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

NCT ID: NCT00673049

Last Updated: 2013-07-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

583 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-04-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

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.

Group Type EXPERIMENTAL

CP 751,871 (Figitumumab)

Intervention Type DRUG

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.

Erlotinib

Intervention Type DRUG

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

Arm B

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)

Group Type ACTIVE_COMPARATOR

Erlotinib

Intervention Type DRUG

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.

Interventions

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CP 751,871 (Figitumumab)

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

Erlotinib

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

Intervention Type DRUG

Erlotinib

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

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Fort Smith, Arkansas, United States

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Hot Springs, Arkansas, United States

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Lakeport, California, United States

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Orange, California, United States

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Orange, California, United States

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Petaluma, California, United States

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Santa Rosa, California, United States

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Thousand Oaks, California, United States

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Westlake Valley, California, United States

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Denver, Colorado, United States

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Lafayette, Colorado, United States

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Hollywood, Florida, United States

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Lake City, Florida, United States

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Lake City, Florida, United States

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Pembroke Pines, Florida, United States

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Alpharetta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Conyers, Georgia, United States

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Cumming, Georgia, United States

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Decatur, Georgia, United States

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Duluth, Georgia, United States

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Lake Spivey, Georgia, United States

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Lawrenceville, Georgia, United States

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Snellville, Georgia, United States

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Bloomington, Illinois, United States

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Peoria, Illinois, United States

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Beech Grove, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Cedar Rapids, Iowa, United States

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Waterloo, Iowa, United States

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Louisville, Kentucky, United States

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Bethesda, Maryland, United States

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New Albany, Mississippi, United States

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Billings, Montana, United States

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Butte, Montana, United States

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Lebanon, New Hampshire, United States

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Manchester, New Hampshire, United States

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Amherst, New York, United States

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Buffalo, New York, United States

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Lake Success, New York, United States

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Manhasset, New York, United States

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New Hyde Park, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Germantown, Tennessee, United States

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San Antonio, Texas, United States

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Charlottesville, Virginia, United States

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Charlottesville, Virginia, United States

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Gloucester, Virginia, United States

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Glouster, Virginia, United States

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Newport News, Virginia, United States

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Williamsburg, Virginia, United States

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Wenatchee, Washington, United States

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Wheeling, West Virginia, United States

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Cody, Wyoming, United States

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Brasschaat, , Belgium

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Mons, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Higienópolis, Sao Paulo/ Brazil, Brazil

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Santo André, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sofia, Bulgaria, Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Independencia, Santiago, RM, Chile

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Kutná Hora, , Czechia

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Nová Ves pod Pleší, , Czechia

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Prague, , Czechia

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Tábor, , Czechia

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Rennes, Cedex 9, France

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Brest, , France

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La Tronche, , France

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Lille, , France

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Marseille, , France

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Marseille, , France

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Saint Pierre La Réunion Cedex, , France

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Saint-Priest-en-Jarez, , France

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Villejuif, , France

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Heraklion, Crete, Greece

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Larissa, , Greece

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Budapest, , Hungary

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Mátraháza, , Hungary

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Székesfehérvár, , Hungary

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Jakarta, DKI Jakarta, Indonesia

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Surabaya, East Java, Indonesia

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Cork, , Ireland

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Riga, , Latvia

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Bydgoszcz, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Olsztyn, , Poland

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Rybnik, , Poland

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Wodzislaw Sl., , Poland

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Ponce, PR, Puerto Rico

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Cluj-Napoca, Cluj, Romania

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Cluj-Napoca, , Romania

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Iași, , Romania

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Sochi, , Russia

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Belgrade, , Serbia

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Kamenitz, , Serbia

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Ljubljana, , Slovenia

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Gyeonggi-do, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Elche, Alicante, Spain

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Barcelona, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Manresa, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Girona, Girona, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Oviedo, Principality of Asturias, Spain

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Seville, Sevilla, Spain

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Seville, Sevilla, Spain

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Basel, , Switzerland

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Basel, , Switzerland

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Ch-4101 Bruderholz, , Switzerland

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Chur, , Switzerland

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Liestal, , Switzerland

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan, , Taiwan

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Dnipropetrovsk, , Ukraine

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kyiv, , Ukraine

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Sumy, , Ukraine

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Sutton, Surrey, United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Belgium Brazil Bulgaria Canada Chile Czechia France Greece Hungary Indonesia Ireland Italy Latvia Poland Puerto Rico Romania Russia Serbia Slovenia South Africa South Korea Spain Switzerland Taiwan Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25395283 (View on PubMed)

Related Links

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

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

Other Identifiers

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A4021018

Identifier Type: -

Identifier Source: org_study_id

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