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.
In 2015, there were near 787,000 patients diagnosed with lung cancer in China. And in the very same year, 631,000 lung cancer patients died of the disease. Lung cancer still causes most cancer related death in here. Approximately 85% of lung cancer is non-small cell lung cancer (NSCLC) compared with small cell lung cancer (\~15%) pathologically. NSCLC include squamous cell NSCLC, adenocarcinoma and large cell carcinoma. Although there are therapies developed to treat the condition, patients with advanced squamous-cell (NSCLC) who have disease progression during or after first-line chemotherapy have limited treatment options in China. 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. 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. As designed in the protocol, 360 eligible subjects would be randomized into two arms in a ratio of 2:1. 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. Both of these arms will be treated with maintenance therapy after planed treatments. Our primary endpoint is overall survival, secondary endpoints are PFS, OSR, ORR, DOR, DCR and other efficacy and safety index.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
188
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Overall survival
OS is the time from the date of randomization to death due to any cause.
Time frame: Up to approximately 3 years
PFS
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).
Time frame: Up to approximately 3 years
OSR of 6 months, 12 months and 18 moths
overall survival rate from the date of randomization till the 6 months,12 months and 18 months
Time frame: Each subject that randomized will be followed up for 18 months to measure the OSR.
ORR
ORR is the proportion of subjects with CR or PR based on RECIST v1.1.
Time frame: Up to approximately 3 years
DOR
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.
Time frame: Up to approximately 3 years
DCR
DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST v1.1.
Time frame: Up to approximately 3 years
The concentration of anti-SCT-I10A antibodies in the serum of subjects
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.
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Time frame: Up to approximately 3 years
The expression level of PD-L1 of subjects' specimens
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.
Time frame: Up to approximately 3 years
Cancer-specific quality of life of the regimens treated subjects
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.
Time frame: Up to approximately 3 years
Lung cancer-specific quality of life of the regimens treated subjects
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.
Time frame: Up to approximately 3 years