This is a phase 2 Study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic PD-L1 positive non-small cell lung cancer (NSCLC)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Daily dosing of golidocitinib
Sintilimab, 200mg, intravenous, every 3 weeks.
Pemetrexed or nab-paclitaxel +carboplatin, intravenous, every 3 weeks for 2 cycles
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Overall response rate (ORR) (cohort1)
Complete response (CR) or partial response (PR) per investigator assessment according to RECIST 1.1
Time frame: through study completion, an average of 1 year
Progression-free survival (PFS) (cohort2)
Time from first administration of study drug to first documented disease progression or death per investigator assessment according to RECIST 1.1
Time frame: through study completion, an average of 1 year
Overall survival (OS)
time from first administration of study drug to death
Time frame: through study completion, up to 36 months
Incidence of Adverse Events
Frequency an severity of AEs according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: through study completion, up to 36 months
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