Metastatic Non-Small Cell Lung CancerPhase 2NCT00872482
A Study of Nimotuzumab in Combination With Radiation Therapy in Patients With Brain Metastases
A Phase 2 study testing nimotuzumab in people with Metastatic Non-Small Cell Lung Cancer, run by YM BioSciences at 15 sites in 5 countries.
Trial summary
This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- nimotuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 15 sitesin 5 countries
- Study dates
- Apr 2009to Jul 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Providing a written informed consent (see Appendix A);
- Age ≥18 years;
- Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);
- At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;
- Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
- KPS ≥70;
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- Absolute neutrophil count ≥ 1500/mm³;
- Platelet count ≥ 50,000/mm³;
- Serum creatinine ≤2.0 mg/dL;
- Serum transaminases ≤2 x the upper limit of normal (ULN);
- Total serum bilirubin ≤2 x ULN;
- And a lactate dehydrogenase (LDH) level ≤1.3 x ULN.
Who cannot join
- Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);
- Prior WBRT, brain metastases resection with no other measurable lesion remaining;
- Extracranial metastases in two or more organs;
- Known leptomeningeal or subarachnoid tumor spread;
- Plan to use radiosurgery or radiation boost after completion of WBRT;
- Plan to use chemotherapy or any other systemic antineoplastic modality during WBRT;
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- Previous use of an anti-EGFR drug;
- Participation in another ongoing therapeutic trial;
- Presence of known HIV seropositivity, severe comorbidities, or other malignant neoplasm within 5 years (except adequately treated basal- or squamous-cell carcinoma of skin or in situ carcinoma of the uterine cervix);
- Hypersensitivity or allergy to any of the drugs to be administered in this study;
- Inability or unwillingness to complete the required assessments;
- Geographic inaccessibility for treatment or follow-up evaluations.
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Canada8 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Center
Calgary, Alberta, T2N4N2
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
Hotel Dieu Hospital
Québec, Quebec, G1H 2J6
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, A1B 3V6
Princess Margaret Hospital
Toronto, Ontario, M5G-2M9
United States3 sites
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Florida Cancer Institute - New Hope
New Port Richey, Florida, 34655
Park Nicollet Institute - Frauenshuh Cancer Center
Saint Louis Park, Minnesota, 55426
Pakistan2 sites
Nuclear Medicine and Radiation Oncology Institute (NORI)
Islamabad
Hameed Latif Hospital, Lahore (HLH)
Town, Lahore
Cuba1 site
Hospital Clínico Quirúrgico Hermanos Ameijeiras
Centro Habana, La Habana
About this study
Official title: A Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
This is a randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
Read the detailed description
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms, administering the study drug during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Randomization will be done 2:1 (experimental:control). Chemotherapy can be added before documented disease progression at the discretion of the physician.
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The primary endpoint is intracranial disease progression over 6 months.
The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.
Tissue samples and serum will be collected for future correlative studies.
All the images will be centrally reviewed at the end of study.
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Being tested
- nimotuzumab
- Keywords
- non-small cell lung cancer, NSCLC, Brain metastases, nimotuzumab, TheraCIM, h-R3, Radiation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nimotuzumabDrug
Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Receives: Drug: nimotuzumab |
| 2 | Placebo comparator | A placebo will be administered by the intravenous route weekly during WBRT and following WBRT.
Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. Receives: Drug: nimotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination
Measured: weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.
Secondary outcomes (1)
Overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJul 2011 (estimated)
Why it stopped: Study closed due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- YM BioSciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Investigators
- Anthony Brade, M.D., Principal investigator, Assitant Professor, Department of Radiation Oncology, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872482
- Sponsor's protocol ID
- YMB1000-018
- Status last verified
- Jun 2011
- First submitted
- 26 Mar 2009
- 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 Randomized, Phase II, Double-Blind Study of Nimotuzumab Plus Whole-Brain Radiation Therapy (WBRT) Compared With WBRT Alone in Patients With Brain Metastases From Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00872482
- Acronym / sponsor ID
- YMB1000-018
- Conditions
- Metastatic Non-Small Cell Lung Cancer
- Keywords
- non-small cell lung cancer, NSCLC, Brain metastases, nimotuzumab, TheraCIM, h-R3, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to low enrollment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- YM BioSciencesIndustry (pharma, biotech, devices)
- Collaborators
- CIMYM BioSciences
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (estimated)
- First posted
- 31 Mar 2009 (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 randomized, Phase II study designed to investigate Nimotuzumab plus whole-brain radiation therapy (WBRT)and to compare it rith WBRT alone in patients with brain metastases from non-small cell lung cancer (NSCLC). The purpose of the study is to assess the efficacy of nimotuzumab in combination with WBRT.
Detailed description
A phase II, randomized, controlled, double blinded and multicenter study with 2 arms, administering the study drug during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or at the discretion of the physician. Randomization will be done 2:1 (experimental:control). Chemotherapy can be added before documented disease progression at the discretion of the physician.
The primary objective is to assess the efficacy of Nimotuzumab in combination with WBRT. The primary endpoint is intracranial disease progression over 6 months.
The secondary endpoints are overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.
Tissue samples and serum will be collected for future correlative studies.
All the images will be centrally reviewed at the end of study.
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 | Drug: nimotuzumabNimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. |
| 2 | Placebo comparator | Drug: nimotuzumabA placebo will be administered by the intravenous route weekly during WBRT and following WBRT. Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Providing a written informed consent (see Appendix A);
- Age ≥18 years;
- Histologic or cytologic confirmed diagnosis of NSCLC of any epithelial type (squamous, adenocarcinoma, large cell, or other);
- At least one newly diagnosed measurable metastatic lesion from NSCLC in the brain;
- Patient had initial diagnosis of brain metastases by image, within 8 weeks of registration
Key exclusion criteria (12 listed)
- Pregnancy, lactation or parturition within the previous 30 days (fertile female or male patients should practice contraception);
- Prior WBRT, brain metastases resection with no other measurable lesion remaining;
- Extracranial metastases in two or more organs;
- Known leptomeningeal or subarachnoid tumor spread;
- Plan to use radiosurgery or radiation boost after completion of WBRT;
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 |
|---|---|---|
| nimotuzumabNimotuzumab (200 mg fixed dose) will be administered by the intravenous route weekly during WBRT and following WBRT Radiotherapy will consist of 30 Gy, in 10 fractions of 3 Gy/day. | Drug | 1, 2 |
Primary outcome
Phase II: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination
Time frame: weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.
1 secondary outcome
Overall survival (OS); time to neurologic progression (TNP) or death with evidence of neurologic progression; OS rate at 6 months; time to intracranial disease progression; and time to overall progression.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Study closed due to low enrollment). 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.
Anthony Brade, M.D. principal investigator
Assitant Professor, Department of Radiation Oncology, University of Toronto
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nimotuzumab in people with Metastatic Non-Small Cell Lung Cancer, run by YM BioSciences at 15 sites in 5 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 12 inclusion and 12 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 15 sites in Canada, United States, Pakistan, Cuba, 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. 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 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 was stopped early (reason given: Study closed due to low enrollment). 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: efficacy.Withhold of intracranial progression at 2, 4 and 6 months in comparison with control arm. Patients will be assessed by lab tests, MRI,neurologic examination (time frame: weekly infusions during radiotherapy and following radiotherapy until disease progression, unacceptable toxicity or withdrawal of consent.). 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.