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

March 10, 2015 updated by: Pfizer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

839

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Charleroi, Belgium, 6000
        • Pfizer Investigational Site
      • Hasselt, Belgium, 3500
        • Pfizer Investigational Site
      • Jette, Belgium, 1090
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Pfizer Investigational Site
      • Rio de Janeiro, RJ, Brazil, 20231 -050
        • Pfizer Investigational Site
    • SP
      • Jau, SP, Brazil, 17210-120
        • Pfizer Investigational Site
      • Jaú, SP, Brazil, 17210-080
        • Pfizer Investigational Site
      • Jaú, SP, Brazil, 17210-120
        • Pfizer Investigational Site
      • Sao Paulo, SP, Brazil, 01224-010
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 01219-000
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 01221-020
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1V 4G5
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N8W 1L9
        • Pfizer Investigational Site
      • Windsor, Ontario, Canada, N8W 2X3
        • Pfizer Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Pfizer Investigational Site
      • Laval, Quebec, Canada, H7M 3L9
        • Pfizer Investigational Site
      • Levis, Quebec, Canada, G6V 3Z1
        • Pfizer Investigational Site
  • China
      • Beijing, China, 100036
        • Pfizer Investigational Site
      • Beijing, China, 101149
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Pfizer Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • Pfizer Investigational Site
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Pfizer Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Praha 8, Czech Republic, 180 81
        • Pfizer Investigational Site
    • CZ
      • Praha 5, CZ, Czech Republic, 150 06
        • Pfizer Investigational Site
  • Germany
      • Bielefeld, Germany, 33611
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76137
        • Pfizer Investigational Site
      • Loewenstein, Germany, 74245
        • Pfizer Investigational Site
      • Mannheim, Germany, 68167
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
  • Hong Kong
      • Kowloon, Hong Kong
        • Pfizer Investigational Site
      • Shatin, Hong Kong
        • Pfizer Investigational Site
  • Hungary
      • Budapest, Hungary, 1529
        • Pfizer Investigational Site
      • Deszk, Hungary, 6772
        • Pfizer Investigational Site
      • Gyula, Hungary, 5703
        • Pfizer Investigational Site
      • Pecs, Hungary, 7635
        • Pfizer Investigational Site
    • Külsőkórház-Pózva
      • Zalaegerszeg, Külsőkórház-Pózva, Hungary, H-8900
        • Pfizer Investigational Site
  • India
      • New Delhi, India, 110085
        • Pfizer Investigational Site
    • Karnataka
      • Bangalore, Karnataka, India, 560027
        • Pfizer Investigational Site
    • Kerala
      • Kochi, Kerala, India, 682 304
        • Pfizer Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411 004
        • Pfizer Investigational Site
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Pfizer Investigational Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Pfizer Investigational Site
  • Israel
      • Beer-Sheva, Israel, 84101
        • Pfizer Investigational Site
      • Kfar Saba, Israel, 44281
        • Pfizer Investigational Site
  • Italy
      • Forli', Italy, 47100
        • Pfizer Investigational Site
      • Milano, Italy, 20100
        • Pfizer Investigational Site
      • Pisa, Italy, 56127
        • Pfizer Investigational Site
      • Roma, Italy, 00144
        • Pfizer Investigational Site
      • S.Andrea delle Fratte (PG), Italy, 06132
        • Pfizer Investigational Site
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 410-769
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • Pfizer Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • Pfizer Investigational Site
  • Netherlands
      • 's-Hertogenbosch, Netherlands, 5211 RW
        • Pfizer Investigational Site
      • Harderwijk, Netherlands, 3844 DG
        • Pfizer Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • Pfizer Investigational Site
    • NH
      • Amsterdam, NH, Netherlands, 1066 CX
        • Pfizer Investigational Site
      • Zaandam, NH, Netherlands, 1502 DV
        • Pfizer Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Pfizer Investigational Site
      • Lodz, Poland, 93-509
        • Pfizer Investigational Site
      • Otwock, Poland, 05-400
        • Pfizer Investigational Site
      • Szczecin-Zdunowo, Poland, 70-891
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-781
        • Pfizer Investigational Site
      • Warszawa, Poland, 00-909
        • Pfizer Investigational Site
      • Warszawa, Poland, 01-138
        • Pfizer Investigational Site
      • Wodzislaw Sl., Poland, 44-300
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3041-801
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1099-023
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1649-035
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1769-001
        • Pfizer Investigational Site
      • Porto, Portugal, 4200-072
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 169610
        • Pfizer Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 82606
        • Pfizer Investigational Site
      • Kosice, Slovakia, 041 91
        • Pfizer Investigational Site
      • Kvetnica pri Poprade, Slovakia, 058 07
        • Pfizer Investigational Site
      • Nitra-Zobor, Slovakia, 949 88
        • Pfizer Investigational Site
  • South Africa
      • Cape Town, South Africa, 7405
        • Pfizer Investigational Site
      • Port Elizabeth, South Africa, 6001
        • Pfizer Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
        • Pfizer Investigational Site
  • Spain
      • Alicante, Spain, 03010
        • Pfizer Investigational Site
      • Castellon, Spain, 12002
        • Pfizer Investigational Site
      • Gerona, Spain, 17007
        • Pfizer Investigational Site
      • Jaen, Spain, 23007
        • Pfizer Investigational Site
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Pfizer Investigational Site
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Pfizer Investigational Site
  • Taiwan
      • Taichung, Taiwan
        • Pfizer Investigational Site
      • Tainan, Taiwan, 704
        • Pfizer Investigational Site
      • Taipei, Taiwan, 100
        • Pfizer Investigational Site
      • Taipei, Taiwan, 112
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Bornova / Izmir, Turkey, 35050
        • Pfizer Investigational Site
      • Istanbul / Ceraahpasa, Turkey, 34303
        • Pfizer Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Pfizer Investigational Site
      • Dundee, United Kingdom, DD1 9SY
        • Pfizer Investigational Site
      • Edinburgh, United Kingdom, EH4 2XU
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G12 0YN
        • Pfizer Investigational Site
      • Leicester, United Kingdom, LE1 5WW
        • Pfizer Investigational Site
      • London, United Kingdom, NW3 2QG
        • Pfizer Investigational Site
      • Wolverhampton, United Kingdom, WV10 0QP
        • Pfizer Investigational Site
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8ED
        • Pfizer Investigational Site
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
    • California
      • Bakersfield, California, United States, 93309
        • Pfizer Investigational Site
    • Michigan
      • St. Joseph, Michigan, United States, 49085
        • Pfizer Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Pfizer Investigational Site
      • St. Louis, Missouri, United States, 63122
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • Washington
      • Spokane, Washington, United States, 99202
        • Pfizer Investigational Site
      • Spokane, Washington, United States, 99204
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
Drug: Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Other Names:
  • Platinol-AQ
Drug: Gemcitabine
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Names:
  • 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
Active Comparator: B
Standard of Care chemotherapy
Drug: Cisplatin
Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles
Other Names:
  • Platinol-AQ
Drug: Gemcitabine + Cisplatin
Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles
Other Names:
  • Gemzar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 656 Events
656 Events

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

November 15, 2005

First Submitted That Met QC Criteria

November 15, 2005

First Posted (Estimate)

November 17, 2005

Study Record Updates

Last Update Posted (Estimate)

March 30, 2015

Last Update Submitted That Met QC Criteria

March 10, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8501002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carcinoma, Non-Small-Cell Lung

Clinical Trials on Cisplatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe