Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer

NCT05445310 | Recruiting Phase 2

• 1 other identifier: AST-PMR2201
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Disease-free survival rate at 3 years

  The rate of survival patients without disease recurrence at 3 years

  3 years following the first dose of study drug

Secondary Outcomes (4)

• Overall survival rate at 3 years

  3 years following the first dose of study drug

• Median disease-free survival

  Approximately 3 years following the first dose of study drugs

• Median overall survival

  Approximately 5 years following the first dose of study drugs

• Adverse events

  Approximately 3 years following the first dose of study drugs

Study Arms (1)

Furmonertinib

EXPERIMENTAL

Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons.

Drug: Furmonertinib

Interventions

Furmonertinib DRUG

Furmonertinib 80mg/d

Furmonertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
• Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
• Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
• EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
• ECOG performance status 0-1.
• Sufficient organ function in liver, renal, kidney and hematology.
• With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.

You may not qualify if:

• Lung cancer with small cell or neuroendocrine cancer cell.
• EGFR exon 20 insertion positive.
• Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
• Women who are pregnant or breastfeeding.
• Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
• Concurrent with other malignancies excluding carcinoma in situ.
• With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics.
• Gastrointestinal disorders which may affect drug taking or absorption.
• With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.
• With history of interstitial lung disease or relative risk.
• Allergic to any component of furmonertinib tablet.
• Mental illness or drug abuse.
• Live vaccination within 30 days before enrollment.
• Other situation judged by investigator such as failure to follow the rules of study.
• Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hopital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aflutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Ruixuan Geng, MD

CONTACT

86-10-69158753; ginkrice@sina.com

Study Design

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

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: July 6, 2022
• Study Start: August 6, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 16, 2023

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)