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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01470716
Recruitment Status : Recruiting
First Posted : November 11, 2011
Last Update Posted : August 25, 2017
Hoffmann-La Roche
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea

Brief Summary:
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Condition or disease Intervention/treatment Phase
NSCLC Stage II NSCLC, Stage IIIA Drug: Erlotinib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Neo-adjuvant Erlotinib for Operable Stage IIB or IIIA Non-small Cell Lunc Cancer With Epidermal Growth Factor Receptor Activation Mutations
Study Start Date : January 2012
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Drug: Erlotinib
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Name: treatment arm

Primary Outcome Measures :
  1. Progression-Free survival [ Time Frame: every 8 week ]
    Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.

Secondary Outcome Measures :
  1. Response rate [ Time Frame: every 4 weeks ]
    The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1

  2. Overall Survival Rate [ Time Frame: every 3months, until death ]
    Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen )

  3. Toxicity profile [ Time Frame: Every 4 weeks ]
    Safety will be evaluated by the frequency, severity, and relationship of adverse event graded by NCI Common Toxicity Criteria version 4.0 that occur during the treatment and follow up periods.

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

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

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): NCT01470716

Contact: JI-YOUN HAN, M.D. PhD. +82-31-920-1154
Contact: SUNG JIN YOON, R.N. +82-31-920-0405

Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
Contact: Ji-youn Han, M.D., Ph.D.    +82-31-920-1154   
Contact: Sung Jin Yoon, RN    +82-31-920-0405   
Sponsors and Collaborators
National Cancer Center, Korea
Hoffmann-La Roche
Principal Investigator: Ji-Youn Han, M.D. PhD. National Cancer Center

Responsible Party: Ji-youn Han, Principal Investigator, National Cancer Center, Korea Identifier: NCT01470716     History of Changes
Other Study ID Numbers: NCCCTS-11-561
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by Ji-youn Han, National Cancer Center, Korea:
EGFR mutation

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung 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