DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
NCT ID: NCT03505710
Last Updated: 2025-05-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
181 participants
INTERVENTIONAL
2018-05-21
2024-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1: HER2 Overexpressing
Participants with HER2-overexpressing(immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Cohort 1a: HER2 Overexpressing
Participants with HER2-overexpressing (immunohistochemistry \[IHC\] 3+ or IHC 2+), unresectable and/or metastatic NSCLC adenocarcinoma who received 5.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Cohort 2: HER2 Mutated
Participants with HER2-mutated, unresectable and/or metastatic NSCLC who received 6.4 mg/kg trastuzumab deruxtecan (DS-8201a).
Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Interventions
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Trastuzumab deruxtecan
Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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: Participant has any known documented 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 and 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
* 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)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out due to imaging at screening
* Has a QT interval corrected by Fridericia's formula (QTcF) 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
AstraZeneca
INDUSTRY
Daiichi Sankyo
INDUSTRY
Responsible Party
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Principal Investigators
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Global Team Leader
Role: STUDY_DIRECTOR
Daiichi Sankyo
Locations
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University of California San Diego (UCSD)
La Jolla, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Washington University School of Medicine at St. Louis
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Washington
Seattle, Washington, United States
Centre Leon Berard
Lyon, Rhne, France
Hôpital Nord - CHU Marseille
Marseille, , France
CHU Larrey
Toulouse, , France
Hôpital Larrey, CHU-Toulouse
Toulouse, , France
Institut Gustave Roussy
Villejuif, Île-de-France Region, France
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, Japan
Shizuoka Cancer Center
Nakatogari, Sunto-gun, Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan
Netherlands Cancer Institute
Amsterdam, , Netherlands
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Countries
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References
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Smit EF. Trastuzumab deruxtecan in HER2-mutant non-small-cell lung cancer: a plain language summary of the DESTINY-Lung01 study. Future Oncol. 2024;20(27):1961-1971. doi: 10.1080/14796694.2024.2355724. Epub 2024 Jul 16.
Smit EF, Felip E, Uprety D, Nagasaka M, Nakagawa K, Paz-Ares Rodriguez L, Pacheco JM, Li BT, Planchard D, Baik C, Goto Y, Murakami H, Saltos A, Pereira K, Taguchi A, Cheng Y, Yan Q, Feng W, Tsuchihashi Z, Janne PA. Trastuzumab deruxtecan in patients with metastatic non-small-cell lung cancer (DESTINY-Lung01): primary results of the HER2-overexpressing cohorts from a single-arm, phase 2 trial. Lancet Oncol. 2024 Apr;25(4):439-454. doi: 10.1016/S1470-2045(24)00064-0.
Li BT, Smit EF, Goto Y, Nakagawa K, Udagawa H, Mazieres J, Nagasaka M, Bazhenova L, Saltos AN, Felip E, Pacheco JM, Perol M, Paz-Ares L, Saxena K, Shiga R, Cheng Y, Acharyya S, Vitazka P, Shahidi J, Planchard D, Janne PA; DESTINY-Lung01 Trial Investigators. Trastuzumab Deruxtecan in HER2-Mutant Non-Small-Cell Lung Cancer. N Engl J Med. 2022 Jan 20;386(3):241-251. doi: 10.1056/NEJMoa2112431. Epub 2021 Sep 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2017-004781-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
JapicCTI-183916
Identifier Type: REGISTRY
Identifier Source: secondary_id
DS8201-A-U204
Identifier Type: -
Identifier Source: org_study_id
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