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This study aimed to explore the efficacy and biomarker explanation of IBI-322 Plus Lenvatinib on extensive stage small cell lung cancer who failed from first line PD-(L)1 inhibitors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Duration of response time less than 3 months |
|
| Cohort B | Experimental | Duration of response time between 3 and 6 months |
|
| Cohort C | Experimental | Duration of response time more than 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI-322 Plus Lenvatinib | Drug | IBI322 is based on the "3+3" model, with a dose ascent starting from 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Defined as the proportion of subjects in complete remission (CR) and partial remission (PR) to the total subjects | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Defined as the time from the beginning of treatment to the first imaging disease progression or death (whichever occurs first) | 1year |
| OS | Defined as the time from the start of treatment to the death of the subject due to any cause. |
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Eligible subjects selected for this study must meet all of the following criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongchang C Zhang, MD | Contact | +8613873123436 | 7+861383123436 | zhangyongchang@csu.edu.cn |
| Nong C Yang, MD | Contact | +8613873123436 | +8613873123436 | yangnong0217@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer hospital | Recruiting | Changsha | Hunan | China |
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| ID | Term |
|---|---|
| D055752 | Small Cell Lung Carcinoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| 1 year |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |