Clinical trial NCT00254904: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 839
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overall Survival
timeFrame: 656 Events
Secondary outcomes:
measure: Patient Reported Outcomes
timeFrame: End of treatment
measure: Overall Safety Profile
timeFrame: 28 days post PF03512676 dosing
measure: Progression Free Survival
timeFrame: Time of primary endpoint
measure: Time to Tumor Progression
timeFrame: Time of progressive disease
measure: Overall Objective Response
timeFrame: End of treatment
measure: Duration of Response
timeFrame: Time of progressive disease
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Bakersfield
country: United States
facility: Pfizer Investigational Site
state: California
city: St. Joseph
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Spokane
country: United States
facility: Pfizer Investigational Site
state: Washington
city: Innsbruck
country: Austria
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Hasselt
country: Belgium
facility: Pfizer Investigational Site
city: Jette
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Jau
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Jaú
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Jaú
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sao Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Laval
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Levis
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Guangzhou
country: China
facility: Pfizer Investigational Site
state: Guangdong
city: Nanjing
country: China
facility: Pfizer Investigational Site
state: Jiangsu
city: Dalian
country: China
facility: Pfizer Investigational Site
state: Liaoning
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Beijing
country: China
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
state: CZ
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Bielefeld
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Loewenstein
country: Germany
facility: Pfizer Investigational Site
city: Mannheim
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Shatin
country: Hong Kong
facility: Pfizer Investigational Site
city: Zalaegerszeg
country: Hungary
facility: Pfizer Investigational Site
state: Külsőkórház-Pózva
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Deszk
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Pecs
country: Hungary
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Pfizer Investigational Site
state: Kerala
city: Pune
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Beer-Sheva
country: Israel
facility: Pfizer Investigational Site
city: Kfar Saba
country: Israel
facility: Pfizer Investigational Site
city: Forli'
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: S.Andrea delle Fratte (PG)
country: Italy
facility: Pfizer Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
state: NH
city: Zaandam
country: Netherlands
facility: Pfizer Investigational Site
state: NH
city: 's-Hertogenbosch
country: Netherlands
facility: Pfizer Investigational Site
city: Harderwijk
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Otwock
country: Poland
facility: Pfizer Investigational Site
city: Szczecin-Zdunowo
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wodzislaw Sl.
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kvetnica pri Poprade
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra-Zobor
country: Slovakia
facility: Pfizer Investigational Site
city: Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
state: Eastern Cape
city: Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Port Elizabeth
country: South Africa
facility: Pfizer Investigational Site
city: Hospitalet de Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Baracaldo
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Castellon
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Jaen
country: Spain
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Bornova / Izmir
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul / Ceraahpasa
country: Turkey
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
state: Avon
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
state: Hampshire
city: Sutton
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Belfast
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Leicester
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: