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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Yonsei University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Byoung Chul Cho, Yonsei University
ClinicalTrials.gov Identifier:
NCT01498562
First received: December 20, 2011
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Non Small Cell Lung Cancer (NSCLC)
Drug: Gefitinib and Nimotuzumab
Drug: Gefitinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Progression free survival rate at 3 months [ Time Frame: 3 months after randomization of last patient ] [ Designated as safety issue: No ]
    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:
  • Progression free survival (PFS) [ Time Frame: 3 months after randomization of last patient ] [ Designated as safety issue: No ]
    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.

  • Overall survival (OS) [ Time Frame: 3 months after randomization of last patient ] [ Designated as safety issue: No ]
    Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause.

  • Overall safety profile [ Time Frame: 3 months after randomization of last patient ] [ Designated as safety issue: Yes ]
    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.

  • Objective response rate (ORR) [ Time Frame: 3 months after randomization of last patient ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: December 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01498562

Contacts
Contact: Byoung Chul Cho, M.D.,Ph.D. 82-2-2228-8126 cbc1971@yuhs.ac

Locations
Korea, Republic of
Severance hospital, Yonsei Cancer Center Recruiting
Seoul, Korea, Republic of
Contact: Byoung Chul Cho, M.D.,Ph.D.    82-2-2-2228-8126    cbc1971@yuhs.ac   
Principal Investigator: Byoung Chul Cho, M.D.,Ph.D.         
Sponsors and Collaborators
Yonsei University
  More Information

Additional Information:
No publications provided

Responsible Party: Byoung Chul Cho, Assistant professor, Yonsei University
ClinicalTrials.gov Identifier: NCT01498562     History of Changes
Other Study ID Numbers: 4-2011-0662
Study First Received: December 20, 2011
Last Updated: December 22, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014