Phase II trial of safety and efficacy after thrice weekly Osimertinib combined with standard of care chemotherapy in patients with Epidermal Growth Factor Receptor (EGFR) Positive advanced Non-small cell lung carcinoma (NSCLC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR) at 9weeks after initiation of the study regimen
研究概览
简要总结
Title : A study to evaluate efficacy of thrice weekly osimertinib combined with chemotherapy in patients with EGFR Positive advanced Non small cell lung carcinoma
Background and rationale:
The current standard of care for EGFR mutant advanced NSCLC worldwide is osimertinib 80mg OD as per the FLAURA trial. However, in India, 80mg OD osimertinib bears a great financial burden on the patients and is unaffordable, hence many patients are started on the first generation TKI, gefintinib as per the IPASS trial. In terms of efficacy, gefitinib has a lower progression free survival and overall survival when compared to osimertinib (10.2 and 31.8 months vs 18.9 and 38.6 months respectively).
According to the intitial results of the FLAURA2 trial, Chemotherapy + Osimertinib has shown promising results and is likely to become the new global standard of care. However, this new standard of care is likely to remain unaffordable in India.We plan to explore the possibility of using chemotherapy along with alternate day dosing of Osimertinib to defray resource constraints while maintaining clinical efficacy as measured by the radiological response rates at 3 months.
Aim: To determine the efficacy of alternate day osimertinib with Carboplatin-pemetrexate chemotherapy in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer
Primary Objective:
Is to determine the objective response rate (ORR) at 9weeks after initiation of the study regimen (ORR as defined by RECIST V1.1-) (Defined as the proportion of patients that respond either partially or fully to therapy)
Secondary Objective:
-
Pharmacokinetics and plasma levels of thrice weekly Osimertinib
-
Time to progression: Defined as the time from Diagnosis until first evidence of disease progression.
-
Measuring variability in osimertinib levels- with analysis for possible factors affecting drug levels.
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Incidence of laboratory and clinical adverse events recorded and graded according to CTCAE v5.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Metastatic non small cell carcinoma 2) EGFR mutation positive lung cancer 3) Performance status 0-1.
排除标准
- •Previously treated lung cancer 2) Unstable CNS metastasis 3) Concurrent other malignancies 4) Major cardiac condition 5) Inadequate bone marrow reserve 6) Pregnancy.
结局指标
主要结局
Objective response rate (ORR) at 9weeks after initiation of the study regimen
时间窗: Objective response rate (ORR) at 9weeks after initiation of the study regimen
次要结局
- 1) Pharmacokinetics(2) Time to Progression)
研究者
Ashish Singh
Christian Medical College