DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated May 30, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Daiichi Sankyo
- Interventions being studied
- Drug: Trastuzumab deruxtecan
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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: 1. safety or well-being of the participant or offspring 2. safety of study staff 3. analysis of results
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- University of California San Diego (UCSD)La Jolla, California
- University of Colorado HospitalAurora, Colorado
- Moffitt Cancer CenterTampa, Florida
- Dana-Farber Cancer InstituteBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Karmanos Cancer InstituteDetroit, Michigan
- Washington University School of Medicine at St. LouisSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- University of WashingtonSeattle, Washington
- Centre Leon BerardLyon, Rhne
- Hôpital Nord - CHU MarseilleMarseille
- CHU LarreyToulouse
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 30, 2025. Always confirm current availability with the study team.