A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
18 Years
N/A
Both
Non-small Cell Lung Cancer Stage II, Non-small Cell Lung Cancer Stage IIIA, Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
Trial Information
A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-Free survival
Outcome Description:
Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.
Outcome Time Frame:
every 8 week
Safety Issue:
No
Principal Investigator
Ji-Youn Han, M.D. PhD.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Center
Authority:
South Korea: Korea Food and Drug Administration (KFDA)
Study ID:
NCCCTS-11-561
NCT ID:
NCT01470716
Start Date:
January 2012
Completion Date:
September 2015
Related Keywords:
- Non-small Cell Lung Cancer Stage II
- Non-small Cell Lung Cancer Stage IIIA
- Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
- EGFR mutation
- NSCLC
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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