Rescue Medications: Participants will receive rescue medications at the investigator's discretion. Recommended rescue medications include tocilizumab for treatment of cytokine release syndrome (CRS); dexamethasone, acetaminophen, and diphenhydramine for CRS/infusion-related reaction (IRR) prophylaxis; and 5-hydroxytryptamine 3 (5-HT3) receptor antagonist, neurokinin 1 (NK-1) receptor antagonist, and corticosteroid for prevention of nausea and vomiting.
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 58 months An AE is defined as 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. The number of participants who experience an AE will be reported.
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) — Up to approximately 21 days DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 21 days) that meets the protocol-specified DLT 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 58 months An AE is defined as 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. The number of participants who discontinue study intervention due to an AE will be reported.
Objective Response Rate (ORR) — Up to approximately 58 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 Blinded Independent Central Review (BICR) will be presented.
Trial sites (52)
Facility
City
Region
Status
Providence Medical Foundation ( Site 0124)
Santa Rosa
California
Recruiting
University of Colorado, Anschutz Cancer Pavilion ( Site 0125)
Aurora
Colorado
Recruiting
Orlando Health Cancer Institute ( Site 0108)
Orlando
Florida
Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood
Kentucky
Recruiting
Washington University School of Medicine ( Site 0134)
St Louis
Missouri
Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack
New Jersey
Recruiting
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)
Portland
Oregon
Recruiting
Avera Cancer Institute- Research ( Site 0104)
Sioux Falls
South Dakota
Recruiting
The University of Tennessee Medical Center ( Site 0120)
Knoxville
Tennessee
Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)
Memphis
Tennessee
Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville
Tennessee
Recruiting
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)
Houston
Texas
Recruiting
University of Virginia Health System ( Site 0122)
Charlottesville
Virginia
Recruiting
CEMIC ( Site 1903)
Caba.
Buenos Aires
Recruiting
Hospital Austral ( Site 1901)
Pilar
Buenos Aires
Recruiting
Sanatorio Parque ( Site 1900)
Rosario
Santa Fe Province
Recruiting
FALP ( Site 0200)
Santiago
Region M. de Santiago
Recruiting
Pontificia Universidad Catolica de Chile ( Site 0202)
Santiago
Region M. de Santiago
Recruiting
Bradfordhill ( Site 0201)
Santiago
Region M. de Santiago
Recruiting
Beijing Cancer Hospital ( Site 1604)
Beijing
Beijing Municipality
Recruiting
Fujian Provincial Cancer Hospital ( Site 1607)
Fuzhou
Fujian
Recruiting
Southern Medical University Nanfang Hospital ( Site 1608)
Guangzhou
Guangdong
Recruiting
Jiangmen Central Hospital ( Site 1611)
Jiangmen
Guangdong
Recruiting
The First Affiliated Hospital of Nanchang University ( Site 1610)
Nanchang
Jiangxi
Recruiting
Shanghai East Hospital ( Site 1600)
Shanghai
Shanghai Municipality
Recruiting
Sichuan Cancer hospital. ( Site 1609)
Chengdu
Sichuan
Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)
Hangzhou
Zhejiang
Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou
Zhejiang
Recruiting
Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne ( Site 0401)
Tübingen
Baden-Wurttemberg
Recruiting
Universitaetsklinikum Jena ( Site 0403)
Jena
Thuringia
Recruiting
Errikos Dunant Hospital Center ( Site 0501)
Athens
Attica
Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 0502)
Athens
Attica
Recruiting
Athens Medical Center ( Site 0504)
Athens
Attica
Recruiting
European Interbalkan Medical Center ( Site 0500)
Thessaloniki
Greece
Recruiting
European Interbalkan Medical Center ( Site 0505)
Thessaloniki
Greece
Recruiting
Rambam Health Care Campus ( Site 0602)
Haifa
Israel
Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan
Israel
Recruiting
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 0702)
Meldola
Forli-Cesena
Recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0701)
Milan
Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0700)
Roma
Italy
Recruiting
+ 12 more sites — see the full list on the official registry below.
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.
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