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Afatinib Plus Nimotuzumb for NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01861223
Recruitment Status : Unknown
Verified February 2014 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 23, 2013
Last Update Posted : February 25, 2014
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
NSCLC Drug: afatinib (30 or 40mg) + nimotuzumab (100 or 200mg) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study of Afatinib Plus Nimotuzumab in Non-small Cell Lung Cancer Patients Who Progressed With Reversible EGFR TKI
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Maximal tolerated dose [ Time Frame: 4 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01861223

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Contact: Myung-Ju Ahn 822-3410-3459

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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Myung-Ju Ahn         
Sub-Investigator: Jong-Mu Sun         
Sponsors and Collaborators
Samsung Medical Center
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Responsible Party: Myung-Ju Ahn, Professor, Samsung Medical Center Identifier: NCT01861223    
Other Study ID Numbers: 2012-11-087-007
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014
Keywords provided by Myung-Ju Ahn, Samsung Medical Center:
acquired resistance
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological