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

Titre officiel

An Open-label, Randomized, Multicentre, Phase 3 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)

Sommaire:

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

Description de l'essai

Primary Outcome:

• Progression Free Survival (PFS) by Blinded Independent Central Review (BICR)

Secondary Outcome:

• Overall Survival (OS)
• Progression Free Survival (PFS) by investigator assessment
• Objective Response Rate (ORR)
• Duration of Response (DoR)
• Time to second progression or death (PFS2)
• Landmark analysis of PFS (PFS12)
• Landmark analysis of OS (OS24)
• Central Nervous System (CNS) - Progression Free Survival (PFS)
• Safety and tolerability of T-DXd versus Standard of Care treatment
• Pharmacokinetics (PK) of T-DXd, total anti-HER2 antibody and DXd in serum
• Immunogenicity of T-DXd
• Patient-reported pulmonary symptoms associated with Non-Small Cell Lung Cancer
• Patient-reported tolerability of T-DXd described using symptomatic AEs
• Patient-reported tolerability of T-DXd described using overall side-effect bother
• Patient-reported tolerability of T-DXd described using physical function

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.

Voir cet essai sur ClinicalTrials.gov