Afatinib Plus Nimotuzumb for NSCLC

NCT ID: NCT01861223

Last Updated: 2014-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2016-05-31

Brief Summary

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

Conditions

NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

afatinib + nimotuzumab

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Myung-Ju Ahn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Myung-Ju Ahn

Role: CONTACT

silkahn@skku.edu

822-3410-3459

Facility Contacts

Myung-Ju Ahn

Role: primary

Other Identifiers

2012-11-087-007

Identifier Type: -

Identifier Source: org_study_id