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
Overview
- Phase
- Phase 2
- Intervention
- Erlotinib
- Conditions
- Non-small Cell Lung Cancer Stage IIIA
- Sponsor
- Chinese Lung Cancer Surgical Group
- Enrollment
- 80
- Locations
- 11
- Primary Endpoint
- Disease-free survival
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to assess the effect and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in patients with stage IIIA NSCLC after complete resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Detailed Description
The LACE meta-analysis identified four cycles of platinum-based program to improve II\~IIIA stage completely resected NSCLC pts the role of 5-year survival, but its treatment-related life threatening toxicity limits its use. The EGFR tyrosine kinase inhibitor (TKI) may provide a dramatic response in pts with pulmonary adenocarcinoma carrying EGFR activating mutations in the metastatic setting. The aim of this study is to investigate the efficacy and safety of erlotinib versus NVB plus cisplatin (NP) as adjuvant treatment in pts with stage IIIA NSCLC after Complete Resection with EGFR activating mutations and to explore a new treatment strategy for this subset.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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-
- •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).
Exclusion Criteria
- •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 disease).
- •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.
Arms & Interventions
Erlotinib arm
In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
Intervention: Erlotinib
Chemo arm
In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
Intervention: vinorelbine/cisplatin
Outcomes
Primary Outcomes
Disease-free survival
Time Frame: 2 years
To evaluate Disease-free survival(DFS) of two groups
Secondary Outcomes
- Number of Participants with Adverse Events(2 years)
- Quality of Life (QOL)(2 years)
- overall survival (OS)(2 years)