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This study is a one arm, open, single center phase II study. The main purpose of this study was to evaluate the tolerance and preliminary efficacy of SHR1316 combined with chest radiotherapy after induction therapy.
This is a single-arm, single-center phase II study. Eligible subjects will receive the following treatment regimens: 4~6 cycles of SHR1316 combined with EP/EC (etoposide, 100mg/m2, D1-3, q3w and cisplatin, 75mg/m², D1, q3w or carboplatin, AUC=5, D1, q3w). Patients with response sequentially received adebrelimab combined with chest radiotherapy based on investigator decision. Patients then the maintenance therapy with adebrelimab until disease progression or intolerable AEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR1316+Chemotherapy +Radiotherapy | Experimental | Paiticipant receive SHR-1316 、Chemotherapy and Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR1316 | Drug | Anti-PD-L1 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | Up to approximately 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | Up to approximately 36 months | |
| Objective Response Rate (ORR) | Up to approximately 36 months | |
| disease control rate (DCR) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of ctDNA status | Change of circulating tumor DNA (ctDNA) status in blood before and after receving treatment | Up to approximately 36 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JinMing Yu, PhD | Shandong Cancer Hospital and Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital and Institute | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39252865 | Derived | Chen D, Zou B, Li B, Gao A, Huang W, Shao Q, Meng X, Zhang P, Tang X, Hu X, Zhang Y, Guo J, Zhao C, Yuan J, Li Q, Zhu C, Yu J, Wang L. Adebrelimab plus chemotherapy and sequential thoracic radiotherapy as first-line therapy for extensive-stage small-cell lung cancer (ES-SCLC): a phase II trial. EClinicalMedicine. 2024 Aug 21;75:102795. doi: 10.1016/j.eclinm.2024.102795. eCollection 2024 Sep. |
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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 |
|---|---|
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
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| Carboplatin | Drug | Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6). |
|
| Etoposide | Drug | Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6). |
|
| Radiation therapy | Radiation | Thoracic radiation therapy ,TRT |
|
| Cisplatin | Drug | Cisplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6). |
|
| Up to approximately 36 months |
| Duration of Response (DOR) | Up to approximately 36 months |
| Adverse events | Safety, incidence and severity of adverse events (AEs) and serious adverse events (SAEs) per CTCAE 5.0 criteria | Up to approximately 36 months |
| 6- and 12-month PFS rates | Percentage of Participants Alive and Without PD, as Assessed by the Investigator Using RECIST v1.1, at 6 Months and 12 Months | 6 Months and 12 Months |
| 1- and 2-year OS rates | Percentage of Participants Alive at 1 Year and 2 Years | 1 Year and 2 Years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009281 |
| Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |