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| Name | Class |
|---|---|
| Huazhong University of Science and Technology | OTHER |
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Patients with extensive-stage small-cell lung cancer (ES-SCLC) have poor prognosis, with limited treatment options. Chemo-immunotherapy is the standard 1st-line therapy for patients with ES-SCLC.When 4 cycles of etoposide+carboplatin (EC) or etoposide+cisplatin(EP) chemotherapy combined with PD-L1 inhibitor are effective, guidelines recommend additional thoracic radiotherapy.
In this study, the investigators bring radiotherapy forward, which means that after 2 cycles of EC chemotherapy plus Adebrelimab, participants with response(PR/CR/SD)will receive concurrent radiotherapy and 2 cycles of EC chemotherapy plus Adebrelimab, then maintenance therapy with Adebrelimab (Q3W).
The purpose of this study is to explore the safety and efficacy of Adebrelimab combined with concurrent chemoradiotherapy in untreated participants with extensive-stage small cell lung cancer.
Participants receive EC chemotherapy combined with Adebrelimab for 2 cycles, and the efficacy will be evaluated. If the efficacy evaluation is SD/PR/CR, concurrent chemoradiotherapy combined with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy + Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (etoposide, carboplatin, radiation, Adebrelimab) | Experimental | Participants receive etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab | Drug | Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-m PFS rate | 6-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 6th month | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate is defined as the proportion of subjects who have a CR or a PR | up to 24 months. |
| PFS | Progression-free survival is defined as the time from the first treatment to the first documented disease progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qimig Wang, Doctor | Contact | 0086-13783590691 | qimingwang1006@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qimig Wang, Doctor | Henan Cancer Hospital | Principal Investigator |
| Guangyuan Hu, Doctor | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | 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 |
|---|---|
| D011878 | Radiotherapy |
| C098534 | EC regimen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Radiation Therapy | Radiation | Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years. |
|
| etoposide, carboplatin(EC) | Drug | Etoposide 100mg/m2 day1-3+carboplatin AUC 5 day 1(EC) combined with Adebrelimab( PD-L1 inhibitor)1200mg day1 Q3w for 2 cycles, and the efficacy is evaluated 3 weeks after the treatment. If the efficacy evaluation is SD/PR/CR, concurrent radiotherapy(45Gy /3Gy/qd/3w) with EC(2 cycles) + Adebrelimab will be initiated. After concurrent chemoradiotherapy+ Adebrelimab, Adebrelimab was maintained until PD or intolerance or for at most 2 years. |
|
| From date of the first treatment to the first documented disease progression, assessed up to 24 months |
| OS | Overall survival is defined as the time from the first treatment to death due to any cause. | From date of the first treatment to death due to any cause, assessed up to 24 months |
| 12-m PFS rate | 12-m PFS rate is defined as the percentage of participants whose disease is still progression-free at the 12th month | 12 months |
| AEs | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 24 months |
| Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei | 430000 | China |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |