A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Lung Cancer (MK-3475-021/KEYNOTE-021)

Status: Recruiting
Phase:
Diagnosis: Lung Cancer
NCT ID: NCT02039674 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-160

 

The purpose of this study is to determine safety, tolerability, and efficacy of pembrolizumab (MK-3475) in combination with chemotherapy or immunotherapy in participants with unresectable or metastatic non-small cell lung cancer (NSCLC).

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Leena Gandhi, MD, PhD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Lecia Sequist, MD, Massachusetts General Hospital

Contacts:
Dana-Farber Cancer Institute: Kelly Masone, 617-632-3383, kmasone@partners.org
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Stage IIIb/IV NSCLC - at least one radiographically measurable lesion - performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status - Females are not pregnant nor of child-bearing potential - if of childbearing potential, females must be willing to use two adequate barrier methods throughout the study - males with a female partner(s) of child-bearing potential must agree to use two adequate barrier methods throughout the trial Exclusion Criteria: - currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of administration of pembrolizumab - expected to require any other form of antineoplastic therapy while on study - is on chronic systemic steroid therapy or on any other form of immunosuppressive medication - has received a live-virus vaccination within 30 days of planned treatment start - history of diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal carcinomatosis which are known risks factors for bowel perforation - history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years - active central nervous system (CNS) metastases and/or carcinomatous meningitis - severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) - active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents - prior treatment with any other anti-programmed cell death protein-1 (anti-PD-1), or PD Ligand-1 (PD-L1) or PD Ligand-2 (PD-L2) agent or an antibody targeting other immuno-regulatory receptors or mechanisms - active infection requiring therapy - history of Human Immunodeficiency Virus (HIV) - active Hepatitis B or C. - symptomatic ascites or pleural effusion - pneumonitis that has required a course of oral steroids to assist with recovery, or a history of interstitial lung disease - pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study - psychiatric disorders and substance (drug/alcohol) abuse
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