Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Non-small Cell Lung Cancer

Treatments

Biological: Pembrolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02007070

MK-3475-025 (Other Identifier)

142500 (Registry Identifier)

3475-025

Details and patient eligibility

About

This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).

Enrollment

38 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
At least one measurable lesion
Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease
Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1
Adequate organ function

Exclusion criteria

Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
Expected to require any other form of systemic or localized antineoplastic therapy while on trial
History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
Active central nervous system (CNS) metastases and/or carcinomatous meningitis
Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
Concurrent or past history of interstitial lung disease
Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab