KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

December 19, 2019

Primary Completion Date

February 13, 2032

Study Completion Date

February 13, 2032

Conditions
Carcinoma, Non-Small-Cell Lung
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Pemetrexed

IV infusion

BIOLOGICAL

Vibostolimab

IV infusion

BIOLOGICAL

Boserolimab

IV infusion

BIOLOGICAL

MK-4830

IV infusion

BIOLOGICAL

MK-0482

IV Infusion

BIOLOGICAL

Ifinatamab Deruxtecan (I-DXd)

IV infusion

BIOLOGICAL

HER3-DXd

IV Infusion

Trial Locations (39)

1121

RECRUITING

Orszagos Koranyi Pulmonologiai Intezet ( Site 0060), Budapest

5004

RECRUITING

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061), Szolnok

9024

RECRUITING

Petz Aladar Megyei Oktato Korhaz ( Site 0062), Győr

10016

ACTIVE_NOT_RECRUITING

Laura and Isaac Perlmutter Cancer Center ( Site 0034), New York

13620

ACTIVE_NOT_RECRUITING

Seoul National University Bundang Hospital ( Site 0081), Seongnam-si

19104

RECRUITING

Abramson Cancer Center of the University of Pennsylvania ( Site 0010), Philadelphia

20007

COMPLETED

Georgetown University ( Site 0036), Washington D.C.

20132

COMPLETED

IRCCS Ospedale San Raffaele ( Site 0171), Milan

21237

COMPLETED

MedStar Franklin Square Medical Center ( Site 0033), Baltimore

28223

RECRUITING

Hospital Universitario Quiron Madrid ( Site 0091), Madrid

43210

RECRUITING

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0015), Columbus

44195

COMPLETED

Cleveland Clinic Main ( Site 0006), Cleveland

50134

COMPLETED

Azienda Ospedaliera Universitaria Careggi ( Site 0173), Florence

57104

RECRUITING

Sanford Cancer Center ( Site 0038), Sioux Falls

58102

RECRUITING

Sanford Fargo Medical Center ( Site 0039), Fargo

68130

COMPLETED

Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031), Omaha

77030

RECRUITING

The University of Texas MD Anderson Cancer Center ( Site 0009), Houston

85234

RECRUITING

Banner MD Anderson Cancer Center ( Site 0001), Gilbert

91010

COMPLETED

City of Hope ( Site 0014), Duarte

94158

COMPLETED

UCSF Medical Center at Mission Bay ( Site 0007), San Francisco

3109601

RECRUITING

Rambam Health Care Campus-Oncology ( Site 0076), Haifa

4428132

RECRUITING

Meir Medical Center ( Site 0071), Kfar Saba

4941492

RECRUITING

Rabin Medical Center ( Site 0074), Petah Tikva

5262000

RECRUITING

Chaim Sheba Medical Center ( Site 0070), Ramat Gan

6423906

RECRUITING

Sourasky Medical Center ( Site 0077), Tel Aviv

8457108

COMPLETED

Soroka Medical Center ( Site 0072), Beersheba

9103102

RECRUITING

Shaare Zedek Medical Center ( Site 0075), Jerusalem

40536-0293

RECRUITING

University of Kentucky Markey Cancer Center ( Site 0019), Lexington

02114

RECRUITING

Massachusetts General Hospital ( Site 0003), Boston

02215

RECRUITING

Dana Farber Cancer Institute ( Site 0002), Boston

03766

RECRUITING

Dartmouth Hitchcock Medical Center ( Site 0016), Lebanon

07601

COMPLETED

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037), Hackensack

00168

ACTIVE_NOT_RECRUITING

Policlinico Gemelli di Roma ( Site 0174), Roma

02-781

ACTIVE_NOT_RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151), Warsaw

80-952

RECRUITING

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150), Gdansk

75-581

ACTIVE_NOT_RECRUITING

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152), Koszalin

03722

ACTIVE_NOT_RECRUITING

Severance Hospital ( Site 0080), Seoul

06351

ACTIVE_NOT_RECRUITING

Samsung Medical Center ( Site 0082), Seoul

08907

RECRUITING

ICO L Hospitalet ( Site 0090), L'Hospitalet de Llobregat

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY