A randomized trial to compare gefitinib plus chemotherapy vs chemotherapy alone in EGFR positive and T790M mutation negative advanced Non-small cell lung cancer patients after progression on first line gefitinib.

Tata Memorial Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Patients of either sex aged 18 years or older
•2.Histologically or cytologically proven diagnosis of NSCLC other than predominantly squamous cell histology with an activating EGFR tyrosine kinase (TK) mutation
•3.Performance Status 0-1
•4.Progressive disease on first-line TKI
•5.T790M mutation negative status.
•6.Written informed consent prior to study treatment.
•7.All patients should have achieved either a stable disease or objective response to the first line TKI and later develop disease progression.
•8.Patients with Brain metastasis

•1.Prior chemotherapy or other systemic anti-cancer treatment (excluding Gefitinib).
•2.Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.
•3.Neutrophils <1.5 x 109/L or platelets <100 x 109/L.
•4.Serum bilirubin >1.5 x the upper limit of normal (ULN).
•5.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x ULN in the absence of liver metastases, or >5 x ULN in the presence of liver metastases.
•6.Creatinine clearance <45 mL/min calculated by either Cockcroftâ??Gault or other validated methods.
•7.Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, renal or hepatic disease) as judged by the investigator.
•8.Other co-existing malignancies or malignancies diagnosed within the last 5 years (except non-melanoma skin cancer or in-situ cervical cancer).
•9.Life expectancy of less than 3 months
•10.Pregnant females

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