To evaluate the efficacy and safety of envafolimab combined with concurrent chemoradiotherapy in limited stage small cell lung cancer.
Envafolimab is the world's first subcutaneous injection of PD-L1 monoclonal antibody. Suitable for adult patients with advanced solid tumors with unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene defects (dMMR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin: Cisplatin: 75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 45Gy at a 95% PTV dose, with a single split dose of 3Gy, once a day, 5 times a week, for a total of 15 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
Envafolimab: 300mg SC d1,Q3W,2 cycles Cisplatin/carboplatin:Cisplatin:75 mg/m2 IV d1,Q3W ,2 cycles or Carboplatin:AUC=5/6 IV d1,Q3W,2cycles Etoposide: 100mg/m2 IV d1,Q3W ,2 cycles Radiotherapy: Provide a prescription dose of 60Gy at a 95% PTV dose, with a single split dose of 2Gy, once per day, 5 times per week, for a total of 30 times. Envafolimab maintenance: 300mg,SC, d1. Q3W, up to 2 years or until PD or intolerable.
2-year PFS rate
2-yaer progression-free survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
ORR
Objective Response Rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause up to 24 months.
DCR
Disease control rate
Time frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
DOR
Duration of response
Time frame: From date of randomization until the date of intolerance the toxicity or PD up to 24 months.
OS
Overall survival
Time frame: From date of randomization until the date of death(up to 24 months)
Adverse event rate Adverse event rate Adverse event rate
Number of participants with adverse events as a measure of safety and tolerability
Time frame: From date of randomization until the date of toxicity or PD (up to 24 months)
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