KCT0005443
Active, not recruiting
未知
Sequential hypofractionated radiotherapy followed by anti-PD-L1 atezolizumab for recurrent or refractory small cell lung cancer
ational Cancer Center0 sites35 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Cancer Center
- Enrollment
- 35
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\)Male or female patient aged 18 years or older
- •2\)Histologically confirmed SCLC and available tumor tissues for PD\-L1 staining
- •3\)Progression during or after platinum\-based chemotherapy.
- •4\)At least one target tumor lesion that has not been irradiated within the past three months and that can accurately be measured in at least one dimension with longest diameter
- •\=10 mm (by CT scan, MRI, caliper measurement) or \=20 mm (by chest X\-ray). (RECIST 1\.1\)
- •5\)Life expectancy of at least three months
- •6\)Performance status of 0, 1, 2 on the ECOG criteria
- •7\)Adequate hematologic and end\-organ function, defined by the following laboratory results obtained within 14 days prior to the first dose of atezolizumab:
- •ANC \=1500 cells/µL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility)
- •WBC counts \= 2500/µL
Exclusion Criteria
- •1\)Previous therapy with anti\-PD\-1 or –PD\-L1 inhibitors
- •2\)Persistence of clinically relevant therapy related toxicities from previous chemotherapy and/or radiotherapy
- •3\)Chemotherapy, treatment with tyrosine kinase inhibitors, or radiotherapy (except for brain and extremities) within the past 3 weeks prior to treatment with the trial drug i.e., the minimum time elapsed since the last anticancer therapy and the first radiotherapy must be 3 weeks
- •4\)Treatment with other investigational drugs or treatment in another clinical trial within the past three weeks before start of therapy or concomitantly with this trial
- •5\)Concomitant yellow fever vaccination
- •6\)Active or untreated CNS metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- •Patients with a history of treated asymptomatic CNS metastases are eligible, provided they meet all of the following criteria:
- •\-Measurable disease outside the CNS
- •\-Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons, cerebellum, medulla, or spinal cord)
- •\-No history of intracranial hemorrhage
Outcomes
Primary Outcomes
Not specified
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