EUCTR2013-005427-16-AT进行中（未招募）1 期
A Phase II, Non-comparative, Open label, Multi-centre, International Study of MEDI4736, in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior Systemic Treatment Regimens Including One Platinum-based Chemotherapy Regimen (ATLANTIC) - ATLANTIC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
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
- •1. Provision of signed, written and dated informed consent prior to any study specific procedures
- •2. Male or female aged 18 years or older
- •3. Patients must have EITHER
- •Histologically- or cytologically-documented NSCLC, OR
- •Recurrent or progressive disease following multimodal therapy for locally advanced disease
- •4. Patients must have received at least 2 prior systemic treatment regimens for treatment of NSCLC
- •5. Patients must have experienced disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional systemic therapy
- •6. Patient’s tumour sample must be PD-L1 positive with =25% of tumour cells with membrane staining (Cohorts 1 and 2) or PD-L1 positive with =90% of tumour cells with membrane staining (Cohort 3).
- •7. Patients must have measurable disease
- •8. Life expectancy =12 weeks at Day 1
- •9. World Health Organisation (WHO) Performance Status of 0 or 1
- •10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
- •11. Adequate organ and marrow function
- •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 594
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 806
排除标准
- •1. Participation in another clinical study with an investigational product (IMP) during the last 4 weeks
- •2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- •3. Mixed small cell and NSCLC histology
- •4. Receipt of any immunotherapy, or IMP within 4 weeks prior to the first dose of study drug
- •5. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •6. Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
- •7. Any prior Grade =3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- •8. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
- •9. Receipt of radiation therapy within 4 weeks prior to starting MEDI4736, or limited field of radiation for palliation within 2 weeks of the first dose of MEDI4736
- •10. Recent major surgery within 4 weeks
- •11. Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
- •12. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- •13. History of primary immunodeficiency
- •14. History of allogeneic organ transplant
- •15. History of hypersensitivity to MEDI4736 or any excipient
- •16. Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
- •17. Uncontrolled intercurrent illness
- •18. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving MEDI4736
- •19. History of another primary malignancy except for:
- •Malignancy treated with curative intent and with no known active disease =5 years before the first dose of study drug and of low potential risk for recurrence
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ.
- •20. Female patients who are pregnant or breast-feeding. Male or female patients of reproductive potential who are not using an effective method of birth control
- •21. Any condition that, in the opinion of the investigator, would interfere with evaluation of MEDI4736 or interpretation of patient safety or study results
- •22. Absence of a tumour sample (archival and recent).
研究者
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