This is a Phase I/IIa dose-finding (Phase I) followed by randomized, double-blind, placebo-controlled, parallel, add-on to cisplatin + docetaxel (Phase IIa) study to evaluate the safety, tolerability, and efficacy profiles of Careseng 1370 in subjects with advanced NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
4,000mg granules in sachet
4,000mg granules in sachet
Maximum change of absolute neutrophil count (ANC) up to End of Treatment visit
End of Treatment will be Day 85
Time frame: Day 1, 8, 15 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Proportion of subjects with anemia, neutropenia, or thrombocytopenia of all grades at post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in white blood cell (WBC) count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in platelet count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in red blood cell (RBC) count from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in serum C-reactive protein (CRP) level from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Maximum change and by visit change in absolute neutrophil count (ANC) from baseline to post-treatment visits
Time frame: Day 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85
Objective response rate (ORR) defined as the proportion of subjects with CR or PR as best overall response evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
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Disease control rate (DCR) defined as the proportion of subjects with CR, PR, or SD as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
Proportion of subjects with complete response (CR), partial response (PR), stable disease (SD), and progression disease (PD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results
Time frame: Day 1, 43, 85
Change in quality of life assessed by the Functional Assessment of Cancer Therapy Lung Cancer (FACT-L) total score from baseline to post-treatment visits
FACT-L total score ranges from 0 to 144. Higher values represent a worse outcome
Time frame: Day 1, 22, 43, 64, 85