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

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ClinicalTrials.gov Identifier: NCT02804776
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Centre, Singapore

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: Gefitinib Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PROGRESS: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
Study Start Date : February 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Gefitinib
Gefitinib 250mg oral daily will be given for 4 weeks prior to surgery
Drug: Gefitinib
250mg oral daily for 4 weeks
Other Name: Iressa




Primary Outcome Measures :
  1. EGFR TKI sensitivity biomarkers determination [ Time Frame: 4 to 6 weeks ]
    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 :
  1. Response rates after 4 weeks of neoadjuvant gefitinib [ Time Frame: 4 to 6 weeks ]
    To determine response rates after 4 weeks of neoadjuvant gefitinib as evaluated by RECIST 1.1


Other Outcome Measures:
  1. Clonal heterogeneity using whole exome and RNA-sequencing of tumour sectors as well as resected lymph nodes [ Time Frame: 4 to 6 weeks ]
  2. Clonal heterogeneity recapitulation through CTC, plasma DNA and functional imaging [ Time Frame: 4 to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (e.g. FEV1 <40% predicted value, artery blood gas PaO2<60mmHg)
  • 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.

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): NCT02804776


Contacts
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Contact: Daniel SW Tan +65 6436 8000 daniel.tan.s.w@singhealth.com.sg

Locations
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Singapore
National Cancer Centre Recruiting
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Investigators
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Principal Investigator: Daniel SW Tan National Cancer Centre, Singapore

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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT02804776     History of Changes
Other Study ID Numbers: ECRU-LUNG-2013
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action