Non-small-cell Lung CancerPhase 1/2NCT00369447
A Study of Nimotuzumab in Combination With External Radiotherapy in Non-Small Cell Lung Cancer
A Phase 1/2 study testing External radiotherapy and nimotuzumab in people with Non-small-cell Lung Cancer, run by YM BioSciences at 13 sites in 3 countries.
Trial summary
This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small-cell Lung Cancer
- What is being tested?
- External radiotherapy and nimotuzumab
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Mar 2009to Jul 2011
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients receiving any other investigational agents
- Previous treatment with anti-EGF-R drug(s)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
- Prior thoracic radiotherapy for this condition
- Prior chemotherapy within 4 weeks of enrolment
- Lesions not suitable for radiotherapy
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- Patients with known sero positive HIV
- Patients with uncontrolled hypercalcemia
- Patients with progressive or untreated brain metastases or treated brain metastases but unable to discontinue steroids
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, severe cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements in the opinion of the investigator
- Pregnant or breast-feeding women
- Any concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix; patients with other prior malignancies are eligible providing prior malignancy cannot be clinically confused with the diagnosis of NSCLC in the opinion of the treating oncologist; in particular, there should be no evidence of current disease activity with respect to the prior malignancy
- Life expectancy of less than 8 weeks
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Canada11 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
London Regional Cancer Center
London, Ontario, N6A 4L6
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T-2M4
Centre Hospitalier de L'Universite de Montreal - Hôpital Notre Dame
Montreal, Quebec, H2L 4M1
Segal Cancer Center - Jewish General Hospital
Montreal, Quebec, H3T 1E2
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Hotel Dieu Hospital
Québec, Quebec, G1R 2J6
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Thunderbay Regional hospital Center
Thunderbay, Ontario, P7B 6V4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
United States1 site
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655
About this study
Official title: A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment.
The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
Read the detailed description
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in. Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy (curative intent chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II component of the study. In the Phase II component, overall survival, local and systemic response rates and quality of life will be evaluated inpatients treated with nimotuzumab in combination with palliative radiation vs. radiation alone.
The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
- Conditions
- Non-small-cell Lung Cancer
- Being tested
- External radiotherapy, nimotuzumab
- Keywords
- Non small cell lung cancer, NSCLC, Nimotuzumab, TheraCIM, h-R3, YM BioSciences, Radiation, Non small cell lung cancer, Stage IIb, III and IV
- 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.
External radiotherapyProcedure or surgery
Radiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable
nimotuzumabBiological
weekly dose until disease progression
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 200 mg dose Receives: Procedure: External radiotherapy; Biological: nimotuzumab |
| 2 | Placebo comparator | Not described Receives: Procedure: External radiotherapy; Biological: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: Overall survival
Measured: Every 8 weeks until disease progression
Secondary outcomes (9)
Phase I: Biologically effective dose
Measured: 2.5 Years
Phase II: Overall response rate
Measured: Every 8 weeks until disease progression
Local response rate
Measured: Every 8 weeks until disease progression
Overall clinical benefit
Measured: Every 8 weeks until disease progression
Local clinical benefit
Measured: Every 8 weeks until disease progression
Time to progression
Measured: Every 8 weeks until disease progression
Time to local progression
Measured: Every 8 weeks until disease progression
Progression-free survival
Measured: 1 year
Phase II: Quality of life
Measured: At week 4, week 8, every 2 months thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionJul 2011 (estimated)
Why it stopped: The study was closed due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small-cell Lung CancerStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Investigators
- Gwyn Bebb, MD, Principal investigator, Tom Baker Cancer CenterAnthony Brade, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369447
- Sponsor's protocol ID
- YMB1000-010
- Status last verified
- Jun 2011
- First submitted
- 24 Aug 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I-II Clinical Study of Nimotuzumab (TheraCIM h-R3) in Combination With External Radiotherapy in Stage IIB, III and IV NSCLC
- ClinicalTrials.gov ID
- NCT00369447
- Acronym / sponsor ID
- YMB1000-010
- Conditions
- Non-small-cell Lung Cancer
- Keywords
- Non small cell lung cancer, NSCLC, Nimotuzumab, TheraCIM, h-R3, YM BioSciences, Radiation, Non small cell lung cancer, Stage IIb, III and IV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was closed due to slow accrual.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 29 Aug 2006 (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.
This is a Phase I-II study designed to investigate nimotuzumab (TheraCIM h-R3) in combination with external radiation in patients with non-small cell lung cancer. The purpose of the Phase I portion of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy and to select the optimal dose for the Phase II component of the study. The primary objective for the Phase II portion of the study is to examine the efficacy of this combination treatment.
The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
Detailed description
This is a randomized, double blind, multicenter Phase II study with Phase I lead-in. Patients enrolled in this study will receive external radiotherapy with or without nimotuzumab (TheraCIM h-R3). The objective of the Phase I component of the study is to evaluate the safety and feasibility of the administration of nimotuzumab with palliative radiation in patients who are unsuitable for radical therapy (curative intent chemoradiation) and to select the optimal biologically effective dose (BED) for Phase II component of the study. In the Phase II component, overall survival, local and systemic response rates and quality of life will be evaluated inpatients treated with nimotuzumab in combination with palliative radiation vs. radiation alone.
The Phase I component of this study has been completed. The Phase II is now closed to recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: External radiotherapy, Biological: nimotuzumab200 mg dose |
| 2 | Placebo comparator | Procedure: External radiotherapy, Biological: nimotuzumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Patients receiving any other investigational agents
- Previous treatment with anti-EGF-R drug(s)
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study.
- Prior thoracic radiotherapy for this condition
- Prior chemotherapy within 4 weeks of enrolment
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 |
|---|---|---|
| External radiotherapyRadiotherapy for first 2 weeks, 10 daily fractions of 30Gy 2 additional fractions to be added if desirable | Procedure or surgery | 1, 2 |
| nimotuzumabweekly dose until disease progression | Biological | 1, 2 |
Primary outcome
Phase II: Overall survival
Time frame: Every 8 weeks until disease progression
9 secondary outcomes
Phase I: Biologically effective dose
Time frame: 2.5 Years
Phase II: Overall response rate
Time frame: Every 8 weeks until disease progression
Local response rate
Time frame: Every 8 weeks until disease progression
Overall clinical benefit
Time frame: Every 8 weeks until disease progression
Local clinical benefit
Time frame: Every 8 weeks until disease progression
Time to progression
Time frame: Every 8 weeks until disease progression
Time to local progression
Time frame: Every 8 weeks until disease progression
Progression-free survival
Time frame: 1 year
Phase II: Quality of life
Time frame: At week 4, week 8, every 2 months thereafter
Results and safety
The study was stopped early (reason given: The study was closed due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2011.
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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.
Gwyn Bebb, MD principal investigator
Tom Baker Cancer Center
Anthony Brade, MD principal investigator
Princess Margaret Hospital, Canada
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing External radiotherapy and nimotuzumab in people with Non-small-cell Lung Cancer, run by YM BioSciences at 13 sites in 3 countries.
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 0 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, United States, Singapore. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: The study was closed due to slow accrual.). Results are not available in the source record.
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?
Phase II: Overall survival (time frame: Every 8 weeks until disease progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2011.