A Phase II, Open Label, Randomized Study of Osimertinib (TAgrisso) alone Versus Osimertinib plus Carboplatin/Pemetrexed for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Whose Disease Has Progressed With Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Whose TUmours Harbour a T790M MutatIon Within the Epidermal Growth Factor Receptor Gene - TAKUMI Trial (LOGIK1604/NEJ032A)

ung Oncology Group in Kyushu (LOGIK)/North East Japan Study Group(NEJSG)0 个研究点目标入组 90 人开始时间: 2016年10月17日最近更新: 2023年10月17日

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 20years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Active double cancer (simultaneous double cancer/multiple cancer, and metachronous double cancer/multiple cancer within 5 years of disease-free period. However, carcinoma in situ and a lesion equivalent to intramucosal carcinoma judged cured by local therapy are not included as active double cancer/multiple cancer). 2) Evidence of interstitial pneumonia or pulmonary fibrosis by chest CT scan /Radiation pneumonitis which required steroid treatment 3) Not able to swallow oral medications 4) Previous treatment history of immune checkpoint inhibitors 5) Infection requiring systemic treatment 6) Fever of >=38(axillary temperature) at the time of enrollment 7) Psychosis or psychotic symptoms that may interfere with the patient's participation in the study 8) Symptomatic brain metastasis (clinically stable brain metastasis is eligible) 9) Adverse event of >=Grade 2 considered attributable to EGFR-TKI of the prior therapy 10) Receiving continuous systemic (oral or intravenous) immunosuppressant therapy 11) Complication of diabetes mellitus treated with continued use of insulin or poorly controlled diabetes mellitus 12) Complication of unstable angina (new-onset angina or exacerbation of angina within the last 3 weeks) or history of myocardial infarction within 6 months. 13) HBs antigen-positive 14) Pregnant or possibly pregnant women, lactating women, or patients who wish to become pregnant 15) Patients who, in the opinion of the attending physician, are inappropriate for the study

研究者

发起方

ung Oncology Group in Kyushu (LOGIK)/North East Japan Study Group(NEJSG)

相似试验

尚未招募

2 期

A trial to learn if taking Osimertinib before and after chemotherapy and radiation therapy is safe and works in adults with non-small cell lung cancer (NSCLC) that cannot be treated with surgery

CTRI/2024/06/069176Fortrea Development India Private Limited

进行中（未招募）

1 期

A trial to learn if taking osimertinib before and after chemotherapy and radiation therapy is safe and works in adults with non-small cell lung cancer (NSCLC) that cannot be treated with surgery

CTIS2023-507798-16-00Astrazeneca AB70

进行中（未招募）

1 期

A study comparing the efficacy and safety of osimertinib when given in combination with chemotherapy versus osimertinib alone in patients with locally advanced or metastatic Non-Small Cell Lung CancerPatients with locally-advanced or metastatic EGFRm (Ex19del and/or L858R) Non-Small Cell Lung Cancer.MedDRA version: 21.1Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2019-000650-61-FRAstraZeneca AB586

招募中

3 期

A study comparing the efficacy and safety of osimertinib when given in combination with chemotherapy versus osimertinib alone in patients with locally advanced or metastatic Non-Small Cell Lung Cancer

2023-508800-39-00AstraZeneca AB27

已完成

3 期

A clinical trial to check if combination therapy of osimertinib plus platinum plus pemetrexed is better than monotherapy (osimertinib) for patient with Epidermal growth factor receptor positive Locally Advance or Metastatic Non- small Cell Lung Cancer.

CTRI/2020/06/025980AstraZeneca AB15

试验速览