Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

Part of paid clinical trials in Aurora, Colorado.

Sponsor
Daiichi Sankyo
Study ID
NCT04644237
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Trastuzumab deruxtecan 100 mg will be provided as a sterile lyophilized powder and reconstituted with 5 mL water for injection (final concentration 20 mg/mL \[ie, 100 mg/5 mL\]). The study drug will be administered as an intravenous (IV) infusion over 30 to 90 min Q3W ± 2 days. The initial dose of study drug will be infused for 90 ± 10 min.

Study Details

This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.

Key Dates

Start date
Mar 19, 2021
Status verified
Nov 2025
Primary completion
Dec 23, 2022
Completion
Aug 23, 2024

Study Design

Enrollment
152 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Trastuzumab deruxtecan 6.4 mg/kg
    Participants will be randomized to receive trastuzumab deruxtecan 6.4 mg/kg administered by intravenous infusion every 3 weeks (Q3W).
  • Experimental: Trastuzumab deruxtecan 5.4 mg/kg
    Participants will be randomized to receive trastuzumab deruxtecan 5.4 mg/kg administered by intravenous infusion every 3 weeks (Q3W).

Primary Outcome Measure

Percentage of Participants With Confirmed Objective Response Rate by Blinded Independent Central Review Following Intravenous Administration of Trastuzumab Deruxtecan in Participants With Metastatic Non-small Cell Lung Cancer [ Time Frame: 9 months after the last participant is randomized to data cut off, up to approximately 21 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of Colorado Denver - Anschutz Medical CampusAuroraColorado80045-
AdventHealth OrlandoOrlandoFlorida32803-
H. Lee Moffitt Cancer Center & Research InstituteTampaFlorida33612-
Norton Cancer InstituteLouisvilleKentucky40241-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital (MGH) - Hematology/OncologyBostonMassachusetts02114-
Henry Ford Cancer Institute/Henry Ford HospitalDetroitMichigan48202-
University of MichiganDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Virgina Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Aurora, CO

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Colorado Denver - Anschutz Medical Campus· Aurora, COAdventHealth Orlando· Orlando, FLH. Lee Moffitt Cancer Center & Research Institute· Tampa, FLNorton Cancer Institute· Louisville, KYDana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital (MGH) - Hematology/Oncology· Boston, MA

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