| Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC |
| International, Randomized, Open-Label, Phase 3 Trial of Gemcitabine/Cisplatin Plus PF-3512676 Versus Gemcitabine/Cisplatin Alone as First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer |
| To assess the efficacy and safety of PF-3512676 administered in combination with gemcitabine/cisplatin chemotherapy as first-line treatment in patients with locally advanced or metastatic Non-Small-Cell Lung Cancer (NSCLC) and to compare it to the efficacy and safety of gemcitabine/cisplatin alone. |
| PF-3512676 dosing was stopped 20 June 2007 in response to DSMC recommendation to close the trial, citing lack of efficacy concerns as the primary reason with a safety issue (thrombocytopenia) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 25 June 2008. |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment |
| Carcinoma, Non-Small-Cell Lung |
- Drug: Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Other Name: Platinol-AQ
- Drug: Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Name: Gemzar
- Drug: PF-3512676
PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
- Drug: Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Name: Gemzar
|
|
|
| Not Provided |
| |
| Terminated |
| 839 |
| June 2008 |
| June 2008 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Advanced Non-Small-Cell Lung Cancer (NSCLC) stage IIIB with pleural effusion or stage IV
- No prior systemic treatment for Non-Small-Cell Lung Cancer (NSCLC) with chemotherapy, immunotherapy, biologic response modifiers or other investigational drugs
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1
Exclusion Criteria:
- Small cell or carcinoid lung cancer
- Known Central Nervous System (CNS) metastasis
- Pre-existing auto-immune or antibody mediated diseases
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Austria, Belgium, Brazil, Canada, China, Czech Republic, Germany, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Singapore, Slovakia, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States |
| France |
| |
| NCT00254904 |
| A8501002 |
| Yes |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| March 2015 |
