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)

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

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer (NSCLC)
• Intervention / Treatment: Drug: Gefitinib and Nimotuzumab; Drug: Gefitinib

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 Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Severance hospital, Yonsei Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months after randomization of last patient
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.	3 months after randomization of last patient
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.	3 months after randomization of last patient
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.	3 months after randomization of last patient

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• 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.

Helpful Links

• PI site

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 20, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Immunological; Protein Kinase Inhibitors; Gefitinib; Nimotuzumab
• Other Study ID Numbers: 4-2011-0662