A Phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA) as 3rd Line Treatment Re-challenge in Patients, Who Have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and Who Responded to Gefitinib in 1st Line and Progressed After 2nd Line Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Clinical Benefit Rate
研究概览
简要总结
the primary objective is to characterise the impact of gefitinib on the Response Evaluation Criteria in Solid Tumours (RECIST) based assessments; objective response rate (ORR ; confirmed complete response(CR) or partial response (PR)) and disease control rate (DCR; confirmed complete response(CR) or partial response (PR) or stable disease (SD)) in patients with EGFR M+ NSCLC
详细描述
A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA�) as 3rd line treatment re-challenge in Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) and who responded to gefitinib in 1st line and progressed after 2nd line chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Known severe hypersensitivity to gefitinib or any of the excipients of the product
- •Prior EGFR TKIs except gefitinib followed by subsequent anti-cancer treatment (including chemotherapy and excluding EGFR-TKIs).
- •Previous adjuvant chemotherapy is allowed. Prior surgery or radiotherapy must be completed more than 6 months before start of study treatment. Palliative radiotherapy must be completed at least 4 weeks before start of study treatment with no persistent radiation toxicity.
- •Progression disease or stable disease (SD) <12 weeks as best response to the 1st line treatment with gefitinib
- •Not progressing during or after the last anti-cancer treatment.
- •Considered to require radiotherapy to the lung at the time of study entry or in the near future
- •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
- •Pre-existing idiopathic pulmonary fibrosis evidenced by CT scan at baseline
- •Insufficient lung function as determined by either clinical examination or an arterial oxygen tension (PaO2) of < 70 Torr
- •Known or suspected brain metastases or spinal cord compression, unless treated with surgery and/or radiation and stable without steroid treatment for at least 4 weeks prior to the first dose of study medication
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort
- •Pregnancy or breast-feeding
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Life expectancy of less than 12 weeks
研究组 & 干预措施
open label single arm with Gefitinib 250MG once daily
Gefitinib 250 mg/day open label until progression disease / toxicity / consent withdrawal
干预措施: Gefitinib 250mg (Drug)
结局指标
主要结局
Clinical Benefit Rate
时间窗: every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)
Clinical benefit rate is the sum of patients with a best visit response of Complete Response, Partial Response or Stable Desease Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response. Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of longest diamteter of target lesions, Stable Desease (SD) defined as no progression for\>= 6 weeks. Objective response rate (RR)=CR+PR
Objective Response Rate
时间窗: every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment)
Objective Response Rate is the sum of Complete response (CR) and Partial Response (PR) response. Evaluated by recist criteria v 1.1., for target lesions and assesed by CT or MRI: Complete Response (CR), Disapperance of all target lesions; Partial Response (PR),\>=30% decrease in the sum of longest diamteter of target lesions; Objective response rate (RR)=CR+PR
次要结局
- Progression Free Survival(every 6 weeks after the Start of Study Treatment until objective disease progression or time of data cut off (6 months after the last patient has started study treatment))
- Time to Worsening of Disease Related Symptoms(every 6 weeks after the Start of Study Treatment until the worsening of desease related symptoms or time of data cut off (6 months after the last patient has started study treatment))
- Overall Survival (OS)(every 6 weeks after the Start of Study Treatment until death or time of data cut off (6 months after the last patient has started study treatment))
- Treatment Duration With Gefitinib(every 6 weeks after the Start of Study Treatment until discontinuation of drug or time of data cut off (6 months after the last patient has started study treatment))