Status:
UNKNOWN
Neoadjuvant Erlotinib for Operable Stage II or IIIA NSCLC With EGFR Mutations
Lead Sponsor:
National Cancer Center, Korea
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
NSCLC Stage II
NSCLC, Stage IIIA
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study examines preoperative Erlotinib in patients with operable stage II and IIIA Non-small-cell lung cancer (NSCLC) harboring EGFR mutations.
Detailed Description
Lung cancer remains the most common cause of cancer-related death in the world. Non-small-cell lung cancer (NSCLC) is the most common type, and it accounts for 85% of cases. Unfortunately, the majorit...
Eligibility Criteria
Inclusion
- Pathologically confirmed stage II \& IIIA non-small cell lung cancer
- EGFR exon 19 or 21 mutations
- Age ≥ 18 years and ECOG performance 0\~1
- Has measurable lesion by RECIST 1.1
- No previous chemotherapy or radiation therapy
- Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr \< 1 x UNL or creatinine clearance \> 60 ml/min, Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, alkaline phosphatase \< 5 x UNL
- Written informed consent form
Exclusion
- Previous chemotherapy or radiation therapy
- Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
- Known allergic history of erlotinib
- Interstitial lung disease or fibrosis on chest radiogram
- Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
- Pregnant or nursing women
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01470716
Start Date
January 1 2012
End Date
June 30 2022
Last Update
April 6 2022
Active Locations (1)
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1
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 410-769