Tests gocatamig and I-DXd in people with extensive-stage small cell lung cancer
Tests two study medicines, gocatamig and I-DXd, for spreading small cell lung cancer.
Key facts
- Who runs it
- Merck Sharp & Dohme LLC
- Where
- Florence, Meldola, Milan, and Rome, ItalySee the 4 sitesAlso in 13 other countries, 61 sites
- Trial code
- NCT07227597
- EU 2025-521032-11-00
- U1111-1318-5025
- Registry title
- A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 170 people, planned
- Started
- 29 Jan 2026
- Expected to end
- 30 Dec 2030
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Gocatamig
- I-DXd
- Atezolizumab
- Carboplatin
- Etoposide
- Rescue Medications
- Record updated
- 9 November 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 aged 18 to 64 with extensive-stage small cell lung cancer, a lung cancer that has spread, who are starting first treatment or have just finished first-line chemotherapy with immunotherapy.
- Age
- 18 Years to 64 Years
- Sex
- All sexes can join.
- Disease stage
- Extensive-stage small cell lung cancer (ES-SCLC) confirmed by tissue or cell tests, with disease that can be measured on scans (RECIST 1.1). Earlier limited-stage SCLC is allowed if more than 6 months have passed since the end of that therapy and progression.
- Earlier treatment
- For some groups: no earlier medicine for ES-SCLC at all. For the maintenance-only group: 3 to 4 cycles of platinum + etoposide chemotherapy with an approved anti-PD-1/L1 medicine as first-line treatment within 6 weeks before joining, with no scan-proven worsening and no other earlier ES-SCLC treatment.
- Biomarker or test result
- No specific gene change or marker is asked for. A tumor tissue sample is needed: an older stored sample or a new biopsy of a tumor spot not treated with radiation before.
Main reasons for not taking part
- Any history of interstitial lung disease or pneumonitis, current or suspected
- Active brain or spinal cord spread of cancer, or cancer in the membranes around the brain or spinal cord
- Past solid organ or other donor tissue transplant
- Serious heart or blood vessel disease within 6 months before the first dose
- Chronic liver disease, or fluid around the lungs, heart or belly that needs repeated drainage
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 history of arterial thrombosis within 6 months before the first dose of study intervention
- 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 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
- 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 other uncontrolled or significant protocol specified cardiovascular disease
- 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 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
- The main exclusion criteria include but are not limited to the following:
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Italy
Also in 13 other countries, 61 sites
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyTaking people
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 4 groups in the trial
- Arm 1, Parts A and B: Gocataming + I-DXdTreatment being tested
Participants who completed standard of care (SOC) induction chemotherapy with concurrent approved anti-programmed cell death 1/ligand 1 protein (anti-PD-1/L1) treatment for ES-SCLC and did not have disease progression per investigator discretion, will receive gocatamig and I-DXd in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Treatment: Gocatamig, I-DXd, and Rescue Medications
- Arm 2, Parts A and B: Gocataming + I-DXdTreatment being tested
Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd during induction and maintenance phases, until documented disease progression or meeting other study discontinuation criteria.
Treatment: Gocatamig, I-DXd, and Rescue Medications
- Arm 3, Part B: Gocataming + I-DXd → gocatamig + atezolizumabTreatment being tested
Participants who did not receive prior systemic treatment for ES-SCLC will receive gocatamig and I-DXd in the induction phase, followed by gocatamig and atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Treatment: Gocatamig, I-DXd, Atezolizumab, and Rescue Medications
- Arm 4, Part B: Carboplatin + etoposide + atezolizumab → atezolizumabExisting treatment, for comparison
Participants who did not receive prior systemic treatment for ES-SCLC will receive SOC (carboplatin + etoposide + atezolizumab) in the induction phase, followed by atezolizumab in the maintenance phase, until documented disease progression or meeting other study discontinuation criteria.
Treatment: Atezolizumab, Carboplatin, and Etoposide
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 Study Evaluating Different MK-6070 and Ifinatamab Deruxtecan (MK-2400)-Based Regimens in First-line Extensive Stage Small Cell Lung Cancer
- Plain-language title
- Tests gocatamig and I-DXd in people with extensive-stage small cell lung cancerGenerated 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.
- Fit questions
- Built from NCT07227597, who can take part
- Record updated
- 9 November 2026