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This study investigates the efficacy and safety of Trastuzumab Deruxtecan as a first-line treatment in patients with HER2-mutated, unresectable locally advanced or metastatic non-small cell lung cancer. It enrolled patients aged 18 and older with a HER2 mutation in exon 19 or 20 who had not received prior systemic therapy. It is a Phase 3 study; it is not currently recruiting but is ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Participants at least 18 years of age * Locally advanced and unresectable NSCLC, 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 Exclusion Criteria: * 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 untreated brain metastases, including asymptomatic or clinically inactive brain metastases * 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