Summary

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

Description

Summary

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

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)

Keywords

Non-Small Cell Lung CancerHER2 over-expressionHER2 mutationUnresectable or metastaticNon-squamousNSCLCLung NeoplasmsCarcinoma, Non-Small-Cell LungTrastuzumabCamptothecinImmunoconjugatesTrastuzumab deruxtecan (DS-8201a)

Eligibility

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 only: 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 sample
  • For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor sample analyzed by CLIA laboratory or equivalent
  • Presence of at least 1 measurable lesion assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Is willing and able to provide an adequate archival tumor 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...

  • Was previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors
  • For Cohort 1 only: 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 QTc 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:
  • safety or well-being of the participant or offspring
  • safety of study staff
  • analysis of results

Locations

  • University of California San Diego (UCSD)accepting new patients
    La JollaCalifornia92093-1503United States
  • University of Washingtonaccepting new patients
    SeattleWashington98109-1023United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT03505710
Phase
Phase 2
Study Type
Interventional
Last Updated