Carcinoma, Non-small-cell LungPhase 2NCT00312975
Randomized Study Of CP-675,206 or Best Supportive Care Immediately After Platinum-Based Therapy For Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing CP-675,206 in people with Carcinoma, Non-small-cell Lung, run by AstraZeneca at 26 sites in 5 countries.
Trial summary
The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small-cell Lung
- What is being tested?
- CP-675,206
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 26 sitesin 5 countries
- Study dates
- May 2006to Feb 2010
- 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
- Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
- Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.
Who cannot join
- No other systemic therapy except 1st-line platinum based treatment
- Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
Trial locations and contacts
26 sites in 5 countries.
26 sites in 5 countries
United States14 sites
Research Site
Alexandria, Louisiana, 71301
Research Site
Atlanta, Georgia, 30309
Research Site
Bentonville, Arkansas, 72712
Research Site
Canton, Ohio, 44718
Research Site
Danbury, Connecticut, 06810
Research Site
Fayetteville, Arkansas, 72703
Research Site
Lexington, Kentucky, 40536-0098
Research Site
New York, New York, 10032
Research Site
Oneida, New York, 13421
Research Site
Orange, California, 92868
Research Site
Oswego, New York, 13126
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Syracuse, New York, 13202
Research Site
Syracuse, New York, 13210-2306
Canada4 sites
Research Site
Calgary, Alberta, T2N 4N2
Research Site
Calgary, Alberta, T2S 3C3
Research Site
Edmonton, Alberta, T6G 1Z2
Research Site
Montreal, Quebec, H3T 1E2
Czechia3 sites
Research Site
Prague, 180 81
Research Site
Tábor, 390 03
Research Site
Ústí nad Labem, 401 13
South Korea3 sites
Research Site
Seoul, 110-744
Research Site
Seoul, 135-710
Research Site
Seoul, 137-701
United Kingdom2 sites
Research Site
London, SE1 9RT
Research Site
Southampton, Hampshire, SO16 6YD
About this study
Official title: Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.
- Conditions
- Carcinoma, Non-small-cell Lung
- Being tested
- CP-675,206, best supportive care
- 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.
CP-675,206Drug
Given intravenously every 3 months
best supportive careDrug
As per investigator discretion. Excludes chemotherapy or other anti-cancer therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Not described Receives: Drug: CP-675,206 |
| Arm B | Active comparator | Not described Receives: Drug: best supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
Measured: 3 months to 2 years from randomization
Secondary outcomes (9)
Survival
Measured: 2 years
Levels of study drug in blood samples taken at specified time points.
Measured: up to 2 years
Whether polymorphisms of certain genes influence safety.
Measured: up to 2 years
Health-related quality of life outcomes.
Measured: up to 2 years
Tumor response
Measured: up to 2 years
Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC
Measured: up to 2 years
Blood levels of any human anti-human antibody response
Measured: up to 2 years
Immune response.
Measured: up to 2 years
Efficacy
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startMay 2006
- Primary completionApr 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-small-cell LungStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00312975
- Sponsor's protocol ID
- A3671015
- Status last verified
- Jun 2012
- First submitted
- 7 Apr 2006
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Non-Comparative Study Of CP-675,206 Or Best Supportive Care Immediately Following First-Line, Platinum-Based Therapy In Patients With Stage IIIB (With Effusion) Or Stage IV Non-Small Cell Lung Cancer That Has Responded Or Remained Stable
- ClinicalTrials.gov ID
- NCT00312975
- Acronym / sponsor ID
- A3671015
- Conditions
- Carcinoma, Non-small-cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 11 Apr 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.
The purpose of this trial is to study how long patients can remain progression free when they receive CP-675,206, compared to how long patients can remain progression free when they receive best supportive care. If you choose to take part, you will be randomized to receive either CP-675,206 as maintenance therapy or best supportive care. Best supportive care means you will not receive any study drug or other treatment for your cancer. Best supportive care could include treatment with antibiotics, analgesic drugs (medicine for pain), blood transfusions or psychosocial and nutritional support, depending on your needs. You have a 50% chance of being randomized to receive CP-675,206.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: CP-675,206 |
| Arm B | Active comparator | Drug: best supportive care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage IIIb (with effusion) or stage IV disease that has responded or remained stable after 6 cycles of a platinum containing 1st-line regimen
- Patients must be able to be randomized between 3 and no more than 6 weeks after the last dose of first-line therapy.
Key exclusion criteria (2 listed)
- No other systemic therapy except 1st-line platinum based treatment
- Symptomatic or uncontrolled brain mets or uncontrolled pleural effusions.
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 |
|---|---|---|
| CP-675,206Given intravenously every 3 months | Drug | Arm A |
| best supportive careAs per investigator discretion. Excludes chemotherapy or other anti-cancer therapy | Drug | Arm B |
Primary outcome
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care.
Time frame: 3 months to 2 years from randomization
9 secondary outcomes
Survival
Time frame: 2 years
Levels of study drug in blood samples taken at specified time points.
Time frame: up to 2 years
Whether polymorphisms of certain genes influence safety.
Time frame: up to 2 years
Health-related quality of life outcomes.
Time frame: up to 2 years
Tumor response
Time frame: up to 2 years
Number of patients with adverse events as a measure of safety of CP-675,206 when administered to patients with NSCLC
Time frame: up to 2 years
Blood levels of any human anti-human antibody response
Time frame: up to 2 years
Immune response.
Time frame: up to 2 years
Efficacy
Time frame: up to 2 years
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 7 Jun 2012.
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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.
26 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 CP-675,206 in people with Carcinoma, Non-small-cell Lung, run by AstraZeneca at 26 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 2 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 7 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Canada, Czechia, South Korea, 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?
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?
The length of time until there is evidence of disease progression in patients treated with CP-675,206 and in patients receiving best supportive care. (time frame: 3 months to 2 years from randomization). 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 7 Jun 2012.