Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

Running, not enrolling · Phase 3

Conditions studied: Non-Small Cell Lung Cancer

In brief

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

Key facts

Study ID

NCT04956692

Run by

Merck Sharp & Dohme LLC

People needed

531

Starts

2021-08-05

Expected to finish

2026-10-14

Last updated by the study team

2024-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC)
• Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC
• Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
• Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease
• Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1
• Male participants are eligible to participate if they agree to use contraception as per protocol unless confirmed to be azoospermic
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method per protocol
• Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
• Submit an archival tumor tissue sample or newly obtained core or incisional biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization
• Has adequate organ function

You may not qualify if…

• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per local site assessment
• Has severe hypersensitivity to study intervention and/or any of its excipients
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
• Has an active infection requiring systemic therapy
• Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B infection or known active Hepatitis C infection
• Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
• Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible
• Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
• Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention
• Is expected to require any other form of antineoplastic therapy while on study
• For participants with nonsquamous histology: Is unable to interrupt aspirin or other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period
• For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation
• Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease
• Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
• Has had an allogenic tissue/solid organ transplant

Where it is running

• St Joseph Heritage Healthcare-Oncology ( Site 0102) — Fullerton, California, United States
• Cancer Blood and Specialty Clinic ( Site 0105) — Los Alamitos, California, United States
• PIH Health Hematology Medical Oncology ( Site 0106) — Whittier, California, United States
• Holy Cross Hospital ( Site 0017) — Fort Lauderdale, Florida, United States
• Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104) — Hollywood, Florida, United States
• Advent Health ( Site 0013) — Orlando, Florida, United States
• Fort Wayne Medical Oncology and Hematology ( Site 0101) — Fort Wayne, Indiana, United States
• Baptist Health Lexington ( Site 0099) — Lexington, Kentucky, United States
• St Luke's Hospital - Kansas City ( Site 0033) — Kansas City, Missouri, United States
• St. Vincent Frontier Cancer Center ( Site 0058) — Billings, Montana, United States
• Montefiore Medical Center [Bronx, NY] ( Site 0040) — The Bronx, New York, United States
• The University of Tennessee Medical Center ( Site 0050) — Knoxville, Tennessee, United States
• Tennessee Oncology ( Site 0051) — Nashville, Tennessee, United States
• Oncology Consultants, PA ( Site 0052) — Houston, Texas, United States
• Millennium Physicians - Oncology ( Site 0097) — Houston, Texas, United States
• Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100) — Blacksburg, Virginia, United States
• West Virginia University ( Site 0056) — Morgantown, West Virginia, United States
• HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307) — Cachoeiro de Itapemirim, Espírito Santo, Brazil
• Hospital Sao Vicente de Paulo ( Site 0311) — Passo Fundo, Rio Grande do Sul, Brazil
• Instituto Joinvilense de Hematologia e Oncologia ( Site 0308) — Joinville, Santa Catarina, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305) — São José do Rio Preto, São Paulo, Brazil
• Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304) — São Paulo, São Paulo, Brazil
• Nouvel Hôpital Civil (NHC) ( Site 1018) — Strasbourg, Bas-Rhin, France
• CHU Limoges CHU Dupuytren ( Site 1011) — Limoges, Haute-Vienne, France
• St. Bernards Medical Center ( Site 0103) — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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