Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation (NCT04858958) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation
China30 participantsStarted 2020-08-10
Plain-language summary
This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation.
The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability.
The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).
In addition, the peripheral blood ctDNA will be collected and analyzed in this study
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Man or woman aged ≥18 years;
* Histologically or cytopathologically confirmed primary non-small cell lung cancer (NSCLC) with predominant non-squamous cell histology;
* The treated patients must have radiological disease progression following the last anti-tumor therapy; and the treatment-naïve patients must have documented positive EGFR exon 20 insertion mutation by laboratory tests prior to enrollment;
* Subjects meeting either of the following conditions (in accordance with the AJCC 8th edition TNM stage classification for lung cancer):
* Treated patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who are confirmed to have radiological or pathological disease progression during or after the last systematic anti-tumor therapy before the first dose of investigational product
* Treatment-naïve patients: patients with locally advanced (judged by investigators as not suitable for surgery or radiotherapy) or metastatic NSCLC who have no prior systematic anti-tumor therapy before the first dose of investigational product. If the time from the completion of adjuvant or neoadjuvant therapy to the first disease progression is \> 6 months, the patients will be eligible for enrollment to the study; if it is ≤6 months, the patients will be regarded as treated patients and evaluated in accordance with the criteria for treated patients
* Having at least one measurable lesion (in accordan…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.