The purpose of this study is to assess the safety and efficacy of Anlotinib (AL3818) combined with pembrolizumab (MK-3475) in treatment-naïve adults with no prior systemic therapy for advanced non-small cell lung cancer (NSCLC) whose tumors have a programmed cell death-ligand 1 (PD-L1) Tumor Proportion Score (TPS) greater than or equal to 1%. The primary study hypotheses is that the combination of Anlotinib and pembrolizumab is superior to pembrolizumab alone(historical data) as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGProgression-free Survival (PFS) as assessed by RECIST 1.1
PFS is defined as the time from date of enrollment to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first per RECIST 1.1.
Time frame: Up to approximately 24 months
Objective Response Rate (ORR) as assessed by RECIST 1.1
ORR is defined as the percentage of participants in the analysis population who have a Complete Response(CR) or a Partial Response(PR) per RECIST 1.1.
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) as assessed by RECIST 1.1
DCR is defined as the percentage of participants in the analysis population who have a CR, PR or stable disease per RECIST 1.1.
Time frame: Up to approximately 24 months
Overall Survival (OS)
OS is defined as the time from date of enrollment to date of death from any cause.
Time frame: Up to 12 months after last patient last visit
Progression Free Survival 2 (PFS2)
PFS2 will be defined as beginning with enrollment and ending with the first of the following events: a) death; b) disease progression on any treatment given after 1st progression. The determination of disease progression will be based on RECIST 1.1 criteria.
Time frame: Up to 12 months after last patient last visit
Toxicity Rate
Toxicity Rate is defined as the percentage of patients, relative to the total of enrolled subjects, experiencing adverse event (AE) including AE of all level, AE of grade 3/4, irAE
Time frame: Up to 12 months after last patient last visit
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