Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC

• ClinicalTrials.gov Identifier: NCT00254904
• Recruitment Status: Terminated
• First Posted: November 17, 2005
• Last Update Posted: March 30, 2015
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: November 15, 2005
• First Posted Date: November 17, 2005
• Last Update Posted Date: March 30, 2015
• Study Start Date: November 2005
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 19, 2007): Overall Survival [ Time Frame: 656 Events ]
• Original Primary Outcome Measures (submitted: November 15, 2005): Overall Survival

Current Secondary Outcome Measures (submitted: December 11, 2008)

• Patient Reported Outcomes [ Time Frame: End of treatment ]
• Overall Safety Profile [ Time Frame: 28 days post PF03512676 dosing ]
• Progression Free Survival [ Time Frame: Time of primary endpoint ]
• Time to Tumor Progression [ Time Frame: Time of progressive disease ]
• Overall Objective Response [ Time Frame: End of treatment ]
• Duration of Response [ Time Frame: Time of progressive disease ]

• Original Secondary Outcome Measures (submitted: November 15, 2005): Overall confirmed objective response rate, duration of response, progression free survival, time to tumor progression, overall safety profile, patient reported outcomes, pharmacokinetics
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Trial of Gemcitabine/Cisplatin + PF-3512676 vs Gemcitabine/Cisplatin Alone in Patients With Advanced NSCLC
• Official Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• 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

Study Arms

• Experimental: A
  Standard of Care chemotherapy plus experimental intervention (PF-3512676)
  Interventions:

  • Drug: Cisplatin
  • Drug: Gemcitabine
  • Drug: PF-3512676
• Active Comparator: B
  Standard of Care chemotherapy
  Interventions:

  • Drug: Cisplatin
  • Drug: Gemcitabine + Cisplatin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 19, 2007): 839
• Original Enrollment (submitted: November 15, 2005): 800
• Actual Study Completion Date: June 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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
• Removed Location Countries: France

Administrative Information

• NCT Number: NCT00254904
• Other Study ID Numbers: A8501002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2015