Clinical trial NCT05445310: Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer
Official title: Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Disease-free survival rate at 3 years
timeFrame: 3 years following the first dose of study drug
Secondary outcomes:
measure: Overall survival rate at 3 years
timeFrame: 3 years following the first dose of study drug
measure: Median disease-free survival
timeFrame: Approximately 3 years following the first dose of study drugs
measure: Median overall survival
timeFrame: Approximately 5 years following the first dose of study drugs
measure: Adverse events
timeFrame: Approximately 3 years following the first dose of study drugs
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hopital
Study officials:
References: