A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Number of Patients With Adverse Events (AEs) Grade ≥ 3
研究概览
简要总结
This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.
详细描述
This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.
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
- 是
入选标准
- •Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
- •Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
- •Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
- •Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
- •ECOG Performance Status of 0-2 at enrolment.
- •No prior exposure to immune-mediated therapy for cancer.
- •Adequate hematologic and organ function.
- •Life expectancy of at least 12 weeks.
- •Body weight >30 kg.
排除标准
- •Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
- •Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
- •Active infection including tuberculosis, HIV, hepatitis B anc C
- •Active or prior documented autoimmune or inflammatory disorders
- •Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
研究组 & 干预措施
Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
干预措施: Durvalumab (Drug)
Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
干预措施: Cisplatin (Drug)
Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
干预措施: Etoposide (Drug)
Durvalumab in Combination with Platinum-Etoposide
Durvalumab 1500 mg via IV infusion will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of Patients With Adverse Events (AEs) Grade ≥ 3
时间窗: During study treatment, until disease progression (median 6 months)
Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0
Number of Patients With Immune-mediated Adverse Events (imAE)
时间窗: During study treatment, until disease progression (median 6 months)
Patients with immune-mediated adverse events (imAE) per patient
次要结局
- Progression Free Survival (PFS).(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years)
- Objetive Response Rate (ORR)(At least every 12 weeks, up to 18 monts)
- Duration of Response (DoR)(From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.)
- Time to Treatment Discontinuation (TTD)(From the first date of treatment until the end of treatment date, assessed up to 2 years.)
- Overal Survival (OS)(From date of inclusion until the date of death, assessed up to 30 months)
- PFS Rate at 6 Months(Every 12 weeks)
- PFS Rate at 12 Months(Every 12 weeks)
- DoR Rate at 12 Months(Every 12 weeks)
- OS Rate at 6 Months(Every 12 weeks)
- OS Rate at 12 Months(Every 12 weeks)
- OS Rate at 18 Months(Every 12 weeks)
- EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)
- EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit(Baseline (cycle 1 day 1) and end of treatment visit.)