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This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adebrelimab + Etoposide + Platinum-based Therapy | Experimental | Participants in this arm will receive Adebrelimab, Etoposide, and Platinum-based therapy. Adebrelimab will be administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle. Following Adebrelimab, Etoposide will be given at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
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| Etoposide + Platinum-based Therapy | Active Comparator | Participants in this arm will receive Etoposide and Platinum-based therapy. Etoposide will be administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) will be administered via intravenous infusion on Day 1 of each cycle. This treatment regimen will be repeated for 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adebrelimab + Etoposide + Platinum-based Therapy | Drug | Intervention Description for Treatment Group: This intervention includes Adebrelimab in combination with Etoposide and Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Adebrelimab is administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle, followed by Etoposide at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate(pCR) | Pathologic complete response (pCR), defined as the absence of tumor cells in all specimens (ypT0N0) . | 7 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival (EFS) | The length of time after primary treatment for a cancer ends that the patient remains free of certain complicationsor events that the treatment was intended toprevent or delay. | Long term follow-up will continue until preoperative progression, postoperative recurrence, or death from any cause at least two years. |
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Inclusion Criteria:
(1) Hematological criteria (within 14 days without blood transfusion, hematopoietic factors, or correcting medications):
a. TBIL ≤ 1.5 × ULN; b. ALT, AST ≤ 2.5 × ULN (if abnormal liver function due to liver metastasis, ≤ 5 × ULN); c. Serum creatinine (sCr) ≤ 1.5 × ULN, estimated glomerular filtration rate (eGFR) ≥ 50 mL/min (Cockcroft-Gault formula); (3) Coagulation function: INR ≤ 1.5 × ULN and APTT ≤ 1.5 × ULN. 11. Female participants of childbearing potential must have a negative serum pregnancy test within 3 days before starting study medication and agree to use a medically accepted method of highly effective contraception during the study and for 3 months after the last dose of study drug (e.g., intrauterine device, contraceptive pills, or condoms). Male participants with female partners of childbearing potential must have undergone surgical sterilization or agree to use effective contraception during the study and for 3 months after the last dose of study drug.
12. Participants must voluntarily consent to participate in this study, sign an informed consent form, demonstrate good compliance, and agree to follow-up visits.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaolong Yan, Dr | Contact | 029-847171569 | yanxiaolong@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tangdu Hospital Affiliated to the Fourth Military Medical University | Recruiting | Xi'an | Shannxi | 710038 | 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 |
|---|---|
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Etoposide + Platinum-based Therapy | Drug | Intervention Description for Control Group: This intervention includes Etoposide in combination with Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Etoposide is administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment. |
|
| Major pathologic response (MPR) |
MPR is defned as less than 10% residual viable tumor after neoadjuvant therapy. |
| 7 days after surgery. |
| Objective response rate (ORR) | Per Response Evaluation Criteria in Solid Tumorsersion 1.1(REClST 1.1) using Investigator assessments, is defneas the number (%) of patients with responseof Complete Response or Partial Response. | 7 days before surgery |
| Disease-free survival(DFS) | The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer. | Long term follow-up will continue until the death of the subiect or the end of the studv. at least two years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |