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Small cell lung cancer(SCLC) has a poor prognosis and a relatively short overall survival time, urgently requiring innovative treatment strategies to improve the prognosis of such patients. Immunotherapy has become an important component of first-line therapy for extensive-stage small cell lung cancer (ES-SCLC). Studies have found that, compared to chemotherapy alone, the combination of Surlidumab with carboplatin and etoposide can extend the median overall survival in ES-SCLC to over 15 months. However, to date, research on the use of immunotherapy in combination with concurrent chemoradiotherapy (CCRT) in limited-stage small cell lung cancer (LS-SCLC) remains limited. This study aims to explore the clinical benefits of Surlidumab in combination with concurrent chemoradiotherapy in LS-SCLC and evaluate the safety of immunotherapy in combination with CCRT as first-line treatment for LS-SCLC. At the same time, it seeks to identify tumor-related biomarkers that can effectively predict the efficacy of immunotherapy and prognosis.
The study plans to include a total of 96 patients who will receive first-line treatment consisting of 4 cycles of etoposide plus cisplatin/carboplatin and concurrent thoracic radiotherapy combined with Surlidumab immunotherapy. Following CCRT+Surlidumab treatment, patients will undergo Surlidumab consolidation therapy until disease progression or for a duration of at least 1 year. The study aims to evaluate the progression-free survival (PFS) and overall survival (OS) of patients compared to those receiving concurrent chemoradiotherapy alone, and to explore the efficacy of immunotherapy in limited-stage small cell lung cancer. Additionally, peripheral blood samples will be collected before treatment and 1 month after CCRT to explore tumor efficacy-related biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Concurrent radiotherapy with chemotherapy (Etoposide+Cisplatin/Carboplatin) with Serplulimab, and followed by consolidation Serplulimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serplulimab | Drug | Undergo 4 cycles of synchronous radiotherapy and chemotherapy combined with Sintilimab immunotherapy, followed by Sintilimab monotherapy for maintenance treatment until disease progression or up to 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | the time length from enrollment to any of the following events: disease progression with first line therapy or death from any cause. Disease progression will be assessed according to RECIST 1.1 | up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | the time length from enrollment to death from any cause. | up to 8 weeks |
| Incidence of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
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Inclusion Criteria:
Aged 18 years or older
Diagnosed with small cell lung cancer by histology or cytology, and staged as limited stage (stage II-III according to the 8th edition of AJCC Cancer Staging)
Treatment-naïve population, not having received any prior targeted therapy, chemotherapy, radiation therapy, or immunotherapy for anti-tumor treatment
Measurable lesions based on RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. ECOG assessment should be conducted within 7 days prior to the first dose of the study intervention
Baseline hematologic, blood biochemistry, and urine biochemistry tests confirming sufficient bone marrow and organ function
Life expectancy of at least 6 months
Male participants: Male participants must agree to use effective contraception during the study treatment and for at least 180 days after the last dose, and must not donate sperm during this period
Female participants must not be pregnant or lactating, and must meet at least one of the following conditions:
(11) Signed informed consent form
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| mengzhao Wang, MD | Contact | 01069155154 | mengzhaowang@sina.com | |
| Yan Xu, MD | Contact | 01069155154 | maraxu@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Mengzhao Wang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | 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 |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
Evaluate adverse events of any cause, treatment-related adverse events, immune-mediated adverse events according to NCI-CTCAE V5.0
| up to 8 weeks |
| objective response rate (ORR) | Proportion of patients with Complete and Partial Responses to first-line therapy. | up to 8 weeks |
| 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 |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |