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CPG 7909 Injection in Non-Small Cell Lung Cancer

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Office of Ronald Yanagihara
Gilroy, California, 95020 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Prior treatment with chemotherapy; patients may have received prior radiotherapy.

- Patients with suspected or known CNS metastases.

NCT00070629
Pfizer
Completed
CPG 7909 Injection in Non-Small Cell Lung Cancer

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CPG 7909 Injection in Non-Small Cell Lung Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Carcinoma, Non-Small Cell Lung
  • Drug: CPG 7909
    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.
    Other Name: ProMune, PF-3512676
  • Drug: Chemotherapy

    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: Chemotherapy

    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

    Other Name: Paclitaxel (Taxol), docetaxel (TAXOTERE) cisplatin and carboplatin (e.g. PARAPLATIN)
  • Experimental: 1
    Chemotherapy (a taxane and a platinum compound) plus CPG 7909 Injection
    Interventions:
    • Drug: CPG 7909
    • Drug: Chemotherapy
  • Active Comparator: 2
    Chemotherapy (a taxane and a platinum compound)
    Intervention: Drug: Chemotherapy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
116
July 2007
Not Provided

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Prior treatment with chemotherapy; patients may have received prior radiotherapy.
  • Patients with suspected or known CNS metastases.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Germany,   United States
 
 
NCT00070629
C017
ProMune
CO17
A8501017
Not Provided
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Not Provided
Pfizer
February 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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