A Phase II Study of Platinum and Etoposide Chemotherapy, Durvalumab With Thoracic Radiotherapy in the First Line Treatment of Patients With Extensive-stage Small-cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Safety of chemo-immunotherapy with concurrent thoracic radiotherapy
研究概览
简要总结
This is a prospective, multi-centre, single arm, phase 2, open label clinical trial of patients with untreated extensive-stage small-cell lung cancer (ES-SCLC) suitable for first-line platinum-based chemotherapy. The aim of the trial is to assess safety, feasibility and describe efficacy of the addition of concurrent thoracic radiotherapy to usual treatment of chemotherapy and immunotherapy (durvalumab) in patients with ES-SCLC.
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
- •Provided written informed consent
- •Histologically or cytologically documented ES-ECLC
- •Thoracic disease deemed suitable for radiation therapy following initial systemic therapy
- •If brain metastases present, then they are to be;
- •asymptomatic without steroid therapy may be included or
- •have required treatment (radiotherapy and/or surgery) and are clinically stable and patient is on a stable or reducing steroid dose of no more than dexamethasone 4mg/day (or equivalent)
- •Patients must be considered suitable to receive platinum-based chemotherapy regimen as first-line treatment for ES-SCLC
- •ECOG performance-status score of 0 or 1 at registration
- •Life expectancy ≥ 12 weeks at registration
- •Body weight > 30 kg
- •No prior exposure to immune-mediated therapy including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed cell death-1, anti-programmed cell death ligand-1, and anti-programmed cell death ligand-2 antibodies, excluding therapeutic anticancer vaccines
- •Adequate organ and marrow function as defined in the Protocol
- •Female patients who;
- •are willing to use adequate contraceptive measures until 90 days after the final dose of trial treatment
- •are not breast feeding
- •have a negative pregnancy test prior at registration if of child bearing potential or have evidence of non-child bearing potential by fulfilling the criteria as stated in the Protocol at screening
排除标准
- •Treatment with any of the following:
- •Concurrent chemotherapy (not relevant to patients registered prior to cycle 2 who will have received a cycle of platinum/etoposide chemotherapy), investigational product, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- •An investigational product during the last 4 weeks
- •High dose radiotherapy to the chest prior to systemic therapy precluding further thoracic radiation therapy. Radiation therapy outside of the chest for palliative care (i.e., bone metastasis) is allowed but must be completed before first dose of the trial medication
- •Immunosuppressive medication within 14 days before the first dose of durvalumab. Some exceptions apply
- •Live, attenuated vaccine within 30 days prior to the first dose of durvalumab
- •Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Durvalumab. Surgical procedures to obtain a lung cancer diagnosis or for palliation are allowed
- •Medical contraindication to, known allergy or hypersensitivity to durvalumab, etoposide, carboplatin (patients with allergy/hypersensitivity to carboplatin may receive cisplatin), cisplatin, or any of their excipients
- •History of allogeneic organ transplantation
- •Has a para-neoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS. Patients with hyponatraemia considered due to SIADH syndrome are eligible
- •Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis. Some exceptions apply
- •Interstitial lung disease/pulmonary fibrosis. Patients with emphysema and associated limited areas of pulmonary fibrosis are eligible
- •Uncontrolled intercurrent illness
- •History of another primary malignancy. Some exceptions apply
- •History of leptomeningeal carcinomatosis
- •History of active primary immunodeficiency
- •Patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab
研究组 & 干预措施
Treatment
Participants will receive Durvalumab concurrently with chemotherapy (etoposide with carboplatin or cisplatin) for 4 cycles.
干预措施: Thoracic Radiotherapy (Radiation)
Treatment
Participants will receive Durvalumab concurrently with chemotherapy (etoposide with carboplatin or cisplatin) for 4 cycles.
干预措施: Etoposide with Carboplatin or Cisplatin (Drug)
Treatment
Participants will receive Durvalumab concurrently with chemotherapy (etoposide with carboplatin or cisplatin) for 4 cycles.
干预措施: Durvalumab (Drug)
结局指标
主要结局
Safety of chemo-immunotherapy with concurrent thoracic radiotherapy
时间窗: From date of consent to 90 days after trial treatment is discontinued
Group 1 and Group 2 will be compared for the presence of toxicity, whereby the proportion of grade 3 or higher pneumonitis and grade 3 or higher oesophagitis will be monitored using the NCI Common Terminology Criteria for Adverse Events v5.
Feasibility of chemo-immunotherapy with concurrent thoracic radiotherapy
时间窗: From date of consent to 90 days after trial treatment is discontinued
Group 1 and Group 2 will be compared for the proportion of participants which received concurrent radiotherapy vs the proportion of participants which did not receive concurrent radiotherapy. The two groups will also be assessed by the proportion of participants in which discontinued thoracic radiotherapy.
次要结局
- Progression free survival(6 and 12 months)
- Overall Survival(12 months)
- Patterns of failure(From date of registration until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 152 weeks)
- Time to local failure and local control(6 and 12 months)