Clincosm LogoSign in Get a demo

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

Sponsor
National Cancer Centre, Singapore (Other)
Overall Status
Completed
CT.gov ID
NCT02804776
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
36.8
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
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
Actual Study Start Date :
Jan 27, 2015
Actual Primary Completion Date :
Feb 21, 2018
Actual Study Completion Date :
Feb 21, 2018

Arms and Interventions

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 Names:
  • Iressa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. EGFR TKI sensitivity biomarkers determination [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 [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 [4 to 6 weeks]

    2. Clonal heterogeneity recapitulation through CTC, plasma DNA and functional imaging [4 to 6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cancer Centre Singapore Singapore 169610

    Sponsors and Collaborators

    • National Cancer Centre, Singapore

    Investigators

    • Principal Investigator: Daniel SW Tan, National Cancer Centre, Singapore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Centre, Singapore
    ClinicalTrials.gov Identifier:
    NCT02804776
    Other Study ID Numbers:
    • ECRU-LUNG-2013
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 2, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Gefitinib

    Study Results

    No Results Posted as of Jun 2, 2021