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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 188
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients should be voluntarily sign the written informed consent.
- •Histologically or cytologically confirmed diagnosis of locally advanced or metastatic squamous NSCLC. Or recurrent squamous NSCLC according UICC/AJCC 8th edition.
- •At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated could be considered as a target lesion only in the condition that progression occurred at the time of 3 months after the end of radiotherapy.
- •Previously treated with one platinum based regimen (including platinum and endostar regimen) and progression occur during or after treatment or unbearable treatment related adverse events.
- •Progression after EGFR-TKIs in patients with driver gene mutation.
- •Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
排除标准
- •Patient who is allergic to recombinant humanized PD-1 monoclonal antibody or the components of the drug.
- •Patient who is allergic to taxane.
- •Previously treated with any of the antibodies targeted on PD-1, PD-L1, PD-2, CD137, CTLA-4, T cell, co-stimulation or drugs targeted on the checkpoint signal pathway.
- •Previously treated with docetaxel.
- •The histopathological subtype is not squamous cell non-small cell lung cancer, or squamous cell < 90% in a mixed carcinoma.
研究组 & 干预措施
SCT-I10A plus Docetaxel
SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles
干预措施: SCT-I10 (Drug)
SCT-I10A plus Docetaxel
SCT-I10A 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W. Maximum of 6 cycles
干预措施: Docetaxel (Drug)
Placebo puls docetaxel
Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles
干预措施: Docetaxel (Drug)
Placebo puls docetaxel
Placebo 200mg, I.V., Q3W; Docetaxel 70-75 mg per square meters of body surface area,I.V., Q3W Maximum of 6 cycles
干预措施: Placebo (Drug)
Maintenance therapy of SCT-I10A
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: SCT-I10A 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.
干预措施: SCT-I10 (Drug)
Maintenance therapy of Placebo
Subjects complete 2-6 cycles of combined therapies, when the evaluation result is CR, PR or SD (RECIST 1.1), the subjects will enter maintain therapy: Placebo 200mg, I.V., Q3W, till progression, loss to follow-up, new antineoplastic therapy or intolerable toxicity.
干预措施: Placebo (Drug)
结局指标
主要结局
Overall survival
时间窗: Up to approximately 3 years
OS is the time from the date of randomization to death due to any cause.
次要结局
- The concentration of anti-SCT-I10A antibodies in the serum of subjects(Up to approximately 3 years)
- The expression level of PD-L1 of subjects' specimens(Up to approximately 3 years)
- Cancer-specific quality of life of the regimens treated subjects(Up to approximately 3 years)
- Lung cancer-specific quality of life of the regimens treated subjects(Up to approximately 3 years)
- PFS(Up to approximately 3 years)
- OSR of 6 months, 12 months and 18 moths(Each subject that randomized will be followed up for 18 months to measure the OSR.)
- ORR(Up to approximately 3 years)
- DOR(Up to approximately 3 years)
- DCR(Up to approximately 3 years)