Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
Conditions
Non-small Cell Lung Cancer Stage II - Non-small Cell Lung Cancer Stage IIIA - Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
EGFR mutation, NSCLC
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Erlotinib
Type: Drug
Overall Status
Recruiting
Summary
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Detailed Description
Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majority of patients with NSCLC have metastatic disease at diagnosis. However, even patients with resectable disease have poor survival. The need to improve survival rates in these patients prompted research exploring the role of systemic therapy in operable NSCLC. In the 1990s, several clinical trials of preoperative chemotherapy (also known as induction chemotherapy) followed by surgery or radiation in patients with locally advanced NSCLC showed improvements in survival. Erlotinib is an orally administered tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR). The presence of somatic mutations in the kinase domain of EGFR strongly correlates with increased responsiveness to EGFR tyrosine kinase inhibitors. Recently three randomized phase III trials showed that first-line use of EGFR-TKIs in patients with EGFR mutant NSCLC significantly improved response rate and progression-free survival (PFS) compared to platinum-based chemotherapy. These findings prompted this phase II trial of preoperative Erlotinib in patients with operable stage II and IIIA NSCLC harboring EGFR mutations.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Pathologically confirmed stage II & IIIA non-small cell lung cancer

- EGFR exon 19 or 21 mutations

- Age ≥ 18 years and ECOG performance 0~1

- Has measurable lesion by RECIST 1.1

- No previous chemotherapy or radiation therapy

- Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL

- Written informed consent form

Exclusion Criteria:

- Previous chemotherapy or radiation therapy

- Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ

- Known allergic history of erlotinib

- Interstitial lung disease or fibrosis on chest radiogram

- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)

- Pregnant or nursing women
Location
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Ji-youn Han, M.D., Ph.D. - +82-31-920-1154 - jymama@ncc.re.kr
Start Date
January 2012
Completion Date
September 2015
Sponsors
National Cancer Center, Korea
Source
National Cancer Center, Korea
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page