Study Comparing Sacituzumab Govitecan and Docetaxel for Advanced Non-Small Cell Lung Cancer

Sponsor: Gilead Sciences

Sponsor score: 60

ClinicalTrials ID:NCT05089734

This clinical trial is comparing two treatments, sacituzumab govitecan and docetaxel, to see which is more effective for patients with advanced or metastatic non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two treatments for advanced non-small cell lung cancer (NSCLC) that has spread to other parts of the body. The study will look at how well sacituzumab govitecan works compared to docetaxel in treating this type of cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Stage 4 non-small cell lung cancer (NSCLC).
  • Must have test results for specific cancer markers (EGFR, ALK, PD-1/PD-L1) before joining the study.
  • Cancer must have worsened after receiving platinum-based chemotherapy combined with anti-PD-1/PD-L1 therapy.
  • No additional treatments allowed if there are no specific genetic changes in the cancer.
  • If there are specific genetic changes (EGFR, ALK), must have tried at least one approved targeted therapy.
  • Cancer must have shown growth on scans after the most recent treatment.
  • Must have measurable cancer on CT or MRI scans.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must have adequate blood counts and liver function.
  • Must have a creatinine clearance of at least 30 mL/min.
  • Must agree to use effective birth control if of childbearing potential.

Exclusion Criteria

  • Have a mix of small-cell lung cancer and NSCLC.
  • Pregnant or breastfeeding women cannot participate.
  • Have received certain cancer treatments recently and not fully recovered from side effects.
  • Have previously received specific treatments like topoisomerase 1 inhibitors or Trop-2-targeted therapy.
  • Have another active cancer.
  • Have NSCLC that can be treated with local therapy alone.
  • Have severe lung problems or other serious health conditions affecting the lungs.
  • Have active cancer spread to the brain or spinal cord.
  • Have serious heart disease.
  • Have active inflammatory bowel disease or recent gastrointestinal perforation.
  • Have a serious infection requiring antibiotics.
  • Have HIV with a detectable viral load or are taking medications that interfere with the study drug.
  • Have active hepatitis B or C infections.

Locations

FACILITYZIPCITYSTATE
Alaska Oncology and Hematology, LLC.99508AnchorageAlaska
USOR - Arizona Oncology Associates Tucson - Wilmot85711TucsonArizona
Beverly Hills Cancer Center90211Beverly HillsCalifornia
Rocky Mountain Cancer Centers - Aurora80012AuroraColorado
Florida Cancer Specialists (Administration and Drug Shipment)33901Fort MyersFlorida
Woodlands Medical Specialists, PA32503PensacolaFlorida
Florida Cancer Specialists33705St. PetersburgFlorida
Florida Cancer Specialists33401West Palm BeachFlorida
University of Chicago Medical Center60607ChicagoIllinois
Illinois Cancer Specialists60714NilesIllinois

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