Carcinoma, Non-Small-Cell Lung
Conditions
Keywords
advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator
Brief summary
To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin 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 paclitaxel
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 (sepsis) also contributing to the decision. Subjects were allowed to complete standard of care treatment/survival follow-up. Data collection was completed on 17 July 2008.
Interventions
DRUGPF-3512676 + Paclitaxel + Carboplatin
* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. * Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.
* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days 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 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 |
|---|---|
| Time to Tumor Progression | Time of progressive disease |
| Progression Free Survival | Time of primary endpoint |
| Overall Objective Response | End of Treatment |
| Patient Reported Outcomes | End of Treatment |
| Overall Safety Profile | 28 days post PF-3512676 dosing |
| Duration of Response | Time of progressive disease |
Countries
Australia, Belgium, Canada, China, Cyprus, Czechia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Portugal, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Outcome results
None listed