A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small… (NCT07227597) | Clinical Trial Compass
RecruitingPhase 1/2
A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
United States, Argentina, Chile170 participantsStarted 2026-01-29
Plain-language summary
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.
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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. Les…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial combining two investigational drugs — Gocatamig and Infinatamab Deruxtecan — that are still being tested together, what is currently known about the safety profile of each drug on its own, and what additional risks might come from combining them?
2The trial is actively measuring how many people have to stop treatment because of side effects — what does that tell us about how tolerable this combination might be, and how would my overall health and lung cancer status affect my ability to handle potential toxicities?
3Given that this is an early-phase study still establishing safe doses, would it make more sense for me to try an established standard-of-care treatment for extensive-stage small cell lung cancer first before considering an experimental combination like this?
4The trial is measuring objective response rate — how tumors shrink or respond to treatment — but since we're still in Phase 1/2, how confident can we be that any response signals seen here would translate into real long-term benefit for me?
5What would my participation in this trial actually look like day-to-day in terms of visits, monitoring, and travel, and if I experience a serious adverse event or dose-limiting toxicity, what happens to my treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 58 months
2
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Timeframe: Up to approximately 21 days
3
Number of Participants Who Discontinue Study Intervention Due to an AE