a Study of SHR1210 in Combination With Paclitaxel-albumin and Carboplatin in Extensive Stage Small Cell Lung Cancer
Study Details
Study Description
Brief Summary
This project is to to explore the safety and efficacy of shr-1210 combined with albumin, paclitaxel and carboplatin in the first-line treatment of extensive small cell lung cancer
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR-1210+Paclitaxel-albumin+Carboplatin SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first day of each cycle, with intravenous drip. |
Drug: SHR-1210
SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
Other Names:
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Outcome Measures
Primary Outcome Measures
- 6-month PFS rate [up to 24 months]
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment
Secondary Outcome Measures
- Overall Response Rate (ORR) [Up to approximately 24 months]
Determined using RECIST v1.1 criteria
- Progression-Free Survival(PFS) [Up to approximately 24 months]
PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first. Patients who have not experienced disease progression or death at the time of analysis will be censored at the time of last tumor assessment.
- Overall Survival(OS) [Up to approximately 24 months]
Defined as the time from randomization to death from any cause
- Number of Subjects with treatment-related adverse events (AEs) [Up to approximately 24 months]
Incidence, nature, and severity of adverse events graded according to the NCI-CTC AE 5.0
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 75 years old
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Confirmed diagnosis of Extensive small cell lung cancer
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Eastern Cooperative Oncology Group performance status (PS) of 0 to 1
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The function of vital organs meets the following requirements. WBC ≥ 3.0 × 109/L, ANC≥1.5×109/L, PLT≥100×10^9/L, Hb≥9g/dL, ALT and AST ≤2.5 times ULN, TBIL ≤1.5 x ULN, CREA ≤1.5 x ULN or CCr≥50mL/min. INR≤1.5 x ULN, APTT ≤1.5 x ULN
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have not received first-line systemic therapy or immunosuppressive therapy for es-sclc
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The estimated survival period is more than 8 weeks
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The subjects voluntarily joined the study, signed informed consent,
Exclusion Criteria:
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Active or untreated CNS metastases were detected by computed tomography (CT) or magnetic resonance imaging (MRI);
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Leptomeningeal diseases
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Uncontrolled or symptomatic hypercalcemia
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Active, known or suspected autoimmune diseases
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have received any T cell co stimulation or immune checkpoint therapy
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Corticosteroids (> 10 mg / day prednisone or equivalent) or other immunosuppressants were used within 14 days before the first dose of study drug
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Subjects had active infections
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Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation
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Known to be allergic to the study drug or excipients, known to have a serious allergic reaction to any kind of monoclonal antibody; have a history of hypersensitivity to Paclitaxel-albumin or Carboplatin
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According to the researcher's judgment, there are other factors that may lead to the termination of the study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ES-SCLC-1st-IIT-SHR1210-naP-CB