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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01470716
Recruitment Status : Active, not recruiting
First Posted : November 11, 2011
Last Update Posted : April 6, 2022
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Ji-youn Han, National Cancer Center, Korea

Tracking Information
First Submitted Date  ICMJE November 4, 2011
First Posted Date  ICMJE November 11, 2011
Last Update Posted Date April 6, 2022
Actual Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
Official Title  ICMJE 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
Brief Summary This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC Stage II
  • NSCLC, Stage IIIA
Intervention  ICMJE Drug: Erlotinib
Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
Other Name: treatment arm
Study Arms  ICMJE Experimental: Study arm
Neo-adjuvant Erlotinib treatment arm.
Intervention: Drug: Erlotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 10, 2011)
26
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Actual Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01470716
Other Study ID Numbers  ICMJE NCCCTS-11-561
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Ji-youn Han, National Cancer Center, Korea
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Cancer Center, Korea
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Hoffmann-La Roche
Investigators  ICMJE
Principal Investigator: Ji-Youn Han, M.D. PhD. National Cancer Center
PRS Account National Cancer Center, Korea
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP