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The enrolment task cannot be gotten within the planned time.It mainly includes patients with non-small cell lung cancer failed in standard treatment,with a short survival period.It is hard to obtain observational endpoints for bone-related events.
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To study the pharmacokinetic characteristics of TQ-B3456 in the human body, recommend a reasonable regimen for subsequent research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3456 | Experimental | p.o. qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3456 | Drug | Observe the safety and pk when the subjects take TQB3456 p.o. qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicities(DLT) | an adverse event cccurring after initiation of TQ-B3456 that met any following criteria:
| Baseline up to 28 days |
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Inclusion Criteria:
- progressive or metastatic non-small cell lung cancer that diagnosed Pathologically or cytologically diagnosed patients who have received EGFR tyrosine kinase inhibitor monotherapy (e.g., gefetinib, erlotinib, ecotinib, afatinib) for disease progression EGFR T790M mutation was confirmed ECOG PS≤1 Adequate blood cell counts, kidney function and liver function Patients should participate in the study voluntarily and sign informed consent
Exclusion Criteria:
Patients with non-small-cell lung cancer who have received osimertinib or other raw materials or preparations for EGFRT790M mutant drugs Hypertension (systolic BP ≥140 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication; Hepatitis B virus patients with active replication (DNA> 500 cps / mL), hepatitis C; Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 241 Huaihai West Road, Xuhui District, Shanghai | Shanghai | Shanghai Municipality | 200030 | China |
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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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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |