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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib | Experimental | Gefitinib 250mg oral daily will be given for 4 weeks prior to surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug | 250mg oral daily for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Response rates after 4 weeks of neoadjuvant gefitinib | To determine response rates after 4 weeks of neoadjuvant gefitinib as evaluated by RECIST 1.1 | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clonal heterogeneity using whole exome and RNA-sequencing of tumour sectors as well as resected lymph nodes | 4 to 6 weeks | |
| Clonal heterogeneity recapitulation through CTC, plasma DNA and functional imaging | 4 to 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel SW Tan | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre | Singapore | 169610 | Singapore |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |