NCT03195569|UnknownFDA Drug
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Sponsor study identifier
observational
15
1 country
1
Study Start
March 1, 2017
Actual (reported)Primary Completion
June 12, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To reveal changes of peripheral markers and blood perfusion parameters in vivo tumor in the study of QL1101 and Avastin® in patients with Non-squamous Non-small Cell Lung Cancer
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 1, 2017
Actual (reported)June 20, 2017
Actual (reported)June 22, 2017
Actual (reported)June 12, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objective response rate
The actual endpoint is best response seen during the study
18 weeks
Number of circulating endothelial cell subsets
To detect the number of circulating activated endothelial cell (aCECs) by flow cytometry
different time points before and after one week of treatment of QL1101 or avastin, an expected average of 2 weeks
The strength of intratumoral blood perfusion index(BV,BF,PS and MTT)
different time points before and after 3 weeks of treatment QL1101 or avastin, an expected average of 6 weeks
Disease control rate
3 months, 6 months, 9 months, 1 year
Treatment-emergent adverse events
18 week
QL1101 + paclitaxel/carboplatin:subjects are given 15 mg/kg QL1101 on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.
Avastin® + paclitaxel/carboplatin:subjects are given 15 mg/kg Avastin® on Day 1 of each cycle with every 3 weeks as a cycle, respectively combined with paclitaxel/carboplatin for 6 cycles.
The patients with Non-squamous Non-small Cell Lung Cancer,who should meet the eligibility criteria.Because the study is QL1101-002 additional research, all people meet QL1101-002 clinical research requirements
Tianjin Medical University Cancer Institute and Hospital
Tainjin, China
First Submitted
June 20, 2017
First Posted
June 22, 2017
Study Start
March 1, 2017
Actual (reported)Primary Completion
June 12, 2018
Estimated (date passed)175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 10, 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 22, 2017
Record last verified: 2017-06
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Source: ClinicalTrials.gov.
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