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DATE: Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer

Sponsor
Yonsei University (Other)
Overall Status
Completed
CT.gov ID
NCT01498562
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
30
Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Reversible EGFR tyrosine kinase inhibitors (TKI), such as gefitinib, were shown to be effective in patients with non-small cell lung cancer (NSCLC). However, patients almost invariably develop resistance to TKIs and have disease progression. Nimotuzumab is a humanized monoclonal antibody targeting the EGFR.

Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.

Study Design

Study Type:
Interventional
Actual Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Randomized Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Patients With Advanced Non-small Cell Lung Cancer: Dual-agent Molecular Targeting of EGFR (DATE)
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gefitinib plus Nimotuzumab

Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)

Drug: Gefitinib and Nimotuzumab
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
Other Names:
  • h-R3

    		•
    Active Comparator: Gefitinib alone

    Mono-therapy group: Gefitinib(250mg daily)

    Drug: Gefitinib
    Mono-therapy group: Gefitinib(250mg daily)
    Other Names:
  • Iressa

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival rate at 3 months [3 months after randomization of last patient]

      The progression-free survival rate at 3 months of the patients with no progression of disease or death due to any cause until 3 months is elapsed after being randomized.

    Secondary Outcome Measures

    1. Progression free survival (PFS) [3 months after randomization of last patient]

      Progression free survival (PFS) defined as the time from randomized date to the progression date or the preceded date of death date due to any cause.

    2. Overall survival (OS) [3 months after randomization of last patient]

      Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause.

    3. Overall safety profile [3 months after randomization of last patient]

      Overall safety profile verified as relevance of adverse events and laboratory abnormality in the study and grades granted based on (USA National Cancer Center) Common Terminology Criteria for Adverse Events such as the type, frequency and severity (CTCAE), v4.0.

    4. Objective response rate (ORR) [3 months after randomization of last patient]

      Overall objective response rate (ORR) is the best response rate stipulated as complete response (CR) or partial response (PR) (target lesion and tumor response defined according to RECIST guideline version 1.1) and identified as percentage of the confirmed patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Provision of written informed consent prior to any study specific procedures

    • Unresectable non-small cell lung cancer

    • ECOG performance status of 0 to 2

    • Male or female; ≥ 20 years of age

    • Subjects whose disease has progressed after platinum-based chemotherapy

    • Subjects with measurable lesion

    Exclusion Criteria:

    • Inadequate organ functions

    • Disease progression after 2 or more previous chemotherapy regimens

    • Prior therapy with EGFR-tyrosine kinase inhibitor or Anti-EGFR Monoclonal Ab

    • Any clinically significant gastrointestinal abnormalities

    • Past medical history of interstitial lung disease

    • Pregnant or lactating female

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Severance hospital, Yonsei Cancer Center Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT01498562
    Other Study ID Numbers:
    • 4-2011-0662
    First Posted:
    Dec 23, 2011
    Last Update Posted:
    Dec 2, 2014
    Last Verified:
    Nov 1, 2014
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Gefitinib
    Nimotuzumab

    Study Results

    No Results Posted as of Dec 2, 2014