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临床试验/ACTRN12618001742268
ACTRN12618001742268已完成2 期

A Phase 2 trial of durvalumab (MEDI4736) and tremelimumab with chemotherapy in metastatic EGFR mutant non-squamous non-small cell lung cancer (NSCLC) following progression on EGFR Tyrosine Kinase Inhibitors (TKIs) (ILLUMINATE).

niversity of Sydney0 个研究点目标入组 100 人开始时间: 2018年10月23日最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
入组人数
100
研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit（—）
性别
All

入选标准

  • •1. Adults, aged 18 years and older (subjects from Taiwan must be 20 years or older) with histologically and/or cytologically confirmed non-squamous non-small cell lung cancer with EGFR mutation of Exon 19 deletion or Exon 21 L858R point mutation.
  • •Patients with co-mutations are allowed as long as one of the mutation is either Exon 19 deletion or Exon 21 L858R point mutation
  • •2. Disease that has progressed and either:
  • •(i) No evidence of EGFR T790M resistance mutation in both tissue re-biopsy and plasma after EGFR tyrosine kinase inhibitor therapy (TKI)*
  • •(ii) T790M mutation (detected in tissue re-biopsy, plasma or both) and progression on 3rd generation EGFR TKI; patients are allowed to have one prior line of TKI therapy before 3rd generation TKI
  • •*Patients who have progressed after first-line or second-line osimertinib where previous testing has not detected a denovo (first-line) or acquired (second-line) T790M resistance mutation are classified as T790M mutation negative.
  • •3. Measurable disease according to RECIST 1.1.
  • •4. ECOG performance status of 0 or 1.
  • •5. Adequate bone marrow function as defined below (within 14 days prior to registration and with values within the ranges specified below):
  • •Platelets greater or equal to 100 x 109/L
  • •Absolute neutrophil count (ANC) greater or equal to 1.0 x 109/L (greater or equal to 1000 per mm3)
  • •Haemoglobin greater or equal to 90 x g/L
  • •6. Adequate liver function (within 14 days prior to registration and with values within the ranges specified below):
  • •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x institutional upper limit of normal (ULN). (or less than or equal to 5 x ULN if liver metastases are present)
  • •Bilirubin less than or equal to 1.5 x ULN
  • •7. Adequate renal function (within 14 days prior to registration): Measured creatinine clearance greater than 40 mL/min or Calculated creatinine clearance greater than 40 mL/min by the Cockcroft-Gault formula92 or by 24-hour urine collection for determination of creatinine clearance
  • •8. Provision of a pre-treatment tumour tissue sample from a biopsy taken within 42 days prior to enrolment (core biopsy preferred) to determine NSCLC histology and for translational research.
  • •9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.
  • •10. 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.
  • •11. Signed written informed consent (main study and optional biobanking).

排除标准

  • •1. Prior immunotherapy with checkpoint inhibitors, including prior anti-PD-1/anti-PD-L1 or anti-CTLA-4 antibodies.
  • •2. Prior chemotherapy for advanced NSCLC.
  • •For recurrent, incurable disease, prior adjuvant chemotherapy or concurrent chemotherapy and radiotherapy with curative intent is allowed, but must have been completed more than 6 months ago.
  • •3. Prior EGFR TKI therapy
  • •Prior EGFR TKI (e.g., erlotinib, gefitinib, afatinib or osimertinib), including experimental TKI agents are allowed, but must be stopped 7 days prior to the first dose of study treatment. (If sufficient washout time has not occurred due to schedule or PK properties, an alternative appropriate washout time based on known duration and time to reversibility of drug related adverse events could be agreed upon by emailing the ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)).
  • •Patients treated with more than 2 lines of prior EGFR TKI are not permitted on the study.
  • •4. Mixed histology with any small cell or squamous component.
  • •5. Life expectancy of less than 3 months.
  • •6. Current enrolment or participation in another clinical study with an unregistered investigational product during the last 12 months, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study must first be discussed with ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)) before study enrolment.
  • •7. Any unresolved toxicity NCI CTCAE Grade greater or equal to 2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria.
  • •Patients with Grade greater or equal to 2 neuropathy will be evaluated on a case-by-case basis after consultation with the ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)
  • •Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included only after consultation with the ILLUMINATE Study Team (illuminate@ctc.usyd.edu.au)
  • •8. Radiotherapy or major surgery (as defined by the local investigator) within 4 weeks of the first dose of study drug. Note the following exceptions, which have a 2-week washout:
  • •Local surgery on isolated lesions for palliative intent
  • •Radiotherapy to control CNS disease identified during screening
  • •9. History of pneumonitis or pulmonary fibrosis with clinically significant impairment of pulmonary function.
  • •10. History of active primary immunodeficiency or allogeneic transplant.
  • •11. 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]). The following are exceptions to this criterion:
  • •Patients with vitiligo or alopecia
  • •Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
  • •Any chronic skin condition that does not require systemic therapy
  • •Patients without active disease in the last 5 years may be included but only after consultation with the study physician
  • •Patients with celiac disease controlled by diet alone
  • •12. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable s

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