Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Study Overview
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Brief Summary
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The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.

Official Title
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Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial

Conditions
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Small Cell Lung Cancer Limited Stage

Intervention / Treatment
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* Drug: Sintilimab
* Drug: Etoposide
* Drug: Cisplatin
* Radiation: radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically confirmed diagnosis of SCLC. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage. Patients should be ≥ 18 years old. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80). With adequate cardiac, pulmonary, bone marrow, hepatic and renal function. With weight loss no more than 10% within 6 months before diagnosis. Informed consent must be signed. Exclusion Criteria: Histology confirmed the mixed NSCLC components; Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.); Any disease or condition contraindicated by radiotherapy or chemotherapy; Malignant pleural effusion and pericardial effusion; Pregnant and lactating women; History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia; Received live vaccination within 28 days before the first administration of the study drug; 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint). The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sintilimab + CRT arm<br>Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles. | Drug: Sintilimab<br>* Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.<br>Drug: Etoposide<br>* Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.<br>* Other names: VP-16;Drug: Cisplatin<br>* cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.<br>* Other names: DDP;Radiation: radiotherapy<br>* Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).<br>|
| Active Comparator: CRT arm<br>Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). | Drug: Etoposide<br>* Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.<br>* Other names: VP-16;Drug: Cisplatin<br>* cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.<br>* Other names: DDP;Radiation: radiotherapy<br>* Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | PFS, defined as the time from the date of randomization to the first date of documented objective progression disease or of death from any cause. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | OS, measured from the date of randomization to the date of death from any cause. | 5 years | 
| Overall response rates | ORR, tumor response will be measured by using the RECIST 1.1. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage