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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)

NCT ID: NCT06780137

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-27

Study Completion Date

2029-08-31

Brief Summary

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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

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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.

Conditions

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Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Part 1 consists of four arms (gocatamig and I-DXd at different dosing intervals). Participants will be randomized to one of the four arms using an interactive response technology (IRT) system. Part 2 consist of three arms (gocatamig monotherapy in participants in Japan, gocatamig monotherapy in participants in China, and gocatamig at different dosing intervals). Part 3 consists of a single arm (gocatamig and durvalumab).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 2 Arm 6: Gocatamig

Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Part 3 Arm 7: Gocatamig and Durvalumab

Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Durvalumab

Intervention Type BIOLOGICAL

IV infusion

Part 1 Arm 1: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Ifinatamab Deruxtecan (I-DXd)

Intervention Type BIOLOGICAL

IV infusion

Part 1 Arm 2: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Ifinatamab Deruxtecan (I-DXd)

Intervention Type BIOLOGICAL

IV infusion

Part 1 Arm 3a: I-DXd Monotherapy

Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Ifinatamab Deruxtecan (I-DXd)

Intervention Type BIOLOGICAL

IV infusion

Part 1 Arm 3b: Gocatamig and I-DXd

Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Ifinatamab Deruxtecan (I-DXd)

Intervention Type BIOLOGICAL

IV infusion

Part 2 Arm 4: Gocatamig Monotherapy in Japan

Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Part 2 Arm 5: Gocatamig Monotherapy in China

Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.

Group Type EXPERIMENTAL

Gocatamig

Intervention Type BIOLOGICAL

IV infusion

Interventions

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Gocatamig

IV infusion

Intervention Type BIOLOGICAL

Ifinatamab Deruxtecan (I-DXd)

IV infusion

Intervention Type BIOLOGICAL

Durvalumab

IV infusion

Intervention Type BIOLOGICAL

Other Intervention Names

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HPN328 MK-6070 DS-7300a MK-2400

Eligibility Criteria

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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 (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)

Miami, Florida, United States

Site Status RECRUITING

University of Chicago ( Site 1108)

Chicago, Illinois, United States

Site Status RECRUITING

Dana Farber Cancer Institute ( Site 1105)

Boston, Massachusetts, United States

Site Status RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)

Hackensack, New Jersey, United States

Site Status RECRUITING

Roswell Park Cancer Institute ( Site 1107)

Buffalo, New York, United States

Site Status RECRUITING

Providence Portland Medical Center ( Site 1101)

Portland, Oregon, United States

Site Status RECRUITING

Sarah Cannon Research Institute ( Site 7001)

Nashville, Tennessee, United States

Site Status RECRUITING

Princess Alexandra Hospital ( Site 5300)

Wooloongabba, Queensland, Australia

Site Status RECRUITING

FALP ( Site 2100)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 2101)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Beijing Cancer Hospital ( Site 5401)

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Cancer Hospital ( Site 5413)

Fuzhou, Fujian, China

Site Status RECRUITING

Shanghai Chest Hospital ( Site 5400)

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Rambam Health Care Campus ( Site 3202)

Haifa, , Israel

Site Status ACTIVE_NOT_RECRUITING

Shaare Zedek Medical Center ( Site 3200)

Jerusalem, , Israel

Site Status RECRUITING

Sheba Medical Center ( Site 3201)

Ramat Gan, , Israel

Site Status RECRUITING

Aichi Cancer Center ( Site 5000)

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

National Cancer Center Hospital East ( Site 5001)

Kashiwa, Chiba, Japan

Site Status RECRUITING

Kansai Medical University Hospital ( Site 5004)

Hirakata, Osaka, Japan

Site Status RECRUITING

Cancer Institute Hospital of JFCR ( Site 5002)

Koto, Tokyo, Japan

Site Status RECRUITING

Seoul National University Hospital ( Site 5100)

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center ( Site 5101)

Seoul, , South Korea

Site Status RECRUITING

HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)

Eixample, Barcelona, Spain

Site Status RECRUITING

Institut Català d'Oncologia - L'Hospitalet ( Site 3317)

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status RECRUITING

Hospital Clinico San Carlos... ( Site 3316)

Madrid, Madrid, Comunidad de, Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron ( Site 3311)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario HM Sanchinarro ( Site 3313)

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen de la Victoria ( Site 3312)

Málaga, , Spain

Site Status RECRUITING

Hacettepe Universite Hastaneleri ( Site 3410)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara Bilkent Sehir Hastanesi ( Site 3412)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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United States Australia Chile China Israel Japan South Korea Spain Turkey (Türkiye)

Central Contacts

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Toll Free Number

Role: CONTACT

Phone: 1-888-577-8839

Email: [email protected]

Facility Contacts

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Study Coordinator

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Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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2024-517926-25-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-6070-002

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031250039

Identifier Type: REGISTRY

Identifier Source: secondary_id

6070-002

Identifier Type: -

Identifier Source: org_study_id