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This is an open-label, single-arm, prospective phase 2 study, evaluating the efficacy and safety of ivonescimab combined with irinotecan liposome for relapsed small cell lung cancer, who progressed on PD-(L)1 -based first-line therapy.
Patients will receive ivonescimab at 20 mg/kg intravenously, on days 1 of every 21-day cycle and irinotecan liposome 56.5mg/m^2 intravenously, on days 1 of every 14-day cycle. Treatment will be discontnued in case of the toxicity became intolerable, the investigator determined that there was no further clinical benefit (based on a combination of RECIST 1.1 imaging assessment and clinical status), 24 months of treatment was completed, or the study was withdrawn for other reasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivonescimab and irinotecan liposome | Experimental | Subjects receive ivonescimab plus irinotecan liposome until progression. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ivonescimab | Drug | 20mg/kg, IV, D1, Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6-month PFS (progression free survival) rate | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death at 6 months. | From the day treatment started to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Grade 3 or higher adverse events (AEs) | Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0. | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | 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 |
|---|---|
| C584112 | irinotecan sucrosofate |
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| irinotecan liposome | Drug | 56.5mg/m^2, IV, D1, Q2W |
|
|
Objective response rate (ORR)is defined as the proportion of subjects with completeresponse(CR)or partial response(PR), based on RECIST v1.1. |
| Interval between the date of enrollment and the date of death from any cause, up to approximately 2 years |
| Disease control rate (DCR) | DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks), based on RECIST v1.1. | Interval between the date of enrollment and the date of death due to any cause , up to a maximum of approximately 2 years |
| Duration of Response (DOR) | DOR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST v1.1) or death due to any cause, whichever occurs first. | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years |
| Progression free survival (PFS) | PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) assessed by the investigator or death due to any cause (whichever occurs first). | Interval between the date of enrollment and the date of progressive disease, or death due to any cause (whichever occurs first), up to a maximum of 2 years |
| Overall survival (OS) | OS is the time from the date of randomization or first dosing date to death due to any cause. | Interval between the date of enrollment and the date of death from any cause, up to a maximum of 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |