An Open label, Multicenter, Phase II Single-arm Trial of AZD9291 in Non-small Cell Lung Cancer (NSCLC) Patients with Uncommon Epidermal Growth Factor Receptor Mutations
- Conditions
- Neoplasms
- Registration Number
- KCT0003459
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 35
?Histologically confirmed metastatic or recurrent stage IV NSCLC with activating EGFR mutation other than deletion in exon 19, L858R, T790M and insertion in exon 20
?Previously treated with at least one line of cytotoxic chemotherapy for metastatic or recurrent NSCLC or progressive/relapsed disease within 6months after the completion of concurrent chemoradiotherapy for unresectable stage IIIA/IIIB disease
?Age = 19years
?ECOG performance status of 0 to 2
?At least one measurable lesion by RECIST 1.1
?Untreated asymptomatic brain metastasis or symptomatic brain metastasis treated with local treatment such as operation, whole brain radiotherapy, or gamma-knife surgery
?At least 2 weeks later after whole brain radiotherapy or at least 4 weeks later after palliative thoracic radiotherapy
?Adequate organ function as evidenced by the following; Absolute neutrophil count > 1.5 x 109/L; Hb > 9.0g/dL; platelets > 100 x 109/L; total bilirubin =1.5 UNL; AST and/or ALT < 2.5 ULN if no demonstrable liver metastases or < 5 UNL in the presence of liver metastases, CCr = 50mL/min
?Written informed consent form
?Prior treatment with EGFR TKI
?Major surgery undertaken less than 4 weeks before the study
?Localized palliative radiotherapy unless completed more than 2 weeks before the study
?Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
?Pregnant or nursing women (Women of reproductive potential have to agree to use an adequate contraceptive method)
?Uncontrolled symptomatic brain metastasis
?Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, or well-treated thyroid cancer
?Concomitant use of CYP3A4 inducers/inhibitors
?Prolonged QT interval in ECG (QTc >450 msec)
?Prior history of interstitial lung disease
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) / Overall survival (OS) / Safety and toxicity profile / Quality of Life