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Clinical Trials in the UK / NCT05089734
Active, not recruiting Phase 3

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

NCT05089734 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 3
Started
2021-11-17
Last updated
2026-05-07

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Sacituzumab Govitecan-hziy (SG)Docetaxel

Sacituzumab Govitecan-hziy (SG): Administered intravenously

Docetaxel: Administered intravenously

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 accordance with per RECIST Version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 before randomization. * Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, absolute neutrophil count ≥ 1500/mm\^3, and platelets ≥ 100,000/μL). * Adequate hepatic function (bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase ≤ 2.5 ULN or ≤ 5 x ULN if known liver metastases, and serum albumin \> 3 g/dL). * Creatinine clearance of at least 30 mL/min as assessed by the Cockcroft-Gault equation. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. Key Exclusion Criteria: * Mixed small-cell lung cancer and NSCLC histology. * Positive serum pregnancy test or women who are lactating. * Received a prior anticancer biologic agent within 4 weeks prior to enrollment or have received prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (ie, \> Grade 2 is considered not recovered) from adverse events (AEs) at the time of study entry. Individuals participating in observational studies are eligible. * Have not recovered (ie, \> Grade 2 is considered not recovered) from AEs due to a previously administered agent. * Previously received treatment with any of the following: * Topoisomerase 1 inhibitors. Any agent including an antibody-drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase 1 * Trop-2-targeted therapy * Docetaxel as monotherapy or in combination with other agents * Active second malignancy * NSCLC that is eligible for definitive local therapy alone. * Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. * Active cardiac disease * Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal perforation within 6 months of enrollment. * Active serious infection requiring antibiotics. * Positive HIV-1 or HIV-2 antibody with detectable viral load OR taking medications that may interfere with SN-38 metabolism. * Positive for hepatitis B surface antigen. Individuals who test positive for hepatitis B core antibody will require hepatitis B virus DNA by quantitative polymerase chain reaction for confirmation of active disease. * Positive hepatitis C antibody and detectable hepatitis C viral load. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (227)

FacilityCityRegionStatus
Alaska Oncology and Hematology, LLC. Anchorage Alaska
USOR - Arizona Oncology Associates Tucson - Wilmot Tucson Arizona
Beverly Hills Cancer Center Beverly Hills California
Rocky Mountain Cancer Centers - Aurora Aurora Colorado
Florida Cancer Specialists (Administration and Drug Shipment) Fort Myers Florida
Woodlands Medical Specialists, PA Pensacola Florida
Florida Cancer Specialists St. Petersburg Florida
Florida Cancer Specialists West Palm Beach Florida
University of Chicago Medical Center Chicago Illinois
Illinois Cancer Specialists Niles Illinois
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Sioux City Iowa
Kansas City VA Medical Center Westwood Kansas
Baptist Health Lexington Lexington Kentucky
Maryland Oncology Hematology, P.A. Clinton Maryland
Lahey Hospital & Medical Center Burlington Massachusetts
Park Nicollet Frauenshuh Cancer Center Saint Paul Minnesota
Nebraska Hematology - Oncology Lincoln Nebraska
Comprehensive Cancer Centers of Nevada Henderson Nevada
Broome Oncology, LLC Johnson City New York
Stony Brook Cancer Center Stony Brook New York
Levine Cancer Institute Charlotte North Carolina
FirstHealth Outpatient Cancer Center Pinehurst North Carolina
W.G (Bill) Hefner VAMC Salisbury North Carolina
Zangmeister Cancer Center Columbus Ohio
Tennessee Oncology, PLLC Chattanooga Tennessee
Baptist Clinical Research Institute Memphis Tennessee
Texas Oncology - Bedford Bedford Texas
Texas Oncology - Denison Denison Texas
Texas Oncology - Denton South Denton Texas
Texas Oncology Cancer Care and Research Center McAllen Texas
USOR - Texas Oncology - McKinney McKinney Texas
Texas Oncology - Paris Paris Texas
Texas Oncology-Plano East Plano Texas
Texas Oncology-Plano West Plano Texas
Shenandoah Oncology Associates, PC Winchester Virginia
University of Wisconsin Clinical Science Center Madison Wisconsin
Froedtert Hospital/Medical College of Wisconsin Milwaukee Wisconsin
Border Medical Oncology Research Unit Albury New South Wales
Southern Highlands Cancer Centre Bowral New South Wales
St Vincent's Public Hospital Darlinghurst New South Wales

+ 187 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05089734 on ClinicalTrials.gov ↗ ← All trials in the UK