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This phase II trial studies how well IBI308 combined with paclitaxel/albumin-bound paclitaxel work in treating participants with small cell lung cancer after failing to platinum-etoposide chemotherapy.
Primary objective :
To estimate progression free survival (PFS) probability of patient who recurrent SCLC treated with IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Secondary Objectives:
I.To evaluate the objective remission rate (ORR), disease control rate. (DCR),durative time of remission ( DoR)and overall survival (OS) of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
II.To evaluate the safety of IBI308 combined with paclitaxel/abumin-bound paclitaxel following progression on platinum-etoposide chemotherapy.
Exploratory Objectives To evaluate the correlation of biomarkers with efficacy and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI308 + Paclitaxel/Albumin-Bound Paclitaxel | Other | IBI308 Combined with Albumin-Bound Paclitaxe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel/Albumin-Bound Paclitaxel | Drug | Paclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6; |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | 12 months | |
| disease control rate (DCR) | 12 months | |
| durative time of remission ( DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junling Li, doctor | Contact | +86 13801178891 | lijunling@cicams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junling Li, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Junling Li | Recruiting | Beijing | Beijing Municipality | 100021 | 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 |
|---|---|
| D000068196 | Albumin-Bound Paclitaxel |
| C000632826 | sintilimab |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 |
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SCLC patients who have failed platinum-etoposide chemotherapy
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| IBI308 | Drug | IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles) |
|
| 12 months |
| objective remission rate (ORR) | 12 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |