Clinical Trials /

PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

NCT02804776

Description:

This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

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

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
  • Official Title: PROGRESS: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery

Clinical Trial IDs

  • ORG STUDY ID: ECRU-LUNG-2013
  • NCT ID: NCT02804776

Conditions

  • Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
GefitinibIressaGefitinib

Purpose

This is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, Epidermal growth factor receptor (EGFR) sensitizing mutation lung cancer.

Detailed Description

      Selected patients will receive 4 weeks of gefitinib before surgery. A Positron Emission
      Tomography - Computed Tomography (PET- CT) will be performed before and after gefitinib to
      assess the response. Circulating tumour cells (CTCs) and plasma Deoxyribonucleic acid (DNA)
      will be acquired at baseline, 2 weeks and 4 weeks after gefitinib treatment. Resected tumor
      will be sectored in details to study the spatial heterogeneity.
    

Trial Arms

NameTypeDescriptionInterventions
GefitinibExperimentalGefitinib 250mg oral daily will be given for 4 weeks prior to surgery
  • Gefitinib

Eligibility Criteria

        Inclusion Criteria:

          -  EGFR mutation positive Non-Small Cell lung cancer (NSCLC) (regardless of smoking
             status), or control group may encompass other molecular subtypes of lung cancer e.g.
             anaplastic lymphoma kinase (ALK) and Kirsten rat sarcoma viral oncogene homolog
             (KRAS).

          -  All early stage patients with NSCLC who are deemed surgically resectable.

          -  All patients must have histologically proven NSCLC, with known EGFR mutation

          -  Patients should be fit for either lobectomy/ pneumonectomy with or without lymph node
             sampling.

          -  Primary tumour should be at least 2 cm in size (Tumor stage 1b).

          -  Willing to provide informed consent.

        Exclusion Criteria:

          -  Known severe hypersensitivity to gefitinib or any of the excipients of this product

          -  Any serious concomitant systemic disorder that, in the opinion of the investigator,
             would compromise the patient's ability to complete the study.

          -  Interstitial lung disease (ILD) or pulmonary fibrosis; impaired pulmonary function

          -  Patients with prior exposure to agents directed at the Human epidermal receptor (HER)
             axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).

          -  Patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer
             therapy (e.g. monoclonal antibody therapy) for lung cancer.

          -  Any unstable systemic disease (including active infection, uncontrolled hypertension,
             unstable angina, congestive heart failure, myocardial infarction within six months,
             serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic
             disease).

          -  Evidence of any other disease, neurological or metabolic dysfunction, physical
             examination or laboratory finding giving reasonable suspicion of a disease or
             condition that contraindicates the use of an investigational drug or puts the subject
             at high risk for treatment-related complications.

          -  Patient who has serious active infection.

          -  Patients who harbouring exon 20 T(Threonine)790M (Methionine) mutation.

          -  Pregnancy or breast feeding.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:21 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:EGFR TKI sensitivity biomarkers determination
Time Frame:4 to 6 weeks
Safety Issue:
Description:Determine EGFR tyrosine kinase inhibitor (TKI) sensitivity biomarkers in responders vs non responders, as categorized by either Response Evaluation Criteria In Solid Tumors (RECIST) stable disease (SD) vs Partial response (PR) or median percentage tumour shrinkage

Secondary Outcome Measures

Measure:Response rates after 4 weeks of neoadjuvant gefitinib
Time Frame:4 to 6 weeks
Safety Issue:
Description:To determine response rates after 4 weeks of neoadjuvant gefitinib as evaluated by RECIST 1.1

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:National Cancer Centre, Singapore

Last Updated

February 1, 2018