Pemetrexed Combined With Synchronous Gefitinib as Adjuvent Therapy in Patient With EGFR Mutant Lung Adenocarcinoma

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized phase III trial is studying gefitinib and synchronous pemetrexed/cisplatin chenmotherapy to see how well it works compared to pemetrexed/cisplatin chenmotherapy alone in treating patients who have undergone surgery for stage II-IIIA(N1-N2) lung adenocarcinoma with EGFR activating mutation in Asian population.

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

Details

• Lead Sponsor: Tang-Du Hospital
• Treatments: Cisplatin; Gefitinib; Pemetrexed

Criteria

Inclusion Criteria:

• Written informed consent provided.

• Males or females aged ≥18 years, < 70 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.