Back to resultsA Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
Primary Purpose
Limited-stage Small Cell Lung Cancer, LS-SCLC
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SHR-1316
Sponsored by
About this trial
This is an interventional treatment trial for Limited-stage Small Cell Lung Cancer, LS-SCLC
Eligibility Criteria
Inclusion Criteria:
- The age is 18-75 years old (including both ends), regardless of gender;
- Histologically confirmed limited stage small cell lung cancer ;
- ECOG PS 0 ~ 1;
- Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
- The last chemotherapy must be finished before or at the same time of radiotherapy.
- The disease did not progress after concurrent chemoradiotherapy;
- The expected survival time was more than 3 months;
- Pulmonary function: FEV1 > 70%;
Exclusion Criteria:
- The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
- Mixed SCLC or NSCLC confirmed by histology;
- Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
- Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
- Extensive SCLC;
- Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
- Interstitial pneumonia
- History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
- HIV, active Hepatitis B or Hepatitis C infection
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SHR-1316
Arm Description
Outcomes
Primary Outcome Measures
PFS
progression-free survival
Secondary Outcome Measures
Full Information
NCT ID
NCT04647357
First Posted
November 27, 2020
Last Updated
November 27, 2020
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT04647357
Brief Title
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
Official Title
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer Without Progression After First Line Concurrent Chemoradiotherapy Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 27, 2020 (Anticipated)
Primary Completion Date
May 27, 2023 (Anticipated)
Study Completion Date
December 27, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
SHR-1316 as Maintenance therapy for limited stage small cell lung cancer without progression after first line platinum based concurrent chemoradiotherapy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited-stage Small Cell Lung Cancer, LS-SCLC
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-1316
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SHR-1316
Intervention Description
Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks
Primary Outcome Measure Information:
Title
PFS
Description
progression-free survival
Time Frame
Up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The age is 18-75 years old (including both ends), regardless of gender;
Histologically confirmed limited stage small cell lung cancer ;
ECOG PS 0 ~ 1;
Patients received at least 2 cycles of platinum based chemotherapy and radiotherapy, and completed within 1 to 42 days before the first medication.
The last chemotherapy must be finished before or at the same time of radiotherapy.
The disease did not progress after concurrent chemoradiotherapy;
The expected survival time was more than 3 months;
Pulmonary function: FEV1 > 70%;
Exclusion Criteria:
The subjects volunteered to participate in the study, signed the informed consent form, had good compliance and cooperated with the follow-up.
Mixed SCLC or NSCLC confirmed by histology;
Locally advanced small cell lung cancer receiving sequential chemoradiotherapy;
Have received anti-tumor therapy of systemic immune checkpoint inhibitors for SCLC;
Extensive SCLC;
Operable SCLC (clinical stage T1-2N0, except for those who are contraindicated or refuse surgery);
Interstitial pneumonia
History of active, known or suspected autoimmune diseases and autoimmune diseases, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.
HIV, active Hepatitis B or Hepatitis C infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaorong Dong, PhD
Phone
027-85872859
Email
xiaorongdong@hust.edu.cn
12. IPD Sharing Statement
Learn more about this trial
A Trial of SHR-1316 Maintenance Therapy for Limited Stage Small Cell Lung Cancer
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