Combining Afatinib and Concurrent Chemotherapy, Followed by Osimertinib and Concurrent Chemotherapy, in Untreated EGFR Positive NSCLC Tumors

Amsterdam UMC0 个研究点目标入组 21 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。

•1. Histologically confirmed NSCLC, positive for EGFR exon 19 deletion or EGFR exon 21 L858R
•2. WHO PS 0-2
•3. Be willing and able to provide written informed consent for the trial.
•4. Be above 18 years of age on day of signing informed consent.
•5. Patients must have radiological measurable disease
•6. Demonstrate adequate organ function, as deemed acceptable by the treating physician in the context of metastatic NSCLC:
•a. Leukocytes = 3,000/mm3
•b. Absolute neutrophil count (ANC) = 1500/mm3
•c. Platelet count = 100,000/mm3
•d. Hemoglobin = 6 mmol/L
•e. Creatinine = 1.5 x ULN or creatinine clearance (CrCl) =40 mL/min (if using the Cockcroft-Gault formula below):
•i. Female CrCl = [(140 - age) x weight x 0.85]/(0.85 x creat in mmol/L)
•ii. Male CrCl = [(140 - age) x weight x 1.00]/(0.81 x creat in mmol/L)
•f. Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome)
•g. AST and ALT = 3 times the upper limit of normal

•1. Inability to provide informed consent
•2. Inability to take study medications
•3. Patients with CNS metastases
•4. Prior EGFR TKI or platinum-doublet therapy for advanced stage NSCLC. Prior (neo)adjuvant treatments are allowed when the last administration is one year or more.
•5. Evidence of interstitial lung disease or active, non-infectious pneumonitis.
•6. Active infection requiring systemic therapy.
•7. Active Hepatitis B or C.
•8. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
•9. Patient is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial, starting with the screening visit.

发起方

Amsterdam UMC