Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic … (NCT05089734) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
United States603 participantsStarted 2021-11-17
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Pathologically documented non-small cell lung cancer (NSCLC) with documented evidence of Stage 4 NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), and programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) results are required. Testing prior to enrollment. Resulting for other actionable genomic alterations is recommended and to be performed as per local standard of care and availability of targeted treatment. For patients with squamous cell carcinoma, EGFR and ALK testing is optional.
* Must have progressed after platinum-based chemotherapy in combination with anti-PD-1/PD-L1 antibody OR platinum-based chemotherapy and anti-PD-1/PD-L1 antibody (in either order) sequentially.
* No additional treatments are allowed in the recurrent/metastatic setting for individuals with no actionable genomic alterations.
* Individuals with EGFR, ALK, or any other known actionable genomic alterations must have also received treatment with at least 1 locally approved and available tyrosine kinase inhibitor 1(TKI) appropriate to the genomic alteration.
* Documented radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
* Measurable disease based on computed tomography (CT) or magnetic resonance imaging (MRI) as assessed by the investigator in acc…