This single arm, open label, single center, prospective study was designed to evaluate the safety and efficacy of Sequential Therapy of Camrelizumab (humanized monoclonal antibody against Programmed death 1 \[PD-1\] ) in combination with Chemotherapy(Irinotecan plus Platinum)and with Apatinib (selective Vascular Endothelial Growth Factor Receptor 2(VEGFR-2) tyrosine kinase inhibitor \[TKI\]) in chemotherapy-naive participants with SCLC. Participants will receive Camrelizumab + Irinotecan + Platinum on 21-day cycles for 4-6 cycles in the induction phase followed by maintenance with Camrelizumab + Apatinib until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6) and maintenance phase (Cycle onward).
Carboplatin: Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6). Cisplatin: Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
Irinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m\^2) on Day 1,8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
Apatinib was administered at a dose of 250 mg during the maintenance phase.
Beijing Union Medical College Hospital
Beijing, China
RECRUITINGProgression-free Survival (PFS) as assessed by RECIST 1.1
PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.
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 2 years.
Duration of Overall Survival (OS)
OS is defined as the time from date of enrollment to date of death from any cause.
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 2 years.
Disease Control Rate (DCR) as assessed by RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Time frame: through study completion, an average of 2 year.
Objective Response Rate (ORR) as assessed by RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response(CR) or a Partial Response(PR) per RECIST 1.1.
Time frame: through study completion, an average of 2 year.
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Time frame: through study completion, an average of 2 year.
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