Small Cell Lung Cancer Limited Stage
Conditions
Keywords
radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage
Brief summary
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
Interventions
DRUGSintilimab
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.
DRUGEtoposide
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
DRUGCisplatin
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
RADIATIONradiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Affiliated Hospital of Guangdong Medical University
First People's Hospital of Foshan
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Contacts
Primary ContactMing Chen, MD. PhD.
Outcome results
None listed