RecruitingPhase 1Phase 2NCT06780137

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)

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


Sponsor

Merck Sharp & Dohme LLC

Enrollment

262 participants

Start Date

Feb 27, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two drugs — gocatamig (MK-6070) and ifinatamab deruxtecan (I-DXd) — in patients with extensive-stage small cell lung cancer (SCLC) that has come back or stopped responding to prior treatment, including platinum-based chemotherapy. Small cell lung cancer is an aggressive type of lung cancer, and this study explores new options for patients who have already been treated. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer - You have received at least one prior line of treatment that included platinum-based chemotherapy - You can provide a tumor tissue sample (archival or fresh biopsy) - If you have HIV, it must be well-controlled on treatment - You are 18 years of age or older **You may NOT be eligible if...** - You have fluid around the lungs, heart, or abdomen that requires repeated draining - You have had or currently have serious lung inflammation (interstitial lung disease or pneumonitis) - You have certain other conditions incompatible with the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALGocatamig

IV infusion

BIOLOGICALIfinatamab Deruxtecan (I-DXd)

IV infusion

BIOLOGICALDurvalumab

IV infusion


Locations(48)

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)

Woolloongabba, Queensland, Australia

Monash Health ( Site 5301)

Clayton, Victoria, 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

West China Hospital of Sichuan University ( Site 5416)

Chengdu, Sichuan, 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

View Full Details on ClinicalTrials.gov

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NCT06780137


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