Status:
UNKNOWN
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Small-cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2025
Estimated Enrollment :
486 Patients enrolled
Trial Details
Trial ID
NCT04691063
Start Date
January 22 2021
End Date
May 15 2025
Last Update
February 26 2021
Active Locations (1)
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1
Jilin Cancer Hospital
Changchun, Jilin, China, 130000