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โ† Trials
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Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

RecruitingPhase 2Ages 18 Years - 80 YearsAllGuangdong Association of Clinical Trials
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Written informed consent provided. 2. Males or females aged โ‰ฅ18 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 โ‰ฅ12 weeks. 8. Adequate hematological function: Absolute neutrophil count (ANC) โ‰ฅ1.8 x 109/L, and Platelet count โ‰ฅ100 x 109/L, and Hemoglobin โ‰ฅ9 g/dL (may be transfused to maintain or exceed this level). 9. Adequate liver function: Total bilirubin โ‰ค 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) โ‰ค 2.5 x ULN in subjects without liver metastases; โ‰ค 5 x ULN in subjects with liver metastases. 10. Adequate renal function: Serum creatinine โ‰ค 1.25 x ULN, or โ‰ฅ 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 38.0โ„ƒ over) Patients who harboring exon 20 T790M mutation, EGFR 20 insertions, ALK fusion, BRAF V600E mutation, MET amplification and KRAS mutation.
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What it tests

  • Adjuvant treatment for MRD positivity
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Where

16 sites
Beijing Friendship Hospital, Capital Medical University
Beijing, China
Chongqing University Three Gorges Hospital
Chongqing, China
The First People's Hospital of Foshan
Foshan, China
Fujian Medical University Union Hospital
Fuzhou, China
Affiliated Cancer Hospital of Guangzhou Medical University
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
Guangdong Provincial People's Hospital
Guanzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China

โ€ฆand 8 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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