Carcinoma, Non-Small Cell LungPhase 2NCT00070629
CPG 7909 Injection in Non-Small Cell Lung Cancer
A Phase 2 study testing CPG 7909 and Chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 24 sites in 3 countries.
Trial summary
Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. 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?
- CPG 7909 and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 24 sitesin 3 countries
- Study dates
- May 2003to Jul 2007
- 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
- Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
- Patients must have measurable disease according to the RECIST criteria.
Who cannot join
- Prior treatment with chemotherapy; patients may have received prior radiotherapy.
- Patients with suspected or known CNS metastases.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States17 sites
Cancer Care Institute of Carolina
Aiken, South Carolina, 29801
Cancer Care of Western North Carolina
Asheville, North Carolina, 28801
HemOnCare
Brooklyn, New York, 11212
Charleston Hematology/Oncology, PA
Charleston, South Carolina, 29403
The Family Cancer Center
Collierville, Tennessee, 38017
VA New Jersey Health Care System
East Orange, New Jersey, 07018
Florida Cancer Specialist
Fort Myers, Florida, 33901
Office of Ronald Yanagihara
Gilroy, California, 95020
Kentucky Cancer Clinic
Hazard, Kentucky, 41701
Indiana Hematology and Oncology Associates
Indianapolis, Indiana, 46202
Southeast Nebraska Hematology Oncology Consultants, PC
Lincoln, Nebraska, 68516
Kenmar Research Institute, LLC
Los Angeles, California, 90057
Marshfield Clinic
Marshfield, Wisconsin, 54449
University of Minnesota
Minneapolis, Minnesota, 55455
Comprehensive Cancer Center of the Dessert
Palm Springs, California, 92262
Providence Portland Medical Center
Portland, Oregon, 97213
Medical Center Vincennes
Vincennes, Indiana, 47591
Germany4 sites
Staedtisches Krankenhaus Martha-Maria
Halle-Dolau, D-06120
Universitätsklinikum Mannheim der Universität Heidelberg
Heidelberg
St. Vincentius-Kliniken gAG, Hamatologie-Onkologie
Karlsruhe, D76137
Klinikum Rechts der Isar
München, 81675
Canada3 sites
Queen Elizabeth II Health
Halifax, Nova Scotia, B3H 1V7
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Center
Ottawa, Ontario, K1H 1C4
About this study
Official title: Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study
Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
- Conditions
- Carcinoma, Non-Small Cell Lung
- Being tested
- CPG 7909, Chemotherapy
- Keywords
- Immunotherapy, lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPG 7909Drug
Also called ProMune, PF-3512676
CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle.
ChemotherapyDrug
A taxane and a platinum compound given on week one of three-week cycles:
Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6
ChemotherapyDrug
Also called Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)
A taxane and a platinum compound given on week one of three-week cycles:
Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection Receives: Drug: CPG 7909; Drug: Chemotherapy |
| 2 | Active comparator | Chemotherapy (a taxane and a platinum compound) Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
Measured: Indeterminate
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Measured: Indeterminate
Secondary outcomes (4)
Secondary Efficacy
Measured: Indeterminate
compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups
Measured: Indeterminate
duration of overall response (CR, PR), survival time, and time to disease progression.
Measured: Indeterminate
To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.
Measured: Indeterminate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study startMay 2003
- Study completionJul 2007
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 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070629
- Sponsor's protocol ID
- C017
- Other IDs
- ProMune, CO17, A8501017
- Status last verified
- Feb 2009
- First submitted
- 6 Oct 2003
- Last updated
- 10 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promune™ (CPG 7909 Injection) In Combination With Chemotherapy In Patients With Advanced Or Metastatic Non-Small Cell Lung Cancer, A Randomized, Multi-Center, Controlled, Phase 2 Study
- ClinicalTrials.gov ID
- NCT00070629
- Acronym / sponsor ID
- C017
- Conditions
- Carcinoma, Non-Small Cell Lung
- Keywords
- Immunotherapy, lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 8 Oct 2003 (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.
Eligible patients will be randomized in a ratio of 2:1 to receive either chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection or chemotherapy alone. Protocol therapy will be administered until disease progression or intolerable toxicity. CpG 7909 Injection will be administered subcutaneously, on Weeks 2 and 3 of each three-week cycle (days 8 and 15) and chemotherapy will be administered on Week 1 (Day 1). Patients will undergo complete disease evaluation at the end of every other treatment cycle until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: CPG 7909, Drug: ChemotherapyChemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection |
| 2 | Active comparator | Drug: ChemotherapyChemotherapy (a taxane and a platinum compound) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically or cytologically confirmed non-small cell lung cancer that is beyond surgical cure or that is metastatic (Stage IIIB or IV according to AJCC).
- Patients must have measurable disease according to the RECIST criteria.
Key exclusion criteria (2 listed)
- Prior treatment with chemotherapy; patients may have received prior radiotherapy.
- Patients with suspected or known CNS metastases.
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 |
|---|---|---|
| CPG 7909Also: ProMune, PF-3512676CPG 7909 Injection will be administered subcutaneously at a starting dose of 0.20 mg/kg at the beginning of Weeks 2 and 3 of the three-week cycle. | Drug | 1 |
| ChemotherapyA taxane and a platinum compound given on week one of three-week cycles: Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6 | Drug | 2 |
| ChemotherapyAlso: Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)A taxane and a platinum compound given on week one of three-week cycles: Regimen A: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Cisplatin 75 mg/m2 Regimen B: Paclitaxel 175 mg/m2 over 1 - 3 hrs, Carboplatin AUC of 6 Regimen C: Docetaxel 75 mg/m2, Cisplatin 75 mg/m2 Regimen D: Docetaxel 75 mg/m2, Carboplatin AUC of 6 | Drug | 1 |
Primary outcome
Efficacy- overall response rate (CR & PR) according to the RECIST criteria
Time frame: Indeterminate
Safety- drug exposure, adverse events, laboratory tests, vital signs, ECG, and physical examinations
Time frame: Indeterminate
4 secondary outcomes
Secondary Efficacy
Time frame: Indeterminate
compare number of patients who achieve complete response, partial response, or stable disease (CR, PR, SD) between the two treatment groups
Time frame: Indeterminate
duration of overall response (CR, PR), survival time, and time to disease progression.
Time frame: Indeterminate
To assess the immunopharmacodynamic response to CPG 7909 Injection plus chemotherapy in responding vs nonresponding patients receiving chemotherapy or the combination.
Time frame: Indeterminate
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 10 Feb 2009.
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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.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CPG 7909 and Chemotherapy in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 24 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 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 10 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Germany, Canada. 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?
Efficacy- overall response rate (CR & PR) according to the RECIST criteria (time frame: Indeterminate). The study lists 2 primary outcomes in all. 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 10 Feb 2009.