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This study aims to evaluate the safety and efficacy of SCTB41 combined with docetaxel in patients with previously treated non-small cell lung cancer. The Phase II part of this study is an open-label, multicenter clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCTB41+docetaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCTB41 | Drug | SCTB41 is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs) | To investigate the safety characteristics. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. | Up to 2 years |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology | Wuhan | Hubei | 430030 | China |
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| docetaxel | Drug | docetaxel is administered at selected dose by intravenous infusion on Day 1 of each 3-week cycle |
|
| Up to 2 years |
| Progression-free survival (PFS) | The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) | Overall survival is defined as the time from the start of treatment until death due to any cause. | Up to 2 years |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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