Gefitinib Versus Vinorelbine/Platinum as Adjuvant Treatment in Stage II-IIIA(N1-N2) NSCLC With EGFR Mutation

• Status: Active, not recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Activating somatic mutations of the tyrosine kinase domain of epidermal growth factor receptor (EGFR) have been characterized in a subset of patients with advanced NSCLC.The EGFR mutation rate was 30% in Chinese Non-small Cell Lung Cancer(NSCLC). Patients harboring these mutations in their tumors show excellent response to EGFR tyrosine kinase inhibitors (EGFR-TKIs). This randomized phase III trial is studying gefitinib to see how well it works compared to cisplatin-based chemotherapy in treating patients who have undergone surgery for stage II-IIIA(N1-N2) NSCLC with EGFR activating mutation in Asian population.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangdong Association of Clinical Trials
• Collaborators: 309th Hospital of Chinese People's Liberation Army; Beijing Cancer Hospital; Beijing Chest Hospital; China Medical University, China; Chinese PLA General Hospital; First Affiliated Hospital, Sun Yat-Sen University; First Hospital of China Medical University; Fudan University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Jiangsu Cancer Institute & Hospital; Jilin Provincial Tumor Hospital; Liaoning Tumor Hospital & Institute; Peking Union Medical College Hospital; Peking University First Hospital; Peking University People's Hospital; Qingdao University; Shanghai Pulmonary Hospital, Shanghai, China; Sun Yat-sen University; Tang-Du Hospital; The Affiliated Hospital of Qingdao University; The First Affiliated Hospital of Soochow University; Tianjin Medical University Cancer Institute and Hospital; Tongji Hospital; West China Hospital; Wuhan Union Hospital, China; Zhejiang Cancer Hospital; Zhejiang University
• Treatments: Cisplatin; Gefitinib; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Males or females aged ≥18 years, < 75 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 II-IIIA(N1-N2) NSCLC with EGFR exon 19 deletions and exon 21 L858R activating mutation.

• Patient who can start the investigational therapy within 3-6 weeks after the complete resection

• ECOG performance status 0-1.

• Life expectancy ≥12 weeks.

• Adequate hematological function: Absolute neutrophil count (ANC) ≥2.0 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 Criteria:

• Known severe hypersensitivity to gefitinib or any of the excipients of this product.

• Known severe hypersensitivity to pre-medications required for treatment with cisplatin / vinorelbine doublet chemotherapy.

• 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, cetuximab, trastuzumab).

• Patients with prior chemotherapy or therapy with systemic anti-tumour therapy (e.g. monoclonal antibody therapy).

• Patients with prior radiotherapy

• 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, 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 harbouring exon 20 T790M mutation.