NL-OMON55743招募中不适用
A Phase Ib, Open-label, Single-center study to assess the safety of cancer-immunotherapy induction with Tremelimumab and Durvalumab prior to Chemoradiotherapy and/or Resection in the treatment of locally advanced NSCLC. - Induction-1 trial
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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. WHO performance status of 0 or 1.
- •4. Pathologically proven NSCLC stage III or inoperable stage II (cT1-3N0-1),
- •according to the 8th edition of the AJCC staging, with a clinical indication
- •for concurrent chemo-irradiation.
- •5. Body weight >30kg
- •6. Patients with locoregional recurrent lung tumour following surgery or a
- •second primary cancer are eligible, unless a pneumonectomy was performed.
- •7. Negative pregnancy test (urine or serum) for female patients with
- •childbearing potential;
- •8. For women of childbearing potential: agreement to remain abstinent (refrain
- •from heterosexual intercourse) or use contraceptive methods that result in a
- •failure rate of <= 1% per year, during the treatment period and for at least 180
- •days after the last dose of Durvalumab and Tremelimumab combination therapy or
- •1 month after the last dose of chemotherapy, whichever is later.
- •A woman is considered to be of childbearing potential if she is postmenarcheal,
- •has not reached a postmenopausal state (>=12 continuous months of amenorrhea
- •with no identified cause other than menopause), and has not undergone surgical
- •sterilization (removal of ovaries and/or uterus).
- •Examples of contraceptive methods with a failure rate of <= 1% per year include
- •bilateral tubal ligation, male sterilization, established proper use of
- •hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine
- •devices (IUDs), and copper IUDs.
- •The following age-specific requirements apply:
- •- Women <50 years of age would be considered post-menopausal if they have been
- •amenorrheic for 12 months or more following cessation of exogenous hormonal
- •treatments and if they have luteinizing hormone and follicle-stimulating
- •hormone levels in the post-menopausal range for the institution or underwent
- •surgical sterilization (bilateral oophorectomy or hysterectomy).
- •- Women >=50 years of age would be considered post-menopausal if they have been
- •amenorrheic for 12 months or more following cessation of all exogenous hormonal
- •treatments, had radiation-induced menopause with last menses >1 year ago, had
- •chemotherapy-induced menopause with last menses >1 year ago, or underwent
- •surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or
- •hysterectomy).
- •9. Adequate organ function. Minimum required laboratory data: see protocol
- •10. All acute toxic effects of any prior radiotherapy, chemotherapy, or
- •surgical procedure must have resolved to Grade <= 1, except alopecia (any
- •grade). Patients with Grade >=2 neuropathy will be evaluated on a case-by-case
- •basis after consultation with the Study Physician.
- •11. Patients should be medically operably defined by:
- •a. Sufficient cardiopulmonary function (Brunelli, Kim, Berger, &
- •Addrizzo-Harris, 2013)
- •b. No major contra-indications for surgery.
排除标准
- •Exclusion Criteria A potential subject who meets any of the following criteria
- •will be excluded from participation in this study:
- •1. Patients with grade 3 dyspnoea or worse at baseline (according to CTCAE
- •version 4.03).
- •2. Prior radiotherapy to the thorax.
- •3. Participation in another clinical study with an investigational product
- •during the last 4 weeks.
- •4. Concurrent enrolment in another clinical study, unless it is an
- •observational (non-interventional) clinical study or the follow-up period of an
- •interventional study.
- •5. Recent major surgery within 4 weeks prior to entry into the study (excluding
- •the placement of vascular access) that would prevent administration of
- •chemotherapy.
- •6. Uncontrolled intercurrent illness, including but not limited to, ongoing or
- •active infection, symptomatic congestive heart failure, uncontrolled
- •hypertension, unstable angina pectoris, 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., Exclusion Criteria 7.
- •Presence of any psychological, familial, sociological or geographical condition
- •potentially hampering compliance with the study protocol and follow*up
- •schedule; those conditions should be discussed with the patient before
- •registration in the trial.
- •8. Any condition that, in the opinion of the investigator, would interfere with
- •evaluation of the CRT or interpretation of patient safety or study results.
- •9. Patients with irreversible toxicity not reasonably expected to be
- •exacerbated by treatment with Durvalumab or Tremelimumab may be included only
- •after consultation with the Study Physician.
- •10. Active or prior documented autoimmune or inflammatory disorders (including
- •inflammatory bowel disease [eg, 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]). The
- •following are exceptions to this criterion:
- •a. Patients with vitiligo or alopecia
- •b. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on
- •hormone replacement
- •c. Any chronic skin condition that does not require systemic therapy
- •d. Patients without active disease in the last 5 years may be included but only
- •after consultation with the study physician
- •e. Patients with celiac disease controlled by diet alone
- •11. Subject noncompliance that, in the opinion of the investigator or sponsor,
- •warrants withdrawal; eg, refusal to adhere to scheduled visits
- •12. General contra-indications for immunotherapy:
- •a. Active infection including tuberculosis (clinical evaluation that includes
- •clinical history, physical examination and radiographic findings, and TB
- •testing in line with local practice), hepatitis B (known positive HBV surface
- •antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive
- •HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as
- 另有 2 项未显示
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