RecruitingRecruiting
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)
NCT06780137 · Merck Sharp & Dohme LLC
In plain English
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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
About this study
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
Inclusion Criteria:
* Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy
* Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)
Exclusion Criteria:
* Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
* History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening
* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
* Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
* History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association \> class II), and/or uncontrolled cardiac arrhythmia
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention
* Active clinically significant infection requiring systemic therapy
* History of allogeneic tissue/solid organ transplant
* History of leptomeningeal disease
* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
* Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
* Known additional malignancy that is progressing or has required active treatment within the past 3 years
* Untreated or symptomatic brain metastases
* Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M \[IgM\] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen \[HbsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]), or hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible.
* Part 1 only: Radiation therapy to the lung \>30 Gy within 6 months before the start of study intervention
* Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
* Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention
* Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer
* Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention
* Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention
* Part 1 only: Clinically significant corneal disease
* Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
Study design
Enrollment target: 262 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-02-27
Estimated completion: 2030-01-17
Last updated: 2026-04-20
Interventions
Biological: GocatamigBiological: Ifinatamab Deruxtecan (I-DXd)Biological: Durvalumab
Primary outcomes
- • Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 44 months)
- • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) (Up to approximately 3 weeks)
- • Number of Participants Who Discontinue Study Intervention Due to an AE (Up to approximately 44 months)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (48)
University of Colorado Anschutz Medical Campus ( Site 1110)Recruiting
Aurora, Colorado, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)Recruiting
Miami, Florida, United States
University of Chicago ( Site 1108)Recruiting
Chicago, Illinois, United States
Dana Farber Cancer Institute ( Site 1105)Recruiting
Boston, Massachusetts, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)Recruiting
Hackensack, New Jersey, United States
Roswell Park Cancer Institute ( Site 1107)Recruiting
Buffalo, New York, United States
Providence Portland Medical Center ( Site 1101)Recruiting
Portland, Oregon, United States
Sarah Cannon Research Institute ( Site 7001)Recruiting
Nashville, Tennessee, United States
Medical College of Wisconsin ( Site 1112)Recruiting
Milwaukee, Wisconsin, United States
Hospital Universitario Austral ( Site 2204)Recruiting
Pilar, Buenos Aires, Argentina
Sanatorio Parque ( Site 2203)Recruiting
Rosario, Santa Fe Province, Argentina
Princess Alexandra Hospital ( Site 5300)Recruiting
Woolloongabba, Queensland, Australia
Monash Health ( Site 5301)Recruiting
Clayton, Victoria, Australia
FALP ( Site 2100)Recruiting
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 2102)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 2101)Recruiting
Santiago, Region M. de Santiago, Chile
Beijing Cancer Hospital ( Site 5401)Recruiting
Beijing, Beijing Municipality, China
Fujian Cancer Hospital ( Site 5413)Recruiting
Fuzhou, Fujian, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)Recruiting
Nanjing, Jiangsu, China
Shanghai Chest Hospital ( Site 5400)Recruiting
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital ( Site 5405)Recruiting
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University ( Site 5416)Recruiting
Chengdu, Sichuan, China
The First Affiliated Hospital, Zhejiang University ( Site 5404)Recruiting
Hangzhou, Zhejiang, China
Rambam Health Care Campus ( Site 3202)Active Not Recruiting
Haifa, Israel
Shaare Zedek Medical Center ( Site 3200)Recruiting
Jerusalem, Israel
Rabin Medical Center ( Site 3203)Recruiting
Petah Tikva, Israel
Sheba Medical Center ( Site 3201)Recruiting
Ramat Gan, Israel
Aichi Cancer Center ( Site 5000)Recruiting
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East ( Site 5001)Recruiting
Kashiwa, Chiba, Japan
Kansai Medical University Hospital ( Site 5004)Recruiting
Hirakata, Osaka, Japan
Cancer Institute Hospital of JFCR ( Site 5002)Recruiting
Koto, Tokyo, Japan
Seoul National University Hospital ( Site 5100)Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 5102)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 5101)Recruiting
Seoul, South Korea
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)Recruiting
Eixample, Barcelona, Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clinico San Carlos... ( Site 3316)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron ( Site 3311)Recruiting
Barcelona, Spain
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)Recruiting
Madrid, Spain
Hospital Universitario HM Sanchinarro ( Site 3313)Recruiting
Madrid, Spain
Hospital Universitario Virgen de la Victoria ( Site 3312)Recruiting
Málaga, Spain
National Cheng Kung University Hospital ( Site 5202)Recruiting
Tainan, Taiwan
Taipei Medical University Hospital ( Site 5201)Recruiting
Taipei, Taiwan
Hacettepe Universite Hastaneleri ( Site 3410)Recruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi ( Site 3412)Recruiting
Ankara, Turkey (Türkiye)
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)Recruiting
London, London, City of, United Kingdom
The Clatterbridge Cancer Centre ( Site 3903)Recruiting
Liverpool, United Kingdom
The Christie NHS Foundation Trust ( Site 3901)Recruiting
Manchester, United Kingdom