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

This study is currently recruiting participants.
Verified August 2017 by Ji-youn Han, National Cancer Center, Korea
Sponsor:
ClinicalTrials.gov Identifier:
NCT01470716
First Posted: November 11, 2011
Last Update Posted: August 25, 2017
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.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea
  Purpose
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.

Condition Intervention Phase
NSCLC Stage II NSCLC, Stage IIIA Drug: Erlotinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ji-youn Han, National Cancer Center, Korea:

Primary Outcome Measures:
  • 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:
  • 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

  • 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 )

  • 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.


Estimated Enrollment: 26
Study Start Date: January 2012
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Drug: Erlotinib
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Name: treatment arm

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.
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01470716


Contacts
Contact: JI-YOUN HAN, M.D. PhD. +82-31-920-1154 jymama@ncc.re.kr
Contact: SUNG JIN YOON, R.N. +82-31-920-0405 jinijiniya@ncc.re.kr

Locations
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    jymama@ncc.re.kr   
Contact: Sung Jin Yoon, RN    +82-31-920-0405    jinijiniya@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Hoffmann-La Roche
Investigators
Principal Investigator: Ji-Youn Han, M.D. PhD. National Cancer Center
  More Information

Responsible Party: Ji-youn Han, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01470716     History of Changes
Other Study ID Numbers: NCCCTS-11-561
First Submitted: November 4, 2011
First Posted: November 11, 2011
Last Update Posted: August 25, 2017
Last Verified: August 2017

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

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