Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations

National Cancer Center (NCC)

Status and phase

Unknown

Phase 2

Conditions

NSCLC, Stage IIIA

NSCLC Stage II

Treatments

Drug: Erlotinib

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01470716

NCCCTS-11-561

Details and patient eligibility

About

This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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