ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas

Sponsor
Peking University People's Hospital
Study ID
NCT05079022
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Adenocarcinoma of Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Furmonertinib — DRUG
    Furmonertinib at 80mg dose will be administered orally once daily.

Study Details

The purpose of this study is to determine the feasibility and effectiveness of ctDNA-MRD based adjuvant furmonertinib therapy in EGFR mutation-positive stage I lung adenocarcinoma patients after complete surgical resection.

Key Dates

Start date
Oct 31, 2021
Status verified
Oct 2021
Primary completion
Mar 31, 2023
Completion
Sep 30, 2024

Study Design

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

Arms

  • Experimental: Furmonertinib
    ctDNA-MRD positive participants received 3 years of furmonertinib once daily as adjuvant therapy after radical surgery until disease progression or unacceptable toxicity occurs.

Primary Outcome Measure

Clearance of ctDNA at 6 months [ Time Frame: 6 months ]

Central Contacts

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