Trastuzumab Deruxtecan, NSCLC Harboring HER2 Exon 19 or 20 Mutations

UCI Specialty Area: Cancer

Principal Investigator: Misako Nagasaka

Official Title: An Open-label, Randomized, Multicenter, Phase III Study to Assess the Efficacy and Safety of Trastuzumab Deruxtecan as First-line Treatment of Unresectable, Locally Advanced, or Metastatic NSCLC Harboring HER2 Exon 19 or 20 Mutations (DESTINY-Lung04)

A Study On:

Lung

Study Description

Eligible participants will be those diagnosed with unresectable, locally advanced or metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20 mutations and who are treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease.

The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with Standard of Care treatment (Investigator's choice of cisplatin or carboplatin + pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse or simply to live longer, compared to patients receiving standard of care treatment. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Eligibility

-Participants at least 18 years of age

-Locally advanced not amenable to curative therapy, or metastatic disease

-Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA

-Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease

-Left ventricular ejection fraction (LVEF) ≥ 50%

-Measurable disease assessed by Investigator based on RECIST 1.1

-Protocol-defined adequate organ function including cardiac, renal, hepatic function

-ECOG 0-1

-Having tumour tissue available for central testing

-Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy)

-Any clinically active brain metastases; previously treated brain metastases allowed

-Active autoimmune or inflammatory disorders

-Medical history of myocardial infarction within 6 months prior to randomization

-History of non-infectious pneumonitis/ILD, current or suspected ILD

-Lung-specific intercurrent clinical significant severe illness

-Contraindication to platinum-based doublet chemotherapy or pembrolizumab

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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