DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
Stopped early · Phase 2
Conditions studied: Non-Small Cell Lung Cancer
In brief
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
Key facts
- Study ID
- NCT03505710
- Run by
- Daiichi Sankyo
- People needed
- 181
- Starts
- 2018-05-21
- Expected to finish
- 2024-04-17
- Last updated by the study team
- 2025-05-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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: 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
You may not qualify if…
- Had been 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)/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:
- safety or well-being of the participant or offspring
- safety of study staff
- analysis of results
Where it is running
- 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
Full record on ClinicalTrials.gov
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