Sequential hypofractionated radiotherapy followed by anti-PD-L1 atezolizumab for recurrent or refractory small cell lung cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0005443
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 35
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
Lymphocyte count = 500/µL
Serum albumin = 2.5 g/dL
Platelet count = 100,000/µL (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.
AST, ALT, and alkaline phosphatase = 2.5 x ULN with the following exceptions:
Patients with documented liver metastases: AST and/or ALT = 5 x ULN
Patients with documented liver or bone metastases: alkaline phosphatase = 5 x ULN
Serum bilirubin = 1.5 x ULN
Patients with known Gilbert’s disease who have serum bilirubin level = 3 x ULN may be enrolled.
INR and aPTT = 1.5 x 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 the first dose of atezolizumab.
Creatinine clearance = 30 mL/min
Cockcroft-Gault, CKD EPI, or MDRD formulas may be used for creatinine clearance calculation. Note that 24-hour urine collection is not required but is allowed.
8)Patient has given written informed consent which must be consistent with the International Conference on Harmonization – Good Clinical Practice (ICH-GCP) and local legislation
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
-No ongoing requirement for corticosteroids as therapy for CNS disease; anticonvulsants at a stable dose allowed
-No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to Cycle 1, Day 1
-No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study
Note: Patients with new asymptomatic CNS metastases detected at the screening scan must receive radiation therapy and/or surgery for CNS metastases. Following treatment, these patients may then be eligible without the need for an additional brain scan prior to enrollment, if all other criteria are met.
7)Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for =2 weeks prior to randomization
8)Leptomeningeal disease
9)Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
10)Uncontrolled tumor-related pain
-Patients requiring pain medication must be on a stable regimen at study entry.
-Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment.
-Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not presently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
11)Uncontrolled hypercalcemia (>1.5 mmol/L ionized calcium or Ca >12 mg/dL or corrected serum calcium >ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab
-Patients who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
-Patients who are receiving denosumab prior to enrollment must be willing and eligible to discontinue its use and replace it with a bisphosphonate instead while in the study.
12)Significant cardiovascular diseases (i.e., hypertension not controlled by medical therapy, unstable angina, history of myocardial infarction within the past 12 months, congestive heart failure > NYHA II, serious cardi
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective Response rate using RECIST v1.1
- Secondary Outcome Measures
Name Time Method Overall survival;Progression-free survival;Toxicity