Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 21
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled.
The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.
Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.
详细描述
The study ATHENEA is a phase II clinical trial intending to enroll 97 patients, who will receive Atezolizumab + Paclitaxel + Carboplatin as induction/neoadjuvant treatment. After the induction treatment all patients will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not.
Depending on the decision each patient will be treated in a different way.
The study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer.
The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population.
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death.
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
- •Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)
- •Confirm the absence of distant disease
- •ECOG (Performance status) 0-1
- •Adequate hematologic and organ function
- •All patients are notified of the investigational nature of this study and signed a written in-formed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention
- •Adequate lung function
- •Patients aged > 18 years
- •For female patients of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception
- •For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form of contraception
- •Oral contraception should always be combined with an additional contraceptive method
- •Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test result within 8 days prior to initiation of study drug.
- •Patient capable of proper therapeutic compliance and accessible for correct follow-up
排除标准
- •Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.
- •Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.
- •Weight loss >10% within the previous 3 months.
- •Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.
- •Malignancies other than Non Small-Cell Lung Cancer (NSCLC) within 3 years prior to enrolment
- •Pleural or pericardial effusion
- •Known hypersensitivity or allergy to atezolizumab formulation.
- •History of autoimmune disease or lung disease
- •Positive test for human immunodeficiency viruses (HIV)
- •Patients with active hepatitis B or hepatitis C or psitive for hepatitis C virus.
- •Active tuberculosis.
- •Symptomatic neuropathy grade > 1 according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0
- •Severe infections within 4 weeks prior to be included in the study
研究组 & 干预措施
Experimental: Neoadjuvant/Induction treatment
Neoadjuvant/Induction treatment prior to surgery:
- Atezolizumab
- Paclitaxel:
- Carboplatin
After assessment by a multidisciplinary team who will decide on the best post-induction treatment
干预措施: Atezolizumab (Drug)
Experimental: Neoadjuvant/Induction treatment
Neoadjuvant/Induction treatment prior to surgery:
- Atezolizumab
- Paclitaxel:
- Carboplatin
After assessment by a multidisciplinary team who will decide on the best post-induction treatment
干预措施: Paclitaxel (Drug)
Experimental: Neoadjuvant/Induction treatment
Neoadjuvant/Induction treatment prior to surgery:
- Atezolizumab
- Paclitaxel:
- Carboplatin
After assessment by a multidisciplinary team who will decide on the best post-induction treatment
干预措施: Carboplatin (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From the date of randomization until end of follow up, up to 60 months.
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
次要结局
- Resectability rate (%)(From the date of randomization until end of follow up, up to 60 months.)
- Pathological complete response (pCR)(From the date of randomization until end of surgery, up to 6 months)
- Overall survival (OS)(From the date of randomization until end of follow up, up to 60 months.)