Pembrolizumab SC: SC injection
Pembrolizumab IV: IV injection
Paclitaxel: IV injection
Nab-Paclitaxel: IV infusion
Carboplatin: IV infusion
Cisplatin: IV infusion
Pemetrexed: IV infusion
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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 Japan