Trial purpose
Cancer treatment
Tumor type
Lung cancer
Age
18+
Trial acronym
EVOKE-SCLC-04
Clinical summary
Summary
This study aims to understand the effectiveness of a drug called Sacituzumab Govitecan (SG) and how solid tumours respond to this drug in comparison to the standard of care in people with previously treated extensive-stage small cell lung cancer (ES-SCLC).
Participants will be randomly allocated to one of two treatment arms.
- Treatment Group A will receive Sacituzumab Govitecan (SG) on days 1 and 8 of a 21-day treatment cycle.
- Treatment Group B will receive Topotecan on days 1 to 5 of a 21-day treatment cycle.
All drugs are administered intravenously.
Conditions
This trial is treating people with small cell lung cancer who have not had any prior treatment with irinotecan, topotecan, SG, SN-38, exatecan derivatives, and similar agents targeting topoisomerase I.
Eligibility
Inclusion
- 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.
Exclusion
- Mixed SCLC and NSCLC histology
- Untreated CNS metastases (pts with treated CNS disease stable for >4 weeks and taking ≤10mg/day prednisone or equivalent are eligible)
- Disease progression <30 days from last dose of 1L platinum-containing chemotherapy (independent of immunotherapy maintenance)
- Active second malignancy (pts with history of malignancy that has been completely treated with no evidence of active cancer for >3 years are eligible)
- Anticancer treatment within 2 weeks prior to enrolment (for chemotherapy, small molecule therapy, radiation therapy) or within 4 weeks prior to enrolment for anticancer biologic agents
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Gilead Sciences
Scientific Title
A Global, Multicenter, Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Standard of Care (SOC) in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer (ES-SCLC)
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