Afatinib Plus Nimotuzumb for NSCLC

Samsung Medical Center

Status and phase

Unknown

Phase 2

Phase 1

Conditions

NSCLC

Treatments

Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)

Study type

Interventional

Funder types

Other

Identifiers

2012-11-087-007

Details and patient eligibility

About

To find the optimal dose of afatinib and nimotuzumab in patients who acquired resistance to gefitinib or erlotinib.

Enrollment

50 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.