PD-L1 Inhibitor Rechallenge After PD-1 Immunotherapy for Patients With Solid Tumor Beyond Lung Cancer
Study Details
Study Description
Brief Summary
Anti-PD-L1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with ES-SCLC in combination with etoposide and either carboplatin or cisplatin in China. The clinical data regarding the PD-L1 inhibitor in other solid tumors are limited.Investigators would observe and analyze the effectiveness and safety of PD-L1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of PD-L1 inhibitor rechallenge after PD-1immunotherapy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PD-L1 rechallenge
|
Drug: PD-L1 inhibitor
Enrolled patients received durvalumab/ Atezolizumab plus chemotherapy or target therapy treatment (durvalumab,1000mg，iv, d1, 21day as a cycle; Atezolizumab,1200mg iv, d1, 21day as a cycle.)
|
Outcome Measures
Primary Outcome Measures
- DCR [At the end of Cycle 3 (each cycle is 21 days)".]
Disease Control Rate
- PFS [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months]
progression-free survival
Secondary Outcome Measures
- OS [From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months]
overall survival
- AE [hrough study completion, an average of 1 year]
adverse event caused by the treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed Informed Consent Form
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Ability to comply with protocol
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Aged ≥ 18 years
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Histologically documented advanced solid tumor beyond lung cancer
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Disease progression during or following at least one line treatment containing PD-1 immunotherapy.
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Measurable disease, as defined by RECIST v1.1
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ECOG performance status of 0 or 1
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Life expectancy ≥ 12 weeks
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Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment:
ANC ≥ 1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) WBC counts > 2.5 × 109/L and < 15 × 109/L Lymphocyte count ≥ 0.5 × 109/L Serum albumin ≥ 2.5 g/dL Platelet count ≥ 100 × 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility) Hemoglobin ≥ 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion.
Liver function tests meeting one of the following criteria:
AST or ALT ≤ 2.5 × upper limit of normal (ULN), with alkaline phosphatase
≤ 2.5 × ULN or AST and ALT ≤ 1.5 × ULN in conjunction with alkaline phosphatase > 2.5 × ULN Serum bilirubin ≤ 1.5 × ULN Patients with known Gilbert's disease who have serum bilirubin level ≤ 3 × ULN may be enrolled. INR and aPTT ≤ 1.5 × ULN This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. Creatinine clearance ≥ 30 mL/min Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration, or Modification of Diet in Renal Disease formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
Exclusion Criteria:
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Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
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Leptomeningeal disease
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Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
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Uncontrolled hypertension
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Autoimmune disease
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Had undergone a serious anaphylactic reaction in previous immunotherapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- The Affiliated Hospital of Qingdao University
Investigators
- Principal Investigator: Xiaochun Zhang, Prof, The Affiliated Hospital of Qingdao University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PDL1-BEY-LUNG