This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. The main endpoint is to compare the overall survival (OS) of these two regimens above.
Name: SCT-I10
Name: Docetaxel
Name: Placebo
Description: OS is the time from the date of randomization to death due to any cause.
Measure: Overall survival Time: Up to approximately 3 yearsDescription: PFS is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).
Measure: PFS Time: Up to approximately 3 yearsDescription: overall survival rate from the date of randomization till the 6 months,12 months and 18 months
Measure: OSR of 6 months, 12 months and 18 moths Time: Each subject that randomized will be followed up for 18 months to measure the OSR.Description: ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Measure: ORR Time: Up to approximately 3 yearsDescription: DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Measure: DOR Time: Up to approximately 3 yearsDescription: DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Measure: DCR Time: Up to approximately 3 yearsDescription: The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.
Measure: The concentration of anti-SCT-I10A antibodies in the serum of subjects Time: Up to approximately 3 yearsDescription: The expression level of PD-L1 of the subjects would be measure by immunohistochemical detection. The results would be used to analyze the correlation of PD-L1 level and outcomes including primary and secondary endpoints including OS, PFS, OSR, ORR, DOR and DCR.
Measure: The expression level of PD-L1 of subjects' specimens Time: Up to approximately 3 yearsDescription: European Organisation for Research and Treatment of Cancer (EORTC) cancer-specific quality of life questionnaire (EORTC QLQ-C30) will be applied in all subjects to collect the score of 30 items of subjects before and after study treatments. For the items from one to twenty-eight, the minimum and maximum scores are 28 and 112 respectively and the higher score means a worse outcome. For the items from twenty-nine to thirty, the minimum and maximum raw scores are 2 and 14 respectively and the higher score means a better outcome. Further analysis could be done based on the calculation.
Measure: Cancer-specific quality of life of the regimens treated subjects Time: Up to approximately 3 yearsDescription: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) will be applied in all subjects to collect the score of 13 specific typical symptoms of lung cancer patients before and after study treatments. The minimum and maximum raw scores are 12 and 52 respectively, the higher score means a worse outcome.
Measure: Lung cancer-specific quality of life of the regimens treated subjects Time: Up to approximately 3 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
A Multicenter Randomized Double-blinded Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of SCT-I10A or Placebo Plus Docetaxel in Treating Advanced Squamous Non-small Cell Lung Cancer. --- I10A ---
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. --- I10A ---
SCT-I10A or Placebo Plus Docetaxel With Previously Treated Squamous Cell Non-small Cell Lung Cancer This is a phase 3 double-blinded randomized multicenter clinical trial of SCT-I10A or placebo plus docetaxel with previously treated squamous cell non-small cell lung cancer patients. --- I10A --- --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects. --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.. --- I10A ---
The concentration of anti-SCT-I10A antibodies in the serum of subjects during or after the study treatments will be measured, its level could indicate the immunogenicity of SCT-I10A.. --- I10A --- --- I10A ---
Hence, we developed a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor monoclonal antibody (SCT-I10A) which inhibits the interaction between PD-1 and its ligands results in the reactivation of active T cell and finally leads to caner immunotherapy. --- I10A ---
We are now carrying out a phase 3 clinical trial to determine whether SCT-I10A plus docetaxel surpass docetaxel monotherapy with previously treated squamous-cell NSCLC patients. --- I10A ---
240 subjects would be treated with SCT-I10A plus docetaxel in the experimental arm while 120 subjects would be treated with placebo plus docetaxel in the active comparator arm. --- I10A ---