A Multicenter, Phase 2 Clinical Trial Based on an Adaptive Design to Evaluate the Safety and Efficacy of Nelmastobart in Combination with Docetaxel in Patients with Advanced/Metastatic Non-Small Cell Lung Cancer Who Are Resistant or Intolerant to Platinum-based Chemotherapy and/or Immunotherapy
This is a singble arm, open label, phase 2 study to evaluate safety and preliminary efficacy for Nelmastobart 800mg and docetaxel 75mg/m2 combination regimen for both AGA negative and positive NSCLC patients who have failed at least 1 line of treatment including platinum based chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Nelmastobart 800mg and Docetaxel 75mg/m2
The Catholic University of Korea St. Vincent's Hospital
Gyeonggi-do, South Korea
NOT_YET_RECRUITINGKangbuk Samsung Hospital
Seoul, South Korea
RECRUITINGKorea University Anam Hospital
Seoul, South Korea
NOT_YET_RECRUITINGProgression free survival by central reviewer
Time from first dose until the date of objective disease progression or death assessed by central reviewer
Time frame: up to 3 years
Overall survival
Time from first dose of study drug until the date of death
Time frame: up to 3 years
Progression Free Survival assessed by Investigator
Time from first dose until the date of objective disease progression or death
Time frame: Up to 3 years
Objective response rate, ORR
Proportional of subjects with confirmed PR/CR, assessed by investigator and central reviewer
Time frame: Up to 3 years
Disease control rate, DCR
Proportion of subjects with confirmed CR, PR, and SD assessed by investigator and central reviewer based on RECIST v1.1
Time frame: Up to 3 years
Duration of Response
Time from the date of first objective response (CR or PR) after investigational drug administration to the first documented disease progression (PD) or death from any cause, with documentation of disease progression status and cause of death, assessed by investigator and central reviewer based on RECIST v1.1
Time frame: Up to 3 years
Progression free survival rate
the proportion of patients without documented progression and alive 6 months after the first dose of study drug
Time frame: 6 month
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Samsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Bundang Hospital
Seoul, South Korea
NOT_YET_RECRUITINGCmax
Maximum plasma concentration
Time frame: 3 weeks
Area under concentration-time curve
Area under the concentration-time curve during steady state
Time frame: 15 weeks
Adverse event
Incidence and severity of AE determined according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version \[v\] 5.0
Time frame: time from the date of the first dose of study drug until 30 days after last dose