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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Gocatamig: IV infusion
Ifinatamab Deruxtecan (I-DXd): IV infusion
Durvalumab: IV infusion
Study summary
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
Eligibility
Primary outcome measure(s)
- Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE in the study will be presented. - Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to approximately 3 weeks
A DLT is defined as any drug-related adverse event (AE) observed during the DLT evaluation period that meet pre-defined DTL criteria. Toxicities will be graded using National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) version 5.0, or the American Society for Transplant and Cellular Therapy (ASTCT) criteria. The number of participants who experience at least one DLT will be presented. - Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 44 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue the study intervention due to an AE in the study will be presented. - Part 1: Objective Response Rate (ORR) — Up to approximately 44 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Colorado Anschutz Medical Campus ( Site 1110) | Aurora | Colorado | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111) | Miami | Florida | Recruiting |
| University of Chicago ( Site 1108) | Chicago | Illinois | Recruiting |
| Dana Farber Cancer Institute ( Site 1105) | Boston | Massachusetts | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103) | Hackensack | New Jersey | Recruiting |
| Roswell Park Cancer Institute ( Site 1107) | Buffalo | New York | Recruiting |
| Providence Portland Medical Center ( Site 1101) | Portland | Oregon | Recruiting |
| Sarah Cannon Research Institute ( Site 7001) | Nashville | Tennessee | Recruiting |
| Medical College of Wisconsin ( Site 1112) | Milwaukee | Wisconsin | Recruiting |
| Hospital Universitario Austral ( Site 2204) | Pilar | Buenos Aires | Recruiting |
| Sanatorio Parque ( Site 2203) | Rosario | Santa Fe Province | Recruiting |
| Princess Alexandra Hospital ( Site 5300) | Woolloongabba | Queensland | Recruiting |
| Monash Health ( Site 5301) | Clayton | Victoria | Recruiting |
| FALP ( Site 2100) | Santiago | Region M. de Santiago | Recruiting |
| Pontificia Universidad Catolica de Chile ( Site 2102) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill ( Site 2101) | Santiago | Region M. de Santiago | Recruiting |
| Beijing Cancer Hospital ( Site 5401) | Beijing | Beijing Municipality | Recruiting |
| Fujian Cancer Hospital ( Site 5413) | Fuzhou | Fujian | Recruiting |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403) | Nanjing | Jiangsu | Recruiting |
| Shanghai Chest Hospital ( Site 5400) | Shanghai | Shanghai Municipality | Recruiting |
| Shanghai Pulmonary Hospital ( Site 5405) | Shanghai | Shanghai Municipality | Recruiting |
| West China Hospital of Sichuan University ( Site 5416) | Chengdu | Sichuan | Recruiting |
| The First Affiliated Hospital, Zhejiang University ( Site 5404) | Hangzhou | Zhejiang | Recruiting |
| Rambam Health Care Campus ( Site 3202) | Haifa | Israel | Active Not Recruiting |
| Shaare Zedek Medical Center ( Site 3200) | Jerusalem | Israel | Recruiting |
| Rabin Medical Center ( Site 3203) | Petah Tikva | Israel | Recruiting |
| Sheba Medical Center ( Site 3201) | Ramat Gan | Israel | Recruiting |
| Aichi Cancer Center ( Site 5000) | Nagoya | Aichi-ken | Recruiting |
| National Cancer Center Hospital East ( Site 5001) | Kashiwa | Chiba | Recruiting |
| Kansai Medical University Hospital ( Site 5004) | Hirakata | Osaka | Recruiting |
| Cancer Institute Hospital of JFCR ( Site 5002) | Koto | Tokyo | Recruiting |
| Seoul National University Hospital ( Site 5100) | Seoul | South Korea | Recruiting |
| Severance Hospital, Yonsei University Health System ( Site 5102) | Seoul | South Korea | Recruiting |
| Samsung Medical Center ( Site 5101) | Seoul | South Korea | Recruiting |
| HOSPITAL CLÍNIC DE BARCELONA ( Site 3310) | Eixample | Barcelona | Recruiting |
| Institut Català d'Oncologia - L'Hospitalet ( Site 3317) | L'Hospitalet de Llobregat | Barcelona | Recruiting |
| Hospital Clinico San Carlos... ( Site 3316) | Madrid | Madrid, Comunidad de | Recruiting |
| Hospital Universitari Vall d'Hebron ( Site 3311) | Barcelona | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315) | Madrid | Spain | Recruiting |
| Hospital Universitario HM Sanchinarro ( Site 3313) | Madrid | Spain | Recruiting |
+ 8 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06780137 on ClinicalTrials.gov ↗ ← All trials in the UK