DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
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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 |
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Recruitment Status :
Recruiting
First Posted : April 23, 2018
Last Update Posted : September 10, 2019
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Sponsor:
Daiichi Sankyo, Inc.
Collaborators:
Daiichi Sankyo Co., Ltd.
AstraZeneca
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
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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 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 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 25, 2020 |
| Estimated Study Completion Date : | August 25, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
Drug Information available for:
Trastuzumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1: HER2 OE
Cohort 1 will enroll approximately 40 subjects with HER2-over-expressing (OE)(immunohistochemistry [IHC] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma to receive trastuzumab deruxtecan (DS-8201a).
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Drug: Trastuzumab deruxtecan (DS-8201a)
The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
Other Names:
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Experimental: Cohort 2: HER2 Mutated
Cohort 2 will enroll approximately 40 subjects with HER2-mutated, unresectable and/or metastatic NSCLC to receive trastuzumab deruxtecan (DS-8201a).
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Drug: Trastuzumab deruxtecan (DS-8201a)
The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
Other Names:
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Primary Outcome Measures :
- 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 :
- ORR of trastuzumab deruxtecan (DS-8201a) assessed by investigator [ Time Frame: within 30 months ]ORR is assessed for each cohort by the investigator
- Duration of Response (DoR) [ Time Frame: within 30 months ]Assessment categories: Investigator, ICR
- Progression-free Survival (PFS) [ Time Frame: within 30 months ]Assessment categories: Investigator, ICR
- 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) ]
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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 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. 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 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
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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
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
| Contact: (for Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information | +81-3-6225-1111(M-F 9-5 JST) | dsclinicaltrial@daiichisankyo.co.jp |
Locations
Show 21 study locations
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Daiichi Sankyo Co., Ltd.
AstraZeneca
Investigators
| Study Director: | Global Team Leader | Daiichi Sankyo, Inc. |
| 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: | September 10, 2019 |
| Last Verified: | September 2019 |
| 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/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Daiichi Sankyo, Inc.:
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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 |