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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by National Cancer Center, Korea
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea
ClinicalTrials.gov Identifier:
NCT01470716
First received: November 4, 2011
Last updated: April 27, 2012
Last verified: November 2011
  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
Non-small Cell Lung Cancer Stage II
Non-small Cell Lung Cancer Stage IIIA
Epithelial Growth Factor Receptor Positive Non-small Cell Lung Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 National Cancer Center, Korea:

Primary Outcome Measures:
  • Progression-Free survival [ Time Frame: every 8 week ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 2015
Estimated Primary Completion Date: June 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 4, 2011
Last Updated: April 27, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by National Cancer Center, Korea:
EGFR mutation
NSCLC

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

ClinicalTrials.gov processed this record on September 18, 2014