Trial of Paclitaxel/Carboplatin + PF-3512676 vs Paclitaxel/Carboplatin Alone in Patients With Advanced Non-Small Cell Lung Cancer

NCT00254891 | Terminated Phase 3 DMC

• 1 other identifier: A8501001
• Study Type: interventional
• Target: 828
• Locations: 26 countries
• Sites: 191

Brief Summary

To assess the efficacy and safety of PF-3512676 administered in combination with paclitaxel/carboplatin 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 paclitaxel

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

advanced carcinoma, non-small cell lung, Phase III, Paclitaxel, Taxol, Carboplatin, Paraplatin, PF-3512676, immunotherapy, immune modulator

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  656 Events

Secondary Outcomes (6)

• Overall Objective Response

  End of Treatment

• Time to Tumor Progression

  Time of progressive disease

• Progression Free Survival

  Time of primary endpoint

• Duration of Response

  Time of progressive disease

• Patient Reported Outcomes

  End of Treatment

Study Arms (2)

A

EXPERIMENTAL

Standard of care chemotherapy plus experiment intervention (PF-3512676)

Drug: PF-3512676 + Paclitaxel + Carboplatin

B

ACTIVE COMPARATOR

Standard of care chemotherapy

Drug: Paclitaxel + Carboplatin

Interventions

PF-3512676 + Paclitaxel + Carboplatin DRUG

* PF-3512676: 0.2 mg/kg subcutaneously Days 8 and 15 of each 21 day cycle x 6 cycles then weekly as maintenance until disease progression or unacceptable toxicity. * Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Also known as: Taxol; Paraplatin

A

Paclitaxel + Carboplatin DRUG

* Paclitaxel: 200 mg/m2 intravenously Day 1 of each 21 day cycle x 6 cycles. * Carboplatin: AUC 6 intravenously Day 1 of each 21 days cycle x 6 cycles.

Also known as: Taxol; Paraplatin

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 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 (191)

Pfizer Investigational Site

Little Rock, Alaska, 72205, United States

Location

Pfizer Investigational Site

Hot Springs, Arkansas, 71913, United States

Location

Pfizer Investigational Site

Chula Vista, California, 91911, United States

Location

Pfizer Investigational Site

La Mesa, California, 91942, United States

Location

Pfizer Investigational Site

Oceanside, California, 92056, United States

Location

Pfizer Investigational Site

Palm Springs, California, 92262-4885, United States

Location

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30306, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30308, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30309, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30322, United States

Location

Pfizer Investigational Site

Atlanta, Georgia, 30342, United States

Location

Pfizer Investigational Site

Decatur, Georgia, 30033, United States

Location

Pfizer Investigational Site

Fayetteville, Georgia, 30214, United States

Location

Pfizer Investigational Site

Macon, Georgia, 31217, United States

Location

Pfizer Investigational Site

Marietta, Georgia, 30060, United States

Location

Pfizer Investigational Site

Tucker, Georgia, 30084, United States

Location

Pfizer Investigational Site

Rockford, Illinois, 61104, United States

Location

Pfizer Investigational Site

Jefferson, Indiana, 47130, United States

Location

Pfizer Investigational Site

New Albany, Indiana, 47150-6809, United States

Location

Pfizer Investigational Site

Cedar Rapids, Iowa, 52403, United States

Location

Pfizer Investigational Site

Dubuque, Iowa, 52001, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40503, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40202, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40217, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40241, United States

Location

Pfizer Investigational Site

Louisville, Kentucky, 40505-4816, United States

Location

Pfizer Investigational Site

Shelbyville, Kentucky, 40065, United States

Location

Pfizer Investigational Site

Covington, Louisiana, 70433, United States

Location

Pfizer Investigational Site

Gretna, Louisiana, 70056, United States

Location

Pfizer Investigational Site

Lafayette, Louisiana, 70503, United States

Location

Pfizer Investigational Site

Marrero, Louisiana, 70006, United States

Location

Pfizer Investigational Site

Marrero, Louisiana, 70072, United States

Location

Pfizer Investigational Site

Metairie, Louisiana, 70006, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70115, United States

Location

Pfizer Investigational Site

Biddeford, Maine, 04005, United States

Location

Pfizer Investigational Site

Brunswick, Maine, 04011, United States

Location

Pfizer Investigational Site

Scarborough, Maine, 04074, United States

Location

Pfizer Investigational Site

Worcester, Massachusetts, 01608, United States

Location

Pfizer Investigational Site

Allegan, Michigan, 49010, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109-0848, United States

Location

Pfizer Investigational Site

Ann Arbor, Michigan, 48109, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49048, United States

Location

Pfizer Investigational Site

Saint Joseph, Michigan, 49085, United States

Location

Pfizer Investigational Site

Columbus, Mississippi, 39705, United States

Location

Pfizer Investigational Site

Corinth, Mississippi, 38834, United States

Location

Pfizer Investigational Site

Tupelo, Mississippi, 38801, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68114, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68124, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68130, United States

Location

Pfizer Investigational Site

Papillion, Nebraska, 68046, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Pfizer Investigational Site

Las Vegas, Nevada, 89106, United States

Location

Pfizer Investigational Site

Albuquerque, New Mexico, 87109, United States

Location

Pfizer Investigational Site

Ruidoso, New Mexico, 88345, United States

Location

Pfizer Investigational Site

Buffalo, New York, 14263, United States

Location

Pfizer Investigational Site

Great Neck, New York, 11023, United States

Location

Pfizer Investigational Site

Asheville, North Carolina, 28801, United States

Location

Pfizer Investigational Site

Brevard, North Carolina, 28712, United States

Location

Pfizer Investigational Site

Lexington, North Carolina, 27292, United States

Location

Pfizer Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

Pfizer Investigational Site

Canton, Ohio, 44718, United States

Location

Pfizer Investigational Site

Dover, Ohio, 44622, United States

Location

Pfizer Investigational Site

Oklahoma City, Oklahoma, 73112-4491, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97227-1191, United States

Location

Pfizer Investigational Site

Langhorne, Pennsylvania, 19047, United States

Location

Pfizer Investigational Site

Chattanooga, Tennessee, 37404-3324, United States

Location

Pfizer Investigational Site

Memphis, Tennessee, 38120, United States

Location

Pfizer Investigational Site

Arlington, Texas, 76012, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75230, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235-7786, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75235, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-8590, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75390-9015, United States

Location

Pfizer Investigational Site

Richardson, Texas, 75080, United States

Location

Pfizer Investigational Site

Trophy Club, Texas, 76262, United States

Location

Pfizer Investigational Site

Bountiful, Utah, 84010, United States

Location

Pfizer Investigational Site

Layton, Utah, 84041, United States

Location

Pfizer Investigational Site

Murray, Utah, 84107, United States

Location

Pfizer Investigational Site

Provo, Utah, 84604, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84106, United States

Location

Pfizer Investigational Site

WVC, Utah, 84120, United States

Location

Pfizer Investigational Site

Burlington, Vermont, 05401, United States

Location

Pfizer Investigational Site

Everett, Washington, 98201, United States

Location

Pfizer Investigational Site

Kennewick, Washington, 99336, United States

Location

Pfizer Investigational Site

Richland, Washington, 99352, United States

Location

Pfizer Investigational Site

Madison, Wisconsin, 53792-5666, United States

Location

Pfizer Investigational Site

Albury, New South Wales, 2640, Australia

Location

Pfizer Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Pfizer Investigational Site

Randwick, New South Wales, 2031, Australia

Location

Pfizer Investigational Site

Pimlico, Queensland, 4812, Australia

Location

Pfizer Investigational Site

Townsville, Queensland, 4814, Australia

Location

Pfizer Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

Pfizer Investigational Site

Bedford Park, South Australia, 5042, Australia

Location

Pfizer Investigational Site

Toorak Gardens, South Australia, 5065, Australia

Location

Pfizer Investigational Site

East Melbourne, Victoria, 3002, Australia

Location

Pfizer Investigational Site

East Ringwood, Victoria, 3135, Australia

Location

Pfizer Investigational Site

Wodonga, Victoria, 3690, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Pfizer Investigational Site

Ghent, 9000, Belgium

Location

Pfizer Investigational Site

Liège, 4000, Belgium

Location

Pfizer Investigational Site

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H2A 1A1, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3G 1A4, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1E2, Canada

Location

Pfizer Investigational Site

Montreal, Quebec, H3T 1M5, Canada

Location

Pfizer Investigational Site

Rimouski, Quebec, G5L 5T1, Canada

Location

Pfizer Investigational Site

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Pfizer Investigational Site

Dalian, Xigang District, Liaoning, 116011, China

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Beijing, 100071, China

Location

Pfizer Investigational Site

Shanghai, 200032, China

Location

Pfizer Investigational Site

Nicosia, 2006, Cyprus

Location

Pfizer Investigational Site

Nová Ves pod Pleší, 26204, Czechia

Location

Pfizer Investigational Site

Ostrava-Poruba, 708 52, Czechia

Location

Pfizer Investigational Site

Ústí nad Labem, 401 13, Czechia

Location

Pfizer Investigational Site

Angers, 49033, France

Location

Pfizer Investigational Site

Caen, 14033, France

Location

Pfizer Investigational Site

Dijon, France

Location

Pfizer Investigational Site

Limoges, 87042, France

Location

Pfizer Investigational Site

Nantes, 44202, France

Location

Pfizer Investigational Site

Paris, 75651, France

Location

Pfizer Investigational Site

Saint-Herblain, 44805, France

Location

Pfizer Investigational Site

Strasbourg, 67065 Cedex, France

Location

Pfizer Investigational Site

Toulouse, 31059, France

Location

Pfizer Investigational Site

Vandœuvre-lès-Nancy, 54511, France

Location

Pfizer Investigational Site

Berlin, 10117, Germany

Location

Pfizer Investigational Site

Bielefeld, 33611, Germany

Location

Pfizer Investigational Site

Bonn, 53105, Germany

Location

Pfizer Investigational Site

Essen, 45122, Germany

Location

Pfizer Investigational Site

Frankfurt, 60590, Germany

Location

Pfizer Investigational Site

Karlsruhe, 76137, Germany

Location

Pfizer Investigational Site

München, 80336, Germany

Location

Pfizer Investigational Site

Athens, Attica, 11526, Greece

Location

Pfizer Investigational Site

Heraklion, Crete, 71 500, Greece

Location

Pfizer Investigational Site

Thessaloniki, Macedonia, 56 403, Greece

Location

Pfizer Investigational Site

Athens, 115 27, Greece

Location

Pfizer Investigational Site

Rio, Patras, 26500, Greece

Location

Pfizer Investigational Site

Pokfulam, Hong Kong

Location

Pfizer Investigational Site

Budapest, 1122, Hungary

Location

Pfizer Investigational Site

Budapest, 1125, Hungary

Location

Pfizer Investigational Site

Budapest, 1529, Hungary

Location

Pfizer Investigational Site

Debrecen, 4032, Hungary

Location

Pfizer Investigational Site

Bangalore, Karnataka, 560 034, India

Location

Pfizer Investigational Site

Kochi, Kerala, 682 026, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411 001, India

Location

Pfizer Investigational Site

Chandigarh, Punjab, 160 012, India

Location

Pfizer Investigational Site

Jaipur, Rajasthan, 302017, India

Location

Pfizer Investigational Site

Ẕerifin, 70300, Israel

Location

Pfizer Investigational Site

Lido Di Camaiore (LU), 55043, Italy

Location

Pfizer Investigational Site

Milan, 20133, Italy

Location

Pfizer Investigational Site

Napoli, 81013, Italy

Location

Pfizer Investigational Site

Pavia, 27100, Italy

Location

Pfizer Investigational Site

Mexico City, Mexico City, 14080, Mexico

Location

Pfizer Investigational Site

Puebla City, Puebla, 72530, Mexico

Location

Pfizer Investigational Site

Tiel, Gelderland, 4002 WP, Netherlands

Location

Pfizer Investigational Site

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Pfizer Investigational Site

Amstelveen, 1186 AM, Netherlands

Location

Pfizer Investigational Site

The Hague, 2545 CH, Netherlands

Location

Pfizer Investigational Site

Otwock, 05-400, Poland

Location

Pfizer Investigational Site

Wodzislaw Sl., 44-300, Poland

Location

Pfizer Investigational Site

Faro, 8000-386, Portugal

Location

Pfizer Investigational Site

Porto, 4099-001, Portugal

Location

Pfizer Investigational Site

Porto, 4202, Portugal

Location

Pfizer Investigational Site

Vila Nova de Gaia, 4400, Portugal

Location

Pfizer Investigational Site

Parktown, Gauteng, South Africa

Location

Pfizer Investigational Site

Cape Town, 7500, South Africa

Location

Pfizer Investigational Site

Cape Town, 7925, South Africa

Location

Pfizer Investigational Site

Johannesburg, 2193, South Africa

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 120-752, South Korea

Location

Pfizer Investigational Site

Badalona, Barcelona, 08916, Spain

Location

Pfizer Investigational Site

Alcorcón, Madrid, 28922, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28041, Spain

Location

Pfizer Investigational Site

Pamplona, Navarre, 31008, Spain

Location

Pfizer Investigational Site

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38320, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Pfizer Investigational Site

Madrid, 28007, Spain

Location

Pfizer Investigational Site

Stockholm, 118 83, Sweden

Location

Pfizer Investigational Site

Uppsala, 751 85, Sweden

Location

Pfizer Investigational Site

Lausanne, CH-1011, Switzerland

Location

Pfizer Investigational Site

Taipei, 112, Taiwan

Location

Pfizer Investigational Site

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

Pfizer Investigational Site

Exeter, Devon, EX2 5DW, United Kingdom

Location

Pfizer Investigational Site

London, SE1 9RT, United Kingdom

Location

Pfizer Investigational Site

Portsmouth, PO3 6AD, United Kingdom

Location

Pfizer Investigational Site

Sheffield, S10 2SJ, United Kingdom

Location

Pfizer Investigational Site

Surrey GU2 5XX, United Kingdom

Location

Pfizer Investigational Site

Swansea, SA2 8QA, United Kingdom

Location

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

ProMune; Paclitaxel; Carboplatin; CP protocol

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

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: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 30, 2015

Record last verified: 2015-03

Locations

IN (5); TW (1); CN (4); CY (1); GB (7); NL (4); FR (10); IT (4); HU (4); SE (2); DE (7); CZ (3); ES (7); CH (1); ME (2); PT (4); GR (5); IL (1); AU (12); BE (2); PL (2); CA (7); KR (2); ZA (4); US (89); HK (1)