First-line Furmonertinib in Advanced NSCLC Patients With EGFR Uncommon Mutation

Sponsor
Chongqing University Cancer Hospital
Study ID
NCT05548348
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 26, 2022
Status verified
Sep 2022
Primary completion
Dec 31, 2023
Completion
Oct 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Furmonertinib treatment
    Furmonertinib will be administered orally at a dose of 160 mg per time, Q.D.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Approximately 12 months from the first patient begin study treatment ]

Central Contacts

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