EUCTR2014-000336-42-IT进行中（未招募）1 期
A Phase III, Randomised, Double-blind, Placebo-controlled, Multi-centre, International Study of MEDI4736 as Sequential Therapy in Patients with Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) Who Have Not Progressed Following Definitive, Platinum-based, Concurrent Chemoradiation Therapy (PACIFIC) - PACIFIC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 880
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 histologically- or cytologically-documented NSCLC who present with locally advanced, unresectable (Stage III) disease
- •4. Patients must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy.
- •5. Patients must have not progressed following definitive, platinumbased, concurrent chemoradiation therapy.
- •6. Patients must provide an archival tumour sample.
- •7. Life expectancy =12 weeks
- •8. World Health Organization (WHO) Performance Status of 0 or 1
- •9. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients.
- •10. 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 484
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 396
排除标准
- •1. Participation in another clinical study with an investigational product 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 non-small cell lung cancer histology
- •4. Receipt of sequential chemoradiation therapy for locally advanced NSCLC
- •5. Patients with locally advanced NSCLC who have progressed whilst receiving definitive platinum based, concurrent chemoradiation therapy
- •6. Receipt of any immunotherapy, or investigational drug within 4 weeks prior to the first dose of study drug
- •7. Current or prior use of immunosuppressive medication within 28 days before the first dose of study drug, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Systemic steroid administration required to
- •manage toxicities arising from radiation therapy delivered as part of the chemoradiation therapy for locally advanced NSCLC is allowed.
- •8. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- •9. Any unresolved toxicity CTCAE >Grade 2 from the prior
- •chemoradiation therapy.
- •10. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study drug may be included (eg, hearing loss) after consultation with the AstraZeneca/MedImmune medical monitor.
- •11. Patients with any grade pneumonitis from prior chemoradiation therapy
- •12. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
- •13. Recent major surgery within 4 weeks
- •14. Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
- •15. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- •16. History of primary immunodeficiency
- •17. History of organ transplant that requires therapeutic
- •immunosuppression
- •18. History of hypersensitivity to MEDI4736 or any excipient
- •19. Uncontrolled intercurrent illness
- •20. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving study drug.
- •21. History of another primary malignancy within 5 years prior to starting study drug, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
- •22. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
- •23. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.
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