A Phase II, Open-label, Multicentre, Single-arm Study of Durvalumab Plus Oleclumab in Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy (LADOGA)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 30
- 试验地点
- 11
- 主要终点
- Progression free survival (PFS) at 12 months
研究概览
简要总结
The purpose of this Phase II, open-label, multicentre, single-arm study is to assess efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) in participants with locally advanced (Stage III), unresectable non-small cell lung cancer (NSCLC), who have not progressed following platinum-based concurrent or sequential chemoradiotherapy (cCRT or sCRT).
详细描述
This is a Phase II, open-label, multicentre, single-arm study assessing the efficacy and safety of durvalumab in combination with oleclumab in participants with locally advanced (Stage III), unresectable NSCLC with WHO performance status of 0 or 1, who have not progressed on prior platinum-based CRT.
All participants will be assigned to receive durvalumab and oleclumab as an IV infusions for up to 12 months (last dose should be administered at week 48). The last administration at Week 48, or until clinical progression, confirmed RECIST 1.1-defined radiological progression, unacceptable toxicity, withdrawal of consent, or an intervention discontinuation criterion is met.
The results of this study will provide clinical data on efficacy and safety of an innovation treatment in the new region - Russian Federation.
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
- •Participant must be ≥ 18 years at the time of screening.
- •Histologically-documented NSCLC and have been treated with concurrent or sequential CRT for locally advanced, unresectable (Stage III) disease.
- •Documented tumour PD-L1 status by qualified lab (local or central).
- •Documented EGFR and ALK wild-type status (local or central).
- •Patients must not have progressed following definitive, platinum based, concurrent or sequential chemoradiotherapy.
- •Participants must have received at least 2 cycles of platinum-based chemotherapy before or concurrent with radiation therapy.
- •Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be enrolled. Radiation therapy should be administered by intensity modulated RT/volumetric modulated arc therapy (preferred) or 3D-conforming technique.
- •WHO performance status of 0 or
- •Adequate organ and marrow function.
排除标准
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
- •Mixed small cell and non-small cell lung cancer histology.
- •Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based CRT.
- •Any unresolved toxicity CTCAE >Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- •Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- •History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to study treatment assignment. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis.
- •Active or prior documented autoimmune or inflammatory disorders (with exceptions).
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
研究组 & 干预措施
Arm 1
durvalumab plus oleclumab as an IV infusions
干预措施: Oleclumab (Drug)
Arm 1
durvalumab plus oleclumab as an IV infusions
干预措施: Durvalumab (Drug)
结局指标
主要结局
Progression free survival (PFS) at 12 months
时间窗: From date of first dose until 12 months
PFS12 is defined as the Kaplan-Meier estimate of PFS at 12 months per RECIST 1.1 as assessed by the investigator.
次要结局
- Progression free survival (PFS) at 6, 18, and 24 months(From date of first dose until 24 months)
- Progression Free Surival (PFS)(Up to 24 months after the last patient's first dose)
- Overall survival (OS) at 12 and 24 months(From date of first dose until 12 and months, respectively)
- Overall Survival (OS)(Up to 24 months after the last patient's first dose)
- Objective response rate (ORR)(Up to 24 months after the last patient's first dose)
- Duration of response (DoR)(Up to 24 months after the last patient's first dose)
- Time to Response (TTR)(Up to 24 months after the last patient's first dose)