Efficacy and Safety of Furmonertinib in Patients With Locally Advanced or Metastatic NSCLC With EGFR Exon 20 Insertion

NCT05466149 | Active Not Recruiting Phase 2

• 1 other identifier: FURMO-003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Furmonertinib in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations. The study plans to enroll approximately 100 patients from approximately 70 sites. Patients are locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy. Furmonertinib Mesilate will be treated 240 mg QD until disease progression or unacceptable toxicity. Primary endpoint is ORR. Secondary endpoints include DOR, DCR, DepOR, PFS, OS, CNS ORR, CNS DOR, CNS PFS, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902).

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• ORR, Objective Response Rate

  Percentage of patients with a confirmed CR or PR relative to the total number of patients.

  Approximately 7.5 months following the last patient enrolled

Secondary Outcomes (9)

• DOR, Duration of response

  Approximately 7.5 months following the last patient enrolled

• DCR, Disease control rate

  Approximately 7.5 months following the last patient enrolled

• Depth of response

  Approximately 7.5 months following the last patient enrolled

• PFS, Progression Free Survival

  Approximately 7.5 months following the last patient enrolled

• OS, Overall Survival

  Approximately 3 years following the last patient enrolled

Study Arms (1)

Furmonertinib 240mg QD

EXPERIMENTAL

Treating patients of locally advanced or metastatic NSCLC with EGFR exon 20 insertions who have progressed during or after platinum-based chemotherapy.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

240mg QD on a continuous dosing schedule.

Also known as: AST2818

Furmonertinib 240mg QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years at time of signing Informed Consent Form
• Histologically or cytologically documented, locally advanced or metastatic NSCLC not amenable to curative surgery or radiotherapy
• Documented validated results from local or central testing (as designated by the Sponsor) of blood or tumor tissue confirming the presence of an EGFR exon 20 insertion mutation
• Documented radiologic progression on or after prior platinum-based chemotherapy (with or without anti-PD1/PD-L1 agents) in the locally advanced or metastatic setting
• Documented radiologic disease progression during or after the last systemic anticancer therapy before the first dose of furmonertinib
• Measurable disease per RECIST v1.1
• ECOG performance status of 0 or 1
• Life expectancy of ≥ 12 weeks
• Patients with CNS metastases are eligible, provided they meet all of the following criteria: Measurable disease outside the CNS; No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for ≥ 2 weeks prior to enrollment; No ongoing symptoms attributed to CNS metastases; No active CNS metastases or spinal cord compression (i.e., progressing or requiring anticonvulsants or corticosteroids for symptomatic control); No evidence of interim CNS disease progression between the completion of CNS-directed therapy and the screening radiographic study; Time since whole brain radiation therapy (WBRT) is ≥ 21 days prior to first dose of study treatment, time since stereotactic radiosurgery (SRS) is ≥ 7 days prior to first dose of study treatment, or time since surgical resection is ≥ 28 days
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment
• For women of childbearing potential or men who are not surgically sterile: Agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs or sperm

You may not qualify if:

• Prior treatment with any EGFR-targeting agents (e.g., EGFR tyrosine kinase inhibitors \[TKIs\], monoclonal antibodies, or bispecific antibodies).
• More than 3 prior systemic anticancer therapy regimens for locally advanced or metastatic NSCLC
• Inability or unwillingness to swallow pills
• Severe acute or chronic infections
• Previous interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid therapy; or having the clinical manifestations of suspected ILD
• History of or active clinically significant cardiovascular dysfunction
• Mean resting corrected QT interval (QTc) \> 470 msec, obtained from triplicate ECGs, using the screening clinic ECG machine derived Fridericia's formula (QTcF) value
• Clinically significant prolonged QT interval or other arrhythmia or clinical status considered by investigators that may increase the risk of prolonged QT interval (e.g., complete left bundle branch block, degree III atrioventricular block, second-degree heart block, PR interval \> 250 msec, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, serious hypokalemia, heart failure) or current use of the drugs that may lead to prolonged QT interval.
• AEs from prior anticancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, endocrinopathy managed with replacement therapy, or Grade ≤ 2 peripheral neuropathy.

Sponsors & Collaborators

• Allist Pharmaceuticals, Inc.: lead

Study Sites (1)

Jilin Province Cancer Hospital

Changchun, Jilin, 130000, China

Location

MeSH Terms

Interventions

aflutinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 20, 2022
• Study Start: September 27, 2022
• Primary Completion: June 27, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)