A Single Arm, Multicenter Study of First-line Furmonertinib Treatment in Patients With Advanced Epidermal Growth Factor Receptor Uncommon Mutation Positive Non-small Cell Lung Cancer

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Furmonertinib, a newly-designed pan-EGFR-TKI with a trifluoroethoxypyridine-based molecule structure, has shown promising clinical efficacy in EGFR Ex19del/L858R/T790M/Ex20ins mutant advanced NSCLC with an acceptable safety profile without new signals from 80mg to 240mg dose level in phase 1-3 clinical trials. Whether EGFR G719X/S768I/L861Q mutation positive advanced NSCLC patients can benefit from first-line furmonertinib 160mg per day has not been reported. This study aims to investigate the efficacy and safety of furmonertinib 160mg per day in EGFR G719X/S768I/L861Q mutant patients under first-line treatment of advanced NSCLC setting.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Provide informed consent prior to any study specific procedures;

• 18 -70 years of age;

• ECOG PS of 0 to 1 at screening with no clinically significant deterioration in the previous 2 weeks, life expectancy ≥12 weeks;

• Pathologically confirmed Non-Small Cell Lung Cancer (NSCLC);

• Locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy (stage IIIB-IV, according to the 8th edition of the AJCC staging system);

• Patient with EGFR G719X or S768I or L861Q mutation diagnosed histologically or cytologically, the reports must be issued or recognized by Tier 3A hospitals. The mutations above may exist alone or together;

• No previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC;

• According to RECIST 1.1, patients have at least one tumor lesion at baseline that meets the following requirements: accurately and repeatably measurable at baseline have no radiotherapy or biopsy;

• For premenopausal women with childbearing potential, a pregnancy test must be performed within 14 days before the first dose, and the pregnancy test (blood or urine test) must be negative; female subjects must not be lactating;

• Willing to use contraception (male patients); Voluntary and agree to follow the study treatment protocol as well as follow-up plan, and can accept the oral medicine treatment.

Locations
Other Locations
China
Army Specialty Medical Center
RECRUITING
Chongqing
Chongqing University Cancer Hospital
RECRUITING
Chongqing
The Second Affilicated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Yongsheng Li, M.D. & Ph.D.
lys@cqu.edu.cn
+8617784310187
Backup
Jianlin Long, M.D.
ga.longjianlin@163.com
+8617830326836
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2025-10-31
Participants
Target number of participants: 30
Treatments
Experimental: Furmonertinib treatment
Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.
Sponsors
Leads: Chongqing University Cancer Hospital
Collaborators: Army Specialty Medical Center, The Second Affilicated Hospital of Chongqing Medical University

This content was sourced from clinicaltrials.gov

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