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Clinical Trial 19743

Cancer Type: Thoracic
Study Type: Treatment
NCT#: NCT03505710

Phase: Phase II
Prinicipal Investigator:

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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

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.

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

Treatments

Therapies

Medications

Trastuzumab Deruxtecan ()

Inclusion Criteria

  • Must have provided informed consent for study participation before performance of any study-specific procedures or test.
  • 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 tissue sample
  • For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor tissue 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 tissue sample. Fine needle aspirates are not acceptable.
  • 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

  • Previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors.
  • For Cohort 1 only: Has known HER2 mutation. 3. Uncontrolled or significant cardiovascular disease, specifics outlined per protocol.
  • Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Has clinically significant corneal disease in the opinion of the Investigator.
  • Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
  • Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated

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