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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer (NSCLC)

Primary Purpose

Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

CP 751,871 (Figitumumab)

Erlotinib

About this trial

This is an interventional treatment trial for Carcinoma, Large Cell focused on measuring IGR-1R, Non small cell lung cancer, CP-751, 871, Figitumumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.

Exclusion Criteria:

Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology.
Prior Erlotinib therapy.
Prior anti IGF IR based investigational therapy.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

The CP 751,871 treatment in combination with erlotinib will be given in three week cycles. CP 751,871 (20 mg/kg) + erlotinib (150 mg/day) CP 751,871 will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Outcomes

Primary Outcome Measures

Overall Survival

The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.

Secondary Outcome Measures

Progression Free Survival (PFS)

Time from randomization to date of first documentation of progression or death due to any cause, whichever came first. Participants last known to be alive and progression-free, who had a baseline and at least 1 on-study disease assessment, were censored at last disease assessment verifying lack of progression. Progression was determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or target lesions over nadir, unequivocal progression of non-target disease, or the appearance of new lesions.

Percentage of Participants With Objective Response

Percentage of participants with objective response (OR) based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. CR are defined as complete disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Maximum Observed Plasma Concentration (Cmax) for Figitumumab

Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)

ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.

Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)

EQ-5D is a participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5 and EOT (21-28 Days After Last Dose)

EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). Most questions use 4 point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms.

Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) Score at Cycles 2, 3, and Then Every Odd Cycle Starting With Cycle 5, and EOT (21-28 Days After Last Dose)

QLQ-LC13 consists of 13 questions relating to disease symptoms specific to lung cancer and treatment side effects typical of treatment with chemotherapy and radiotherapy. The 13 questions comprise 1 multi-item scale for dyspnea and 10 single-item symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, and medicine for pain). Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Full Information

NCT ID

NCT00673049

First Posted

May 5, 2008

Last Updated

July 22, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00673049

Brief Title

Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Acronym

NSCLC

Official Title

Randomized, Open Label, Phase 3 Trial Of Erlotinib Alone Or In Combination With CP-751,871 In Patients With Advanced Non Small Cell Lung Cancer Of Non Adenocarcinoma Histology

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

May 2008 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Detailed Description

This study was terminated on March 8, 2010 due to an analysis by an independent Data Safety Monitoring Committee (DSMC) indicating that the addition of CP-751,871 [figitumumab] to erlotinib [Tarceva] would be unlikely to meet the primary endpoint of improving overall survival when compared to erlotinib alone. This Oncology study continues as terminated, however for ethical reasons some patients, noted with resultant benefit, continue receiving treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma, Adenosquamous Cell

Keywords

IGR-1R, Non small cell lung cancer, CP-751, 871, Figitumumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

583 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A

Arm Type

Experimental

Arm Description

Arm Title

Arm B

Arm Type

Active Comparator

Arm Description

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)

Intervention Type

Drug

Intervention Name(s)

CP 751,871 (Figitumumab)

Intervention Description

CP 751,871 (20 mg/kg) will be administered as an IV infusion on study Days 1 and 2 in Cycle 1, and every three weeks (from Day 1) (Cycle) thereafter.

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

Erlotinib (one tablet of 150 mg/day PO).

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Intervention Description

Erlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food.

Primary Outcome Measure Information:

Title

Overall Survival

Description

The time from date of randomization to date of death due to any cause. For participants who were alive, overall survival was censored at the last contact.

Time Frame

Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months

Secondary Outcome Measure Information:

Title

Progression Free Survival (PFS)

Description

Time Frame

Baseline, 6, 9, 12, 15, 18 weeks after randomization, thereafter assessed every 6 weeks until disease progression during treatment (or every 8 weeks until disease progression during off-treatment), up to 29.7 months

Title

Percentage of Participants With Objective Response

Description

Time Frame

Title

Maximum Observed Plasma Concentration (Cmax) for Figitumumab

Time Frame

Cycle 1 (Day 1 [predose], Day 2 [1 hour after end of infusion] ), Cycles 2, 4, 6 (predose), Cycle 5 (predose, 1 hour after end of infusion) for figi plus erlo group; Cycles 1, 2,4 (predose) for erlo, then figi group

Title

Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

Time Frame

Title

Percentage of Participants Reporting Positive for Total Anti-drug Antibodies (ADA)

Description

ADAs are immunogenicity indicators to figitumumab. Participants reporting positive for ADAs are indicated by an endpoint titer of no less than 6.64.

Time Frame

Cycles 1, 2, 4 (predose), End of Treatment ([EOT] 21-28 days after last dose), about 150 days after last figi dose for figi plus erlo group; Cycles 1, 2, 4 (predose), EOT, about 150 days after last figi dose for erlo, then figi group

Title

Counts of Circulating Tumor Cell (CTC) Expressing Positive Insulin-Like Growth Factor 1 Receptor (IGF-1R)

Time Frame

Baseline, Cycle 2 Day 1 (predose) and EOT (21-28 days after last dose)

Title

Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility at Cycles 2, 3, Then Every Other Cycle and EOT (21-28 Days After Last Dose)

Description

Time Frame

Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every other cycle and EOT (21-28 days after last dose)

Title

Description

Time Frame

Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)

Title

Description

Time Frame

Baseline (Cycle 1 Day 1 predose), Cycles 2, 3 (Day 1), every odd cycle starting with Cycle 5 and EOT (21-28 days after last dose)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST. Exclusion Criteria: Primary NSCLC adenocarcinoma and its subtypes or unknown/unspecified histology. Prior Erlotinib therapy. Prior anti IGF IR based investigational therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Fort Smith

State/Province

Arkansas

ZIP/Postal Code

72903

Country

United States

Facility Name

Pfizer Investigational Site

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Pfizer Investigational Site

City

Lakeport

State/Province

California

ZIP/Postal Code

95453

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868-3298

Country

United States

Facility Name

Pfizer Investigational Site

City

Orange

State/Province

California

ZIP/Postal Code

92868

Country

United States

Facility Name

Pfizer Investigational Site

City

Petaluma

State/Province

California

ZIP/Postal Code

94954

Country

United States

Facility Name

Pfizer Investigational Site

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Pfizer Investigational Site

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

Pfizer Investigational Site

City

Westlake Valley

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

Pfizer Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80205

Country

United States

Facility Name

Pfizer Investigational Site

City

Lafayette

State/Province

Colorado

ZIP/Postal Code

80026

Country

United States

Facility Name

Pfizer Investigational Site

City

Hollywood

State/Province

Florida

ZIP/Postal Code

33021

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake City

State/Province

Florida

ZIP/Postal Code

32024

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake City

State/Province

Florida

ZIP/Postal Code

32055

Country

United States

Facility Name

Pfizer Investigational Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33028

Country

United States

Facility Name

Pfizer Investigational Site

City

Alpharetta

State/Province

Georgia

ZIP/Postal Code

30005

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Pfizer Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Pfizer Investigational Site

City

Conyers

State/Province

Georgia

ZIP/Postal Code

30094

Country

United States

Facility Name

Pfizer Investigational Site

City

Cumming

State/Province

Georgia

ZIP/Postal Code

30041

Country

United States

Facility Name

Pfizer Investigational Site

City

Decatur

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Pfizer Investigational Site

City

Duluth

State/Province

Georgia

ZIP/Postal Code

30096

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Spivey

State/Province

Georgia

ZIP/Postal Code

30236

Country

United States

Facility Name

Pfizer Investigational Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Pfizer Investigational Site

City

Snellville

State/Province

Georgia

ZIP/Postal Code

30078

Country

United States

Facility Name

Pfizer Investigational Site

City

Bloomington

State/Province

Illinois

ZIP/Postal Code

61701

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61615

Country

United States

Facility Name

Pfizer Investigational Site

City

Beech Grove

State/Province

Indiana

ZIP/Postal Code

46107

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46237

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

Pfizer Investigational Site

City

Cedar Rapids

State/Province

Iowa

ZIP/Postal Code

52402

Country

United States

Facility Name

Pfizer Investigational Site

City

Waterloo

State/Province

Iowa

ZIP/Postal Code

50701

Country

United States

Facility Name

Pfizer Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40207

Country

United States

Facility Name

Pfizer Investigational Site

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Pfizer Investigational Site

City

New Albany

State/Province

Mississippi

ZIP/Postal Code

38652

Country

United States

Facility Name

Pfizer Investigational Site

City

Billings

State/Province

Montana

ZIP/Postal Code

59102

Country

United States

Facility Name

Pfizer Investigational Site

City

Butte

State/Province

Montana

ZIP/Postal Code

59701

Country

United States

Facility Name

Pfizer Investigational Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Pfizer Investigational Site

City

Manchester

State/Province

New Hampshire

ZIP/Postal Code

03102

Country

United States

Facility Name

Pfizer Investigational Site

City

Amherst

State/Province

New York

ZIP/Postal Code

14221

Country

United States

Facility Name

Pfizer Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Pfizer Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

Pfizer Investigational Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

Country

United States

Facility Name

Pfizer Investigational Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Pfizer Investigational Site

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

Pfizer Investigational Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Pfizer Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

Facility Name

Pfizer Investigational Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73071

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73102

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

Pfizer Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74133

Country

United States

Facility Name

Pfizer Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Pfizer Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Pfizer Investigational Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Pfizer Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908-0334

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22908-0716

Country

United States

Facility Name

Pfizer Investigational Site

City

Gloucester

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

Pfizer Investigational Site

City

Glouster

State/Province

Virginia

ZIP/Postal Code

23061

Country

United States

Facility Name

Pfizer Investigational Site

City

Newport News

State/Province

Virginia

ZIP/Postal Code

23601

Country

United States

Facility Name

Pfizer Investigational Site

City

Williamsburg

State/Province

Virginia

ZIP/Postal Code

23185

Country

United States

Facility Name

Pfizer Investigational Site

City

Wenatchee

State/Province

Washington

ZIP/Postal Code

98801

Country

United States

Facility Name

Pfizer Investigational Site

City

Wheeling

State/Province

West Virginia

ZIP/Postal Code

26003-6300

Country

United States

Facility Name

Pfizer Investigational Site

City

Cody

State/Province

Wyoming

ZIP/Postal Code

82414

Country

United States

Facility Name

Pfizer Investigational Site

City

Brasschaat

ZIP/Postal Code

2930

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20230 -130

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Rio de Janeiro

State/Province

ZIP/Postal Code

20231 -050

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Higienopolis

State/Province

Sao Paulo/ Brazil

ZIP/Postal Code

01224-010

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Santo André

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01221-020

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sao Paulo

State/Province

ZIP/Postal Code

01224-010

Country

Brazil

Facility Name

Pfizer Investigational Site

City

São Paulo

State/Province

ZIP/Postal Code

01219-000

Country

Brazil

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1527

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Pfizer Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Pfizer Investigational Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Independencia

State/Province

Santiago, RM

ZIP/Postal Code

8380455

Country

Chile

Facility Name

Pfizer Investigational Site

City

Kutna Hora

ZIP/Postal Code

284 01

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Nova Ves pod Plesi

ZIP/Postal Code

26204

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Praha 8

ZIP/Postal Code

180 81

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Tabor

ZIP/Postal Code

390 03

Country

Czech Republic

Facility Name

Pfizer Investigational Site

City

Rennes

State/Province

Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

Pfizer Investigational Site

City

BREST Cedex

ZIP/Postal Code

29609

Country

France

Facility Name

Pfizer Investigational Site

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Pfizer Investigational Site

City

Lille

ZIP/Postal Code

59020 Cedex

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille Cedex 09

ZIP/Postal Code

13009

Country

France

Facility Name

Pfizer Investigational Site

City

Marseille Cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Pfizer Investigational Site

City

Saint Pierre la Réunion Cedex

ZIP/Postal Code

97448

Country

France

Facility Name

Pfizer Investigational Site

City

St Priest En Jarez Cedex

ZIP/Postal Code

42277

Country

France

Facility Name

Pfizer Investigational Site

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

Pfizer Investigational Site

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Pfizer Investigational Site

City

Larisa

ZIP/Postal Code

41110

Country

Greece

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1525

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Matrahaza

ZIP/Postal Code

H-3233

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Jakarta

State/Province

DKI Jakarta

ZIP/Postal Code

13230

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Surabaya

State/Province

East Java

ZIP/Postal Code

60286

Country

Indonesia

Facility Name

Pfizer Investigational Site

City

Cork

Country

Ireland

Facility Name

Pfizer Investigational Site

City

Dublin 24

Country

Ireland

Facility Name

Pfizer Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

Pfizer Investigational Site

City

Avellino

ZIP/Postal Code

83100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Aviano (PN)

ZIP/Postal Code

33081

Country

Italy

Facility Name

Pfizer Investigational Site

City

Cattolica (RN)

ZIP/Postal Code

47841

Country

Italy

Facility Name

Pfizer Investigational Site

City

Modena

ZIP/Postal Code

41100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Orbassano (TO)

ZIP/Postal Code

10043

Country

Italy

Facility Name

Pfizer Investigational Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Pfizer Investigational Site

City

Rimini

ZIP/Postal Code

47900

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00157

Country

Italy

Facility Name

Pfizer Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

410-769

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

120-752

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Pfizer Investigational Site

City

Riga

ZIP/Postal Code

LV 1002

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Riga

ZIP/Postal Code

LV 1079

Country

Latvia

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-108

Country

Poland

Facility Name

Pfizer Investigational Site

City

Krakow

ZIP/Postal Code

31-215

Country

Poland

Facility Name

Pfizer Investigational Site

City

Lublin

ZIP/Postal Code

20-954

Country

Poland

Facility Name

Pfizer Investigational Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

Pfizer Investigational Site

City

Olsztyn

ZIP/Postal Code

10-513

Country

Poland

Facility Name

Pfizer Investigational Site

City

Rybnik

ZIP/Postal Code

44-200

Country

Poland

Facility Name

Pfizer Investigational Site

City

Wodzislaw Sl.

ZIP/Postal Code

44-300

Country

Poland

Facility Name

Pfizer Investigational Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Pfizer Investigational Site

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Pfizer Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Pfizer Investigational Site

City

Iasi

ZIP/Postal Code

700106

Country

Romania

Facility Name

Pfizer Investigational Site

City

Krasnodar

ZIP/Postal Code

350040

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Moscow

ZIP/Postal Code

143423

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Sochi

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St-Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

St. Petersburg

ZIP/Postal Code

198255

Country

Russian Federation

Facility Name

Pfizer Investigational Site

City

Belgrade

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Sremska Kamenica

ZIP/Postal Code

21204

Country

Serbia

Facility Name

Pfizer Investigational Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Pfizer Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Facility Name

Pfizer Investigational Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Pfizer Investigational Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Pfizer Investigational Site

City

L'hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08097

Country

Spain

Facility Name

Pfizer Investigational Site

City

Manresa

State/Province

Barcelona

ZIP/Postal Code

08243

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sabadell

State/Province

Barcelona

ZIP/Postal Code

08208

Country

Spain

Facility Name

Pfizer Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Pfizer Investigational Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

Pfizer Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41009

Country

Spain

Facility Name

Pfizer Investigational Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Pfizer Investigational Site

City

Basel

ZIP/Postal Code

CH-4031

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Basel

ZIP/Postal Code

CH-4058

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

CH-4101 Bruderholz

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Liestal

ZIP/Postal Code

CH-4410

Country

Switzerland

Facility Name

Pfizer Investigational Site

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Taoyuan County

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Pfizer Investigational Site

City

Dnipropetrovsk

ZIP/Postal Code

49102

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Donetsk

ZIP/Postal Code

83092

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Kharkiv

ZIP/Postal Code

61070

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Kyiv

ZIP/Postal Code

03115

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Sumy

ZIP/Postal Code

40005

Country

Ukraine

Facility Name

Pfizer Investigational Site

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25395283

Citation

Scagliotti GV, Bondarenko I, Blackhall F, Barlesi F, Hsia TC, Jassem J, Milanowski J, Popat S, Sanchez-Torres JM, Novello S, Benner RJ, Green S, Molpus K, Soria JC, Shepherd FA. Randomized, phase III trial of figitumumab in combination with erlotinib versus erlotinib alone in patients with nonadenocarcinoma nonsmall-cell lung cancer. Ann Oncol. 2015 Mar;26(3):497-504. doi: 10.1093/annonc/mdu517. Epub 2014 Nov 13.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4021018&StudyName=Trial%20Of%20CP-751%2C%20871%20And%20Erlotinib%20In%20Refractory%20Lung%20Cancer

Description

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Learn more about this trial

Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

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Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer (NSCLC)

Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial