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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05445310
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 6, 2022
Status verified
May 2022
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

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

Arms

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

Primary Outcome Measure

Disease-free survival rate at 3 years [ Time Frame: 3 years following the first dose of study drug ]

Central Contacts

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