Actively Recruiting
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)
Led by Merck Sharp & Dohme LLC · Updated on 2026-04-20
262
Participants Needed
48
Research Sites
255 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 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
CONDITIONS
Official 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has histologically or cytologically confirmed extensive-stage small cell lung cancer (Stage IV) after at least one prior platinum-based chemotherapy treatment
- Able to provide an archival or fresh tumor tissue sample
- If HIV positive, must have well-controlled HIV on antiretroviral therapy (ART)
You will not qualify if you...
- Pleural effusion, pericardial effusion, or ascites requiring repeated drainage
- History of interstitial lung disease or pneumonitis, or current/suspected pneumonitis/ILD not ruled out by imaging
- Severe lung problems due to other pulmonary illnesses
- Active or history of immune deficiency except well-controlled HIV on ART
- History of major cardiovascular events or diseases within 6 months before study
- History of arterial thrombosis (such as stroke or transient ischemic attack) within 6 months before study
- Active serious infections needing systemic therapy
- History of organ or tissue transplant
- History of leptomeningeal disease
- Recent radiotherapy or radiation toxicity requiring steroids
- Use of chronic systemic steroids above 10 mg prednisone equivalent or other immunosuppressive therapy within 7 days before study
- Other progressing malignancies needing treatment within past 3 years
- Untreated or symptomatic brain metastases
- Active viral hepatitis (A, B, or C), unless successfully treated and virus undetectable
- For Part 1 only: recent high-dose lung or abdominal radiation, anticancer hormonal treatment, recent systemic or antibody-based cancer therapy, chloroquine/hydroxychloroquine use, significant corneal disease, or certain cardiovascular diseases
AI-Screening
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Trial Site Locations
Total: 48 locations
1
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora, Colorado, United States, 80045
Actively Recruiting
2
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami, Florida, United States, 33136
Actively Recruiting
3
University of Chicago ( Site 1108)
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey, United States, 07601
Actively Recruiting
6
Roswell Park Cancer Institute ( Site 1107)
Buffalo, New York, United States, 14263
Actively Recruiting
7
Providence Portland Medical Center ( Site 1101)
Portland, Oregon, United States, 97213
Actively Recruiting
8
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee, United States, 37203
Actively Recruiting
9
Medical College of Wisconsin ( Site 1112)
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
10
Hospital Universitario Austral ( Site 2204)
Pilar, Buenos Aires, Argentina, B1629WWA
Actively Recruiting
11
Sanatorio Parque ( Site 2203)
Rosario, Santa Fe Province, Argentina, S2000DSV
Actively Recruiting
12
Princess Alexandra Hospital ( Site 5300)
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
13
Monash Health ( Site 5301)
Clayton, Victoria, Australia, 3168
Actively Recruiting
14
FALP ( Site 2100)
Santiago, Region M. de Santiago, Chile, 7500921
Actively Recruiting
15
Pontificia Universidad Catolica de Chile ( Site 2102)
Santiago, Region M. de Santiago, Chile, 8330032
Actively Recruiting
16
Bradfordhill ( Site 2101)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
17
Beijing Cancer Hospital ( Site 5401)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
18
Fujian Cancer Hospital ( Site 5413)
Fuzhou, Fujian, China, 350014
Actively Recruiting
19
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
Nanjing, Jiangsu, China, 210008
Actively Recruiting
20
Shanghai Chest Hospital ( Site 5400)
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
21
Shanghai Pulmonary Hospital ( Site 5405)
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
22
West China Hospital of Sichuan University ( Site 5416)
Chengdu, Sichuan, China, 610041
Actively Recruiting
23
The First Affiliated Hospital, Zhejiang University ( Site 5404)
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
24
Rambam Health Care Campus ( Site 3202)
Haifa, Israel, 3109601
Active, Not Recruiting
25
Shaare Zedek Medical Center ( Site 3200)
Jerusalem, Israel, 9103102
Actively Recruiting
26
Rabin Medical Center ( Site 3203)
Petah Tikva, Israel, 4941492
Actively Recruiting
27
Sheba Medical Center ( Site 3201)
Ramat Gan, Israel, 5265601
Actively Recruiting
28
Aichi Cancer Center ( Site 5000)
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
29
National Cancer Center Hospital East ( Site 5001)
Kashiwa, Chiba, Japan, 277-0882
Actively Recruiting
30
Kansai Medical University Hospital ( Site 5004)
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
31
Cancer Institute Hospital of JFCR ( Site 5002)
Koto, Tokyo, Japan, 135-8550
Actively Recruiting
32
Seoul National University Hospital ( Site 5100)
Seoul, South Korea, 03080
Actively Recruiting
33
Severance Hospital, Yonsei University Health System ( Site 5102)
Seoul, South Korea, 03722
Actively Recruiting
34
Samsung Medical Center ( Site 5101)
Seoul, South Korea, 06351
Actively Recruiting
35
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample, Barcelona, Spain, 08036
Actively Recruiting
36
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
37
Hospital Clinico San Carlos... ( Site 3316)
Madrid, Madrid, Comunidad de, Spain, 28040
Actively Recruiting
38
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona, Spain, 08035
Actively Recruiting
39
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid, Spain, 28040
Actively Recruiting
40
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid, Spain, 28050
Actively Recruiting
41
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga, Spain, 29010
Actively Recruiting
42
National Cheng Kung University Hospital ( Site 5202)
Tainan, Taiwan, 704
Actively Recruiting
43
Taipei Medical University Hospital ( Site 5201)
Taipei, Taiwan, 11030
Actively Recruiting
44
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara, Turkey (Türkiye), 06230
Actively Recruiting
45
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara, Turkey (Türkiye), 06800
Actively Recruiting
46
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London, London, City of, United Kingdom, W1T 7HA
Actively Recruiting
47
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool, United Kingdom, L7 8YA
Actively Recruiting
48
The Christie NHS Foundation Trust ( Site 3901)
Manchester, United Kingdom, M20 4BX
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
9
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