Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator
Brief summary
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.
Detailed description
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.
Interventions
DRUGCisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
DRUGGemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
DRUGPF-3512676
PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | 656 Events |
Secondary
| Measure | Time frame |
|---|---|
| Overall Safety Profile | 28 days post PF03512676 dosing |
| Progression Free Survival | Time of primary endpoint |
| Patient Reported Outcomes | End of treatment |
| Overall Objective Response | End of treatment |
| Duration of Response | Time of progressive disease |
| Time to Tumor Progression | Time of progressive disease |
Countries
Austria, Belgium, Brazil, Canada, China, Czechia, Germany, Hong Kong, Hungary, India, Israel, Italy, Netherlands, Poland, Portugal, Singapore, Slovakia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed