This prospective, randomized, controlled phase II study aims to evaluate the efficacy of combination therapy with Envafolimab and chemotherapy in first-line extensive stage SCLC, as well as the impact of Trilaciclib on the incidence of myelosuppression and anti-tumor effects in patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Etoposide: 80-100mg/m2, Q3W, intravenous infusion is administered on day 1, 2 and 3 of each cycle. Carboplatin: AUC=5, Q3W, intravenous infusion is administered on day 1 of each cycle.
Envafolimab: 300mg, Q3W, subcutaneous injection is administered on day 1 of each cycle.
Trilaciclib: 240mg/m2, Q3W, intravenous infusion should be completed within 4 hours before daily chemotherapy
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe incidence of grade ≥ 3 neutropenia during chemotherapy treatment
According to CTCAE5.0
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of ≥ grade 3 thrombocytopenia or anemia during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The duration of severe neutropenia in the first treatment cycle
Time frame: From enrollment to the end of Cycle 1 (each cycle is 21 days)
The incidence of febrile neutropenia during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of granulocyte colony-stimulating factor (PEG-G-CSF/G-CSF) during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
Disease burden of patients during chemotherapy
Based on EQ-5D-5L scales scores(The score range is from 5 to 25 points, with higher scores indicating better outcomes)
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of erythropoietin (ESA) during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of recombinant human interleukin-11 during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of thrombopoietin (TPO) during chemotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The usage rate of iron supplement during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of platelet transfusion during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
The incidence of red blood cell transfusion during chemotherapy
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
ORR
Objective response rate
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DCR
disease control rate
Time frame: From enrollment to the end of Cycle 6 (each cycle is 21 days)
DOR
Duration of response
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
PFS
Progression-Free-Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
OS
Overall survival
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months