HERTHENA–Lung02
Research type
Research Study
Full title
HERTHENA–Lung02: A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy
IRAS ID
1005077
Contact name
Eric Richards
Contact email
Sponsor organisation
Daiichi Sankyo, Inc.
Eudract number
2021-005879-40
Clinicaltrials.gov Identifier
Research summary
Lung cancer is the most common cancer and the leading cause of cancer-related mortality worldwide, with an estimated 2.2 million new cases in 2020 (11.4% of all new cases) and 1.8 million deaths (18% of all cancer deaths) globally. Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancers.
The study drug Patritumab deruxtecan is being developed by Daiichi Sankyo, Inc. to treat patients with lung cancer, as well as patients with breast and colorectal cancers. Patritumab deruxtecan is designed to bring chemotherapy inside HER3-positive cancer cells and kill them.
In this study we are looking to see whether patritumab deruxtecan has any effect on slowing tumour growth in lung cancer tumours compared to chemotherapy alone. The purpose of this study is to understand patritumab deruxtecan for its safety, how well it is tolerated, and how well it works.
Approximately 560 participants will be randomly assigned by chance to 1 of 2 study Arms in equal numbers and randomly (like flipping a coin):
• Arm 1: participants will be treated with patritumab deruxtecan every three weeks
• Arm 2: participants will be treated with chemotherapy every 3 weeks.
Study duration will depend on how each participant’s cancer responds to the study drug and their ability to be safely treated without significant side effects. After the study treatment ends participants can expect one end of treatment visit, one 40-day follow-up visit, and additional follow-up visits every 3 months.REC name
London - City & East Research Ethics Committee
REC reference
22/LO/0428
Date of REC Opinion
11 Jul 2022
REC opinion
Further Information Favourable Opinion