🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the UK / NCT06780137
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
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 1/2
Started
2025-02-27
Last updated
2026-09-09

Condition(s) studied

Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

GocatamigIfinatamab 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)

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.

On this site

📄 Imfinzi (durvalumab) drug profile →

More Merck Sharp & Dohme LLC trials in the UK

Other trials for the same condition

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