EUCTR2011-005157-31-IT进行中（未招募）不适用
A phase II Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as 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 previously responded to gefitinib and received subsequent chemotherapy or other active anti-cancer therapy excluding EGFR-TKIs - ICARUS
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Provision of informed consent prior to any study specific procedures
- •2. Histologically or cytologically confirmed NSCLC with an activating sensitising
- •EGFR TK mutation as it was determined before starting the first gefitinib treatment
- •by using a well-validated and robust methodology: adenocarcinoma, including
- •Bronchoalveolar Carcinoma (BAC), squamous cell carcinoma, large cell carcinoma,
- •adenosquamous carcinoma or undifferentiated carcinoma or not-otherwise specified
- •3. Female or male patients aged 18 years or over with Locally advanced or metastatic
- •stage IIIB/IV disease, not suitable for therapy of curative intent or stage IV
- •(metastatic) disease, eligible for gefitinib re-challenge treatment for NSCLC who
- •have already received gefitinib with a documented complete (CR) or partial
- •response (PR) or stable disease (SD) >12 weeks as the best response to their 1st
- •gefitinib treatment and progressing during or after a subsequent anti-cancer therapy
- •(excluding EGFR-TKIs) treatment, including but not limited to doublet platinum
- •based chemotherapy or docetaxel monotherapy or pemetrexed monotherapy.
- •4. Measurable disease defined as at least one lesion, not previously irradiated, that can
- •be accurately measured at baseline as = 10 mm in the longest diameter (except
- •lymph nodes which must have short axis = 15 mm) with spiral CT or MRI and
- •which is suitable for accurate repeated measurements.
- •5. WHO / ECOG / Zubrod performance status 0-2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. 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.
- •3. Progression disease or stable disease (SD) <12 weeks as best response to the 1st line
- •treatment with gefitinib
- •4. Not progressing during or after the last anti-cancer treatment.
- •5. Considered to require radiotherapy to the lung at the time of study entry or in the
- •near future
- •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. Insufficient lung function as determined by either clinical examination or an arterial
- •oxygen tension (PaO2) of < 70 Torr
- •9. 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
- •10. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer
- •11. Concomitant use of known CYP 3A4 inducers such as phenytoin, carbamazepine,
- •rifampicin, barbiturates, or St John's Wort
- •12. Pregnancy or breast-feeding
- •13. As judged by the investigator, any evidence of severe or uncontrolled systemic
- •disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal
- •14. Evidence of any other significant clinical disorder or laboratory finding that makes
- •it undesirable for the patient to participate in the study
- •15. Other co-existing malignancies or malignancies diagnosed within the last 5 years
- •with the exception of basal cell carcinoma or cervical cancer in situ
- •16. Life expectancy of less than 12 weeks
- •17. Treatment with a non-approved or investigational drug within 30 days before Day 1
- •of study treatment
- •18. Involvement in the planning and/or conduct of the study (applies to both
- •AstraZeneca staff and/or staff at the study site)
- •19. Previous enrolment or treatment in the present study.
研究者
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