Phase
Condition
Small Cell Lung Cancer
Treatment
Gocatamig
Durvalumab
MK-6070
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has histologically or cytologically confirmed SCLC that is extensive stage (definedas Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemictherapy that included platinum-based chemotherapy
Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample
Human immunodeficiency virus (HIV) infected participants must have well controlledHIV on antiretroviral therapy (ART)
Exclusion
Exclusion Criteria:
Pleural effusion, pericardial effusion, or ascites requiring recurrent drainageprocedure
History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that requiredsteroids or has current pneumonitis/ILD, and or suspected ILD/pneumonitis
Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses
Active or history of immune deficiency with the exception of HIV-infectedparticipants with well controlled HIV on ART
History within 6 months before the first dose of study intervention ofcoronary/peripheral artery bypass graft and/or any coronary/peripheral angioplastyor clinically significant cardiovascular disease such as myocardial infarction,symptomatic congestive heart failure (CHF) (New York Heart Association > class II),and/or uncontrolled cardiac arrhythmia
History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6months before the first dose of study intervention
Active clinically significant infection requiring systemic therapy
History of allogeneic tissue/solid organ transplant
History of leptomeningeal disease
Received prior radiotherapy within 2 weeks of start of study intervention, or hasradiation-related toxicities, requiring corticosteroids
Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily ofprednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention
Known additional malignancy that is progressing or has required active treatmentwithin the past 3 years
Untreated or symptomatic brain metastases
Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M [IgM] positive in the setting of associated signs/symptoms), hepatitis B (hepatitisB virus surface antigen [HbsAg] positive and/or detectable hepatitis B virus [HBV]deoxyribonucleic acid [DNA]), or hepatitis C (hepatitis C virus [HCV] antibodypositive and detectable HCV ribonucleic acid). Participants with HBV withundetectable viral load after treatment are eligible. Participants with HCV withundetectable virus after treatment are eligible.
Part 1 only: Radiation therapy to the lung >30 Gy within 6 months before the startof study intervention
Part 1 only: Abdominal radiation within 4 weeks before start of study intervention
Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasinghormone [LHRH]) within 2 weeks before start of study intervention
Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy)or investigational agents within 3 weeks or 5 half-lives, whichever is longer
Part 1 only: Antibody-based cancer therapy within 3 weeks before start of studyintervention
Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of studyintervention
Part 1 only: Clinically significant corneal disease
Part 1 only: Has other uncontrolled or significant protocol-specified cardiovasculardisease
Study Design
Study Description
Connect with a study center
Princess Alexandra Hospital ( Site 5300)
Wooloongabba, Queensland 2152274 4102
AustraliaActive - Recruiting
Bradfordhill ( Site 2101)
Santiago, Region M. De Santiago 8420383
ChileSite Not Available
FALP ( Site 2100)
Santiago., Region M. De Santiago 7500921
ChileSite Not Available
Bradfordhill ( Site 2101)
Santiago 3871336, Region M. de Santiago 8420383
ChileActive - Recruiting
FALP ( Site 2100)
Santiago 3871336, Region M. de Santiago 7500921
ChileActive - Recruiting
Rambam Health Care Campus ( Site 3202)
Haifa, 3109601
IsraelSite Not Available
Rambam Health Care Campus ( Site 3202)
Haifa 294801, 3109601
IsraelActive - Recruiting
Shaare Zedek Medical Center ( Site 3200)
Jerusalem, 9103102
IsraelSite Not Available
Shaare Zedek Medical Center ( Site 3200)
Jerusalem 281184, 9103102
IsraelActive - Recruiting
Sheba Medical Center ( Site 3201)
Ramat Gan, 5265601
IsraelSite Not Available
Sheba Medical Center... ( Site 3201)
Ramat Gan, 5265601
IsraelActive - Recruiting
Sheba Medical Center ( Site 3201)
Ramat Gan 293788, 5265601
IsraelActive - Recruiting
Aichi Cancer Center ( Site 5000)
Nagoya 1856057, Aichi-ken 1865694 464-8681
JapanActive - Recruiting
National Cancer Center Hospital East ( Site 5001)
Kashiwa, Chiba 277-0882
JapanSite Not Available
National Cancer Center Hospital East ( Site 5001)
Kashiwa 1859924, Chiba 2113014 277-0882
JapanActive - Recruiting
Kansai Medical University Hospital ( Site 5004)
Hirakata, Osaka 573-1191
JapanSite Not Available
Kansai Medical University Hospital ( Site 5004)
Hirakata 1862540, Osaka 1853904 573-1191
JapanActive - Recruiting
Cancer Institute Hospital of JFCR ( Site 5002)
Koto, Tokyo 1850144 135-8550
JapanActive - Recruiting
Samsung Medical Center ( Site 5101)
Seoul, 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital ( Site 5100)
Seoul, 03080
Korea, Republic ofSite Not Available
Samsung Medical Center ( Site 5101)
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital ( Site 5100)
Seoul 1835848, 03080
South KoreaActive - Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample 6544100, Barcelona 08036
SpainActive - Recruiting
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
L Eixample, Barcelona 08036
SpainSite Not Available
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat 3120619, Barcelona 08907
SpainActive - Recruiting
Hospital Clinico San Carlos... ( Site 3316)
Madrid, Madrid, Comunidad De 28040
SpainActive - Recruiting
Hospital Clinico San Carlos... ( Site 3316)
Madrid 3117735, Madrid, Comunidad de 28040
SpainActive - Recruiting
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona, 08035
SpainSite Not Available
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid, 28040
SpainSite Not Available
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid, 28050
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid 3117735, 28050
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria ( Site 3312)
Malaga, 29010
SpainSite Not Available
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga 2514256, 29010
SpainActive - Recruiting
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara, 06800
TurkeySite Not Available
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara, 06230
TurkeyActive - Recruiting
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara 323786, 06800
Turkey (Türkiye)Active - Recruiting
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara 323786, 06230
Turkey (Türkiye)Active - Recruiting
University of Chicago ( Site 1108)
Chicago, Illinois 60637
United StatesSite Not Available
University of Chicago ( Site 1108)
Chicago 4887398, Illinois 4896861 60637
United StatesActive - Recruiting
Dana Farber Cancer Institute ( Site 1105)
Boston, Massachusetts 02215
United StatesSite Not Available
Dana Farber Cancer Institute ( Site 1105)
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack, New Jersey 07601
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack 5098706, New Jersey 5101760 07601
United StatesActive - Recruiting
Roswell Park Cancer Institute ( Site 1107)
Buffalo 5110629, New York 5128638 14263
United StatesActive - Recruiting
Providence Portland Medical Center ( Site 1101)
Portland, Oregon 97213
United StatesSite Not Available
Providence Portland Medical Center ( Site 1101)
Portland 5746545, Oregon 5744337 97213
United StatesActive - Recruiting
Sarah Cannon Research Institute ( Site 7001)
Nashville, Tennessee 37203
United StatesSite Not Available
Sarah Cannon Research Institute ( Site 7001)
Nashville 4644585, Tennessee 4662168 37203
United StatesActive - Recruiting
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