NL-OMON52389招募中2 期
Combining Afatinib and concurrent chemotherapy, followed by Osimertinib and concurrent chemotherapy, in untreated EGFR positive NSCLC tumors - COMBINATIO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 21
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
- •- Histologically confirmed NSCLC, positive for non-exon20insertion uncommon
- •EGFR mutations that are eligible for afatinib therapy in first line
- •- WHO PS 0-2
- •- Be willing and able to provide written informed consent for the trial.
- •-Be above 18 years of age on day of signing informed consent.
- •- Patients must have radiological measurable disease
- •- Demonstrate adequate organ function, as deemed acceptable by the treating
- •physician in the context of metastatic NSCLC:
- •- Leukocytes >= 3,000/mm3
- •- Absolute neutrophil count (ANC) >= 1500/mm3
- •- Platelet count >= 100,000/mm3
- •- Hemoglobin >= 6 mmol/L
- •- Creatinine <= 1.5 x ULN or creatinine clearance (CrCl) >=40 mL/min (if using
- •the Cockcroft-Gault formula below): Female CrCl = [(140 - age) x weight x
- •0.85]/(0.85 x creat in mmol/L); Male CrCl = [(140 - age) x weight x 1.00]/(0.81
- •x creat in mmol/L)
- •- Total Bilirubin <= 1.5 x ULN (except subjects with Gilbert Syndrome)
- •- AST and ALT <= 3 times the upper limit of normal
排除标准
- •- Inability to provide informed consent
- •- Inability to take study medications
- •- Patients with symptomatic or unstable CNS metastases
- •- Prior EGFR TKI or platinum-doublet therapy for advanced stage NSCLC. Prior
- •(neo)adjuvant treatments are allowed when the last administration is one year
- •- Evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •- Active infection requiring systemic therapy.
- •- Active Hepatitis B or C.
- •- Psychiatric or substance abuse disorders that would interfere with
- •cooperation with the requirements of the trial.
- •- Patient is pregnant or breastfeeding, or expecting to conceive within the
- •projected duration of the trial, starting with the screening visit.
研究者
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