A phase II, open label, single arm study to assess the efficacy of AZD9291 in patients with locally advanced/metastatic non-small cell lung cancer who are harboring T790M mutation detected by liquid biopsy and whose disease has progressed with previous epidermal growth factor receptor tyrosine kinase inhibitor therapy(WJOG8815L)
- Conditions
- EGFR mutation positive advanced or metastatic NSCLC
- Registration Number
- JPRN-UMIN000022076
- Lead Sponsor
- Clinical trial coordinating committee for WJOG8815L investigator-initiated multicenter clinical trial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate
- Secondary Outcome Measures
Name Time Method 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)