A phase II randomised controlled trial of Interim Response Adapted Therapy based on mutant allele frequency (MAF) of plasma EGFR mutation (or) inadequate radiological response among patients with advanced EGFR-m lung cancer in the 1st line setting - i-RATE

CMC Vellore0 个研究点目标入组 0 人开始时间: 待定最近更新: 2022年4月4日

试验速览

暂无简介。

•1. Patient aged >= 18 years
•2. Newly diagnosed advanced lung cancer (AJCC stage IIIB/ IVA/IVB) with sensitizing mutation in EGFR (exon 19 or exon 21)
•3. Started on 1st line treatment with 1st generation EGFR TKIs
•4. ECOG performance status 0, 1 or 2
•5. â??High riskâ?? disease defined as: MAF non-clearers at 3-4 months (12-16 weeks) while on 1st gen TKI [OR] inadequate radiological response (ie) stable disease at 3-4 (12-16 weeks) months as per RECIST 1.1
•6. Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
•7. Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
•8. Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
•9. No concurrent uncontrolled medical conditions
•10. No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
•11. Adequate contraceptive precautions if relevant
•12. Ability to provide informed written consent
•13. Controlled treated brain metastases

•1. Uncommon EGFR mutation (Exon 18/20)
•2. Exon 19/21 mutant in combination with denovo T790M mutation
•3. Patients started on1st line chemotherapy/TKI combination (or) osimertinib
•4. Hypersensitivity to carboplatin or pemetrexed
•5. Pregnancy or breastfeeding
•6. Medical or psychiatric conditions that compromise the patients ability to give informed consent
•7. Past history of interstitial lung disease
•8. Participation in any investigational drug study in the previous four weeks

发起方

CMC Vellore