EUCTR2010-023362-44-SI进行中（未招募）1 期
ITAC 2 TRIAL: INTERMITTENT TKI AND CHEMOTHERAPY FOR PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER - ITAC 2
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •For inclusion in the study, patients should meet the following criteria:
- •patient's understanding of the disease and treatment and signed written informed consent
- •age 18 years or older
- •histo-pathological or cytological diagnosis of non-small cell lung cancer of non-squamous type
- •positive for mutation of EGFR
- •disease stage IV (Stage IV a or IV b) and unsuitable for surgical treatment or for radiotherapy with curative intent
- •no history of other malignancy; or in complete remission for > 3 years if previously treated for other malignancy
- •chemo-naïve; or more than 3 years after chemotherapy for other cancer; or received not more than 1 cycle of chemotherapy for this cancer
- •no previous treatment with TKIs
- •if previously treated by radiotherapy, all acute radiation-related toxicity has resolved and the interval is > 2 weeks for total dose = 30 Gy or > 10 days for total dose < 30 Gy
- •no clinical symptoms of brain metastases. Patients after surgery and/or radiotherapy for brain metastases and patients with asymptomatic small (< 2 cm) brain metastases are eligible if they meet other eligibility criteria
- •according to clinical presentation, no indication for radiotherapy is foreseen until eventual progression of the disease. An exception to this rule are patients with asymptomatic small brain metastases who may be treated with whole-brain radiotherapy in fractions not greater than 2.5 Gy during maintenance treatment with erlotinib (i.e. after completion of 4 cycles of gemcitabine/cisplatin + erlotinib)
- •measurable and previously unirradiated disease. Bone metastases as the only measurable lesions are not eligible
- •performance status = 70% (Karnofsky); or ECOG 0 – 2
- •hemoglobin > 100 g/L
- •neutrophils > 2.0 g/L
- •platelets > 100 x 109 /L
- •kidney function: creatinine within normal limits + ECC > 60 mL/min; or ECC > 100 mL/min
- •liver function: bilirubin < 1.25 x UNL; AST/ALT < 2 x UNL (in case of liver metastases AST/ALT < 5 x UNL)
- •cardiac compensation
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •Stage IV a or IV b with solitary metastasis considered for surgery and/or radiotherapy with curative intent
- •peripheral neuropathy grade 2 or more (common toxicity criteria – CTC, NCI), unless mechanical in origin
- •vascular disease grade 2 or more (CTC)
- •active infection or other serious concomitant disease;
- •treatment with unapproved medicinal product within 30 days prior to start of study treatment
- •pregnancy, breastfeeding, or refusal of using acceptable methods of birth control throughout the study to prevent pregnancy.
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