drugset / Trial / NCT05338970

HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

NCT05338970 ↗

Phase 3 Active not recruiting 586 enrolled Daiichi Sankyo Merck Sharp & Dohme LLC · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

Timeline

Start
2022-07-08
Primary completion
2024-05-31
Completion
2026-06-30

Outcome

Met primary endpoint

release “第3相HERTHENA-Lung02試験の結果に基づき、局所進行または転移を有するEGFR変異NSCLC患者に対して、Patritumab Deruxtecan(HER3-DXd)が2剤併用化学療法と比較し無増悪生存期間の統計学的な有意性を示す” msd.co.jp ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule — Intravenous
Comparator Cisplatin Other / unclassified 75 mg/m2 Intravenous
Subject Patritumab deruxtecan Monoclonal antibody 5.6 mg/kg Intravenous
Comparator Pemetrexed Small molecule 500 mg/m2 Intravenous