At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Gocatamig (biological), Ifinatamab Deruxtecan (I-DXd) (biological), Durvalumab (biological)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Gocatamig — biological: IV infusion · Ifinatamab Deruxtecan (I-DXd) — biological: IV infusion · Durvalumab — biological: IV infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 327
- Started
- 2025-02-27
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for small cell lung cancer
- • Phase1/Phase2 - 327 participants
- • Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with small cell lung cancer
Where?
- • London - National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
- • Liverpool - The Clatterbridge Cancer Centre ( Site 3903)
- • Manchester - The Christie NHS Foundation Trust ( Site 3901)
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ of systemic therapy that included platinum-based chemotherapy
- ✓ well controlled HIV on antiretroviral therapy (ART)
What the study is looking for
- ✓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)
Who cannot take part
- ✗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...
- ✗Current history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- ✗Has clinically severe lung compromise resulting from intercurrent lung illnesses
- ✗Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART
See the full criteria
Where Is This Study? (3 UK sites)
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London W1T 7HA, United Kingdom
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool L7 8YA, United Kingdom
The Christie NHS Foundation Trust ( Site 3901)
Manchester M20 4BX, United Kingdom
How to Get in Touch
Toll Free Number
Sponsor contactCONTACT
