A randomized study to compare gefitinib with bevacizumab vs gefitinib in EGFR mutation positive non-small cell lung cancer in the palliative setting.

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

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•1.Patient aged >= 18 years
•2.Histologically or cytologically confirmed NSCLC with EGFR mutation positive for exon 19, 21 or 18
•3.Disease is not amenable to curative intent therapy; palliative intent therapy is planned.
•4.No prior palliative chemotherapy, or palliative biological (including targeted therapies such as EGFR and vascular epidermal growth factor inhibitors) or immunological therapy.Previous adjuvant chemotherapy is permitted if treatment was completed at least 6 months before day 1. Palliative radiotherapy to a metastatic site is permitted.
•5.Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) with at least one measurable lesion.
•6.ECOG performance status (PS) of 0 to 2
•7.Adequate organ function, including the following:
•i)Adequate bone marrow reserve: absolute neutrophil counts (ANC) >= 1.5X109/L, Platelets >=100X109/L
•ii)Hepatic: bilirubin <= 1.5 times the upper limit of normal(x ULN), alanine aminotransferase (ALT) & aspartate aminotransferase (AST) <= 3.0 times the ULN if no demonstrable liver metastases (AST,ALT <= 5 XULN is acceptable if liver is involved by tumour).
•iii)Renal: Serum creatinine <= 1.5 x ULN or creatinine clearance >= 50 ml/min

•1.Known severe hypersensitivity to gefitinib or any of the excipients of this product
•2.Known severe hypersensitivity to bevacizumabor any of the excipients of this product.
•3.History or presence of any other malignancy within the last 3 years, with the exception of basal cell carcinoma of the skin or cervical cancer in situ
•4.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.
•5.Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline.
•6.Any unresolved chronic toxicity greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from previous anticancer therapy.
•7.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
•8.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study.
•9.Pregnancy or breast feeding
•10.Life expectancy of <= 12 weeks
•11.Treatment with an investigational drug within 30 days before day of study treatment.

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