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BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGFR-TKI and Chemotherapy | Experimental | gefitinib with pemetrexed/gemcitabine and carboplatin |
|
| EGFR-TK Inhibitor | Experimental | Gefitinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EGFR-TK Inhibitor | Drug | EGFR-TKI (gefitinib 250mg per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progress Free Survival | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | up to 24 months | |
| Overall Response Rate | up to 12 months | |
| Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caicun Zhou, MD PHD | Contact | 8613301825532 | caicunzhoudr@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Caicun Zhou, MD, PHD | Shanghai Pulmonary Hospital, Tongji University | Principal Investigator |
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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 |
| D004358 | Drug Therapy |
| D000068437 | Pemetrexed |
| D000093542 | Gemcitabine |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| EGFR-TKI | Drug | EGFR-TKI (gefitinib 250mg per day) |
|
|
| EGFR-TKI and Chemotherapy | Drug | pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w |
|
|
Safety |
| up to 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013812 | Therapeutics |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |