DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
Reason given: Last participant transitioned to alternative study.
Key facts
- Where
- Ann Arbor, Aurora, Boston, Detroit, La Jolla, New York, Seattle, St Louis, and Tampa, United StatesSee the 9 sites
- Phase
- Phase 2
Where in United States
- University of MichiganAnn Arbor, United StatesNo longer taking part
- University of Colorado HospitalAurora, United StatesNo longer taking part
- Dana-Farber Cancer InstituteBoston, United StatesNo longer taking part
- Karmanos Cancer InstituteDetroit, United StatesNo longer taking part
- University of California San Diego (UCSD)La Jolla, United StatesNo longer taking part
- Memorial Sloan-Kettering Cancer CenterNew York, United StatesNo longer taking part
- University of WashingtonSeattle, United StatesNo longer taking part
- Washington University School of Medicine at St LouisSt Louis, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Daiichi Sankyo
- Trial code
- NCT03505710
- Record updated
- 30 May 2025
- Original description
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.Read full original descriptionShow less
A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC) (DESTINY-Lung01)
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
Inclusion: Age ≥20 years old in Japan, ≥18 years old in other countries; Pathologically documented unresectable and/or metastatic non-squamous NSCLC; Has relapsed from or is refractory to standard treatment or for which no standard treatment is available; For Cohort 1 and Cohort 1a: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor tissue sample; For Cohort 2 only: Participant has any known documented activating HER2 mutation from an archival tumor tissue sample analyzed by CLIA laboratory or equivalent. Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment; Presence of at least 1 measurable lesion assessed by the investigator and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; Is willing and able to provide an adequate archival tumor tissue sample; Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen; Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
Exclusion: Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors; Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia; Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening; Has a medical history of clinically significant lung disease; Is suspected to have certain other protocol-defined diseases based on imaging at screening period; Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:; safety or well-being of the participant or offspring; safety of study staff; analysis of results; Has a QT interval corrected by Fridericia's formula (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in females; For Cohort 1 and Cohort 1a: Has known HER2 mutation.