Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Phase 3 Active not recruiting 603 enrolled Gilead Sciences

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

Timeline

Start: 2021-11-17
Primary completion: 2023-11-29
Completion: 2027-01

Outcome

Missed primary endpoint

paper The primary end point was not met. PMID 38843511 ↗

registry p = 0.0534; Hazard Ratio (HR) 0.84 (95% CI 0.68 to 1.04) NCT05089734 ↗

release “The Phase 3 EVOKE-01 study did not meet its primary endpoint of overall survival (OS) in previously treated metastatic non-small cell lung cancer (NSCLC).” gilead.com ↗

release “As announced in January 2024, EVOKE-01 did not meet its primary endpoint of overall survival.” gilead.com ↗

Publications

Paz-Ares LG, Juan-Vidal O, Mountzios GS, Felip E, Reinmuth N, de Marinis F, Girard N, Patel VM, Takahama T, Owen SP, Reznick DM, Badin FB, Cicin I, Mekan S, Patel R, Zhang E, Karumanchi D, Garassino MC. Sacituzumab Govitecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer: The Randomized, Open-Label Phase III EVOKE-01 Study. J Clin Oncol. 2024 Aug 20;42(24):2860-2872. doi: 10.1200/JCO.24.00733. Epub 2024 May 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Sacituzumab Govitecan	Monoclonal antibody	10 mg/kg	Intravenous