Carcinoma, Non-Small-Cell LungPhase 2NCT00321815
Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
A Phase 2 study testing PF-3512676 + Erlotinib and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 35 sites in United States.
Trial summary
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen. 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?
- PF-3512676 + Erlotinib and Erlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 35 sitesUnited States
- Study dates
- Aug 2006to Jun 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
- Advanced, EGFR-positive NSCLC
- ECOG Performance Status 0, 1 or 2
- Measurable disease
Who cannot join
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Pfizer Investigational Site
Bridgeton, Missouri, 63044
Pfizer Investigational Site
Chesterfield, Missouri, 63017
Pfizer Investigational Site
Cincinnati, Ohio, 45209
Pfizer Investigational Site
Cincinnati, Ohio, 45219
Pfizer Investigational Site
Corona, California, 92879
Pfizer Investigational Site
Crestview Hills, Kentucky, 41017
Pfizer Investigational Site
Dallas, Texas, 75230
Pfizer Investigational Site
Dallas, Texas, 75246
Pfizer Investigational Site
Dalls, Texas, 75246
Pfizer Investigational Site
Daphne, Alabama, 36526
Pfizer Investigational Site
Deerfield Beach, Florida, 33442
Pfizer Investigational Site
Fairfield, Ohio, 45014
Pfizer Investigational Site
Glendora, California, 91741
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Hershey, Pennsylvania, 17033-0850
Pfizer Investigational Site
Huntsville, Alabama, 35805
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Kirkwood, Missouri, 63122
Pfizer Investigational Site
Louisville, Kentucky, 40202
Pfizer Investigational Site
Mason City, Iowa, 50401
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Munster, Indiana, 46321
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Norwalk, Connecticut, 06856
Pfizer Investigational Site
Pasadena, California, 91105
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19104
Pfizer Investigational Site
Philadephia, Pennsylvania, 19104
Pfizer Investigational Site
Pomona, California, 91767
Pfizer Investigational Site
Rancho Cucamonga, California, 91730
Pfizer Investigational Site
San Mateo, California, 94402
Pfizer Investigational Site
Somerville, New Jersey, 08876
Pfizer Investigational Site
Stony Brook, New York, 11794
Pfizer Investigational Site
West Covina, California, 91790
About this study
Official title: A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- PF-3512676 + Erlotinib, Erlotinib
- Keywords
- advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator
- 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.
PF-3512676 + ErlotinibDrug
PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity.
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
ErlotinibDrug
Also called Tarceva
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Standard of Care chemotherapy plus experimental intervention (PF-3512676) Receives: Drug: PF-3512676 + Erlotinib |
| B | Active comparator | Standard of Care chemotherapy Receives: Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: 50Events
Secondary outcomes (5)
Overall Safety Profile
Measured: 28 days post treatment
Time to Tumor Progression
Measured: End of treatment
Overall Objective Response Rate
Measured: Time of disease progression
Duration of Response
Measured: Time of disease progression
Overall Survival
Measured: Time of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionJun 2010
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 Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321815
- Sponsor's protocol ID
- A8501006
- Status last verified
- Dec 2010
- First submitted
- 3 May 2006
- Last updated
- 23 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Belani CP, Nemunaitis JJ, Chachoua A, Eisenberg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ. Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer. Cancer Biol Ther. 2013 Jul;14(7):557-63. doi: 10.4161/cbt.24598. Epub 2013 May 10.
PubMed 23792641
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen
- ClinicalTrials.gov ID
- NCT00321815
- Acronym / sponsor ID
- A8501006
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- advanced carcinoma non-small cell lung EGFR positive Erlotinib Tarceva PF-3512676 Phase II immunotherapy immune modulator
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 May 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.
To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: PF-3512676 + ErlotinibStandard of Care chemotherapy plus experimental intervention (PF-3512676) |
| B | Active comparator | Drug: ErlotinibStandard of Care chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Advanced, EGFR-positive NSCLC
- ECOG Performance Status 0, 1 or 2
- Measurable disease
Key exclusion criteria (2 listed)
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated 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 |
|---|---|---|
| PF-3512676 + ErlotinibPF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity | Drug | A |
| ErlotinibAlso: TarcevaErlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity | Drug | B |
Primary outcome
Progression-Free Survival
Time frame: 50Events
5 secondary outcomes
Overall Safety Profile
Time frame: 28 days post treatment
Time to Tumor Progression
Time frame: End of treatment
Overall Objective Response Rate
Time frame: Time of disease progression
Duration of Response
Time frame: Time of disease progression
Overall Survival
Time frame: Time of death
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 23 Dec 2010.
- Derived from this study: PubMed 23792641Belani CP, Nemunaitis JJ, Chachoua A, Eisenberg PD, Raez LE, Cuevas JD, Mather CB, Benner RJ, Meech SJ. Phase 2 trial of erlotinib with or without PF-3512676 (CPG 7909, a Toll-like receptor 9 agonist) in patients with advanced recurrent EGFR-positive non-small cell lung cancer. Cancer Biol Ther. 2013 Jul;14(7):557-63. doi: 10.4161/cbt.24598. Epub 2013 May 10.
- To obtain contact information for a study center near you, click here.Link 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.
Pfizer CT.gov Call Center study director
Pfizer
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PF-3512676 + Erlotinib and Erlotinib in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 35 sites in United States.
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 3 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 23 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 (time frame: 50Events). 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 NCT00321815, 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 23 Dec 2010.