A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003)
Recruiting · NCT07227597 · Interventional (participants receive a specific treatment) · Lead sponsor: Merck Sharp & Dohme LLC
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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. Lesions situated in a previously irradiated area are considered measurable if growth has been shown in such lesions since the completion of radiation
Exclusion criteria
- The main exclusion criteria include but are not limited to the following:
- Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- 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 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 other uncontrolled or significant protocol specified cardiovascular disease
- Has history of arterial thrombosis within 6 months before the first dose of study intervention
- 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 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 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
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- 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
Where it is running
52 locations listed across 11 US states.
- Providence Medical Foundation ( Site 0124) - Santa Rosa, California, United States
- University of Colorado, Anschutz Cancer Pavilion ( Site 0125) - Aurora, Colorado, United States
- Orlando Health Cancer Institute ( Site 0108) - Orlando, Florida, United States
- Saint Elizabeth Medical Center Edgewood ( Site 0112) - Edgewood, Kentucky, United States
- Washington University School of Medicine ( Site 0134) - St Louis, Missouri, United States
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101) - Hackensack, New Jersey, United States
- Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107) - Portland, Oregon, United States
- Avera Cancer Institute- Research ( Site 0104) - Sioux Falls, South Dakota, United States
- The University of Tennessee Medical Center ( Site 0120) - Knoxville, Tennessee, United States
- Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133) - Memphis, Tennessee, United States
- SCRI Oncology Partners ( Site 7000) - Nashville, Tennessee, United States
- Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113) - Houston, Texas, United States
- University of Virginia Health System ( Site 0122) - Charlottesville, Virginia, United States
- Hospital Universitari Vall d'Hebron ( Site 1001) - Barcelona, Spain
- Rambam Health Care Campus ( Site 0602) - Haifa, Israel
- Hospital Universitario Gregorio Maranon ( Site 1003) - Madrid, Spain
- Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701) - Milan, Italy
- Sheba Medical Center ( Site 0601) - Ramat Gan, Israel
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700) - Roma, Italy
- Seoul National University Hospital ( Site 1402) - Seoul, South Korea
- Severance Hospital Yonsei University Health System ( Site 1403) - Seoul, South Korea
- Asan Medical Center ( Site 1404) - Seoul, South Korea
- Samsung Medical Center ( Site 1401) - Seoul, South Korea
- European Interbalkan Medical Center ( Site 0500) - Thessaloniki, Greece
- European Interbalkan Medical Center ( Site 0505) - Thessaloniki, Greece
- Errikos Dunant Hospital Center ( Site 0501) - Athens, Attica, Greece
- THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502) - Athens, Attica, Greece
- Athens Medical Center ( Site 0504) - Athens, Attica, Greece
- Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401) - Tübingen, Baden-Wurttemberg, Germany
- Faculty of Medicine Siriraj Hospital ( Site 3000) - Bangkoknoi, Bangkok, Thailand
- Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 3002) - Dusit, Bangkok, Thailand
- Beijing Cancer Hospital ( Site 1604) - Beijing, Beijing Municipality, China
- CEMIC ( Site 1903) - Caba., Buenos Aires, Argentina
- Hospital Austral ( Site 1901) - Pilar, Buenos Aires, Argentina
- Songklanagarind hospital ( Site 3001) - Hat Yai, Changwat Songkhla, Thailand
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702) - Meldola, Forli-Cesena, Italy
- Fujian Provincial Cancer Hospital ( Site 1607) - Fuzhou, Fujian, China
- Southern Medical University Nanfang Hospital ( Site 1608) - Guangzhou, Guangdong, China
- Jiangmen Central Hospital ( Site 1611) - Jiangmen, Guangdong, China
- The First Affiliated Hospital of Nanchang University ( Site 1610) - Nanchang, Jiangxi, China
- Hospital San Pedro ( Site 1004) - Logroño, La Rioja, Spain
- Hospital Universitario Insular de Gran Canaria ( Site 1002) - Las Palmas de Gran Canaria, Las Palmas, Spain
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0902) - Warsaw, Masovian Voivodeship, Poland
- FALP ( Site 0200) - Santiago, Region M. de Santiago, Chile
- Pontificia Universidad Catolica de Chile ( Site 0202) - Santiago, Region M. de Santiago, Chile
- Bradfordhill ( Site 0201) - Santiago, Region M. de Santiago, Chile
- Sanatorio Parque ( Site 1900) - Rosario, Santa Fe Province, Argentina
- Shanghai East Hospital ( Site 1600) - Shanghai, Shanghai Municipality, China
- Sichuan Cancer hospital. ( Site 1609) - Chengdu, Sichuan, China
- Universitaetsklinikum Jena ( Site 0403) - Jena, Thuringia, Germany
- The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602) - Hangzhou, Zhejiang, China
- Taizhou Hospital of Zhejiang Province ( Site 1601) - Taizhou, Zhejiang, China