A Phase 2 interventional study of camrelizumab and Apatinib Mesylate in Small-cell Lung Cancer, sponsored by Chinese Academy of Medical Sciences. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
This single-arm, Phase II, multicenter study was designed to evaluate the safety and efficacy of Camrelizumab (anti-programmed death-receptor 1 [PD-1] antibody) in combination with Apatinib+carboplatin plus (+) etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be receive camrelizumab +apatinib+ carboplatin + etoposide on 21-day cycles for four -six cycles in the induction phase followed by maintenance with camrelizuab +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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 69 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Chinese Academy of Medical Sciences is the lead sponsor of 235 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
Induced stage:camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally +Etoposide (100mg/m2 IV continuously on Day 1, 2 and 3)+Carboplatin(AUC 5 mg/mL/min IV on Day 1 ; maintenance stage:Camrelizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus Apatinib capsules 250 mg given orally, once daily in 21-day cycle .
Drug: camrelizumab · Drug: Apatinib Mesylate · Drug: Carboplatin · Drug: Etoposide
Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
Also known as: SHR-1210
Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.
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 1-4/6).
Etoposide intravenous infusion was administered at a dose of 100 mg/m\^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).
Progression-Free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as at least 20% increase in the sum of the longest diameter of target lesions compared to baseline, or unequivocal progression in non-target lesion(s), or the appearance of new lesion(s).
Time frame: Baseline until PD or death, whichever occurs first (up to approximately 13 months)
Overall survival (OS)
Baseline until death from any cause
Time frame: up to approximately 20 months
Overall response rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) .
Time frame: up to 12 months
Disease control rate (DCR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 12 months
Duration of response(DOR)
For participants who demonstrate CR or PR, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first
Time frame: up to 12 months
PFS rate of 6 months progression-free survival
PFS rate of progression-free survival at 6 months: the percentage of subjects who did not develop disease progression or die of any cause at 6 months after beganing.
Time frame: up to 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Chinese Academy of Medical Sciences