Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)

Study Identifier
M16-289
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Dutch, French, Japanese, Korean, Spanish, Turkish

Study Details

Medical Condition
  • Lung Cancer - Small Cell Lung Cancer (SCLC)
  • Study Drug
  • Rovalpituzumab tesirine
  • Topotecan
  • Dexamethasone
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.

    Study Locations

    Location
    Status
    Location
    Clearview Cancer Institute /ID# 155873
    Huntsville, Alabama, United States, 35805
    Status
    Not applicable
    Location
    Mitchell Cancer Institute /ID# 158151
    Mobile, Alabama, United States, 36604
    Status
    Not applicable
    Location
    Carti /Id# 156982
    Little Rock, Arkansas, United States, 72205
    Status
    Not applicable
    Location
    Highlands Oncology Group /ID# 155902
    Springdale, Arkansas, United States, 72762
    Status
    Not applicable
    Location
    Cedars-Sinai Medical Center /ID# 157102
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Moore UC San Diego Cancer Center /ID# 156965
    La Jolla, California, United States, 92093
    Status
    Not applicable
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