Phase 1b Dose Escalation and Dose Expansion Study in Patients with Advanced or Metastatic NSCLC
Research type
Research Study
Full title
A Phase 1b Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, and Antitumor Activity of Furmonertinib in Patients with Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Activating EGFR or HER2 Mutations, Including Exon 20 Insertion Mutations
IRAS ID
1005456
Contact name
Jerry Hsu
Contact email
Sponsor organisation
ArriVent BioPharma, Inc.
Eudract number
2021-005831-22
ISRCTN Number
ISRCTN99682126
Research summary
The purpose of this study is to learn about how the study drug, furmonertinib, works in participants with non-small cell lung cancer (NSCLC) who have a mutation in a specific gene and how it may help them. For participants with this type of NSCLC, the study will help researchers to learn how safe the study drug is, to learn how much of the study drug to give to patients, and to compare the effects, good or bad, of the study drug.
Globally, lung cancer is the second most commonly diagnosed cancer and the leading cause of cancer-related deaths among men and women, with an estimated 2.2 million new cancer cases and 1.8 million deaths reported in 2020. NSCLC is the predominant subtype of lung cancer, accounting for approximately 85% of all cases.
Up to about 108 men and women (aged 18 years or over) with NSCLC may take part in this study. Patients that have NSCLC that has spread and has not responded to treatment or for which previous treatment was stopped because they could not tolerate the side effects would be eligible to take part.
This study has three parts:
1. Screening (to see if you are eligible for the study)
2. Treatment
3. Follow-up (to check on you after treatment is finished)The study has a dose escalation phase, which will try to establish the maximum tolerated dose of the study drug, with up to 48 participants; and a dose expansion phase, which will collect further data on participants with different tumour mutations, with up to 60 participants.
The total time for a participant to be in the study will depend on how their lung cancer responds to treatment. This could range from 1 day to up to 48 months.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0118
Date of REC Opinion
8 Jul 2022
REC opinion
Further Information Favourable Opinion