Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01130753
• Other study ID #: 2006-08-029
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2010
• Last updated: May 29, 2013
• Start date: January 2007
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study propose neoadjuvant chemotherapeutic role by erlotinib.

Description:

It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.

Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.

So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer

• Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women

• 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:

• Pulmonary carcinoid tumor

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Erlotinib
• Lung Neoplasms
• Neoadjuvant Therapy

Intervention

Drug:
• Erlotinib
Erlotinib 150mg per day for 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic down-staging		36 months	No
Secondary	Response rate		36 months	No
Secondary	Toxicity		36 months	Yes
Secondary	Progression free survival		36 months	No
Secondary	Overall survival		36 months	No