Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
695 patients around the world
Available in Argentina, United States, Brazil
Gilead Sciences
14Research sites
695Patients around the world
This study is for people with
Lung cancer
Small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
Histologically confirmed diagnosis of SCLC.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by investigator per RECIST v1.1 criteria.
Documentation of radiological disease progression after 1 prior line of platinum-containing chemotherapy (defined as at least 2 cycles of treatment) with or without therapy directed against programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1; PD-1 and PD-L1 are hereafter referred to as PD-(L)1) for ES-SCLC.
Chemotherapy-free interval (CTFI) time from the last dose of first-line platinum-containing chemotherapy to the occurrence of progressive disease is less than 30 days (independent of the immunotherapy maintenance).
Received any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.
Untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have stable CNS disease (ie, without evidence of progression) for at least 4 weeks prior to enrollment and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases, and are taking less than or equal to 10 mg/day of prednisone or its equivalent.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Perdriel 74, CABA, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata