Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer
NCT00321815
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- Advanced, EGFR-positive NSCLC
- ECOG Performance Status 0, 1 or 2
- Measurable disease
- Known CNS metastasis
- Pre-existing autoimmune or antibody mediated disease
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Descriptive Information | ||||
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Brief Title ICMJE | Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer | |||
Official Title ICMJE | 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 | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Carcinoma, Non-Small-Cell Lung | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 43 | |||
Original Enrollment ICMJE | 130 | |||
Actual Study Completion Date ICMJE | June 2010 | |||
Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00321815 | |||
Other Study ID Numbers ICMJE | A8501006 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer Inc | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |