Afatinib Plus Nimotuzumb for NSCLC

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

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

Study Overview

• Status: Unknown
• Conditions: NSCLC
• Intervention / Treatment: Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Myung-Ju Ahn; Phone Number: 822-3410-3459; Email: silkahn@skku.edu

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Samsung Medical Center
    • Contact: Myung-Ju Ahn
    • Sub-Investigator: Jong-Mu Sun

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: afatinib + nimotuzumab	Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (Estimate): May 23, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2014
• Last Update Submitted That Met QC Criteria: February 23, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: erlotinib; gefitinib; acquired resistance
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Afatinib; Nimotuzumab
• Other Study ID Numbers: 2012-11-087-007