Ireland
--:--IST
Recruiting Phase 1/2

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)

NCT06780137 · tracked via the Priya Life Science UK tracker
Phase
Phase 1/2
Started
2025-02-27
Last updated
2026-10-06

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Gocatamig →Ifinatamab Deruxtecan (I-DXd) →Durvalumab →

Gocatamig: IV infusion

Ifinatamab Deruxtecan (I-DXd): IV infusion

Durvalumab: IV infusion

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 * Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroids * Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out * 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

Primary outcome measure(s)

  • Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 44 months
    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented.
  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to approximately 3 weeks
    A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) 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 44 months
    An AE is 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented.
  • Part 1: Objective Response Rate (ORR) — Up to approximately 44 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 the investigator will be presented.

Trial sites (48)

FacilityCityRegionStatus
University of Colorado Anschutz Medical Campus ( Site 1110) Aurora Colorado Recruiting
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) Miami Florida Recruiting
University of Chicago ( Site 1108) Chicago Illinois Recruiting
Dana Farber Cancer Institute ( Site 1105) Boston Massachusetts Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) Hackensack New Jersey Recruiting
Roswell Park Cancer Institute ( Site 1107) Buffalo New York Recruiting
Providence Portland Medical Center ( Site 1101) Portland Oregon Recruiting
Sarah Cannon Research Institute ( Site 7001) Nashville Tennessee Recruiting
Medical College of Wisconsin ( Site 1112) Milwaukee Wisconsin Recruiting
Hospital Universitario Austral ( Site 2204) Pilar Buenos Aires Recruiting
Sanatorio Parque ( Site 2203) Rosario Santa Fe Province Recruiting
Princess Alexandra Hospital ( Site 5300) Woolloongabba Queensland Recruiting
Monash Health ( Site 5301) Clayton Victoria Recruiting
FALP ( Site 2100) Santiago Region M. de Santiago Recruiting
Pontificia Universidad Catolica de Chile ( Site 2102) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 2101) Santiago Region M. de Santiago Recruiting
Beijing Cancer Hospital ( Site 5401) Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital ( Site 5413) Fuzhou Fujian Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) Nanjing Jiangsu Recruiting
Shanghai Chest Hospital ( Site 5400) Shanghai Shanghai Municipality Recruiting
Shanghai Pulmonary Hospital ( Site 5405) Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University ( Site 5416) Chengdu Sichuan Recruiting
The First Affiliated Hospital, Zhejiang University ( Site 5404) Hangzhou Zhejiang Recruiting
Rambam Health Care Campus ( Site 3202) Haifa Israel Active Not Recruiting
Shaare Zedek Medical Center ( Site 3200) Jerusalem Israel Recruiting
Rabin Medical Center ( Site 3203) Petah Tikva Israel Recruiting
Sheba Medical Center ( Site 3201) Ramat Gan Israel Recruiting
Aichi Cancer Center ( Site 5000) Nagoya Aichi-ken Recruiting
National Cancer Center Hospital East ( Site 5001) Kashiwa Chiba Recruiting
Kansai Medical University Hospital ( Site 5004) Hirakata Osaka Recruiting
Cancer Institute Hospital of JFCR ( Site 5002) Koto Tokyo Recruiting
Seoul National University Hospital ( Site 5100) Seoul South Korea Recruiting
Severance Hospital, Yonsei University Health System ( Site 5102) Seoul South Korea Recruiting
Samsung Medical Center ( Site 5101) Seoul South Korea Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) Eixample Barcelona Recruiting
Institut Català d'Oncologia - L'Hospitalet ( Site 3317) L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Clinico San Carlos... ( Site 3316) Madrid Madrid, Comunidad de Recruiting
Hospital Universitari Vall d'Hebron ( Site 3311) Barcelona Spain Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) Madrid Spain Recruiting
Hospital Universitario HM Sanchinarro ( Site 3313) Madrid Spain Recruiting

+ 8 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 NCT06780137 on ClinicalTrials.gov ↗ ← All trials in the UK