search
Back to results

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

Primary Purpose

Lung Neoplasms, Erlotinib, Neoadjuvant Therapy

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Erlotinib
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Outcomes

Primary Outcome Measures

Pathologic down-staging

Secondary Outcome Measures

Response rate
Toxicity
Progression free survival
Overall survival

Full Information

First Posted
May 17, 2010
Last Updated
May 29, 2013
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01130753
Brief Title
Efficacy of Erlotinib in Neoadjuvant Setting in Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

5. Study Description

Brief Summary
This study propose neoadjuvant chemotherapeutic role by erlotinib.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms, Erlotinib, Neoadjuvant Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Erlotinib
Intervention Description
Erlotinib 150mg per day for 8 weeks
Primary Outcome Measure Information:
Title
Pathologic down-staging
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
36 months
Title
Toxicity
Time Frame
36 months
Title
Progression free survival
Time Frame
36 months
Title
Overall survival
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs