Back to resultsPRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery (PROGRESS)
Primary Purpose
Non-small Cell Lung Cancer
Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer
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 (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.
Sites / Locations
- National Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gefitinib
Arm Description
Gefitinib 250mg oral daily will be given for 4 weeks prior to surgery
Outcomes
Primary Outcome Measures
EGFR TKI sensitivity biomarkers determination
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
Response rates after 4 weeks of neoadjuvant gefitinib
To determine response rates after 4 weeks of neoadjuvant gefitinib as evaluated by RECIST 1.1
Full Information
NCT ID
NCT02804776
First Posted
June 14, 2016
Last Updated
May 31, 2021
Sponsor
National Cancer Centre, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02804776
Brief Title
PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
Acronym
PROGRESS
Official Title
PROGRESS: PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 27, 2015 (Actual)
Primary Completion Date
February 21, 2018 (Actual)
Study Completion Date
February 21, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gefitinib
Arm Type
Experimental
Arm Description
Gefitinib 250mg oral daily will be given for 4 weeks prior to surgery
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
Iressa
Intervention Description
250mg oral daily for 4 weeks
Primary Outcome Measure Information:
Title
EGFR TKI sensitivity biomarkers determination
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
Time Frame
4 to 6 weeks
Secondary Outcome Measure Information:
Title
Response rates after 4 weeks of neoadjuvant gefitinib
Description
To determine response rates after 4 weeks of neoadjuvant gefitinib as evaluated by RECIST 1.1
Time Frame
4 to 6 weeks
Other Pre-specified Outcome Measures:
Title
Clonal heterogeneity using whole exome and RNA-sequencing of tumour sectors as well as resected lymph nodes
Time Frame
4 to 6 weeks
Title
Clonal heterogeneity recapitulation through CTC, plasma DNA and functional imaging
Time Frame
4 to 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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 (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel SW Tan
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PRe-Operative Gefitinib in Resectable EGFR Mutation Positive Lung Cancer With Sector Sequencing for Biomarker Discovery
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