EUCTR2017-002208-28-DE进行中（未招募）1 期
An Open-Label, Multi-Drug, Biomarker-Directed, Multi-Centre Phase II Umbrella Study in Patients with Non-Small Cell Lung Cancer, who Progressed on an anti-PD-1/PD-L1 Containing Therapy (HUDSON). - HUDSO
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 570
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- At least 18 years of age at the time of signing the informed consent form.
- •- Patient must have histologically or cytologically confirmed metastatic or locally advanced and recurrent NSCLC which is progressing.
- •- Patients eligible for second- or later-line therapy, who must have received an anti PD 1/PD-L1 containing therapy and a platinum-doublet Regimen for locally advanced or metastatic NSCLC either separately or in combination. Prior durvalumab is acceptable. The patient must have had disease progression on a prior anti-PD-1/PD-L1 therapy.
- •- Suitable for a new tumour biopsy. For Module 10 and Module 11 only:
- •If in agreement with the sponsor study physician, a patient may be exempt from a biopsy at pre-screening if a tumour tissue sample is obtained after progression on prior anti-PD-(L)1 therapy and = 3 months prior to pre-screening; a tumour sample taken within the previous 24 months is acceptable if no such sample is available.
- •- ECOG/WHO performance status of 0 to 1, and a minimum life expectancy of 12 weeks.
- •- Patient must have at least 1 lesion that can be accurately measured. A previously irradiated lesion can be considered a target lesion if the lesion has clearly progressed.
- •- Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 285
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 285
排除标准
- •Exclusion Criteria:
- •- Patients whose tumour samples have targetable alterations in EGFR and/or ALK are excluded. In addition, patients whose tumour samples are known to have targetable alterations in ROS1, BRAF, MET or RET, are to be excluded.
- •- Active or prior documented autoimmune or inflammatory disorders.
- •- Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
- •- Female patients who are pregnant or breastfeeding, or male or female patients of reproductive potential who are not willing to employ effective birth control.
- •- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients or history of severe hypersensitivity reactions to other monoclonal antibodies.
- •- Patient has spinal cord compression or symptomatic brain metastases.
- •- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Patients may receive treatment with bisphosphonates or receptor activator of nuclear factor kappa-? ligand (RANKL) inhibitors for the treatment of bone metastases.
- •-history of active primary immunodeficiency
研究者
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