Actively Recruiting
A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Led by Merck Sharp & Dohme LLC · Updated on 2026-05-07
170
Participants Needed
23
Research Sites
256 weeks
Total Duration
On this page
Sponsors
M
Merck Sharp & Dohme LLC
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with extensive-stage small cell lung cancer confirmed by tissue or cell analysis
- For maintenance therapy with gocatamig + I-DXd: completed 3 to 4 cycles of platinum + etoposide chemotherapy with anti PD-1/L1 within 6 weeks before enrollment
- No disease progression by RECIST 1.1 criteria for maintenance therapy group
- No prior systemic treatment for extensive-stage small cell lung cancer for other treatment groups
- Prior limited-stage small cell lung cancer allowed if more than 6 months since previous therapy ended and progression
- Able to provide pretreatment tumor tissue sample or new biopsy from a non-irradiated tumor
- Measurable disease as per RECIST 1.1, including lesions with growth after radiation
You will not qualify if you...
- Presence of pleural, pericardial effusion, or ascites needing repeated drainage
- History or suspicion of interstitial lung disease or pneumonitis
- Severe lung problems from other lung illnesses
- History of serious brain or spinal cord bleeding
- Active neurologic paraneoplastic syndrome
- Recent significant heart or vascular disease within 6 months before study
- Other uncontrolled cardiovascular diseases
- Arterial thrombosis within 6 months before study
- Chronic liver disease
- History of allogeneic tissue or organ transplant
- History of leptomeningeal disease
- HIV infection with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar T-cell receptor agents
- Radiotherapy within 2 weeks before study or radiation-related toxicity requiring steroids
- Active progressing malignancy requiring treatment within past 3 years
- Active autoimmune disease needing systemic treatment in past 2 years except replacement therapy
- Active central nervous system metastases or carcinomatous meningitis
- Major surgery within 4 weeks or minor surgery within 2 weeks before study or planned major surgery during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
Orlando Health Cancer Institute ( Site 0108)
Orlando, Florida, United States, 32806
Actively Recruiting
2
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood, Kentucky, United States, 41017
Actively Recruiting
3
Washington University School of Medicine ( Site 0134)
St Louis, Missouri, United States, 63110
Actively Recruiting
4
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
5
Avera Cancer Institute- Research ( Site 0104)
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
6
The University of Tennessee Medical Center ( Site 0120)
Knoxville, Tennessee, United States, 37920
Actively Recruiting
7
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee, United States, 37203
Actively Recruiting
8
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)
Houston, Texas, United States, 77030
Actively Recruiting
9
FALP ( Site 0200)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
10
Pontificia Universidad Catolica de Chile ( Site 0202)
Santiago, Region M. de Santiago, Chile, 8330032
Actively Recruiting
11
Bradfordhill ( Site 0201)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
12
Beijing Cancer Hospital ( Site 1604)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
13
The First Affiliated Hospital of Nanchang University ( Site 1610)
Nanchang, Jiangxi, China, 330209
Actively Recruiting
14
Shanghai East Hospital ( Site 1600)
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
15
Sichuan Cancer hospital. ( Site 1609)
Chengdu, Sichuan, China, 610213
Actively Recruiting
16
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
17
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou, Zhejiang, China, 317000
Actively Recruiting
18
Rambam Health Care Campus ( Site 0602)
Haifa, Israel, 3109601
Actively Recruiting
19
Sheba Medical Center ( Site 0601)
Ramat Gan, Israel, 5265601
Actively Recruiting
20
Seoul National University Hospital ( Site 1402)
Seoul, South Korea, 03080
Actively Recruiting
21
Severance Hospital Yonsei University Health System ( Site 1403)
Seoul, South Korea, 03722
Actively Recruiting
22
Asan Medical Center ( Site 1404)
Seoul, South Korea, 05505
Actively Recruiting
23
Samsung Medical Center ( Site 1401)
Seoul, South Korea, 06351
Actively Recruiting
Research Team
T
Toll Free Number
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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