Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Phase 2

• Conditions: Small Cell Lung Cancer Limited Stage
• Interventions: Drug: Sintilimab; Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy

• Registration Number: NCT04189094
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-27
• Study First Submitted QC: 2019-12-04
• Last Update Submitted: 2019-12-04
• Study First Posted: 2019-12-06
• Last Update Posted: 2019-12-06
• Study Start: 2020-01-01
• Primary Completion: 2021-07-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Histologically/cytologically confirmed diagnosis of SCLC.
2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage.
3. Patients should be ≥ 18 years old.
4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80).
5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function.
6. With weight loss no more than 10% within 6 months before diagnosis.
7. Informed consent must be signed.

Exclusion Criteria

1. Histology confirmed the mixed NSCLC components;
2. 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.);
3. Any disease or condition contraindicated by radiotherapy or chemotherapy;
4. Malignant pleural effusion and pericardial effusion;
5. Pregnant and lactating women;
6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia;
7. Received live vaccination within 28 days before the first administration of the study drug;
8. 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.
9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint).
10. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sintilimab + CRT arm	radiotherapy	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.
CRT arm	radiotherapy	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).
Sintilimab + CRT arm	Sintilimab	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.
Sintilimab + CRT arm	Etoposide	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.
Sintilimab + CRT arm	Cisplatin	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.
CRT arm	Etoposide	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).
CRT arm	Cisplatin	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).

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years	OS, measured from the date of randomization to the date of death from any cause.
Overall response rates	2 years	ORR, tumor response will be measured by using the RECIST 1.1.