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Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
NCT05536505 · Guangdong Association of Clinical Trials
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Adjuvant Treatment Based on Minimal Residual Disease for Resectable Non-squamous Non-Small-Cell-Lung-Cancer With EGFR Mutations
About this study
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.
Eligibility criteria
Inclusion Criteria:
1. Written informed consent provided.
2. Males or females aged ≥18 years, \< 80 years.
3. Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
4. Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation.
5. Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy.
6. ECOG performance status 0-1.
7. Life expectancy ≥12 weeks.
8. Adequate hematological function: Absolute neutrophil count (ANC) ≥1.8 x 109/L, and Platelet count ≥100 x 109/L, and Hemoglobin ≥9 g/dL (may be transfused to maintain or exceed this level).
9. Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
10. Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
11. Female subjects should not be pregnant or breast-feeding.
Exclusion Criteria:
1. Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product.
2. Inability to comply with protocol or study procedures.
3. A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
4. A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
5. Interstitial pneumonia.
6. Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab).
7. Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
8. Patients with prior radiotherapy to primary lesion or lymph nodes.
9. History of another malignancy in the last 5 years with the exception of the following: Other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted.
10. Any unstable systemic disease (including active infection, uncontrolled hypertension (systolic pressure \> 160mmHg, diastolic pressure \> 100mmHg), unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
11. Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
12. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
13. Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) Patients who harboring exon 20 T790M mutation, EGFR 20 insertions, ALK fusion, BRAF V600E mutation, MET amplification and KRAS mutation.
Study design
Enrollment target: 180 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-09-13
Estimated completion: 2030-10-01
Last updated: 2022-09-14
Interventions
Genetic: Adjuvant treatment for MRD positivity
Primary outcomes
- • Disease Free Survival (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 (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)
Sponsor
Guangdong Association of Clinical Trials · other
Contacts & investigators
ContactYi-Long Wu, MD · contact · syylwu@live.cn · 020-83827812
ContactRi-Qiang Liao · contact
All locations (16)
Beijing Friendship Hospital, Capital Medical UniversityNot Yet Recruiting
Beijing, China
Chongqing University Three Gorges HospitalNot Yet Recruiting
Chongqing, China
The First People's Hospital of FoshanNot Yet Recruiting
Foshan, China
Fujian Medical University Union HospitalNot Yet Recruiting
Fuzhou, China
Affiliated Cancer Hospital of Guangzhou Medical UniversityNot Yet Recruiting
Guangzhou, China
Nanfang Hospital Southern Medical UniversityNot Yet Recruiting
Guangzhou, China
Guangdong Provincial People's HospitalRecruiting
Guanzhou, China
The Second Affiliated Hospital Zhejiang University School of MedicineNot Yet Recruiting
Hangzhou, China
The First Affiliated Hospital of USTC Anhui Provincial HospitalNot Yet Recruiting
Hefei, China
The Affiliated Hospital of Inner Mongolia HospitalNot Yet Recruiting
Hohhot, China
The Affiliated Hospital of Qingdao UniversityNot Yet Recruiting
Qingdao, China
Zhongshan Hospital Fudan UniversityNot Yet Recruiting
Shanghai, China
Shenzhen People's HospitalNot Yet Recruiting
Shenzhen, China
Tongji Hospital Tongji College of HUSTNot Yet Recruiting
Wuhan, China
The First Affiliated Hospital of Xiamen UniversityNot Yet Recruiting
Xiamen, China
Zhongshan City People's HospitalNot Yet Recruiting
Zhongshan, China