Toripalimab and JS004 Combined With Platinum-based Chemotherapy for Relapsed and Extensive-stage Small Cell Lung Cancer: a Single-center, Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
For extensive-stage small cell lung cancer (SCLC), platinum-chemotherapy (cisplatin or carboplatin) combined with etoposide as the first-line treatment is recommended. However, the recurrence rate is extremely high after the initial first-line treatment. For those who relapse or progress within more than six minths after the end of the-first-line treatment, chose the current guideline recommendation trearment plan has the poor prognosis. A new immunotherapeutic strategy is needed to achieve better anti-tumor effects. JS004 is a new antibody targeting B and T lymphocyte attenuator (BTLA), which restrains immune cells; function and leads to immune escape of tumor cells. The combination of PD-1 and BTLA antibodies has shown a good therapeutic effect in solid tumors. This trial aims to investigate the efficacy and safety of the therapeutic regimen of toripalimab and JS004 combined with platinum-based doublet chemotherapy in extensive-stage SCLC or relapsed within more than six months after radical treatment SCLC.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient shall sign the Informed Consent Form;
- •Aged 18 ≥ years;
- •Histological or cytological diagnosis of SCLC by needle biopsy or EBUS, and extensive stage or recurrent confirmed by imageological examinations or relapsed within more than six months after radical treatment SCLC;
- •Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1;
- •Life expectancy is at least 12 weeks;
- •At least 1 measurable lesion according to RECIST 1.1;
- •Patients with good function of other main organs (liver, kidney, blood system, etc.);
- •Fertile female patients must voluntarily use effective contraceptives from the start of the trial to within 30 days after its completion, and urine or serum pregnancy test results within 7 days prior to enrollment are negative;
- •Unsterilized male patients must voluntarily use effective contraception during the trial period and for 30 days after its conclusion.
排除标准
- •Patients with a malignancy other than SCLC within five years prior to the start of this trial;
- •Participants with any unstable systemic disease (including uncontrolled hypertension, severe arrhythmia, etc.);
- •With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
- •Participants who are allergic to the test drug or any auxiliary materials;
- •Participants with active hepatitis B, hepatitis C or HIV;
- •Participants with Interstitial lung disease currently;
- •Pregnant or lactating women;
- •Any malabsorption;
- •Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
- •Other factors that researchers think it is not suitable for enrollment.
研究组 & 干预措施
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
干预措施: Toripalimab (Drug)
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
干预措施: Etoposide (Drug)
Therapy With Toripalimab Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab until the disease progressed.
干预措施: Platinum (Drug)
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
干预措施: JS004 (Drug)
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
干预措施: Toripalimab (Drug)
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
干预措施: Etoposide (Drug)
Therapy With Toripalimab and JS004 Combined With Platinum-based Doublet Chemotherapy
In this arm, 50 patients with extensive-stage small cell lung cancer or relapsed within more than 6 months after SCLC radical treatment will receive 4 circles of toripalimab and JS004 combined with platinum-based doublet chemotherapy. Then patients received maintenance treatment with toripalimab and JS004 until the disease progressed.
干预措施: Platinum (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 60 months
It is defined as the time (months) from the first administration of drug in this study to the disease progression or death (including any cause of death in the case of no progression) as recorded in CRF, regardless of whether the patient exits from the treatment or receives other anti-cancer treatment before progression.
次要结局
- Objective response rate (ORR)(up to 30 months)
- Treatment-related adverse event (TRAE)(Up to 30 months)
- Overall survival (OS)(up to 60 months)
- Health related quality of life (HRQol)：EORTC-QLQ-C30(up to 5 months)
- Health related quality of life (HRQol)：LC13(up to 5 months)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China