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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Neoplasms, Erlotinib, Neoadjuvant Therapy

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathologic down-staging

Outcome Time Frame:

36 months

Safety Issue:

No

Authority:

Korea: Food and Drug Administration

Study ID:

2006-08-029

NCT ID:

NCT01130753

Start Date:

January 2007

Completion Date:

December 2012

Related Keywords:

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

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