A Phase II Trial of Erlotinib Versus Combination of Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage IIIA Non-small-cell Lung Cancer After Complete Resection With Sensitizing EGFR Mutation in Exon 19 or 21 and Wild-type K-ras
- Written informed consent provided.
- Males or females aged ≥18 years.
- Chest CT, brain CT or MRI, ECT, abdominal and double-neck B-, or whole body PET-CT
examination in 4 weeks before complete resection.
- Pathological diagnosed of non-small cell lung cancer.
- Diagnosed as stage IIIA.
- In 4 weeks after complete resection pts start to accept the adjuvant therapy in this
study, previously did not receive any anti-tumor therapy.
- EGFR activating mutation in exon 19 or 21 and KARS
- ECOG performance status 0-1.
- Life expectancy ≥3 months.
- Adequate hematological function:Absolute neutrophil count (ANC) ≥1.5 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.
- Adequate renal function:Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60
- Able to comply with the required protocol and follow-up procedures, and able to
receive oral medications.
- Patients must be nonpregnant and non-lactating.Patients of childbearing potential
must implement an effective method of contraception during the study. All female
Patients, except those who are postmenopausal or surgically sterilized, must have a
negative pre-study serum or urine pregnancy test. .
- 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.
- Patients with prior radiotherapy.
- History of another malignancy in the last 5 years with the exception of the
following:Cured basal cell carcinoma of the skin and cured in situ carcinoma of the
uterine cervix are permitted.
- Any evidence confirmed tumor recurrence before adjuvant treatment.
- 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
- Any evidence of clinically active interstitial lung disease.
- Eye inflammation or eye infection not fully treated or conditions predisposing the
subject to this.
- Known human immunodeficiency virus (HIV) infection.
- Known hypersensitivity to Tarceva or NVB or cisplatin.
- Pregnancy or breast-feeding women.
- ECOG performance status ≥ 2.
- Ingredients mixed with small cell lung cancer patients
- 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.