EGFR mutation positive advanced or metastatic NSCLC
Conditions
Interventions
Once-daily oral administration of 80 mg of AZD9291
Sponsors
Clinical trial coordinating committee for WJOG8815L investigator-initiated multicenter clinical trial
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent prior to any study-related procedures and testing. 2. Ages 20 years and over 3. Histological or cytological confirmation diagnosis of adenocarcinoma of the lung 4. Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy 5. Radiological documentation of disease progression 6. Patients with at least one or more EGFR-TKI treatment regimens in prior treatment 7. Confirmation that the tumor harbors associated with any of EGFR TKI sensitivity (including G719X, exon 19 deletion, L858R, L861Q) 8. Confirmation of tumor T790M mutation positive status, using real-time PCR (Cobas EGFR mutation test v.2.) or digital PCR (Bio-Rad Droplet digital PCR), from a plasma sample taken after confirmation of disease progression on the most recent treatment regimen 9. WHO PS 0-1 with no deterioration over the 2 weeks prior to consent and a minimum life expectancy of 12 weeks 10. At least one lesion, not previously irradiated and not chosen for biopsy during the study screening period, that can be accurately measured at baseline as 10mm or more in the longest diameter (except lymph nodes which must have short axis of 15mm or more) with CT or MRI 11. Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential at screening
Exclusion criteria
Exclusion criteria: 1.Involvement in the planning and/or conduct of the study 2.Treatment with any of the following: - Treatment with an EGFR-TKI within 8 days or approximately 5x half-life of the first dose of study treatment - Any cytotoxic chemotherapy within 14 days of the first dose of study treatment - Or previous treatment with a 3rd generation EGFR TKIs - Major surgery within 4 weeks of the first dose of study treatment - Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study treatment - Patients currently receiving medications known to be potent inhibitors or inducers of cytochrome P4503A4(CYP3A4) - Treatment with an investigational drug within approximately five half-lives of the compound 3.Any unresolved toxicities from prior therapy greater than CTCAE grade 2 (with the exception of alopecia and G2, prior platinum-therapy related neuropathy) 4.Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 4 weeks prior to start of study treatment. 5.Any evidence of severe or difficult-to-control systemic diseases(difficult-to-control hypertension and active bleeding diatheses, hepatitis B, hepatitis C and HIV etc.) 6.Refractory nausea and vomiting, chronic gastrointestinal diseases or inability to swallow the formulated product or previous bowel resection, etc. that may significantly affect adequate absorption of investigational product 7.Patients with resting corrected QT interval more than 470 msec, any clinically important abnormalities in resting ECG, or any risk factors of QTc prolongation or arrhythmic events 8.Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD 9.Inadequate bone marrow reserve or organ function as demonstrated by any of the laboratory values 10.Women who are breast-feeding 11.History of malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response, disease control rate, Tumor Shrinkage, progression free survival (PFS), oOverall survival (OS) and frequency and percentage of all adverse events (by grade) | — |
Countries
Japan
Contacts
Public ContactTakayuki Takahama
Kinki University, Faculty of Medicine Department of Medical Oncology
Outcome results
None listed