Non Small Cell Lung Cancer (NSCLC)Phase 2DATENCT01498562
Phase II Study of Gefitinib Plus Nimotuzumab Versus Gefitinib in Non-small Cell Lung Cancer
A Phase 2 study testing Gefitinib and Nimotuzumab and Gefitinib in people with Non Small Cell Lung Cancer (NSCLC), run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer (NSCLC)
- What is being tested?
- Gefitinib and Nimotuzumab and Gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to Jun 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
Combining nimotuzumab to gefitinib may not only potentiate cellular cytotoxicity, but may also assist in overcoming inherent or acquired resistance to gefitinib alone.
Read the 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.
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Being tested
- Gefitinib and Nimotuzumab, Gefitinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gefitinib and NimotuzumabDrug
Also called h-R3
Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
GefitinibDrug
Also called Iressa
Mono-therapy group: Gefitinib(250mg daily)
| Study group | Role | What they receive |
|---|---|---|
| Gefitinib plus Nimotuzumab | Experimental | Combination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly) Receives: Drug: Gefitinib and Nimotuzumab |
| Gefitinib alone | Active comparator | Mono-therapy group: Gefitinib(250mg daily) Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after randomization of last patient
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after randomization of last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498562
- Sponsor's protocol ID
- 4-2011-0662
- Acronym
- DATE
- Status last verified
- Nov 2014
- First submitted
- 20 Dec 2011
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 27823977
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01498562
- Acronym / sponsor ID
- DATE / 4-2011-0662
- Conditions
- Non Small Cell Lung Cancer (NSCLC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gefitinib plus Nimotuzumab | Experimental | Drug: Gefitinib and NimotuzumabCombination therapy group: Gefitinib(250mg daily) and Nimotuzumab (200mg weekly) |
| Gefitinib alone | Active comparator | Drug: GefitinibMono-therapy group: Gefitinib(250mg daily) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gefitinib and NimotuzumabAlso: h-R3Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly) | Drug | Gefitinib plus Nimotuzumab |
| GefitinibAlso: IressaMono-therapy group: Gefitinib(250mg daily) | Drug | Gefitinib alone |
Primary outcome
Progression free survival rate at 3 months
Time frame: 3 months after randomization of last patient
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.
4 secondary outcomes
Progression free survival (PFS)
Time frame: 3 months after randomization of last patient
Overall survival (OS)
Time frame: 3 months after randomization of last patient
Overall safety profile
Time frame: 3 months after randomization of last patient
Objective response rate (ORR)
Time frame: 3 months after randomization of last patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 27823977Kim 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.
- PI siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib and Nimotuzumab and Gefitinib in people with Non Small Cell Lung Cancer (NSCLC), run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival rate at 3 months (time frame: 3 months after randomization of last patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01498562, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.