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

Primary Purpose

Non Small Cell Lung Cancer (NSCLC)

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gefitinib and Nimotuzumab
Gefitinib
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospital, Yonsei Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Gefitinib plus Nimotuzumab

Gefitinib alone

Arm Description

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

Mono-therapy group: Gefitinib(250mg daily)

Outcomes

Primary Outcome Measures

Progression free survival rate at 3 months
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)
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)
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
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)
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.

Full Information

First Posted
December 20, 2011
Last Updated
November 26, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01498562
Brief Title
Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
Acronym
DATE
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 Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gefitinib plus Nimotuzumab
Arm Type
Experimental
Arm Description
Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)
Arm Title
Gefitinib alone
Arm Type
Active Comparator
Arm Description
Mono-therapy group: Gefitinib(250mg daily)
Intervention Type
Drug
Intervention Name(s)
Gefitinib and Nimotuzumab
Other Intervention Name(s)
h-R3
Intervention Description
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
Iressa
Intervention Description
Mono-therapy group: Gefitinib(250mg daily)
Primary Outcome Measure Information:
Title
Progression free survival rate at 3 months
Description
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.
Time Frame
3 months after randomization of last patient
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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.
Time Frame
3 months after randomization of last patient
Title
Overall survival (OS)
Description
Overall survival (OS) defined as the period from randomly assigned point of time to the date of death due to any cause.
Time Frame
3 months after randomization of last patient
Title
Overall safety profile
Description
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.
Time Frame
3 months after randomization of last patient
Title
Objective response rate (ORR)
Description
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.
Time Frame
3 months after randomization of last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Severance hospital, Yonsei Cancer Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27823977
Citation
Kim HR, Jang JS, Sun JM, Ahn MJ, Kim DW, Jung I, Lee KH, Kim JH, Lee DH, Kim SW, Cho BC. A randomized, phase II study of gefitinib alone versus nimotuzumab plus gefitinib after platinum-based chemotherapy in advanced non-small cell lung cancer (KCSG LU12-01). Oncotarget. 2017 Feb 28;8(9):15943-15951. doi: 10.18632/oncotarget.13056. Erratum In: Oncotarget. 2017 Aug 14;8(33):55766.
Results Reference
derived
Links:
URL
http://www.iseverance.com/
Description
PI site

Learn more about this trial

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

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