EUCTR2019-000058-77-DE进行中（未招募）1 期
Prospective Phase-II Trial of induction chemotherapy and chemoradiotherapy plus/minus the PD-L1 antibody durvalumab followed by surgery or definitive chemoradiation boost and consolidation durvalumab in resectable stage III NSCLC - ESPADURVA
niversity Hospital Essen0 个研究点目标入组 90 人开始时间: 2019年8月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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. Body weight >30 kg
- •2. Age = 18 years and = 75 years
- •3. Male or female patients. Female (as well as male) patients have to take care of effective measures of anticonception
- •4. Histologically proven non-small cell lung cancer
- •5. Selected patients with non-small cell lung cancer stages IIIA and IIIB:
- •IIIA: one or more lymph node levels involved at EBUS/mediastinoscopy
- •IIIA: bulky N2-disease histologically proven at EBUS/cervical mediastinoscopy / parasternal mediastinotomy, not diffuse mediastinal involvement
- •selected IIIB: N3-disease with contralateral mediastinal nodes involved at EBUS / mediastinoscopy
- •potentially resectable T4-disease:
- •o involvement of the pulmonary artery (angiogr.-CT/MRI/TEE),
- •o involvement of the carina (histologically proven),
- •o involvement of the left atrium (angiogr.-CT/MRI/TEE),
- •o involvement of the vena cava (angiogr.-CT/MRI/TEE),
- •o involvement of ipsilateral intrapulmonary satellite nodules,
- •o mediastinal involvement (not diffuse)
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •7. Resectable disease at the time of inclusion
- •8. Fulfillment of adequate criteria for functional and medical resectability as described in the ERS/ESTS guidelines [Brunelli et al 2009] and acceptable general clinical condition for multimodality treatment (interdisciplinary committee)
- •9. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations
- •10. Must have a life expectancy of > 12 weeks
- •11. Adequate normal organ and marrow function as defined below:
- •o Haemoglobin = 9.0 g/dL
- •o Absolute neutrophil count (ANC) > 1.5 x 109/L (> 1500 per mm3)
- •o Platelet count = 100 x 109/L (= 100.000 per mm3)
- •o Serum bilirubin = 1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
- •o AST (SGOT)/ALT (SGPT) = 2.5 x institutional upper limit of normal
- •o Measured creatinine clearance (CL) > 40 mL/min or Calculated creatinine
- •CL > 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance
- •12. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause
- •13. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
- •14. Stable cardiac function (no Myocardial infarction (MI) within 6 months, no heart failure NYHA III-IV)
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. resectable IIB or selected IIIA
- •2. unresectable disease pre-treatment
- •3. mixed histology with areas of small cell carcinoma
- •4. clinically symptomatic vena cava superior syndrome
- •5. diffuse mediastinal involvement
- •6. patients with T3N3 and T4N3 tumors
- •7. invasion of the thoracic aorta
- •8. invasion of the heart
- •9. invasion of the esophagus
- •10. invasion of spine
- •11. Pancoast-syndrome in tumors of the superior sulcus
- •12. malignant pericardial effusion
- •13. malignant pleural effusion
- •14. involvement of the contralateral hilar nodes
- •15. endobronchial tumor extension to the contralateral main stem bronchus
- •16. ipsi- or contralateral supraclavicular nodes
- •17. lung or heart function not allowing at the time of inclusion the intended surgical procedure
- •18. previous administration of chemotherapy and/or radiotherapy within five years prior to
- •randomization
- •19. previous immunotherapy within five years prior to
- •randomization
- •20. insufficient patients compliance
- •21. loss of weight > 10 % in the last six months
- •22. missing written informed consent or definitive refusal for participation
- •23. Participation in another clinical study with an investigational product during the last 12 months
- •24. Concurrent enrolment in another clinical study, unless it is an observational clinical study or during the follow-up period of an interventional study
- •25. Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day
- •26. History of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT scan
- •27. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions is acceptable
- •28. Major surgical procedure within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
- •29. History of allogenic organ transplantation
- •30. History of a stem cell transplantation
- •31. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
- •32. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled diabetes, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
- •33. History of another primary malignancy
- •34. History of active primary immunodeficiency
- •35. Active infection including tuberculosis hepatitis B, hepatitis C, or human immunodeficiency virus. Patients with a past or resolved HBV infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- •36. Current or prior use of immunosuppres
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