NCT01861223Unknown1 期
A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Maximal tolerated dose
研究概览
简要总结
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of stage IIIB or IV NSCLC
- •Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
- •Disease progression on treatemtn with gefitinib or erlotinib within 30 days
- •Biopsy on disease progression
- •Age ≥20 years
- •ECOG performance status of 0, 1, or 2
- •Measurable disease by the criteria of RECIST 1.1
- •Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT < 5 UNL; creatinine clearance ≥ 45 mL/min
排除标准
- •Known interstitial lung disease
- •Prior treatment with EGFR targeting antibodies or BIBW 2992
- •Prior three or more lines of chemotherapy for advanced NSCLC
- •Significant bowel disease impairing drug absorption
- •Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- •Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.
研究组 & 干预措施
afatinib + nimotuzumab
Experimental
干预措施: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) (Drug)
结局指标
主要结局
Maximal tolerated dose
时间窗: 4 weeks
To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib
次要结局
未报告次要终点
研究者
Myung-Ju Ahn
Professor
Samsung Medical Center
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Pemigatinib + Afatinib in Advanced Refractory Solid TumorsAdvanced Solid TumorUnresectable Solid TumorMetastatic Solid TumorCholangiocarcinomaNCT06302621Massachusetts General Hospital70
进行中（未招募）
1 期
Afatinib and selumetinib in advanced KRAS mutant positive and PIK3CA wildtype non-small cell lung cancer and colorectal cancerPatients with histological or cytological proof of advanced KRAS mutant and PIK3CA wildtype non small cell lung cancer (NSCLC) and colorectal cancer (CRC). In part B: for which first-line treatment failed.MedDRA version: 21.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029521 Term: Non-small cell lung cancer stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029515 Term: Non-small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1 Level: PT Classification code 10029518 Term: Non-small cell lung cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-001855-22-NLetherlands Cancer Institute- Antoni van Leeuwenhoek Hospital140
终止
1 期
Afatinib and Necitumumab in Patients With EGFR Mutation Positive Advanced or Metastatic Non-small Cell Lung CancerNon-Small Cell Lung CarcinomaNCT03054038Vanderbilt-Ingram Cancer Center22
已完成
2 期
Afatinib Plus Bevacizumab After Acquired Resistance to EGFR-TKI in EGFR-mutant NSCLCon-small cell lung cancerJPRN-UMIN000014710Foundation for Biomedical Research and Innovation32
Unknown
2 期
A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of EsophagusSquamous Cell Carcinoma of EsophagusNCT02353936Yonsei University30