Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Small Cell Lung Cancer Limited Stage
• Intervention / Treatment: Drug: Sintilimab; Drug: Etoposide; Drug: Cisplatin; Radiation: radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ming Chen, MD. PhD.; Phone Number: 86-571-88122199; Email: chenming@zjcc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sintilimab + CRT arm; 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; 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.; Drug: Etoposide; Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.; Other Names: VP-16; Drug: Cisplatin; cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.; Other Names: DDP; Radiation: radiotherapy; Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
ACTIVE_COMPARATOR: CRT arm; 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; Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.; Other Names: VP-16; Drug: Cisplatin; cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.; Other Names: DDP; Radiation: radiotherapy; Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; First People's Hospital of Foshan; The Affiliated Hospital of Guangdong Medical College
• Investigators: Principal Investigator: Ming Chen, MD. PhD., Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2023

Study Registration Dates

• First Submitted: November 27, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (ACTUAL): December 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: chemotherapy; immunotherapy; lung cancer; radiotherapy; PD-1 inhibitor; small cell; limited-stage
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Etoposide; Cisplatin
• Other Study ID Numbers: IRB-2019-164

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No