GS-US-600-6165 (EVOKE-SCLC-04)

• Research type

  Research Study

• Full 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)

• IRAS ID

  1011575

• Contact name

  Jilpa Patel

• Contact email

  jilpa.patel13@gilead.com

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2024-515884-69

• Clinicaltrials.gov Identifier

  NCT06801834

• Research summary

  The study is a global, multicenter, randomized, open-label, Phase 3 study designed to assess the effect of sacituzumab govitecan (SG) compared with topotecan in participants with extensive stage small cell lung cancer (ES-SCLC) who had disease progression after 1 prior line
  of platinum-containing therapy. Participants will be randomly assigned in a 1:1 ratio to SG (Treatment Group A) and standard of care (SOC)(topotecan; Treatment Group B).

  Study Population: Participants must be at least 18 years of age with ES-SCLC who had disease progression after 1 prior line of platinum-containing therapy.

  Number of Participants Planned: Approximately 695.

  Duration of Intervention: Participants will receive study drug until progressive disease (PD; as determined by BICR per RECIST v1.1), death, unacceptable toxicity, or another treatment discontinuation criterion is met.

  Study Procedures/Frequency: Patient participation will include screening, treatment, and survival follow-up. Screening will last no longer than 28 days to confirm eligibility and establish disease characteristics prior to randomisation.

  Researchers want to learn about:
  • How the disease responds to SG compared to topotecan
  • The effect of SG on survival (how long you live) compared to topotecan
  • The effect of SG on your SCLC symptoms (such as shortness of breath) and quality of life compared to topotecan
  • The side effects and tolerability of SG compared to topotecan
  • Other supporting data related to SG compared to topotecan

• REC name

  Wales REC 5

• REC reference

  25/WA/0121

• Date of REC Opinion

  2 Jun 2025

• REC opinion

  Further Information Favourable Opinion