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

NCT00254904 | Terminated Phase 3 DMC

• 1 other identifier: A8501002
• Study Type: interventional
• Target: 839
• Locations: 24 countries
• Sites: 120

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

advanced carcinoma, non-small cell lung, Phase III, Gemcitabine, Gemzar, Cisplatin, Platinol, PF-3512676, immunotherapy, immune modulator

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  656 Events

Secondary Outcomes (6)

• Patient Reported Outcomes

  End of treatment

• Overall Safety Profile

  28 days post PF03512676 dosing

• Progression Free Survival

  Time of primary endpoint

• Time to Tumor Progression

  Time of progressive disease

• Overall Objective Response

  End of treatment

Study Arms (2)

A

EXPERIMENTAL

Standard of Care chemotherapy plus experimental intervention (PF-3512676)

Drug: Cisplatin; Drug: Gemcitabine; Drug: PF-3512676

B

ACTIVE COMPARATOR

Standard of Care chemotherapy

Drug: Cisplatin; Drug: Gemcitabine + Cisplatin

Interventions

Cisplatin DRUG

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

Also known as: Platinol-AQ

A

Gemcitabine DRUG

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

Also known as: Gemzar

A

PF-3512676 DRUG

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

A

Gemcitabine + Cisplatin DRUG

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

Also known as: Gemzar

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (120)

Pfizer Investigational Site

Birmingham, Alabama, 35233, United States

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Birmingham, Alabama, 35294, United States

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Bakersfield, California, 93309, United States

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Saint Joseph, Michigan, 49085, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63110, United States

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St Louis, Missouri, 63122, United States

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New York, New York, 10032, United States

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Spokane, Washington, 99202, United States

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Spokane, Washington, 99204, United States

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Innsbruck, A-6020, Austria

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Brussels, 1070, Belgium

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Brussels, 1200, Belgium

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Charleroi, 6000, Belgium

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Hasselt, 3500, Belgium

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Jette, 1090, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Rio de Janeiro, Rio de Janeiro, 20230-130, Brazil

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Rio de Janeiro, Rio de Janeiro, 20231 -050, Brazil

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Jaú, São Paulo, 17210-080, Brazil

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Jaú, São Paulo, 17210-120, Brazil

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São Paulo, São Paulo, 01219-000, Brazil

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São Paulo, São Paulo, 01221-020, Brazil

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São Paulo, São Paulo, 01224-010, Brazil

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Toronto, Ontario, M5G 2M9, Canada

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Windsor, Ontario, N8W 1L9, Canada

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Windsor, Ontario, N8W 2X3, Canada

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Greenfield Park, Quebec, J4V 2H1, Canada

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Laval, Quebec, H7M 3L9, Canada

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Lévis, Quebec, G6V 3Z1, Canada

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Québec, Quebec, G1V 4G5, Canada

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Guangzhou, Guangdong, 510060, China

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Nanjing, Jiangsu, 210002, China

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Dalian, Liaoning, 116023, China

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Beijing, 100036, China

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Beijing, 101149, China

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Prague, CZ, 150 06, Czechia

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Olomouc, 775 20, Czechia

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Prague, 180 81, Czechia

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Bielefeld, 33611, Germany

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Karlsruhe, 76137, Germany

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Löwenstein, 74245, Germany

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Mannheim, 68167, Germany

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München, 81675, Germany

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Tübingen, 72076, Germany

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Kowloon, Hong Kong

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Shatin, Hong Kong

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Zalaegerszeg, Külsőkórház-Pózva, H-8900, Hungary

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Budapest, 1529, Hungary

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Deszk, 6772, Hungary

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Gyula, 5703, Hungary

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Pécs, 7635, Hungary

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Bangalore, Karnataka, 560027, India

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Kochi, Kerala, 682 304, India

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Pune, Maharashtra, 411 004, India

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New Delhi, New Delhi, 110085, India

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Ludhiana, Punjab, 141001, India

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Lucknow, Uttar Pradesh, 226003, India

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Beersheba, 84101, Israel

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Kfar Saba, 44281, Israel

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Forlì, 47100, Italy

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Milan, 20100, Italy

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Pisa, 56127, Italy

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Roma, 00144, Italy

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S.Andrea Delle Fratte (PG), 06132, Italy

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Amsterdam, North Holland, 1066 CX, Netherlands

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Zaandam, North Holland, 1502 DV, Netherlands

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's-Hertogenbosch, 5211 RW, Netherlands

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Harderwijk, 3844 DG, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Gdansk, 80-952, Poland

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Lodz, 93-509, Poland

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Otwock, 05-400, Poland

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Szczecin-Zdunowo, 70-891, Poland

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Warsaw, 00-909, Poland

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Warsaw, 01-138, Poland

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Warsaw, 02-781, Poland

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Wodzislaw Sl., 44-300, Poland

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Coimbra, 3041-801, Portugal

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Lisbon, 1099-023, Portugal

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Lisbon, 1649-035, Portugal

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Lisbon, 1769-001, Portugal

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Porto, 4200-072, Portugal

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Singapore, Singapore, 169610, Singapore

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Bratislava, 82606, Slovakia

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Košice, 041 91, Slovakia

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Kvetnica Pri Poprade, 058 07, Slovakia

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Nitra-Zobor, 949 88, Slovakia

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Port Elizabeth, Eastern Cape, 6001, South Africa

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Cape Town, 7405, South Africa

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Port Elizabeth, 6001, South Africa

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Gyeonggi-do, 410-769, South Korea

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Seoul, 135-710, South Korea

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Seoul, 137-701, South Korea

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Seoul, 138-736, South Korea

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Alicante, Alicante, 03010, Spain

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Santander, Cantabria, 39008, Spain

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Castellon, Castellon, 12002, Spain

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Girona, Gerona, 17007, Spain

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Jaén, Jaen, 23007, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Taichung, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 112, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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Bornova / Izmir, 35050, Turkey (Türkiye)

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Istanbul / Ceraahpasa, 34303, Turkey (Türkiye)

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Bristol, Avon, BS2 8ED, United Kingdom

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Belfast, BT9 7AB, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Leicester, LE1 5WW, United Kingdom

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London, NW3 2Qg, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

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Related Publications (1)

• 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.

  PMID: 41332393 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Cisplatin; Gemcitabine; ProMune

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 17, 2005
• Study Start: November 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

ES (7); BR (7); CA (7); CN (5); IL (2); NL (5); HK (2); HU (5); PL (8); PT (5); TW (4); ZA (3); IT (5); SL (4); BE (7); CZ (3); US (10); AU (1); DE (6); IN (6); SG (1); TU (3); GB (10); KR (4)