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

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.
 
ClinicalTrials.gov Identifier: NCT01498562
Recruitment Status : Completed
First Posted : December 23, 2011
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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
Non Small Cell Lung Cancer (NSCLC) Drug: Gefitinib and Nimotuzumab Drug: Gefitinib 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
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Study Type : Interventional  (Clinical Trial)
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 : December 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Gefitinib

Arms and Interventions
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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 Name: h-R3
Active Comparator: Gefitinib alone
Mono-therapy group: Gefitinib(250mg daily)
 Drug: Gefitinib
Mono-therapy group: Gefitinib(250mg daily)
Other Name: Iressa


Outcome Measures
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Primary Outcome Measures :
  1. Progression free survival rate at 3 months [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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 ClinicalTrials.gov identifier (NCT number): NCT01498562


Locations
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Korea, Republic of
Severance hospital, Yonsei Cancer Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Yonsei University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01498562    
Other Study ID Numbers: 4-2011-0662
First Posted: December 23, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Gefitinib
Nimotuzumab
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological