EUCTR2014-000726-37-IT进行中（未招募）1 期
A phase Ib/II, multicenter, open-label study of EGF816 in combination with INC280 in adult patients with EGFR mutated non-small cell lungcancer - NA
OVARTIS FARMA S.P.A.0 个研究点目标入组 78 人开始时间: 2020年11月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 78
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
- •¿ Patients with histologically documented, locally advanced or recurrent (stage IIIB who are not eligible for combined modality treatment) or
- •metastatic (Stage IV) non-small cell lung cancer.
- •¿ Patients must have locally documented EGFR mutation L858R and/or ex19del, or a characterized de novo EGFR T790M mutation.
- •¿ Presence of at least one measurable lesion according to RECIST v.1.1
- •¿ ECOG performance status =2
- •¿ Patients must be screened for HBV. Patients who are either HBsAg positive or HBV-DNA positive must be willing and able to take antiviral
- •therapy 1-2 weeks prior to 1st dose of EGF816 treatment and continue on antiviral therapy for at least 4 weeks after the last dose of EGF816.
- •Additional management of the patients would be provided by a physician with expertise in management of HBV, if needed
- •¿ Patients must be screened for HCV. Patients must have negative hepatitis C antibody (HCV Ab) or are HCV Ab positive but with an undetectable level of HCV-RNA. Note: patients with detectable HCV-RNA are not eligible for the study
- •¿ Phase Ib: patients must have either an acceptable local result, detailing their c-MET and EGFR T790M status in a biopsy collected at or
- •post progression on the previous EGFR TKI therapy or sufficient tumor material available from a biopsy collected at or post progression on the
- •previous EGFR-TKI therapy for central assessment of c-MET and EGFRT790M. For Phase II Group 1, patients must have sufficient material available from a biopsy collected at or any time after progression on prior EGFR TKI for central assessment of c-MET and EGFRT790M. For Phase II Group 2, patients must have sufficient material collected at any time sent for central assessment of c-MET and EGFRT790M.
- •¿ Phase Ib only: documented progression of disease according to RECIST v1.1 while on continuous treatment with EGFR TKI (e.g. erlotinib, gefitinib or afatinib).
- •¿ Phase II Group 1 only: Patients with acquired resistance to EGFR TKI treatment defined as documented clinical benefit (CR (any duration), PR
- •(any duration), or SD for at least 6 months) on prior EGFR TKI therapy (e.g. erlotinib, gefitinib or afatinib) and subsequently demonstrated
- •progression according to RECIST v1.1.
- •¿ Phase II Group 2 only: Advanced NSCLC patients who have not been previously treated with any therapy known to inhibit EGFR and harbor de novo T790M mutation
- •Please refer to protocol for further details and/or additional inclusion criteria.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 23
排除标准
- •¿ Phase Ib and Phase II Group 1 only: More than than one previous treatment with erlotinib, gefitinb, or afatinib, and/or previous treatment
- •with any investigational agent known to inhibit EGFR (mutant or wildtype)
- •¿ Phase Ib and Phase II Group 1 only: Patients who have received more than three prior lines of antineoplastic therapy (including EGFR TKI) in
- •the advanced setting.
- •¿ Phase II Group 2 only: Patients who have received more than two previous lines of antineoplastic therapies in advance setting.
- •¿ Phase II Group 2 only: Previous treatment with an investigational or marketed agent that inhibits EGFR. EGFR inhibitors include (but not limited to) erlotinib, gefitinib or other anti-EGFR or EGFR monoclonal antibody therapy or dual TKI inhibitors.
- •¿ Previous treatment with a c-MET inhibitor or HGF-targeting therapy
- •¿ Patients with brain metastases
- •¿ History of another malignancy (Exception: Patients who have been disease-free for 3 years, or patients with a history of adequately treated
- •in-situ carcinoma of the uterine cervix, basal or squamous cell carcinoma, non-melanomatous cancer of skin, history of stage IA melanoma that has been cured, are eligible)
- •¿ Undergone a bone marrow or solid organ transplant
- •¿ Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not mandatory)
- •¿ Patients receiving concomitant immunosuppressive agents or chronic
- •corticosteroids use at the time of study entry except for control of brain metastases, topical applications, inhaled sprays, eye drops or local
- •¿ Patients wth clinically significant, uncontrolled cardiovascular disease
- •¿ Presence or history of interstitial lung disease or interstitial pneumonitis, including clinically signifiicant radiation pneumonitis significantly alter absorption of study treatment
- •¿ Patients have out of range laboratory values (as defined in the protocol)
- •Please refer to protocol for further details and/or additional exclusion criteria.
研究者
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