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

Non Small Cell Lung Cancer (NSCLC) Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01498562
• Other study ID #: 4-2011-0662
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2011
• Last updated: November 26, 2014
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: November 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer (NSCLC)

Intervention

Drug:
• Gefitinib and Nimotuzumab
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
• Gefitinib
Mono-therapy group: Gefitinib(250mg daily)

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital, Yonsei Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No

External Links

•   PI site