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Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Primary Purpose

Small Cell Lung Cancer Limited Stage

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Sintilimab

Etoposide

Cisplatin

radiotherapy

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer Limited Stage focused on measuring radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sintilimab + CRT arm

CRT arm

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall survival

OS, measured from the date of randomization to the date of death from any cause.

Overall response rates

ORR, tumor response will be measured by using the RECIST 1.1.

Full Information

NCT ID

NCT04189094

First Posted

November 27, 2019

Last Updated

December 4, 2019

Sponsor

Zhejiang Cancer Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan

1. Study Identification

Unique Protocol Identification Number

NCT04189094

Brief Title

Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 1, 2020 (Anticipated)

Primary Completion Date

July 1, 2021 (Anticipated)

Study Completion Date

July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhejiang Cancer Hospital

Collaborators

First Affiliated Hospital, Sun Yat-Sen University, Affiliated Hospital of Guangdong Medical University, First People's Hospital of Foshan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Cancer Limited Stage

Keywords

radiotherapy, chemotherapy, immunotherapy, PD-1 inhibitor, lung cancer, small cell, limited-stage

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sintilimab + CRT arm

Arm Type

Experimental

Arm Description

Arm Title

CRT arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

VP-16

Intervention Description

Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.

Intervention Type

Radiation

Intervention Name(s)

radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-free survival

Description

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.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

OS, measured from the date of randomization to the date of death from any cause.

Time Frame

5 years

Title

Overall response rates

Description

ORR, tumor response will be measured by using the RECIST 1.1.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Chen, MD. PhD.

Phone

86-571-88122199

chenming@zjcc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Chen, MD. PhD.

Organizational Affiliation

Cancer Hospital of the University of Chinese Academy of Science (Zhejiang Cancer Hospital)

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC

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