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
- Conditions
- T790M-positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Registration Number
- JPRN-UMIN000024438
- Lead Sponsor
- ung Oncology Group in Kyushu (LOGIK)/North East Japan Study Group(NEJSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 90
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression free survival
- Secondary Outcome Measures
Name Time Method response rate, overall survival, incidence of adverse events