Status:
UNKNOWN
Uncommon EGFR AZD9291
Lead Sponsor:
Samsung Medical Center
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
EGFR (ErbB1) mutations define a lung cancer subtype with exquisite sensitivity to EGFR tyrosine kinase inhibitors (TKIs). While in-frame deletion in exon 19 (Del19) and a point mutation (L858R) in exo...
Detailed Description
This is a single-arm phase II trial to evaluate the efficacy of AZD9291 (experimental) NSCLC patients with uncommon EGFR mutation. The primary endpoint of the study is objective response rate. Recentl...
Eligibility Criteria
Inclusion
- 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
- metastatic or recurrent NSCLC
- Be 19years of age on day of signing informed consent
- ECOG performance status of 0 to 2
- At least one measurable lesion by RECIST 1.1(The part of radiation treatment in the palliative setting is excluded.)
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03424759
Start Date
January 1 2016
End Date
July 31 2019
Last Update
February 7 2018
Active Locations (1)
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1
Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, South Korea, 135-710