Iressa RE-challenge in advanced NSCLC EGFR mutated patients who responded to an EGFR-TKI used as first-line or previous treatment. NVALT 16 - NVALT16, IRENE trial

VALT0 个研究点目标入组 92 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: VALT
入组人数: 92

研究概览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

入排标准

年龄范围: 18 至 99（—）

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.
•6. Life expectancy at least12 weeks

排除标准

•1. Known severe hypersensitivity to gefitinib or any of the excipients of the product
•2. Progressive disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with an EGFR-TKI
•3. Consideration to require radiotherapy to the lung at the time of study entry or in the near future
•4. 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
•5. Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation.
•6. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
•7. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
•8. Pregnancy or breast-feeding
•9. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
•10. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
•11. Other co-existing malignancies or malignancies diagnosed within the last 2 years with the exception of basal cell carcinoma or cervical cancer in situ
•12. Treatment with a non-approved or investigational drug within 30 days before day 1 of study treatment
•13. Involvement in the planning and/or conduct of the study (applies to both NVALT staff or staff at the study site)
•15. Previous enrolment or treatment in the present study.

研究者

发起方

VALT

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终止

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