Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer Afte… (NCT02504372) | Clinical Trial Compass
CompletedPhase 3
Study of Pembrolizumab (MK-3475) vs Placebo for Participants With Non-small Cell Lung Cancer After Resection With or Without Standard Adjuvant Therapy (MK-3475-091/KEYNOTE-091)
1,177 participantsStarted 2015-11-06
Plain-language summary
In this study, participants with Stage IB/II-IIIA non-small cell lung cancer (NSCLC) who have undergone surgical resection (lobectomy or pneumonectomy) with or without adjuvant chemotherapy will be treated with pembrolizumab or placebo. The primary study hypothesis is that pembrolizumab will provide improved disease-free survival (DFS) versus placebo.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Pathological diagnosis of NSCLC confirmed at surgery, any histology. Participants with two synchronous primary non-small cell lung cancers are excluded from the study
* Union for International Cancer Control (UICC) v7 Stage IB with T ≥ 4 cm, II-IIIA NSCLC after complete surgical resection with resection margins proved microscopically free of disease (R0). Carcinoma in situ can be present at the bronchial margin
* Available tumor sample obtained at surgical resection for programmed cell death ligand-1 (PD-L1) Immunohistochemistry (IHC) expression assessment
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Adequate organ function performed within 10 days of treatment initiation
* Female participants of childbearing potential must have a negative urine or serum pregnancy test at screening (within 72 hours of first infusion of study medication). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the participant to be eligible
* Female participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity starting with the first infusion of study treatment through 120 days after the last infusion of study treatment
* Female participants who are breast feeding must discontinue nursing prior to the first infusion of study medication and until 120 days after the last infusion…
What they're measuring
1
Disease-Free Survival (DFS)
Timeframe: Up to approximately 84 months
2
DFS in Programmed Death Ligand-1 (PDL-1) Strong Positive Participants With Tumor Proportion Score (TPS) ≥50%