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
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.
Inclusion Criteria:
Exclusion Criteria:
S.Andrea Delle Fratte (PG), 06132, Italy
Szczecin-Zdunowo, 70-891, Poland
Wodzislaw Sl., 44-300, Poland
Kvetnica Pri Poprade, 058 07, Slovakia
Nitra-Zobor, 949 88, Slovakia
Bornova / Izmir, 35050, Turkey (Türkiye)
Istanbul / Ceraahpasa, 34303, Turkey (Türkiye)