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Clinical Trials in the USA / NCT04956692
Active, not recruiting Phase 3

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)

NCT04956692 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2021-08-05
Last updated
2024-12-03

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pembrolizumab SCPembrolizumab IVPaclitaxelNab-PaclitaxelCarboplatinCisplatinPemetrexed

Pembrolizumab SC: SC injection

Pembrolizumab IV: IV injection

Paclitaxel: IV injection

Nab-Paclitaxel: IV infusion

Carboplatin: IV infusion

Cisplatin: IV infusion

Pemetrexed: IV infusion

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (126)

FacilityCityRegionStatus
St. Bernards Medical Center ( Site 0103) Jonesboro Arkansas
St Joseph Heritage Healthcare-Oncology ( Site 0102) Fullerton California
Cancer Blood and Specialty Clinic ( Site 0105) Los Alamitos California
PIH Health Hematology Medical Oncology ( Site 0106) Whittier California
Holy Cross Hospital ( Site 0017) Fort Lauderdale Florida
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104) Hollywood Florida
Advent Health ( Site 0013) Orlando Florida
Fort Wayne Medical Oncology and Hematology ( Site 0101) Fort Wayne Indiana
Baptist Health Lexington ( Site 0099) Lexington Kentucky
St Luke's Hospital - Kansas City ( Site 0033) Kansas City Missouri
St. Vincent Frontier Cancer Center ( Site 0058) Billings Montana
Montefiore Medical Center [Bronx, NY] ( Site 0040) The Bronx New York
The University of Tennessee Medical Center ( Site 0050) Knoxville Tennessee
Tennessee Oncology ( Site 0051) Nashville Tennessee
Oncology Consultants, PA ( Site 0052) Houston Texas
Millennium Physicians - Oncology ( Site 0097) Houston Texas
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100) Blacksburg Virginia
West Virginia University ( Site 0056) Morgantown West Virginia
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307) Cachoeiro de Itapemirim Espírito Santo
Hospital Sao Vicente de Paulo ( Site 0311) Passo Fundo Rio Grande do Sul
Instituto Joinvilense de Hematologia e Oncologia ( Site 0308) Joinville Santa Catarina
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305) São José do Rio Preto São Paulo
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304) São Paulo São Paulo
Nouvel Hôpital Civil (NHC) ( Site 1018) Strasbourg Bas-Rhin
CHU Limoges CHU Dupuytren ( Site 1011) Limoges Haute-Vienne
Hôpital Foch ( Site 1019) Suresnes Hauts-de-Seine
Institut Regional du Cancer de Montpellier - ICM ( Site 1003) Montpellier Herault
Centre Hospitalier Sud Réunion ( Site 1020) Saint-Pierre La Reunion
Hopital Guillaume & Rene Laennec ( Site 1007) Saint-Herblain Loire-Atlantique
Centre Hospitalier de Pau ( Site 1016) Pau Pyrenees-Atlantiques
CHU de Rouen ( Site 1013) Rouen Seine-Maritime
Hopital Cochin ( Site 1002) Paris France
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602) Guatemala City Guatemala
Clinica Privada Dr. Rixci Ramirez ( Site 0601) Guatemala City Guatemala
INTERVASC ( Site 0605) Guatemala City Guatemala
Grupo Angeles SA ( Site 0604) Guatemala City Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 0600) Quetzaltenango Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106) Kecskemét Bács-Kiskun county
Petz Aladar Megyei Oktato Korhaz ( Site 1110) Győr Győr-Moson-Sopron
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103) Szolnok Jász-Nagykun-Szolnok

+ 86 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04956692 on ClinicalTrials.gov ↗ ← All trials in the USA