non-small-cell lung cancer
Conditions
Interventions
investigational material(s)
Generic name etc : osimertinib
INN of investigational material : osimertinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigat
Sponsors
Kazuhiko Nakagawa (Coordinating Investigator)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age of 20 years or older at the time of informed consent 2.Histologically or cytologically confirmed nonsquamous NSCLC 3.Locally advanced or recurrent cancer not amenable to curative surgical or radical radiation therapy 4.Evidence of any EGFR-TKI-sensitive mutation (including G719X, exon 19 deletion, L858R, and L861Q) before the first EGFR-TKI therapy 5.Never treated with a third-generation EGFR-TKI (e.g., osimertinib, ASP8273, CO-1686) 6.ECOG performance status of 0 to 2 and life expectancy of>=12 weeks 7.The Cohort 1- or Cohort 2-specific criteria must be met. Only Cohort 1 - Disease progression of brain metastatic lesions alone without progression of extracranial lesions is radiologically diagnosed during first- or second-generation EGFR-TKI therapy. - Asymptomatic metastatic brain tumor with longest diameter of >=5mm, which has not been treated with radiation therapy. - A brain metastasis tissue (e.g., surgery) or plasma sample collected after progression of brain metastasis during first- or second-generation EGFR-TKI therapy meets sensitive mutation-positive (G719X, exon 19 deletion, L858R, or L861Q) and T790M-negative, neither sensitive mutation nor T790M is detectable (no analysis results are available), or testing is not feasible. Only Cohort 2 - Progression is radiologically diagnosed after first- or second-generation EGFR-TKI therapy and platinum-based chemotherapy. - tumor collected after disease progression during first- or second-generation EGFR-TKI therapy shows that the disease is sensitive mutation-positive (G719X, exon 19 deletion, L858R, or L861Q) and T790M-negative.
Exclusion criteria
Exclusion criteria: 1.CTCAE grade 1 or higher toxicity related to prior therapy persisting at the start of study treatment 2.Spinal cord compression or symptomatic brain metastasis. 3.Severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding tendency, or evidence of active infection, including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV) infection. 4.Intractable nausea or vomiting, chronic gastrointestinal disease, inability to swallow medication, or history of major bowel resection that interferes with complete absorption of osimertinib 5.QTc >470 msec, clinically important abnormality in cardiac rhythm, conduction, or waveform in resting ECG, factors that increase the risk of QTc prolongation or arrhythmic event: 6.History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid therapy, or evidence of clinically active interstitial lung disease 7.Reduced bone marrow or organ function 8.History of hypersensitivity to active or inactive ingredients of osimertinib or drugs that are chemically or pharmacologically similar to osimertinib 9.Pregnant or lactating women 10.Concurrent cancer 11.Not qualified for the study, in the opinion of the investigator, when the patient is unlikely to comply with the study procedures, restrictions, or requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Cohort 1: Response rate of metastatic brain tumor, Cohort 2: Response rate Cohort 1: Response rate of metastatic brain tumor will be evaluated using RANO-BM criteria, Cohort 2: Response rate will be evaluated according to RECIST version 1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Progression free survival (PFS), overall survival (OS), and safety PFS will be assessed based on RECIST version 1.1 and CTCAE will be used for safety assessment and so on. | — |
Countries
Japan
Contacts
Public ContactMitsuru Shimomura
West Japan Oncology Group
Outcome results
None listed