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

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

NCT ID: NCT01470716

Condition: NSCLC Stage II
NSCLC, Stage IIIA

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Erlotinib Hydrochloride

Conditions: Keywords:
EGFR mutation
NSCLC

Study type: Interventional

Study phase: Phase 2

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Erlotinib
Description: Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Arm group label: Study arm

Other name: treatment arm

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:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Zip: 410-769
Country: Korea, Republic of

Start date: January 2012

Completion date: June 30, 2022

Lead sponsor:
Agency: National Cancer Center, Korea
Agency class: Other

Collaborator:
Agency: Hoffmann-La Roche
Agency class: Industry

Source: National Cancer Center, Korea

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01470716