This is a Phase Ⅰ/Ⅱa, multi-center, open-label study, aiming to evaluate the safety, tolerability, pharmacokinetic (PK), and efficacy of BR790 in combination with anlotinib in adult participants with advanced NSCLC.
This study is a Phase Ⅰ/Ⅱa, multi-center, open-label study of BR790 in combination with anlotinib with a dose escalation part followed by a dose expansion part in adult subjects with advanced NSCLC. Participants will be treated until disease progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
BR790 will be administered orally, variable dose on Day 1 of each 21-day cycle, Anlotinib will be administered as PO fixed dose on Day1-14 of each 21-day cycle
Maximum tolerated dose/Recommended Phase Ⅱ Dose(MTD/RP2D)
To evaluate the MTD/RP2D of BR790 in combination with anlotinib (Part 1)
Time frame: 2 years
Objective Response Rate (ORR)
To evaluate the objective response rate (ORR) of BR790 in combination with anlotinib. ORR is defined as the proportion of subjects who achieve a Complete Response (CR) or Partial Response (PR) as assessed by RECIST v1.1 (Part 2)
Time frame: 2 years
Progression-Free Survival (PFS)
PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first.
Time frame: 2 years
Duration of overall response (DOR)
DOR is defined as the time from the first documented CR or PR per RECIST v1.1 to disease recurrence or disease progression (PD) whichever occurs first.
Time frame: 2 years
Disease Control Rate(DCR)
DCR is defined as the proportion of subjects who achieve a Complete Response (CR) 、Partial Response (PR) or Stable Disease (SD) as assessed by RECIST v1.1
Time frame: 2 years
Overall Survival (OS)
OS is defined as the time from study treatment initiation to death from any cause or last day known to be alive.
Time frame: 2 years
Adverse Events(AEs)
Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values and vital signs for combination therapy
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Time frame: 2 years
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of BR790/anlotinib
Time frame: 2 years
Plasma concentration (Cmax)
Highest observed plasma concentration of BR790/anlotinib
Time frame: 2 years