DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/31/2019
Start Date:May 21, 2018
End Date:October 30, 2020
Contact:(for Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111(M-F 9-5 JST)

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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)

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.


Inclusion Criteria:

- 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

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:

1. safety or well-being of the participant or offspring

2. safety of study staff

3. analysis of results
We found this trial at
8
sites
1275 York Ave
New York, New York 10021
(212) 639-2000
Phone: 646-888-4201
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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Seattle, Washington 98104
(206) 543-2100
Phone: 206-288-7487
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Phone: 734-647-6883
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-6036
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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Detroit, Michigan 48201
Phone: 313-576-8753
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Detroit, MI
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La Jolla, California 92093
Phone: 858-822-4171
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La Jolla, CA
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Tampa, Florida 33612
Phone: 813-745-4673
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Tampa, FL
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Villejuif, ile-de-France 94805
Phone: +33 142114564
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Villejuif,
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