Non Small Cell Lung CancerPhase 2NCT00460551
Zalutumumab in Combination With Chemo-Radiation in a Certain Type of Lung Cancer
A Phase 2 study testing Zalutumumab, Induction chemotherapy and Radiotherapy in people with Non Small Cell Lung Cancer, run by Genmab at 8 sites in 5 countries.
Trial summary
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone. 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?
- Zalutumumab, Induction chemotherapy and Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Apr 2007to Oct 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- NSCLC stage IIIA-IIIB
- Performance status 0 or 1 (Zubrod or WHO Scale)
Who cannot join
- Evidence of metastases either in a separate lobe of the lung, or extra thoracic
- Patients with high risk of radiation pneumonitis and or compromised lung function
- Estimated life expectancy of less than 3 months
- Prior chemotherapy for lung cancer
- Prior radiotherapy to the chest
- Prior surgery with curative intent for lung cancer
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Belgium3 sites
UZ Gent
Ghent, 9000
CHR La Citadelle
Liège, 4000
CHU Sart-Tilman Domaine Universitaire du Sart-Tilman
Liège, 4000
United States2 sites
Providence Portland Medical Center
Portland, Oregon, 97213-2967
Study site
Towson, Maryland, 21204
United Kingdom1 site
The Institute of Cancer Research and the Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.
Read the detailed description
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Zalutumumab, Induction chemotherapy, Radiotherapy
- 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.
ZalutumumabBiological
8 mg/kg
Induction chemotherapyDrug
Combination of cisplatin and docetaxel administered as two cycles given every three weeks
RadiotherapyRadiation
64 Gy in 32 fractions over 6.5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Zalutumumab 8 mg/kg | Experimental | Not described Receives: Biological: Zalutumumab; Drug: Induction chemotherapy; Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival Verified by Imaging Techniques.
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
Measured: Until disease progression
Secondary outcomes (1)
Adverse Events
Number of participants reporting at least one adverse event
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionOct 2008
Why it stopped: Due to considerations regarding the appropriate therapeutic regimen for these patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by GenmabThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steen Lisby, MD, PHD, Study director, Genmab employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460551
- Sponsor's protocol ID
- GEN204
- Status last verified
- Dec 2011
- First submitted
- 12 Apr 2007
- Last updated
- 6 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Chemo-Radiation in Stage IIIA-IIIB Non Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00460551
- Acronym / sponsor ID
- GEN204
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to considerations regarding the appropriate therapeutic regimen for these patients.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 16 Apr 2007 (estimated)
- Results
- Posted 5 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.
Detailed description
Originally the study was planned as Part 1A, Part 1B and Part 2. Part 1A was one arm with zalatumumab fixed dose 8 mg/kg. Part 1B was planned as zalutumumab dose-titration and Part 2 adding a comparator. The trial was prematurely closed for enrolment when patients had only been enrolled in Part 1A due to published results showing increased toxicity from induction chemotherapy without any survival benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zalutumumab 8 mg/kg | Experimental | Biological: Zalutumumab, Drug: Induction chemotherapy, Radiation: Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NSCLC stage IIIA-IIIB
- Performance status 0 or 1 (Zubrod or WHO Scale)
Key exclusion criteria (6 listed)
- Evidence of metastases either in a separate lobe of the lung, or extra thoracic
- Patients with high risk of radiation pneumonitis and or compromised lung function
- Estimated life expectancy of less than 3 months
- Prior chemotherapy for lung cancer
- Prior radiotherapy to the chest
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 |
|---|---|---|
| Zalutumumab8 mg/kg | Biological | Zalutumumab 8 mg/kg |
| Induction chemotherapyCombination of cisplatin and docetaxel administered as two cycles given every three weeks | Drug | Zalutumumab 8 mg/kg |
| Radiotherapy64 Gy in 32 fractions over 6.5 weeks | Radiation | Zalutumumab 8 mg/kg |
Primary outcome
Progression Free Survival Verified by Imaging Techniques.
Time frame: Until disease progression
Disease progression was planned to be confirmed using RECIST criteria J Natl Cancer Inst 2000;92:205-16
1 secondary outcome
Adverse Events
Time frame: Up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steen Lisby, MD, PHD study director
Genmab employee
8 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 Zalutumumab, Induction chemotherapy and Radiotherapy in people with Non Small Cell Lung Cancer, run by Genmab at 8 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 2 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: stopped early, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium, United States, France, Netherlands, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 5 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Verified by Imaging Techniques. (time frame: 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 6 Dec 2011.