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Carcinoma, Non-Small-Cell LungPhase 3NCT00254904

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

A Phase 3 study testing Cisplatin, Gemcitabine and PF-3512676 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 120 sites in 24 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
Cisplatin, Gemcitabine and PF-3512676
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
839 participants
Where
120 sitesin 24 countries
Study dates
Nov 2005to Jun 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Small cell or carcinoid lung cancer
  • Known Central Nervous System (CNS) metastasis
  • Pre-existing auto-immune or antibody mediated diseases

Trial locations and contacts

120 sites in 24 countries.

120 sites in 24 countries

United States10 sites

  • Pfizer Investigational Site

    Bakersfield, California, 93309

  • Pfizer Investigational Site

    Birmingham, Alabama, 35233

  • Pfizer Investigational Site

    Birmingham, Alabama, 35294

  • Pfizer Investigational Site

    Minneapolis, Minnesota, 55455

  • Pfizer Investigational Site

    New York, New York, 10032

  • Pfizer Investigational Site

    Saint Joseph, Michigan, 49085

  • Pfizer Investigational Site

    Spokane, Washington, 99202

  • Pfizer Investigational Site

    Spokane, Washington, 99204

  • Pfizer Investigational Site

    St Louis, Missouri, 63110

  • Pfizer Investigational Site

    St Louis, Missouri, 63122

Other trials in United States

United Kingdom10 sites

  • Pfizer Investigational Site

    Belfast, BT9 7AB

  • Pfizer Investigational Site

    Bristol, Avon, BS2 8ED

  • Pfizer Investigational Site

    Dundee, DD1 9SY

  • Pfizer Investigational Site

    Edinburgh, EH4 2XU

  • Pfizer Investigational Site

    Glasgow, G12 0YN

  • Pfizer Investigational Site

    Leicester, LE1 5WW

  • Pfizer Investigational Site

    London, NW3 2Qg

  • Pfizer Investigational Site

    Southampton, Hampshire, SO16 6YD

  • Pfizer Investigational Site

    Sutton, Surrey, SM2 5PT

  • Pfizer Investigational Site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Poland8 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Lodz, 93-509

  • Pfizer Investigational Site

    Otwock, 05-400

  • Pfizer Investigational Site

    Szczecin-Zdunowo, 70-891

  • Pfizer Investigational Site

    Warsaw, 00-909

  • Pfizer Investigational Site

    Warsaw, 01-138

  • Pfizer Investigational Site

    Warsaw, 02-781

  • Pfizer Investigational Site

    Wodzislaw Sl., 44-300

Other trials in Poland

Belgium7 sites

  • Pfizer Investigational Site

    Brussels, 1070

  • Pfizer Investigational Site

    Brussels, 1200

  • Pfizer Investigational Site

    Charleroi, 6000

  • Pfizer Investigational Site

    Hasselt, 3500

  • Pfizer Investigational Site

    Jette, 1090

  • Pfizer Investigational Site

    Leuven, 3000

  • Pfizer Investigational Site

    Liège, 4000

Other trials in Belgium

Brazil7 sites

  • Pfizer Investigational Site

    Jaú, São Paulo, 17210-080

  • Pfizer Investigational Site

    Jaú, São Paulo, 17210-120

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20230-130

  • Pfizer Investigational Site

    Rio de Janeiro, Rio de Janeiro, 20231 -050

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01219-000

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01221-020

  • Pfizer Investigational Site

    São Paulo, São Paulo, 01224-010

Other trials in Brazil

Canada7 sites

  • Pfizer Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • Pfizer Investigational Site

    Laval, Quebec, H7M 3L9

  • Pfizer Investigational Site

    Lévis, Quebec, G6V 3Z1

  • Pfizer Investigational Site

    Québec, Quebec, G1V 4G5

  • Pfizer Investigational Site

    Toronto, Ontario, M5G 2M9

  • Pfizer Investigational Site

    Windsor, Ontario, N8W 1L9

  • Pfizer Investigational Site

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Spain7 sites

  • Pfizer Investigational Site

    Alicante, Alicante, 03010

  • Pfizer Investigational Site

    Barakaldo, Vizcaya, 48903

  • Pfizer Investigational Site

    Castellon, Castellon, 12002

  • Pfizer Investigational Site

    Girona, Gerona, 17007

  • Pfizer Investigational Site

    Jaén, Jaen, 23007

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Pfizer Investigational Site

    Santander, Cantabria, 39008

Other trials in Spain

Germany6 sites

  • Pfizer Investigational Site

    Bielefeld, 33611

  • Pfizer Investigational Site

    Karlsruhe, 76137

  • Pfizer Investigational Site

    Löwenstein, 74245

  • Pfizer Investigational Site

    Mannheim, 68167

  • Pfizer Investigational Site

    München, 81675

  • Pfizer Investigational Site

    Tübingen, 72076

Other trials in Germany

India6 sites

  • Pfizer Investigational Site

    Bangalore, Karnataka, 560027

  • Pfizer Investigational Site

    Kochi, Kerala, 682 304

  • Pfizer Investigational Site

    Lucknow, Uttar Pradesh, 226003

  • Pfizer Investigational Site

    Ludhiana, Punjab, 141001

  • Pfizer Investigational Site

    New Delhi, New Delhi, 110085

  • Pfizer Investigational Site

    Pune, Maharashtra, 411 004

Other trials in India

China5 sites

  • Pfizer Investigational Site

    Beijing, 100036

  • Pfizer Investigational Site

    Beijing, 101149

  • Pfizer Investigational Site

    Dalian, Liaoning, 116023

  • Pfizer Investigational Site

    Guangzhou, Guangdong, 510060

  • Pfizer Investigational Site

    Nanjing, Jiangsu, 210002

Other trials in China

Hungary5 sites

  • Pfizer Investigational Site

    Budapest, 1529

  • Pfizer Investigational Site

    Deszk, 6772

  • Pfizer Investigational Site

    Gyula, 5703

  • Pfizer Investigational Site

    Pécs, 7635

  • Pfizer Investigational Site

    Zalaegerszeg, Külsőkórház-Pózva, H-8900

Other trials in Hungary

Italy5 sites

  • Pfizer Investigational Site

    Forlì, 47100

  • Pfizer Investigational Site

    Milan, 20100

  • Pfizer Investigational Site

    Pisa, 56127

  • Pfizer Investigational Site

    Roma, 00144

  • Pfizer Investigational Site

    S.Andrea Delle Fratte (PG), 06132

Other trials in Italy

Netherlands5 sites

  • Pfizer Investigational Site

    's-Hertogenbosch, 5211 RW

  • Pfizer Investigational Site

    Amsterdam, North Holland, 1066 CX

  • Pfizer Investigational Site

    Harderwijk, 3844 DG

  • Pfizer Investigational Site

    Nijmegen, 6525 GA

  • Pfizer Investigational Site

    Zaandam, North Holland, 1502 DV

Other trials in Netherlands

Portugal5 sites

  • Pfizer Investigational Site

    Coimbra, 3041-801

  • Pfizer Investigational Site

    Lisbon, 1099-023

  • Pfizer Investigational Site

    Lisbon, 1649-035

  • Pfizer Investigational Site

    Lisbon, 1769-001

  • Pfizer Investigational Site

    Porto, 4200-072

Other trials in Portugal

Slovakia4 sites

  • Pfizer Investigational Site

    Bratislava, 82606

  • Pfizer Investigational Site

    Košice, 041 91

  • Pfizer Investigational Site

    Kvetnica Pri Poprade, 058 07

  • Pfizer Investigational Site

    Nitra-Zobor, 949 88

Other trials in Slovakia

South Korea4 sites

  • Pfizer Investigational Site

    Gyeonggi-do, 410-769

  • Pfizer Investigational Site

    Seoul, 135-710

  • Pfizer Investigational Site

    Seoul, 137-701

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Taiwan4 sites

  • Pfizer Investigational Site

    Taichung

  • Pfizer Investigational Site

    Tainan, 704

  • Pfizer Investigational Site

    Taipei, 100

  • Pfizer Investigational Site

    Taipei, 112

Other trials in Taiwan

Czechia3 sites

  • Pfizer Investigational Site

    Olomouc, 775 20

  • Pfizer Investigational Site

    Prague, CZ, 150 06

  • Pfizer Investigational Site

    Prague, 180 81

Other trials in Czechia

South Africa3 sites

  • Pfizer Investigational Site

    Cape Town, 7405

  • Pfizer Investigational Site

    Port Elizabeth, Eastern Cape, 6001

  • Pfizer Investigational Site

    Port Elizabeth, 6001

Other trials in South Africa

Turkey (Türkiye)3 sites

  • Pfizer Investigational Site

    Ankara, 06100

  • Pfizer Investigational Site

    Bornova / Izmir, 35050

  • Pfizer Investigational Site

    Istanbul / Ceraahpasa, 34303

Other trials in Turkey (Türkiye)

Hong Kong2 sites

  • Pfizer Investigational Site

    Kowloon

  • Pfizer Investigational Site

    Shatin

Other trials in Hong Kong

Israel2 sites

  • Pfizer Investigational Site

    Beersheba, 84101

  • Pfizer Investigational Site

    Kfar Saba, 44281

Other trials in Israel

Austria1 site

  • Pfizer Investigational Site

    Innsbruck, A-6020

Other trials in Austria

Singapore1 site

  • Pfizer Investigational Site

    Singapore, Singapore, 169610

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Cisplatin, Gemcitabine, PF-3512676, Gemcitabine + Cisplatin
Keywords
advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Also called Platinol-AQ

    Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

  • GemcitabineDrug

    Also called Gemzar

    Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

  • PF-3512676Drug

    PF-3512676 0.2 mg/kg subcutaneously days 8 and 15 x 6 cycles and then weekly until disease progression or unacceptable toxicity

  • CisplatinDrug

    Also called Platinol-AQ

    Cisplatin 75 mg/m2 intravenously on day 1 of each 21 day cycle x 6 cycles

  • Gemcitabine + CisplatinDrug

    Also called Gemzar

    Gemcitabine 1250 mg/m2 intravenously on days 1 and 8 of each 21 cycle x 6 cycles

Study groups in NCT00254904
Study groupRoleWhat they receive
AExperimentalStandard of Care chemotherapy plus experimental intervention (PF-3512676)
Receives: Drug: Cisplatin; Drug: Gemcitabine; Drug: PF-3512676
BActive comparatorStandard of Care chemotherapy
Receives: Drug: Cisplatin; Drug: Gemcitabine + Cisplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Measured: 656 Events

Secondary outcomes (6)

  1. Patient Reported Outcomes

    Measured: End of treatment

  2. Overall Safety Profile

    Measured: 28 days post PF03512676 dosing

  3. Progression Free Survival

    Measured: Time of primary endpoint

  4. Time to Tumor Progression

    Measured: Time of progressive disease

  5. Overall Objective Response

    Measured: End of treatment

  6. Duration of Response

    Measured: Time of progressive disease

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

Why it stopped: See Termination Reason in Detailed Description

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
839 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00254904
Sponsor's protocol ID
A8501002
Status last verified
Mar 2015
First submitted
15 Nov 2005
Last updated
30 Mar 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Roeland EJ, Fintelmann FJ, Yang R, Tarasenko L, Bonomi PD. Evaluation of Weight Gain and Overall Survival of Men Versus Women With Advanced Non-Small Cell Lung Cancer. J Cachexia Sarcopenia Muscle. 2025 Dec;16(6):e70131. doi: 10.1002/jcsm.70131.

    PubMed 41332393

  • Roeland EJ, Fintelmann FJ, Hilton F, Yang R, Whalen E, Tarasenko L, Calle RA, Bonomi PD. The relationship between weight gain during chemotherapy and outcomes in patients with advanced non-small cell lung cancer. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1030-1040. doi: 10.1002/jcsm.13426. Epub 2024 Mar 11.

    PubMed 38468440

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cisplatin, Gemcitabine and PF-3512676 in people with Carcinoma, Non-Small-Cell Lung, run by Pfizer at 120 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, United Kingdom, Poland, Belgium, Brazil and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: See Termination Reason in Detailed Description). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 656 Events). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00254904, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.

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Clinical Trial NCT00254904 | AzTrials