A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)
Start Date
2/27/2025
Completion Date
4/27/2029
Summary
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
Detailed Description
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Gocatamig
Ifinatamab Deruxtecan (I-DXd)
Durvalumab
Conditions
Locations
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado 80045
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida 33136
United States
University of Chicago ( Site 1108)
Chicago, Illinois 60637
United States
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts 02215
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey 07601
United States
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York 14263
United States
Providence Portland Medical Center ( Site 1101)
Portland, Oregon 97213
United States
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee 37203
United States
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin 53226
United States
Hospital Universitario Austral ( Site 2204)
Pilar, Buenos Aires B1629WWA
Argentina
Sanatorio Parque ( Site 2203)
Rosario, Santa Fe Province S2000DSV
Argentina
Princess Alexandra Hospital ( Site 5300)
Woolloongabba, Queensland 4102
Australia
Monash Health ( Site 5301)
Clayton, Victoria 3168
Australia
FALP ( Site 2100)
Santiago, Region M. de Santiago 7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 2102)
Santiago, Region M. de Santiago 8330032
Chile
Bradfordhill ( Site 2101)
Santiago, Region M. de Santiago 8420383
Chile
Beijing Cancer Hospital ( Site 5401)
Beijing, Beijing Municipality 100142
China
Fujian Cancer Hospital ( Site 5413)
Fuzhou, Fujian 350014
China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
Nanjing, Jiangsu 210008
China
Shanghai Chest Hospital ( Site 5400)
Shanghai, Shanghai Municipality 200030
China
Shanghai Pulmonary Hospital ( Site 5405)
Shanghai, Shanghai Municipality 200433
China
West China Hospital of Sichuan University ( Site 5416)
Chengdu, Sichuan 610041
China
The First Affiliated Hospital, Zhejiang University ( Site 5404)
Hangzhou, Zhejiang 310000
China
Rambam Health Care Campus ( Site 3202)
Haifa, 3109601
Israel
Shaare Zedek Medical Center ( Site 3200)
Jerusalem, 9103102
Israel
Rabin Medical Center ( Site 3203)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 3201)
Ramat Gan, 5265601
Israel
Aichi Cancer Center ( Site 5000)
Nagoya, Aichi-ken 464-8681
Japan
National Cancer Center Hospital East ( Site 5001)
Kashiwa, Chiba 277-0882
Japan
Kansai Medical University Hospital ( Site 5004)
Hirakata, Osaka 573-1191
Japan
Cancer Institute Hospital of JFCR ( Site 5002)
Koto, Tokyo 135-8550
Japan
Seoul National University Hospital ( Site 5100)
Seoul, 03080
South Korea
Severance Hospital, Yonsei University Health System ( Site 5102)
Seoul, 03722
South Korea
Samsung Medical Center ( Site 5101)
Seoul, 06351
South Korea
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample, Barcelona 08036
Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat, Barcelona 08907
Spain
Hospital Clinico San Carlos... ( Site 3316)
Madrid, Madrid, Comunidad de 28040
Spain
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona, 08035
Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid, 28040
Spain
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid, 28050
Spain
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga, 29010
Spain
National Cheng Kung University Hospital ( Site 5202)
Tainan, 704
Taiwan
Taipei Medical University Hospital ( Site 5201)
Taipei, 11030
Taiwan
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara, 06230
Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara, 06800
Turkey (Türkiye)
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London, London, City of W1T 7HA
United Kingdom
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool, L7 8YA
United Kingdom
The Christie NHS Foundation Trust ( Site 3901)
Manchester, M20 4BX
United Kingdom