Tests gocatamig and I-DXd in adults with lung cancer that returned
Tests two new drugs, alone or combined, in adults with lung cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Tainan and Taipei, TaiwanSee the 2 sitesAlso in 11 other countries, 46 sites
- Trial code
- NCT06780137
- EU 2024-517926-25-00
- JRCT2031250039
- U1111-1313-1108
- Registry title
- 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)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 327 people, planned
- Started
- 27 Feb 2025
- Expected to end
- 15 Feb 2029
- Type of study
- Interventional, 9 groups
- Treatments tested
- Gocatamig
- Ifinatamab Deruxtecan (I-DXd)
- Durvalumab
- Record updated
- 6 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with extensive-stage small cell lung cancer that came back or did not respond after earlier treatment that included platinum-based chemotherapy.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Extensive-stage small cell lung cancer (Stage IV), confirmed by tissue or cell tests
- Earlier treatment
- Must have had at least 1 earlier line of systemic therapy that included platinum-based chemotherapy
- Biomarker or test result
- Must be able to give an archival tumor tissue sample or a fresh biopsy sample. People with HIV can join only if their HIV is well controlled on antiretroviral therapy (ART).
Main reasons for not taking part
- Any history of interstitial lung disease or pneumonitis (except radiation pneumonitis that did not need steroids)
- Untreated or symptomatic brain metastases, or a history of leptomeningeal disease
- Active viral hepatitis, or an active infection that needs systemic therapy
- History of a solid organ or allogeneic tissue transplant
- Serious heart or blood vessel disease, or a stroke or arterial clot, in the past 6 months
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
- 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
- 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
- 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
- Active clinically significant infection requiring systemic therapy
- History of allogeneic tissue/solid organ transplant
- History of leptomeningeal disease
- Known additional malignancy that is progressing or has required active treatment within the past 3 years
- 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: Clinically significant corneal disease
- Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure
- Untreated or symptomatic brain metastases
Where in Taiwan
Also in 11 other countries, 46 sites
- National Cheng Kung University Hospital (Site 5202)Tainan, TaiwanContact: Study CoordinatorTaking people
- Taipei Medical University Hospital (Site 5201)Taipei, TaiwanContact: Study CoordinatorTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 9 groups in the trial
- Part 1 Arm 1: Gocatamig and I-DXdTreatment being tested
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig and Ifinatamab Deruxtecan (I-DXd)
- Part 1 Arm 2: Gocatamig and I-DXdTreatment being tested
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig and Ifinatamab Deruxtecan (I-DXd)
- Part 1 Arm 3a: I-DXd MonotherapyTreatment being tested
Participants will receive I-DXd until documented disease progression or discontinuation criteria are met.
Treatment: Ifinatamab Deruxtecan (I-DXd)
- Part 1 Arm 3b: Gocatamig and I-DXdTreatment being tested
Participants will receive gocatamig and I-DXd at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig and Ifinatamab Deruxtecan (I-DXd)
- Part 2 Arm 4: Gocatamig Monotherapy in JapanTreatment being tested
Participants in Japan will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig
- Part 2 Arm 5: Gocatamig Monotherapy in ChinaTreatment being tested
Participants in China will receive escalating doses of gocatamig until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig
- Part 2 Arm 6: GocatamigTreatment being tested
Participants will receive gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig
- Part 3 Arm 7: Gocatamig and DurvalumabTreatment being tested
Participants will receive gocatamig and durvalumab at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig and Durvalumab
- Part 2 Arm 8: Gocatamig (Alternate Presentation)Treatment being tested
Participants will receive an alternate presentation of gocatamig at a determined dose until documented disease progression or discontinuation criteria are met.
Treatment: Gocatamig
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- A Phase 1b/2 Open-Label Clinical Study to Evaluate the Safety and Efficacy of MK-6070 and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer
- Plain-language title
- Tests gocatamig and I-DXd in adults with lung cancer that returnedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 October 2026