The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A
|
Drug: SHR-1316; Carboplatin; Etoposide；Radiotherapy
SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）
|
| Placebo Comparator: Treatment group B
|
Drug: Palcebo; Carboplatin; Etoposide；Radiotherapy
Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）
|
Outcome Measures
Primary Outcome Measures
- OS [up to 36 months]
Overall Survival
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female, 18-75 years of age.
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Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
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ECOG PS 0~1.
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At least 1 measurable lesion as defined by RECIST v1.1.
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Adequate organ function.
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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.
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Signed the informed consent form.
Exclusion Criteria:
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Mixed SCLC or NSCLC.
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Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
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Extensive-stage SCLC.
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Subjects who is surgically resectable.
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Subjects with malignant pleural effusion.
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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.
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Active, known, or suspected autoimmune diseases.
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History of malignant tumors.
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Subjects with severe cardiovascular disease.
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Events of arterial/venous thrombosis within 6 months prior to the first dose.
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Subjects with serious infection.
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Subjects with active pulmonary tuberculosis (TB).
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Subjects with immunodeficiency diseases.
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Subjects with active hepatitis B virus or hepatitis C virus infection.
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Systemic immunosuppressants administation within 14 days prior to the first dose.
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Subjects who received major surgery within 28 days prior to the first dose.
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Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
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Subjects who have previously received tissue/organ transplants.
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Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
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Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jilin Cancer Hospital | Changchun | Jilin | China | 130000 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR-1316-III-302