EUCTR2012-005272-34-NL进行中（未招募）不适用
Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment. - IRENE
ederlandse Vereniging van Artsen voor Longziekten en Tuberculose NVALT0 个研究点开始时间: 2013年1月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Histologically or cytologically confirmed NSCLC with an activating sensitising EGFR TK mutation as determined before starting the first EGFR-TKI treatment by using a well-validated and robust methodology
- •2. Female or male patients aged 18 years or over with locally advanced or metastatic stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV (metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who have already received an EGFR-TKI with a documented complete (CR) or partial response (PR) or stable disease (SD) >12 weeks as the best response to their 1st EGFR-TKI treatment and who have received any subsequent anti-cancer therapy (excluding EGFR-TKIs) treatment, including but not limited to doublet platinum based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy, on which they progressed.
- •3. Measurable disease defined as at least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with spiral CT or MRI and which is suitable for accurate repeated measurements.
- •4. WHO / ECOG / Zubrod performance status 0-2.
- •5. Possibility of obtaining tumour material before the start of the study treatment.
- •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 92
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known severe hypersensitivity to gefitinib or any of the excipients of the product
- •2. Prior surgery or radiotherapy must be completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment with no persistent radiation toxicity. Previous adjuvant chemotherapy is allowed.
- •3. Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI
- •4. Consideration to require radiotherapy to the lung at the time of study entry or in the near future
- •5. Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
- •6. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
- •7. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •8. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
- •9. Pregnancy or breast-feeding
- •10. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •11. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •12. Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ
- •13. Life expectancy of less than 12 weeks
- •14. Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
- •15. Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
- •16. Previous enrolment or treatment in the present study.
研究者
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