Phase
Condition
N/ATreatment
Atezolizumab
Carboplatin
Gocatamig
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has a histologically or cytologically confirmed diagnosis of extensive-stage smallcell lung cancer (ES-SCLC)
For participants receiving gocatamig + ifinatamab deruxtecan (I-DXd) in maintenanceonly:
Completed 3 to 4 cycles of platinum + etoposide chemotherapy with concurrentapproved 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 SolidTumors 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, orgocatamig + I-DXd in induction followed by gocatamig + atezolizumab in maintenance,or carboplatin + etoposide + atezolizumab in induction followed by atezolizumab inmaintenance: No prior systemic ES-SCLC treatment allowed
Applicable to all participants: prior limited-stage small cell lung cancer (SCLC) isallowed 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 newlyobtained core, incisional, or excisional biopsy of a tumor lesion not previouslyirradiated
Measurable disease by RECIST 1.1 as assessed by the local siteinvestigator/radiology. Lesions situated in a previously irradiated area areconsidered measurable if growth has been shown in such lesions since the completionof radiation
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has pleural effusion, pericardial effusion, or ascites requiring recurrent drainageprocedures
Has any history of interstitial lung disease (ILD)/pneumonitis irrespective ofsteroid use, current ILD, ILD that cannot be ruled out by imaging at screening, orsuspected ILD
Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses
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 anycoronary/peripheral angioplasty or clinically significant cardiovascular diseasesuch as myocardial infarction, symptomatic congestive heart failure (CHF), and/oruncontrolled cardiac arrhythmia within 6 months before the first dose of studyintervention
Has other uncontrolled or significant protocol specified cardiovascular disease
Has history of arterial thrombosis within 6 months before the first dose of studyintervention
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'ssarcoma 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 deathligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory orcoinhibitory T-cell receptor
Has received prior radiotherapy within 2 weeks of start of study intervention, orhas radiation-related toxicities, requiring corticosteroids
Has known additional malignancy that is progressing or has required active treatmentwithin the past 3 years
Has active autoimmune disease that has required systemic treatment in the past 2years except replacement therapy
Has known active central nervous system (CNS) metastases and/or carcinomatousmeningitis
Has major surgery within 4 weeks or minor surgery within 2 weeks ofallocation/randomization (or first dose), or is anticipated to require a majorsurgical procedure during the study
Study Design
Study Description
Connect with a study center
CEMIC ( Site 1903)
Caba., Buenos Aires C1431FWO
ArgentinaActive - Recruiting
Hospital Austral ( Site 1901)
Pilar, Buenos Aires B1629AHJ
ArgentinaActive - Recruiting
Bradfordhill ( Site 0201)
Santiago, Region M. de Santiago 8420383
ChileActive - Recruiting
FALP ( Site 0200)
Santiago, Region M. de Santiago 7500921
ChileActive - Recruiting
Pontificia Universidad Catolica de Chile ( Site 0202)
Santiago, Region M. de Santiago 8330032
ChileActive - Recruiting
Beijing Cancer Hospital ( Site 1604)
Beijing, Beijing Municipality 100142
ChinaActive - Recruiting
Southern Medical University Nanfang Hospital ( Site 1608)
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
Jiangmen Center Hospital ( Site 1611)
Jiangmen, Guangdong 529000
ChinaActive - Recruiting
Jiangmen Central Hospital ( Site 1611)
Jiangmen, Guangdong 529000
ChinaActive - Recruiting
The First Affiliated Hospital of Nanchang University ( Site 1610)
Nanchang, Jiangxi 330209
ChinaActive - Recruiting
Shanghai East Hospital ( Site 1600)
Shanghai, Shanghai Municipality 200000
ChinaActive - Recruiting
Sichuan Cancer hospital. ( Site 1609)
Chengdu, Sichuan 610213
ChinaActive - Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 1602)
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Taizhou Hospital of Zhejiang Province ( Site 1601)
Taizhou, Zhejiang 317000
ChinaActive - Recruiting
Rambam Health Care Campus ( Site 0602)
Haifa, 3109601
IsraelActive - Recruiting
Sheba Medical Center ( Site 0601)
Ramat Gan, 5265601
IsraelActive - Recruiting
Asan Medical Center ( Site 1404)
Seoul, 05505
South KoreaActive - Recruiting
Samsung Medical Center ( Site 1401)
Seoul, 06351
South KoreaActive - Recruiting
Seoul National University Hospital ( Site 1402)
Seoul, 03080
South KoreaActive - Recruiting
Severance Hospital Yonsei University Health System ( Site 1403)
Seoul, 03722
South KoreaActive - Recruiting
Hospital Universitario Insular de Gran Canaria ( Site 1002)
Las Palmas de Gran Canaria, Las Palmas 35016
SpainActive - Recruiting
Providence Medical Foundation ( Site 0124)
Santa Rosa, California 95403
United StatesActive - Recruiting
Orlando Health Cancer Institute ( Site 0108)
Orlando, Florida 32806
United StatesActive - Recruiting
Saint Elizabeth Medical Center Edgewood ( Site 0112)
Edgewood, Kentucky 41017
United StatesActive - Recruiting
Washington University School of Medicine ( Site 0134)
St Louis, Missouri 63110
United StatesActive - Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0101)
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Providence Cancer Institute, Franz Clinic - Eastside ( Site 0107)
Portland, Oregon 97213
United StatesActive - Recruiting
Avera Cancer Institute- Research ( Site 0104)
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
The University of Tennessee Medical Center ( Site 0120)
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Lt. Col. Luke Weathers, Jr. VA Medical Center ( Site 0133)
Memphis, Tennessee 38105
United StatesActive - Recruiting
SCRI Oncology Partners ( Site 7000)
Nashville, Tennessee 37203
United StatesActive - Recruiting
Houston Methodist Hospital - Houston Methodist Neal Cancer Center ( Site 0113)
Houston, Texas 77030
United StatesActive - Recruiting
University of Virginia Health System ( Site 0122)
Charlottesville, Virginia 22908
United StatesActive - Recruiting

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