A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

• Status: Not yet recruiting
• Trial end date: 2027-03-01
• Target enrollment: 0
• Participant gender: All

Summary

DESTINY-Lung04 will investigate the efficacy and safety of Trastuzumab Deruxtecan (T-DXd) versus Standard of Care (SoC) as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) with HER2 Exon 19 or 20 mutations

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Daiichi Sankyo, Inc.
• Treatments: Carboplatin; Pembrolizumab; Pemetrexed; Trastuzumab

Criteria

Inclusion Criteria:

• 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

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 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