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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 Italy tracker
Phase
Phase 1/2
Started
2026-01-29
Last updated
2026-10-09

Condition(s) studied

Small Cell Lung Cancer Extensive Stage

Investigational drug(s) / intervention(s)

Gocatamig →I-DXd →Atezolizumab →Carboplatin →Etoposide →Rescue 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)

  • 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)

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
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.

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 Italy