A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
All subjects enrolled in this clinical trial will receive peripheral blood MRD status assessment within 1 week and 1 month after surgery, and will be divided into MRD positive group (+) and MRD negative group (-) according to their results , followed by MRD status assessment every 12 weeks. The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy. The MRD negative group (-) directly entered the follow-up observation period. When the MRD status of peripheral blood turned positive, the subjects received osimertinib treatment. When the MRD turned negative again, the subjects entered the drug withdrawal observation period.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
The MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy.
Beijing Friendship Hospital, Capital Medical University
Beijing, China
NOT_YET_RECRUITINGChongqing University Three Gorges Hospital
Disease Free Survival
Disease free survival (DFS)- defined as the time from operation to the first documented disease progression or death, whichever occurs first.
Time frame: From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
3 yeas DFS rate
To compare 3y-DFS rates between the two arms
Time frame: From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall survival
To evaluate the overall survival of both arms
Time frame: OS is defined as the time from opeartion to death, regardless of disease recurrence, assessed up to 100 months
Ri-Qiang Liao
CONTACT
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Chongqing, China
The First People's Hospital of Foshan
Foshan, China
NOT_YET_RECRUITINGFujian Medical University Union Hospital
Fuzhou, China
NOT_YET_RECRUITINGAffiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, China
NOT_YET_RECRUITINGNanfang Hospital Southern Medical University
Guangzhou, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guanzhou, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of USTC Anhui Provincial Hospital
Hefei, China
NOT_YET_RECRUITINGThe Affiliated Hospital of Inner Mongolia Hospital
Hohhot, China
NOT_YET_RECRUITING...and 6 more locations