A Phase 2 interventional study of Anlotinib and Nivolumab in Non Small Cell Lung Cancer, sponsored by The First Affiliated Hospital with Nanjing Medical University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-26.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment
This study evaluates the safety and efficacy of anlotinib in combination with nivilumab as second-line treatment in advanced NSCLC patients. The primary endpoint of the study is progression-free survival (PFS);the secondary endpoints are disease control rate (DCR), objective response rate (ORR), overall survival (OS) and safety.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Anlotinib · Drug: Nivolumab
Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
Nivolumab will be given at a dose of 240 mg every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
Time frame: 6 months
Objective Response Rate (ORR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Disease control rate (DCR)
Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time.
Time frame: 12 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Until 30 day safety follow-up visit
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University