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

NCT ID: NCT01470716

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2022-06-30

Brief 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.

Conditions

NSCLC Stage II; NSCLC, Stage IIIA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study arm

Neo-adjuvant Erlotinib treatment arm.

Group Type: EXPERIMENTAL

Erlotinib

Intervention Type: DRUG

Neo-adjuvant Erlotinib treatment during maximum 8 weeks.

Interventions

Erlotinib

Neo-adjuvant Erlotinib treatment during maximum 8 weeks.

Intervention Type: DRUG

Other Intervention Names

treatment arm

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ji-youn Han

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ji-Youn Han, M.D. PhD.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center

Locations

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

NCCCTS-11-561

Identifier Type: -

Identifier Source: org_study_id