A Phase 2 interventional study of Sunvozertinib combination with Anlotinib in NSCLC, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
The study will evaluate the efficacy and safety of treatment with sunvozertinib in combination with Anlotinib in patients whose disease has progressed following first-line EGFR-TKIs treatment.
Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Any of the following cardiac criteria:
i) Mean resting QTc >470 msec ii) Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram iii) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events
Drug: Sunvozertinib combination with Anlotinib
Sunvozertinib 300 mg once daily (QD) with Anlotinib 12mg once daily (QD in Day 1-14) ,21 days in one cycle.
ORR
Objective response rate (ORR) as assessed by the investigator according to RECIST 1.1 criteria.
Time frame: initiate from first dose until the date of confirmed response, assessed up to 24 weeks
PFS
PFS as assessed by the investigator according to RECIST 1.1
Time frame: initiate from first dose, every 6 weeks until PD or study close, an average of 1 year
OS
initiate from first dose to death from any cause
Time frame: through study completion, an average of 1.5 years
DoR
The period from the first judgment of CR or PR to PD
Time frame: an average of 1 year
AE
TRAE as assessed by the investigator according to CTCAE 5.0
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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