for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
completion around



The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.

Official Title

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)


Non-Small Cell Lung Cancer, HER2 over-expression, HER2 mutation, Unresectable or metastatic, Non-squamous, NSCLC, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Trastuzumab, Trastuzumab deruxtecan, HER2 Overexpressing, HER2 Mutated


You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Had been previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
  • For Cohort 1 and Cohort 1a: Has known HER2 mutation
  • 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 QT interval corrected by Fridericia's formula (QTcF) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  • 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:
    1. safety or well-being of the participant or offspring
    2. safety of study staff
    3. analysis of results


  • University of California San Diego (UCSD)
    La Jolla California 92093-1503 United States
  • University of Colorado Hospital
    Aurora Colorado 80045 United States


in progress, not accepting new patients
Start Date
Completion Date
Daiichi Sankyo, Inc.
Phase 2 research study
Study Type
About 181 people participating
Last Updated