A Prospective Study to Evaluate the Safety of Concurrent Durvalumab (MEDI4736) With Chemoradiation Therapy（CRT）Followed by Durvalumab for Chinese Unresectable Stage III Non Small Cell Lung Cancer（NSCLC）
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Grade ≥3 immune-mediated Adverse event
研究概览
简要总结
This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
详细描述
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subjects with histologically or cytologically-documented NSCLC
- •Locally advanced, unresectable (Stage III) NSCLC
- •World Health Organization (WHO) performance status 0-1
- •At least one measurable lesion, not previously irradiated
- •Must have a life expectancy of at least 12 weeks at randomization
- •Adequate lung function: Pre- or post-bronchodilator forced expiratory volume 1 of 1.0 L or >40% predicted value and DLCO >30% predicted value
- •Must provide an archived tumor tissue block(or at least 15 newly cut unstained slides)≤3 years old; if archived sample unavailable then must provide a recent(≤3 months) tumor biopsy.
排除标准
- •Mixed small-cell and NSCLC histology
- •Receipt of prior or current cancer treatment, including but not limited to, radiation therapy, investigational agents, chemotherapy, Durvalumab and mAbs.
- •Prior exposure to immune-mediated therapy, including but not limited to, other anti- CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies.
- •Patients whose radiation treatment plans are likely to encompass a volume of whole lung receiving ≥20 Gy in total (V20) of more than 35% of lung volume
- •Planned radiation cardiac dose V50>25%
- •Any medical contraindication of platinum-based doublet chemotherapy as listed in the local labelling or known allergy/hypersensitivity to investigational product and/or its excipients
- •History of the following: allogeneic organ transplantation, active or prior autoimmune or inflammatory disorders, another primary malignancy, leptomeningeal carcinomatosis, active primary immunodeficiency
- •Uncontrolled intercurrent illness or active infection
研究组 & 干预措施
Durvalumab + platinum-based chemotherapy and radiation
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
干预措施: Durvalumab (Drug)
Durvalumab + platinum-based chemotherapy and radiation
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
干预措施: Carboplatin/ Paclitaxel (Drug)
Durvalumab + platinum-based chemotherapy and radiation
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
干预措施: Pemetrexed/ Cisplatin (Drug)
Durvalumab + platinum-based chemotherapy and radiation
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
干预措施: Pemetrexed/ Carboplatin (Drug)
Durvalumab + platinum-based chemotherapy and radiation
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy:
cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment.
干预措施: Radiation (Radiation)
结局指标
主要结局
Grade ≥3 immune-mediated Adverse event
时间窗: From the date of first dose until disease progression,assessed up to 4 years
Grade ≥3 immune-mediated Adverse event
次要结局
- Objective response rate(ORR)(From the date of first dose until the date of objective disease progression or death,assessed up to 4 years)
- Time to death or distant metastasis(TTDM)(From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years)
- Overall Survival (OS)(From the date of first dose until death due to any cause,assessed up to 4 years)
- Duration of response(DOR)(From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years)
- Progression-free survival (PFS)(From date of first dose until the date of objective disease progression or death,assessed up to 4 years)
- Disease control rate(DCR)(From the date of first dose until 24 weeks.)
研究者
Jinming Yu
Professor
Shandong Cancer Hospital and Institute