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Recruiting Phase 2

Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC

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About this study

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).

Condition
MRD
Tested
Adjuvant treatment for MRD positivity
Sponsor
Guangdong Association of Clinical Trials

Who can join

Age
18 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Maximum age: 80 years
  • Study condition: MRD
  • Written informed consent provided.
  • Males or females aged ≥18 years, \< 80 years.
  • Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
  • 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.
  • Patients who have recovered from R0 resection including lobectomy, sleeve surgery and pneumonectomy.
  • ECOG performance status 0-1.
  • Life expectancy ≥12 weeks.
  • 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).
  • 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.
  • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
  • Female subjects should not be pregnant or breast-feeding.

Exclusion 13

  • Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product.
  • Inability to comply with protocol or study procedures.
  • A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
  • A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
  • Interstitial pneumonia.
  • Patients with prior exposure to agents directed at the HER axis (e.g. erlotinib, gefitinib, icotinib, cetuximab, trastuzumab).
  • Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).
  • Patients with prior radiotherapy to primary lesion or lymph nodes.
  • 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.
  • 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).
  • Eye inflammation or eye infection not fully treated or conditions predisposing the subject to this.
  • 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.
  • 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.

Where

16 sites, 16 recruiting

Guangdong Provincial People's Hospital

Guanzhou, China

Recruiting

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Recruiting

Chongqing University Three Gorges Hospital

Chongqing, China

Recruiting

The First People's Hospital of Foshan

Foshan, China

Recruiting

Fujian Medical University Union Hospital

Fuzhou, China

Recruiting

Affiliated Cancer Hospital of Guangzhou Medical University

Guangzhou, China

Recruiting

and 10 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.