Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer (DATE)
This study is currently recruiting participants.
Verified December 2011 by Yonsei University
Sponsor:
Yonsei University
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
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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
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 Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013