EUCTR2014-001077-14-RO进行中（未招募）1 期
An open label, single-arm phase IV study to assess the efficacy and safety of afatinib as second-line therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring an EGFR mutation (Del19 or L858R) who have failed first-line treatment with platinum-based chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •1. Pathologically confirmed diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or Stage IV adenocarcinoma of the lung. Patients with mixed histology are eligible if adenocarcinoma is the predominant histology.
- •2. Documented EGFR mutation (L858R and/or Deletion 19) with no other known EGFR mutation.
- •3. Measureable disease according to RECIST 1.1.
- •4. Radiologically confirmed progression or recurrence of disease during or following first line therapy with a platinum-based chemotherapy regimen.
- •5. Age >18 years.
- •6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
- •7. Adequate organ function, defined as all of the following: Absolute neutrophil count (ANC) > 1500 / mm3, Platelet count >75,000 / mm3, Estimated creatinine clearance > 45ml / min, Total Bilirubin < 1.5 times upper limit of institution normal, Aspartate amino transferase (AST) and alanine amino transferase (ALT) < three times the upper limit of institution normal (ULN) (if related to liver metastases < five times ULN).
- •8. Recovered from any previous therapy-related toxicity to less than or equal to CTCAE Grade 1 at study entry (except for alopecia and stable sensory neuropathy which must be less than or equal to CTCAE Grade 2).
- •9. Life expectancy of at least three months.
- •10. Written informed consent that is consistent with ICH-GCP guidelines.
- •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 170
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •1. More than one line of prior therapy for disease.
- •2. Previously received less than 3 cycles of platinum-based chemotherapy due to toxicity and/or intolerance of treatment.
- •3. Previous treatment with any EGFR targeting TKI or antibody.
- •4. Chemotherapy, biological therapy or investigational agents within three weeks prior to the start of study treatment.
- •5. Hormonal treatment within two weeks prior to start of study treatment.
- •6. Radiotherapy within 4 weeks prior to study treatment, except for palliative radiation to target organs other than chest and single dose palliative treatment for symptomatic metastasis.
- •7. Major surgery within 4 weeks before starting study treatment or surgery scheduled during the projected course of the study.
- •8. Known hypersensitivity to afatinib or the excipients of afatinib.
- •9. History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of 3, unstable angina or poorly controlled arrhythmia as determined by the investigator or myocardial infarction within 6 months prior to study treatment.
- •10. Women of child-bearing potential (WOCBP) and men who are able to father a child, unwilling to be abstinent or use adequate contraception prior to study entry, for the duration of study participation and for at least 28 days after treatment has ended.
- •11. Female patients of childbearing potential who are nursing or pregnant or do not agree to submit to pregnancy testing required by this protocol.
- •12. Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient's ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug.
- •13. Previous or concomitant malignancies at other sites, except; a) effectively treated non-melanoma skin cancers, b) effectively treated carcinoma in situ of the cervix, c) effectively treated ductal carcinoma in situ, d) other effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
- •14. Requiring treatment with any of the listed prohibited concomitant medications
- •that cannot be stopped for the duration of trial participation.
- •15. Known pre-existing interstitial lung disease.
- •16. Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn's disease, ulcerative colitis, chronic diarrhea, malabsorption).
- •17. Active hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
- •18. Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment.
- •19. Meningeal carcinomatosis.
- •20. Presence or history of brain or subdural metastases, unless patient has completed local therapy and has discontinued the use of corticosteroids or has been on stable dose of corticosteroids for at least 4 weeks before starting study treatment. Any symptoms attributed to brain metastases must be stable for at least 4 weeks before starting study treatment.
研究者
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