A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 58 months
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. - Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to approximately 21 days
DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT criteria. The number of participants who experience at least one DLT will be presented. - Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 58 months
An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported. - Objective Response Rate (ORR) — Up to approximately 58 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Trial sites (55)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
| Fundación Arturo López Pérez ( 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 |
| Harbin Medical University Cancer Hospital ( Site 1606) | Harbin | Heilongjiang | 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 |
| University General Hospital of Heraklion ( Site 0503) | Heraklion | Irakleio | 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 |
+ 15 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
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 Italy