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Trial record 1 of 1 for:    ds8201-a-u204
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DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03505710
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Trastuzumab deruxtecan (DS-8201a) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab

Arm Intervention/treatment
Experimental: Cohort 1: HER2 Over-expressing
Cohort 1 will enroll participants with HER2-over-expressing(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma to receive 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Drug: Trastuzumab deruxtecan (DS-8201a)
The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
Other Names:
  • DS-8201a
  • Experimental product

Experimental: Cohort 1a: HER2 Over-expressing
Cohort 1a will enroll participants with HER2-over-expressing (immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma to receive 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Drug: Trastuzumab deruxtecan (DS-8201a)
The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
Other Names:
  • DS-8201a
  • Experimental product

Experimental: Cohort 2: HER2 Mutated
Cohort 2 will enroll participants with HER2-mutated, unresectable and/or metastatic NSCLC to receive 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Drug: Trastuzumab deruxtecan (DS-8201a)
The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
Other Names:
  • DS-8201a
  • Experimental product




Primary Outcome Measures :
  1. Objective response rate (ORR) of trastuzumab deruxtecan (DS-8201a) assessed by independent central review (ICR) [ Time Frame: within 30 months ]
    ORR is assessed for each cohort by ICR, based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1


Secondary Outcome Measures :
  1. ORR of trastuzumab deruxtecan (DS-8201a) assessed by investigator [ Time Frame: within 30 months ]
    ORR is assessed for each cohort by the investigator

  2. Duration of Response (DoR) [ Time Frame: within 30 months ]
    Assessment categories: Investigator, ICR

  3. Progression-free Survival (PFS) [ Time Frame: within 30 months ]
    Assessment categories: Investigator, ICR

  4. Overall Survival (OS) [ Time Frame: until the end of the trial, including 40-day follow-up visit, followed by long-term follow-up visits until death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first (within approximately 30 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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: Documented any known 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 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

Exclusion Criteria:

  • Was 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) that required steroids, has current ILD, or where suspected ILD cannot be ruled out due to imaging at screening
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505710


Contacts
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Contact: (Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111(M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp
Contact: (US sites only) Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Locations
Show Show 21 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
AstraZeneca
Investigators
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Study Director: Global Team Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT03505710    
Other Study ID Numbers: DS8201-A-U204
2017-004781-94 ( EudraCT Number )
JapicCTI-183916 ( Registry Identifier: JAPIC )
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
HER2 over-expression
HER2 mutation
Unresectable or metastatic
Non-squamous
NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Trastuzumab
Camptothecin
Immunoconjugates
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs