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Clinical Trials in the USA / NCT07227597
Recruiting Phase 1/2

A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)

NCT07227597 · tracked via the Priya Life Science USA tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/2
Started
2026-01-29
Last updated
2026-08-21

Condition(s) studied

Small Cell Lung Cancer Extensive Stage

Investigational drug(s) / intervention(s)

GocatamigI-DXdAtezolizumabCarboplatinEtoposideRescue Medications

Gocatamig: Intravenous (IV) administration

I-DXd: IV administration

Atezolizumab: IV administration

Carboplatin: IV administration

Etoposide: IV administration

Rescue Medications: Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) * For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenance only: * Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrent approved anti-programmed cell death 1/Ligand 1 (anti PD-1/L1) as first line (1L) treatment of ES-SCLC within 6 weeks prior to enrollment * No radiological disease progression per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) * No other prior systemic ES-SCLC therapy allowed * Rechallenge therapy counts as an additional line and leads to exclusion * For participants receiving gocatamig + I-DXd in induction and maintenance, or gocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance, or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab in maintenance: No prior systemic ES-SCLC treatment allowed * Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) is allowed if \> 6 months have passed since the end of previous therapy and progression * Must be able to provide a pretreatment archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated * Measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, current ILD, ILD that cannot be ruled out by imaging at screening, or suspected ILD * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Has history of clinically significant intracranial bleeding or spinal cord bleeding * Has active neurologic paraneoplastic syndrome * Has history 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), and/or uncontrolled cardiac arrhythmia within 6 months before the first dose of study intervention * Has other uncontrolled or significant protocol specified cardiovascular disease * Has history of arterial thrombosis within 6 months before the first dose of study intervention * Has chronic liver disease * Has history of allogeneic tissue/solid organ transplant * Has history of leptomeningeal disease * Is infected with human immunodeficiency virus (HIV) and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has major surgery within 4 weeks or minor surgery within 2 weeks of allocation/randomization (or first dose), or is anticipated to require a major surgical procedure during the study

Primary outcome measure(s)

Trial sites (52)

FacilityCityRegionStatus
Providence Medical Foundation ( Site 0124) Santa Rosa California Recruiting
University of Colorado, Anschutz Cancer Pavilion ( Site 0125) Aurora Colorado Recruiting
Orlando Health Cancer Institute ( Site 0108) Orlando Florida Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0112) Edgewood Kentucky Recruiting
Washington University School of Medicine ( Site 0134) St Louis Missouri Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) Hackensack New Jersey Recruiting
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) Portland Oregon Recruiting
Avera Cancer Institute- Research ( Site 0104) Sioux Falls South Dakota Recruiting
The University of Tennessee Medical Center ( Site 0120) Knoxville Tennessee Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133) Memphis Tennessee Recruiting
SCRI Oncology Partners ( Site 7000) Nashville Tennessee Recruiting
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) Houston Texas Recruiting
University of Virginia Health System ( Site 0122) Charlottesville Virginia Recruiting
CEMIC ( Site 1903) Caba. Buenos Aires Recruiting
Hospital Austral ( Site 1901) Pilar Buenos Aires Recruiting
Sanatorio Parque ( Site 1900) Rosario Santa Fe Province Recruiting
FALP ( Site 0200) Santiago Region M. de Santiago Recruiting
Pontificia Universidad Catolica de Chile ( Site 0202) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0201) Santiago Region M. de Santiago Recruiting
Beijing Cancer Hospital ( Site 1604) Beijing Beijing Municipality Recruiting
Fujian Provincial Cancer Hospital ( Site 1607) Fuzhou Fujian Recruiting
Southern Medical University Nanfang Hospital ( Site 1608) Guangzhou Guangdong Recruiting
Jiangmen Central Hospital ( Site 1611) Jiangmen Guangdong Recruiting
The First Affiliated Hospital of Nanchang University ( Site 1610) Nanchang Jiangxi Recruiting
Shanghai East Hospital ( Site 1600) Shanghai Shanghai Municipality Recruiting
Sichuan Cancer hospital. ( Site 1609) Chengdu Sichuan Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602) Hangzhou Zhejiang Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1601) Taizhou Zhejiang Recruiting
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401) Tübingen Baden-Wurttemberg Recruiting
Universitaetsklinikum Jena ( Site 0403) Jena Thuringia Recruiting
Errikos Dunant Hospital Center ( Site 0501) Athens Attica Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502) Athens Attica Recruiting
Athens Medical Center ( Site 0504) Athens Attica Recruiting
European Interbalkan Medical Center ( Site 0500) Thessaloniki Greece Recruiting
European Interbalkan Medical Center ( Site 0505) Thessaloniki Greece Recruiting
Rambam Health Care Campus ( Site 0602) Haifa Israel Recruiting
Sheba Medical Center ( Site 0601) Ramat Gan Israel Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702) Meldola Forli-Cesena Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701) Milan Italy Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700) Roma Italy Recruiting

+ 12 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07227597 on ClinicalTrials.gov ↗ ← All trials in the USA