Back to resultsThe Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
Primary Purpose
Small-cell Lung Cancer
Status
Enrolling by invitation
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SHR-1316; Carboplatin; Etoposide；Radiotherapy
Palcebo; Carboplatin; Etoposide；Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Small-cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Male or female, 18-75 years of age.
- Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
- ECOG PS 0~1.
- At least 1 measurable lesion as defined by RECIST v1.1.
- Adequate organ function.
- Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
- Signed the informed consent form.
Exclusion Criteria:
- Mixed SCLC or NSCLC.
- Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
- Extensive-stage SCLC.
- Subjects who is surgically resectable.
- Subjects with malignant pleural effusion.
- Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
- Active, known, or suspected autoimmune diseases.
- History of malignant tumors.
- Subjects with severe cardiovascular disease.
- Events of arterial/venous thrombosis within 6 months prior to the first dose.
- Subjects with serious infection.
- Subjects with active pulmonary tuberculosis (TB).
- Subjects with immunodeficiency diseases.
- Subjects with active hepatitis B virus or hepatitis C virus infection.
- Systemic immunosuppressants administation within 14 days prior to the first dose.
- Subjects who received major surgery within 28 days prior to the first dose.
- Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
- Subjects who have previously received tissue/organ transplants.
- Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
- Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
Sites / Locations
- Jilin Cancer Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group A
Treatment group B
Arm Description
Outcomes
Primary Outcome Measures
OS
Overall Survival
Secondary Outcome Measures
Full Information
NCT ID
NCT04691063
First Posted
December 25, 2020
Last Updated
February 24, 2021
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04691063
Brief Title
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
Official Title
A Multi-center, Randomized, Double-blinded, Phase III Trial of SHR-1316 or Placebo in Combination With Chemo-radiotherapy in Patients With Limited-stage Small-cell Lung Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
May 15, 2025 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
SHR-1316 in combination with chemo-radiotherapy.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
486 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A
Arm Type
Experimental
Arm Title
Treatment group B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-1316; Carboplatin; Etoposide；Radiotherapy
Intervention Description
SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）
Intervention Type
Drug
Intervention Name(s)
Palcebo; Carboplatin; Etoposide；Radiotherapy
Intervention Description
Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）
Primary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
up to 36 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:
Male or female, 18-75 years of age.
Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
ECOG PS 0~1.
At least 1 measurable lesion as defined by RECIST v1.1.
Adequate organ function.
Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
Signed the informed consent form.
Exclusion Criteria:
Mixed SCLC or NSCLC.
Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
Extensive-stage SCLC.
Subjects who is surgically resectable.
Subjects with malignant pleural effusion.
Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
Active, known, or suspected autoimmune diseases.
History of malignant tumors.
Subjects with severe cardiovascular disease.
Events of arterial/venous thrombosis within 6 months prior to the first dose.
Subjects with serious infection.
Subjects with active pulmonary tuberculosis (TB).
Subjects with immunodeficiency diseases.
Subjects with active hepatitis B virus or hepatitis C virus infection.
Systemic immunosuppressants administation within 14 days prior to the first dose.
Subjects who received major surgery within 28 days prior to the first dose.
Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
Subjects who have previously received tissue/organ transplants.
Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
Facility Information:
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
We'll reach out to this number within 24 hrs