Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
DATE
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)
1 other identifier
interventional
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedDecember 2, 2014
November 1, 2014
2.5 years
December 20, 2011
November 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months after randomization of last patient
Secondary Outcomes (4)
Progression free survival (PFS)
3 months after randomization of last patient
Overall survival (OS)
3 months after randomization of last patient
Overall safety profile
3 months after randomization of last patient
Objective response rate (ORR)
3 months after randomization of last patient
Study Arms (2)
Gefitinib plus Nimotuzumab
EXPERIMENTALCombination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly)
Gefitinib alone
ACTIVE COMPARATORMono-therapy group: Gefitinib(250mg daily)
Interventions
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance hospital, Yonsei Cancer Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 27823977DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 23, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
December 2, 2014
Record last verified: 2014-11