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

VUmc0 个研究点目标入组 92 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•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;

•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;

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