High-dose, pulsatile erlotinib after progression on standard dose erlotinib in EGFR-mutated NSCLC patients - Pulsatile erlotinib

Vrije Universiteit Medisch Centrum0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•* Histologically confirmed stage IV non-squamous NSCLC patients.
•* Patients with an activating EGFR mutation who progressed on erlotinib or gefitinib monotherapy in daily dose of 150 mg or 250 mg respectively. (Patients with unknown mutation status that have exhibited a response to these agents or stable disease for at least 6 months while on treatment with gefitinib or erlotinib are also eligible).
•* Tumor biopsy available for EGFR mutation analysis at progression
•* At least one measurable disease site, according to RECIST 1.1 criteria.
•* WHO performance status 0-2.
•* Willing and able to comply with the study prescriptions
•* 18 years or older.
•* Not pregnant or breast feeding and willing to take adequate contraceptive measures during the study.
•* Ability to give and having given written informed consent before patient registration.

•Uncontrolled infectious disease.
•Other active malignancy.
•Major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
•Treatment with investigational drugs.
•Known prior hypersensitivity to erlotinib.

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