Clinical Trials /

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

NCT01470716

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
  • 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

Clinical Trial IDs

  • ORG STUDY ID: NCCCTS-11-561
  • NCT ID: NCT01470716

Conditions

  • NSCLC Stage II
  • NSCLC, Stage IIIA

Interventions

DrugSynonymsArms
Erlotinibtreatment armStudy arm

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Study armExperimentalNeo-adjuvant Erlotinib treatment arm.
  • Erlotinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-Free survival
Time Frame:every 8 week
Safety Issue:
Description: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

Measure:Response rate
Time Frame:every 4 weeks
Safety Issue:
Description:The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1
Measure:Overall Survival Rate
Time Frame:every 3months, until death
Safety Issue:
Description:Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen )
Measure:Toxicity profile
Time Frame:Every 4 weeks
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Center, Korea

Trial Keywords

  • EGFR mutation
  • NSCLC

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