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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)
Sponsor: Merck Sharp & Dohme LLC
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
Official title: A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
262
Start Date
2025-02-27
Completion Date
2030-01-17
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
Gocatamig
IV infusion
Ifinatamab Deruxtecan (I-DXd)
IV infusion
Durvalumab
IV infusion
Locations (46)
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida, United States
University of Chicago ( Site 1108)
Chicago, Illinois, United States
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, United States
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York, United States
Providence Portland Medical Center ( Site 1101)
Portland, Oregon, United States
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, United States
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin, United States
Hospital Universitario Austral ( Site 2204)
Pilar, Buenos Aires, Argentina
Sanatorio Parque ( Site 2203)
Rosario, Santa Fe Province, Argentina
Princess Alexandra Hospital ( Site 5300)
Brisbane, Queensland, Australia
FALP ( Site 2100)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 2102)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 2101)
Santiago, Region M. de Santiago, Chile
Beijing Cancer Hospital ( Site 5401)
Beijing, Beijing Municipality, China
Fujian Cancer Hospital ( Site 5413)
Fuzhou, Fujian, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
Nanjing, Jiangsu, China
Shanghai Chest Hospital ( Site 5400)
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital ( Site 5405)
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital, Zhejiang University ( Site 5404)
Hangzhou, Zhejiang, China
Rambam Health Care Campus ( Site 3202)
Haifa, Israel
Shaare Zedek Medical Center ( Site 3200)
Jerusalem, Israel
Rabin Medical Center ( Site 3203)
Petah Tikva, Israel
Sheba Medical Center ( Site 3201)
Ramat Gan, Israel
Aichi Cancer Center ( Site 5000)
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 5001)
Kashiwa, Chiba, Japan
Kansai Medical University Hospital ( Site 5004)
Hirakata, Osaka, Japan
Cancer Institute Hospital of JFCR ( Site 5002)
Koto, Tokyo, Japan
Seoul National University Hospital ( Site 5100)
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 5102)
Seoul, South Korea
Samsung Medical Center ( Site 5101)
Seoul, South Korea
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample, Barcelona, Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico San Carlos... ( Site 3316)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid, Spain
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid, Spain
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga, Spain
National Cheng Kung University Hospital ( Site 5202)
Tainan, Taiwan
Taipei Medical University Hospital ( Site 5201)
Taipei, Taiwan
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara, Turkey (Türkiye)
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London, London, City of, United Kingdom
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool, United Kingdom
The Christie NHS Foundation Trust ( Site 3901)
Manchester, United Kingdom