Status:
UNKNOWN
Afatinib Plus Nimotuzumb for NSCLC
Lead Sponsor:
Samsung Medical Center
Conditions:
NSCLC
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
Brief Summary
To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of stage IIIB or IV NSCLC
- Presence of EGFR sensitizing mutations (L858R mutation in exon 21 or exon 19 deletion) or response by RECIST on prior gefitinib or erlotinib or stable disease on prior gefitinib or erlotinib for at least 6 months
- Disease progression on treatemtn with gefitinib or erlotinib within 30 days
- Biopsy on disease progression
- Age ≥20 years
- ECOG performance status of 0, 1, or 2
- Measurable disease by the criteria of RECIST 1.1
- Adequate organ function as evidenced by the following; Absolute neutrophil count \> 1.5 x 109/L; platelets \> 100 x 109/L; total bilirubin ≤1.5 UNL; AST and/or ALT \< 5 UNL; creatinine clearance ≥ 45 mL/min
Exclusion
- Known interstitial lung disease
- Prior treatment with EGFR targeting antibodies or BIBW 2992
- Prior three or more lines of chemotherapy for advanced NSCLC
- Significant bowel disease impairing drug absorption
- Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia
- Have symptomatic, untreated, or uncontrolled central nervous system (CNS) metastases. Patients with treated CNS metastases are eligible provided their disease is radiographically stable, asymptomatic, and corticosteroid use has been discontinued for at least 2 weeks prior to the first dose of study drug. Screening of asymptomatic patients without history of CNS metastases is not required.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01861223
Start Date
May 1 2013
End Date
May 1 2016
Last Update
February 25 2014
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea