Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Small Cell Lung Cancer Limited Stage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04189094
• Other study ID #: IRB-2019-164
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: November 2019
• Source: Zhejiang Cancer Hospital
• Contact: Ming Chen, MD. PhD.
• Phone: 86-571-88122199
• Email: chenming[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer Limited Stage
• Small Cell Lung Carcinoma

Intervention

Drug:
• Sintilimab
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.
• Etoposide
Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
• Cisplatin
cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Radiation:
• radiotherapy
Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital	First Affiliated Hospital, Sun Yat-Sen University, First People's Hospital of Foshan, The Affiliated Hospital of Guangdong Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival	OS, measured from the date of randomization to the date of death from any cause.	5 years
Secondary	Overall response rates	ORR, tumor response will be measured by using the RECIST 1.1.	2 years