A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Start Date
1/29/2026
Completion Date
12/30/2030
Summary
Researchers are looking for new ways to treat extensive-stage small cell lung cancer (ES-SCLC). ES-SCLC is a type of lung cancer that has spread throughout the lung, to the other lung, or to other parts of the body. A standard (usual) treatment for ES-SCLC uses both chemotherapy and immunotherapy. * Chemotherapy is a treatment that works to destroy cancer cells or stop them from growing. * Immunotherapy is a treatment that helps the immune system fight cancer. Gocatamig and I-DXd (short for ifinatamab deruxtecan) are study medicines. Researchers want to know if giving gocatamig and I-DXd together can treat ES-SCLC. Researchers will also look at giving the study medicines with standard treatment. Gocatamig is a T-cell engager therapy. I-DXd is an antibody drug conjugate. * T-cell engager therapy is a certain type of immunotherapy that uses T-cells to find and destroy cancer cells. * A T-cell is a type of white blood cell, which are cells that help the body fight infection. * An antibody drug conjugate (ADC) is a treatment that attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn: * About the safety of combining gocatamig and I-DXd and if people tolerate them together * If people who receive gocatamig and I-DXd have ES-SCLC respond, which means the cancer gets smaller or goes away
Detailed Description
In Part A, participants will be allocated to Arm 1 or Arm 2 per investigator's discretion. In Part B, participants will be allocated to Arm 1 per investigator's discretion and randomized to Arms 2, 3, and 4.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Gocatamig
I-DXd
Atezolizumab
Carboplatin
Etoposide
Rescue Medications
Conditions
Locations
Providence Medical Foundation ( Site 0124)
Santa Rosa, California 95403
United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0125)
Aurora, Colorado 80045
United States
Orlando Health Cancer Institute ( Site 0108)
Orlando, Florida 32806
United States
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood, Kentucky 41017
United States
Washington University School of Medicine ( Site 0134)
St Louis, Missouri 63110
United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack, New Jersey 07601
United States
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)
Portland, Oregon 97213
United States
Avera Cancer Institute- Research ( Site 0104)
Sioux Falls, South Dakota 57105
United States
The University of Tennessee Medical Center ( Site 0120)
Knoxville, Tennessee 37920
United States
Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)
Memphis, Tennessee 38105
United States
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
United States
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)
Houston, Texas 77030
United States
University of Virginia Health System ( Site 0122)
Charlottesville, Virginia 22908
United States
CEMIC ( Site 1903)
Caba., Buenos Aires C1431FWO
Argentina
Hospital Austral ( Site 1901)
Pilar, Buenos Aires B1629AHJ
Argentina
Sanatorio Parque ( Site 1900)
Rosario, Santa Fe Province S2000DSV
Argentina
FALP ( Site 0200)
Santiago, Region M. de Santiago 7500921
Chile
Pontificia Universidad Catolica de Chile ( Site 0202)
Santiago, Region M. de Santiago 8330032
Chile
Bradfordhill ( Site 0201)
Santiago, Region M. de Santiago 8420383
Chile
Beijing Cancer Hospital ( Site 1604)
Beijing, Beijing Municipality 100142
China
Southern Medical University Nanfang Hospital ( Site 1608)
Guangzhou, Guangdong 510515
China
Jiangmen Central Hospital ( Site 1611)
Jiangmen, Guangdong 529000
China
The First Affiliated Hospital of Nanchang University ( Site 1610)
Nanchang, Jiangxi 330209
China
Shanghai East Hospital ( Site 1600)
Shanghai, Shanghai Municipality 200000
China
Sichuan Cancer hospital. ( Site 1609)
Chengdu, Sichuan 610213
China
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)
Hangzhou, Zhejiang 310003
China
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou, Zhejiang 317000
China
Universitaetsklinikum Jena ( Site 0403)
Jena, Thuringia 07747
Germany
Rambam Health Care Campus ( Site 0602)
Haifa, 3109601
Israel
Sheba Medical Center ( Site 0601)
Ramat Gan, 5265601
Israel
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)
Milan, 20133
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)
Roma, 00168
Italy
Seoul National University Hospital ( Site 1402)
Seoul, 03080
South Korea
Severance Hospital Yonsei University Health System ( Site 1403)
Seoul, 03722
South Korea
Asan Medical Center ( Site 1404)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 1401)
Seoul, 06351
South Korea
Hospital San Pedro ( Site 1004)
Logroño, La Rioja 26006
Spain
Hospital Universitario Insular de Gran Canaria ( Site 1002)
Las Palmas de Gran Canaria, Las Palmas 35016
Spain
Hospital Universitari Vall d'Hebron ( Site 1001)
Barcelona, 08035
Spain
Hospital Universitario Gregorio Maranon ( Site 1003)
Madrid, 28007
Spain
Faculty of Medicine Siriraj Hospital ( Site 3000)
Bangkoknoi, Bangkok 10700
Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002)
Dusit, Bangkok 10300
Thailand
Songklanagarind hospital ( Site 3001)
Hat Yai, Changwat Songkhla 90110
Thailand