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
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 ↗
Publications
- Mok T, Janne PA, Nishio M, Novello S, Reck M, Steuer C, Wu YL, Fougeray R, Fan PD, Meng J, Sternberg DW, Esker S, Yu HA. HERTHENA-Lung02: phase III study of patritumab deruxtecan in advanced EGFR-mutated NSCLC after a third-generation EGFR TKI. Future Oncol. 2024 May;20(15):969-980. doi: 10.2217/fon-2023-0602. Epub 2023 Dec 14.
- Yu HA, Goto Y, Hayashi H, Felip E, Chih-Hsin Yang J, Reck M, Yoh K, Lee SH, Paz-Ares L, Besse B, Bironzo P, Kim DW, Johnson ML, Wu YL, John T, Kao S, Kozuki T, Massarelli E, Patel J, Smit E, Reckamp KL, Dong Q, Shrestha P, Fan PD, Patel P, Sporchia A, Sternberg DW, Sellami D, Janne PA. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor-Mutated Non-Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. J Clin Oncol. 2023 Dec 10;41(35):5363-5375. doi: 10.1200/JCO.23.01476. Epub 2023 Sep 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |