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Clinical Trial 19743

Cancer Type: Thoracic
Interventions:Trastuzumab Deruxtecan

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Andreas Saltos

Call 813-745-6100
or 1-800-679-0775
Overview

Study 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)

Summary

Objective

Primary Objective: The primary objective is to evaluate the objective response rate (ORR) of trastuzumab deruxtecan in HER2-overexpressing and/or HER2 mutated advanced NSCLC subjects. The secondary objectives are: To evaluate duration of response (DoR),disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) To further evaluate the safety of trastuzumab deruxtecan To determine the pharmacokinetics (PK) of trastuzumab deruxtecan

Inclusion Criteria

  • Age 18 or older
  • 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

  • Exclusion Criteria

  • 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, or analysis of results