Afatinib Plus Nimotuzumb for NSCLC

NSCLC Clinical Trial

Official title:

A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01861223
• Other study ID #: 2012-11-087-007
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 21, 2013
• Last updated: February 23, 2014
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: February 2014
• Source: Samsung Medical Center
• Contact: Myung-Ju Ahn
• Phone: 822-3410-3459
• Email: silkahn[@]skku.edu
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• NSCLC

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal tolerated dose	To establish maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) for BIBW 2992 and nimotuzumab in patients with acquired resistance to erlotinib or gefitinib	4 weeks	Yes