CTRI/2022/08/044570尚未招募3 期
A Randomized Study to compare Gefitinib to Gefitinib with Chemotherapy inEGFR Mutation Positive Non-Small Cell Lung Cancer Patients with CompromisedPerformance Status.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
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
入选标准
- •1. Age = 18 years
- •2. Histologically or cytologically confirmed NSCLC with EGFR mutation positive for exon 19, 21 or 18
- •3. Patients planned for palliative intent therapy, i.e., patients in whom radical curative-intent therapy is not possible.
- •4. ECOG performance status 2 to 4 at baseline. Patients with PS 2 who are felt by the treating physician to be unfit for combination platinum-based chemotherapy will be considered for the trial. All patients with PS 3 and 4 at baseline will be considered eligible for the trial.
- •5. Patient should be planned for palliative intent therapy in the first line. No prior line of palliative chemotherapy, or palliative biological therapy, including targeted therapies such as EGFR and vascular epidermal growth factor (VGEF) inhibitors or immunological therapy is permitted. Patients may have been started on an oral TKI or chemotherapy for the current diagnosis within the past six weeks on a compassionate basis while awaiting the results of molecular testing. Previous therapy in the definitive setting is permitted. Palliative radiotherapy to a metastatic site is permitted.
- •6. Adequate organ function, including the following:
- •i)Adequate bone marrow reserve: absolute neutrophil (segmented and bands) counts (ANC) = 1.5 X 109/L, Platelets = 100 X 109/L
- •ii)Hepatic: Serum bilirubin = 2 times the upper limit of normal (x ULN), Alanine aminotransferase (ALT) & aspartate aminotransferase (AST) = 3.5 times the ULN if no demonstrable liver metastases (AST, ALT = 5 XULN is acceptable if liver is involved by tumor).
- •iii)Serum Creatinine = 1.5 times the ULN or Creatinine Clearance = 45 ml/min.
排除标准
- •1.Any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), as judged by the investigator.
- •2. Known severe hypersensitivity to gefitinib or any of the excipients of this product.
- •3. Known severe hypersensitivity to carboplatin, pemetrexed or any of the excipients of these products.
- •4. Known severe hypersensitivity to pre-medications required for treatment with platinum and pemetrexed doublet chemotherapy.
- •5. History or presence of any other malignancy with the exception of basal cell carcinoma or cervical cancer in situ, or curatively treated malignancies that are in remission for over 3 years. Curatively treated NSCLC is an exception; patients with curatively treated NSCLC, who have now recurred and are planned for first line palliative intent therapy may be considered for this trial.
- •6. 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.
- •7. Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline.
- •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
研究者
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