Phase I/II study of oral administration of S 49076 given in combination with gefitinib in patients with EGFR mutated advanced non-small-cell lung cancer who have progressed after treatment with EGFR tyrosine kinase inhibitor.

Institut de Recherche International Servier0 个研究点目标入组 171 人开始时间: 2017年6月27日最近更新: 2018年8月20日

适应症

试验速览

暂无简介。

•-Male or female patient aged = 18 years old or legal age of the majority in the country.
•-Histologically or cytologically confirmed stage IIIB/IV NSCLC ( locally advanced or metastatic, non-eligible for radical chemoradiotherapy or surgery with curative intention).
•-Progression will have occurred on single agent EGFR TKI treatment (erlotinib, gefitinib, icotinib, afatinib,dacomitinib) in the 1st line setting or in the 2nd line (after a first line of chemotherapy).
•-Patients must meet definition of acquired resistance based on the modified Jackman criteria.
•-Patients must have measurable tumour disease according to RECIST v1.1. (with at least one measurable lesion).
•-Estimated life expectancy > 12 weeks.
•-Eastern Cooperative Oncology Group (ECOG) performance status = 1
•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 114
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 57

•-Foreseeable poor compliance to the study procedures.
•-Legally incapacitated person under guardianship or trusteeship.
•-Pregnant or breast-feeding women.
•-Unable to undergo CT scans or MRI.
•-Patients who have received more than 1 line of chemotherapy and more than 1 line of erlotinib, gefitinib, icotinib ,afatinib or dacotinimib.
•-Blood transfusion within 2 weeks prior to the inclusion.
•-Major surgery within 4 weeks prior to the inclusion
•-Prior radiotherapy within 4 weeks prior to the inclusion (within 1 week for palliative radiotherapy at localised lesions)

发起方

Institut de Recherche International Servier