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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01130753
Recruitment Status : Completed
First Posted : May 26, 2010
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Keunchil Park, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Lung Neoplasms Erlotinib Neoadjuvant Therapy Drug: Erlotinib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2007
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Intervention Details:
    Drug: Erlotinib
    Erlotinib 150mg per day for 8 weeks

Primary Outcome Measures :
  1. Pathologic down-staging [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 36 months ]
  2. Toxicity [ Time Frame: 36 months ]
  3. Progression free survival [ Time Frame: 36 months ]
  4. Overall survival [ Time Frame: 36 months ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01130753

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Keunchil Park, Principal investigator, Samsung Medical Center Identifier: NCT01130753     History of Changes
Other Study ID Numbers: 2006-08-029
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action