Clinical trial NCT02007070: Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)
Official title: An Open-label, Non-randomized, Multi-center Phase Ib Study of MK-3475 in Subjects With PD-L1 Positive Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Keywords: PD1
PD-1
PDL1
PD-L1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2013-12-10
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: Number of Participants Experiencing Adverse Events (AEs)
timeFrame: Up to 27 months (Up to 90 days after last dose of study drug)
measure: Number of Participants Discontinuing Study Drug Due to AEs
timeFrame: Up to 2 years
Secondary outcomes:
measure: Progression Free Survival (PFS) by RECIST 1.1 in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: Duration of Response (DOR) by RECIST 1.1 in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: Overall Survival (OS) in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: ORR Per Immune-Related Response Criteria (irRC) in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: PFS Per irRC in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: DOR Per irRC in Strongly PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: ORR Per RECIST 1.1 in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: PFS by RECIST 1.1 in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: DOR by RECIST 1.1 in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: OS in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: ORR Per irRC in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: PFS Per irRC in PD-L1 Positive Participants
timeFrame: Up to 2 years
measure: DOR Per irRC in PD-L1 Positive Participants
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nishio M, Takahashi T, Yoshioka H, Nakagawa K, Fukuhara T, Yamada K, Ichiki M, Tanaka H, Seto T, Sakai H, Kasahara K, Satouchi M, Han SR, Noguchi K, Shimamoto T, Kato T. KEYNOTE-025: Phase 1b study of pembrolizumab in Japanese patients with previously treated programmed death ligand 1-positive advanced non-small-cell lung cancer. Cancer Sci. 2019 Mar;110(3):1012-1020. doi: 10.1111/cas.13932. Epub 2019 Feb 16.