Patritumab Deruxtecan in patients with Non-Small Cell Lung Cancer
Research type
Research Study
Full title
HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer(NSCLC)
IRAS ID
294283
Contact name
Martin Forster
Contact email
Sponsor organisation
DAIICHI SANKYO, INC
Eudract number
2020-000730-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
133343, IND
Duration of Study in the UK
1 years, 7 months, 7 days
Research summary
Lung cancer is the most common cancer and the leading cause of cancer-related mortality worldwide, with an estimated 2.1 million new cases in 2018 (11.6% of all new cases) and 1.8 million deaths (18.4% 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. The purpose of this study is to understand patritumab deruxtecan for its safety, how well it is tolerated, and how well it works.
Approximately 420 participants. Participants will be randomly assigned by chance to 1 of 2 study Arms in equal numbers and randomly (like flipping a coin):
• Arm 1: 5.6 mg/kg dose fixed dose of patritumab deruxtecan every three weeks
• Arm 2: Up-titration (going from a lower to a higher dose for the first three cycles) dose of patritumab deruxtecan every three weeks
• Cycle 1 – 3.2 mg/kg dose
• Cycle 2 – 4.8 mg/kg dose
• Cycle 3 & additional cycles – 6.4 mg/kg dose
During the study, one of the treatment arms may be removed.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 - South East Research Ethics Committee
REC reference
21/LO/0461
Date of REC Opinion
17 Jun 2021
REC opinion
Favourable Opinion