 2021

Summary

The current study will compare pembrolizumab (MK-3475) plus maintenance olaparib, vs. pembrolizumab plus maintenance olaparib placebo for the treatment of squamous NSCLC. The study's 2 primary hypotheses are:

  1. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to progression-free survival (PFS) per RECIST 1.1 by blinded independent clinical review (BICR).
  2. Pembrolizumab plus maintenance olaparib is superior to pembrolizumab plus maintenance olaparib placebo with respect to overall survival (OS).

Description

This study has 2 phases: an Induction Phase (4 Cycles) and a Maintenance Phase (Up to 31 cycles of pembrolizumab). In the Induction Phase, participants receive pembrolizumab plus carboplatin plus a taxane (paclitaxel or nab-paclitaxel). In the Maintenance Phase, participants with a partial or complete disease response or with stable disease after completing four cycles of induction therapy and who meet eligibility criteria will be randomly assigned to receive pembrolizumab plus maintenance olaparib OR pembrolizumab plus maintenance olaparib placebo. In the Maintenance Phase, participants randomly assigned to receive pembrolizumab for up to 31 cycles plus maintenance olaparib OR maintenance olaparib placebo until centrally verified progressive disease (PD), intolerable toxicities, or physician decision."

Details
Condition Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung, Carcinoma, Squamous Cell, Non-small-cell Lung
Treatment carboplatin, Placebo, Paclitaxel, Pembrolizumab, Nab-paclitaxel, olaparib
Clinical Study IdentifierNCT03976362
SponsorMerck Sharp & Dohme Corp.
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 Criteria

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
Clear my responses

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