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Carcinoma, Large CellPhase 3NSCLCNCT00673049

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

A Phase 3 study testing CP 751,871 (Figitumumab) and Erlotinib in people with Carcinoma, Large Cell and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 175 sites in 27 countries.

Terminated

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

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CP 751,871 (Figitumumab) and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
583 participants
Where
175 sitesin 27 countries
Study dates
May 2008to Apr 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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.

Who cannot join

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

Trial locations and contacts

175 sites in 27 countries.

175 sites in 27 countries

United States69 sites

  • Pfizer Investigational Site

    Alpharetta, Georgia, 30005

  • Pfizer Investigational Site

    Amherst, New York, 14221

  • Pfizer Investigational Site

    Atlanta, Georgia, 30308

  • Pfizer Investigational Site

    Atlanta, Georgia, 30322

  • Pfizer Investigational Site

    Atlanta, Georgia, 30342

  • Pfizer Investigational Site

    Beech Grove, Indiana, 46107

  • Pfizer Investigational Site

    Bethesda, Maryland, 20817

  • Pfizer Investigational Site

    Billings, Montana, 59102

  • Pfizer Investigational Site

    Bloomington, Illinois, 61701

  • Pfizer Investigational Site

    Buffalo, New York, 14263

  • Pfizer Investigational Site

    Butte, Montana, 59701

  • Pfizer Investigational Site

    Cedar Rapids, Iowa, 52402

  • Pfizer Investigational Site

    Charlottesville, Virginia, 22908-0334

  • Pfizer Investigational Site

    Charlottesville, Virginia, 22908-0716

  • Pfizer Investigational Site

    Cody, Wyoming, 82414

  • Pfizer Investigational Site

    Columbus, Ohio, 43210

  • Pfizer Investigational Site

    Columbus, Ohio, 43221

  • Pfizer Investigational Site

    Conyers, Georgia, 30094

  • Pfizer Investigational Site

    Cumming, Georgia, 30041

  • Pfizer Investigational Site

    Decatur, Georgia, 30033

  • Pfizer Investigational Site

    Denver, Colorado, 80205

  • Pfizer Investigational Site

    Duluth, Georgia, 30096

  • Pfizer Investigational Site

    Fort Smith, Arkansas, 72903

  • Pfizer Investigational Site

    Germantown, Tennessee, 38138

  • Pfizer Investigational Site

    Gloucester, Virginia, 23601

  • Pfizer Investigational Site

    Glouster, Virginia, 23061

  • Pfizer Investigational Site

    Hollywood, Florida, 33021

  • Pfizer Investigational Site

    Hot Springs, Arkansas, 71913

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46237

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46260

  • Pfizer Investigational Site

    Lafayette, Colorado, 80026

  • Pfizer Investigational Site

    Lake City, Florida, 32024

  • Pfizer Investigational Site

    Lake City, Florida, 32055

  • Pfizer Investigational Site

    Lake Spivey, Georgia, 30236

  • Pfizer Investigational Site

    Lake Success, New York, 11042

  • Pfizer Investigational Site

    Lakeport, California, 95453

  • Pfizer Investigational Site

    Lawrenceville, Georgia, 30046

  • Pfizer Investigational Site

    Lebanon, New Hampshire, 03756

  • Pfizer Investigational Site

    Louisville, Kentucky, 40207

  • Pfizer Investigational Site

    Manchester, New Hampshire, 03102

  • Pfizer Investigational Site

    Manhasset, New York, 11030

  • Pfizer Investigational Site

    New Albany, Mississippi, 38652

  • Pfizer Investigational Site

    New Hyde Park, New York, 11040

  • Pfizer Investigational Site

    Newport News, Virginia, 23601

  • Pfizer Investigational Site

    Norman, Oklahoma, 73071

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73102

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73109

  • Pfizer Investigational Site

    Oklahoma City, Oklahoma, 73120

  • Pfizer Investigational Site

    Orange, California, 92868-3298

  • Pfizer Investigational Site

    Orange, California, 92868

  • Pfizer Investigational Site

    Pembroke Pines, Florida, 33028

  • Pfizer Investigational Site

    Peoria, Illinois, 61615

  • Pfizer Investigational Site

    Petaluma, California, 94954

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19104

  • Pfizer Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Pfizer Investigational Site

    San Antonio, Texas, 78229

  • Pfizer Investigational Site

    Santa Rosa, California, 95403

  • Pfizer Investigational Site

    Snellville, Georgia, 30078

  • Pfizer Investigational Site

    The Bronx, New York, 10461

  • Pfizer Investigational Site

    The Bronx, New York, 10467

  • Pfizer Investigational Site

    Thousand Oaks, California, 91360

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74104

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74133

  • Pfizer Investigational Site

    Tulsa, Oklahoma, 74136

  • Pfizer Investigational Site

    Waterloo, Iowa, 50701

  • Pfizer Investigational Site

    Wenatchee, Washington, 98801

  • Pfizer Investigational Site

    Westlake Valley, California, 91360

  • Pfizer Investigational Site

    Wheeling, West Virginia, 26003-6300

  • Pfizer Investigational Site

    Williamsburg, Virginia, 23185

Other trials in United States

Spain12 sites

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Elche, Alicante, 03203

  • Pfizer Investigational Site

    Girona, Girona, 17007

  • Pfizer Investigational Site

    L'Hospitalet de Llobregat, Barcelona, 08097

  • Pfizer Investigational Site

    Madrid, Madrid, 28007

  • Pfizer Investigational Site

    Madrid, Madrid, 28033

  • Pfizer Investigational Site

    Madrid, Madrid, 28041

  • Pfizer Investigational Site

    Manresa, Barcelona, 08243

  • Pfizer Investigational Site

    Oviedo, Principality of Asturias, 33006

  • Pfizer Investigational Site

    Sabadell, Barcelona, 08208

  • Pfizer Investigational Site

    Seville, Sevilla, 41009

  • Pfizer Investigational Site

    Seville, Sevilla, 41013

Other trials in Spain

France9 sites

  • Pfizer Investigational Site

    Brest, 29609

  • Pfizer Investigational Site

    La Tronche, 38700

  • Pfizer Investigational Site

    Lille, 59020 Cedex

  • Pfizer Investigational Site

    Marseille, 13009

  • Pfizer Investigational Site

    Marseille, 13915

  • Pfizer Investigational Site

    Rennes, Cedex 9, 35033

  • Pfizer Investigational Site

    Saint Pierre La Réunion Cedex, 97448

  • Pfizer Investigational Site

    Saint-Priest-en-Jarez, 42277

  • Pfizer Investigational Site

    Villejuif, 94805

Other trials in France

Poland9 sites

  • Pfizer Investigational Site

    Bydgoszcz, 85-796

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Krakow, 31-108

  • Pfizer Investigational Site

    Krakow, 31-215

  • Pfizer Investigational Site

    Lublin, 20-954

  • Pfizer Investigational Site

    Olsztyn, 10-357

  • Pfizer Investigational Site

    Olsztyn, 10-513

  • Pfizer Investigational Site

    Rybnik, 44-200

  • Pfizer Investigational Site

    Wodzislaw Sl., 44-300

Other trials in Poland

Brazil8 sites

  • Pfizer Investigational Site

    Higienópolis, Sao Paulo/ Brazil, 01224-010

  • Pfizer Investigational Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • 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

    Santo André, São Paulo, 09060-650

  • 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

Italy8 sites

  • Pfizer Investigational Site

    Avellino, 83100

  • Pfizer Investigational Site

    Aviano (PN), 33081

  • Pfizer Investigational Site

    Cattolica (RN), 47841

  • Pfizer Investigational Site

    Modena, 41100

  • Pfizer Investigational Site

    Orbassano (TO), 10043

  • Pfizer Investigational Site

    Padova, 35128

  • Pfizer Investigational Site

    Rimini, 47900

  • Pfizer Investigational Site

    Roma, 00157

Other trials in Italy

Russia6 sites

  • Pfizer Investigational Site

    Krasnodar, 350040

  • Pfizer Investigational Site

    Moscow, 115478

  • Pfizer Investigational Site

    Moscow, 143423

  • Pfizer Investigational Site

    Saint Petersburg, 194044

  • Pfizer Investigational Site

    Saint Petersburg, 198255

  • Pfizer Investigational Site

    Sochi, 354057

Other trials in Russia

Switzerland5 sites

  • Pfizer Investigational Site

    Basel, CH-4031

  • Pfizer Investigational Site

    Basel, CH-4058

  • Pfizer Investigational Site

    Ch-4101 Bruderholz

  • Pfizer Investigational Site

    Chur, 7000

  • Pfizer Investigational Site

    Liestal, CH-4410

Other trials in Switzerland

Ukraine5 sites

  • Pfizer Investigational Site

    Dnipropetrovsk, 49102

  • Pfizer Investigational Site

    Donetsk, 83092

  • Pfizer Investigational Site

    Kharkiv, 61070

  • Pfizer Investigational Site

    Kyiv, 03115

  • Pfizer Investigational Site

    Sumy, 40005

Other trials in Ukraine

Bulgaria4 sites

  • Pfizer Investigational Site

    Sofia, Bulgaria, 1756

  • Pfizer Investigational Site

    Sofia, 1233

  • Pfizer Investigational Site

    Sofia, 1527

  • Pfizer Investigational Site

    Varna, 9000

Other trials in Bulgaria

Czechia4 sites

  • Pfizer Investigational Site

    Kutná Hora, 284 01

  • Pfizer Investigational Site

    Nová Ves pod Pleší, 26204

  • Pfizer Investigational Site

    Prague, 180 81

  • Pfizer Investigational Site

    Tábor, 390 03

Other trials in Czechia

United Kingdom4 sites

  • Pfizer Investigational Site

    London, SW3 6JJ

  • Pfizer Investigational Site

    London, W6 8RF

  • Pfizer Investigational Site

    Manchester, M20 4BX

  • Pfizer Investigational Site

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Hungary3 sites

  • Pfizer Investigational Site

    Budapest, 1525

  • Pfizer Investigational Site

    Mátraháza, H-3233

  • Pfizer Investigational Site

    Székesfehérvár, 8000

Other trials in Hungary

Ireland3 sites

  • Pfizer Investigational Site

    Cork

  • Pfizer Investigational Site

    Dublin, 8

  • Pfizer Investigational Site

    Dublin

Other trials in Ireland

Romania3 sites

  • Pfizer Investigational Site

    Cluj-Napoca, Cluj, 400015

  • Pfizer Investigational Site

    Cluj-Napoca, 400015

  • Pfizer Investigational Site

    Iași, 700106

Other trials in Romania

South Korea3 sites

  • Pfizer Investigational Site

    Gyeonggi-do, 410-769

  • Pfizer Investigational Site

    Seoul, 120-752

  • Pfizer Investigational Site

    Seoul, 138-736

Other trials in South Korea

Taiwan3 sites

  • Pfizer Investigational Site

    Taichung, 404

  • Pfizer Investigational Site

    Taipei, 112

  • Pfizer Investigational Site

    Taoyuan County, 333

Other trials in Taiwan

Belgium2 sites

  • Pfizer Investigational Site

    Brasschaat, 2930

  • Pfizer Investigational Site

    Mons, 7000

Other trials in Belgium

Canada2 sites

  • Pfizer Investigational Site

    Montreal, Quebec, H3T 1E2

  • Pfizer Investigational Site

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Greece2 sites

  • Pfizer Investigational Site

    Heraklion, Crete, 71110

  • Pfizer Investigational Site

    Larissa, 41110

Other trials in Greece

Indonesia2 sites

  • Pfizer Investigational Site

    Jakarta, DKI Jakarta, 13230

  • Pfizer Investigational Site

    Surabaya, East Java, 60286

Other trials in Indonesia

Latvia2 sites

  • Pfizer Investigational Site

    Riga, LV 1002

  • Pfizer Investigational Site

    Riga, LV 1079

Other trials in Latvia

Serbia2 sites

  • Pfizer Investigational Site

    Belgrade, 11000

  • Pfizer Investigational Site

    Kamenitz, 21204

Other trials in Serbia

South Africa2 sites

  • Pfizer Investigational Site

    Bloemfontein, 9301

  • Pfizer Investigational Site

    Cape Town, 7925

Other trials in South Africa

Chile1 site

  • Pfizer Investigational Site

    Independencia, Santiago, RM, 8380455

Other trials in Chile

Puerto Rico1 site

  • Pfizer Investigational Site

    Ponce, PR, 00716

Other trials in Puerto Rico

Slovenia1 site

  • Pfizer Investigational Site

    Ljubljana, 1000

Other trials in Slovenia

About this study

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

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).

Read the 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.

Being tested
CP 751,871 (Figitumumab), Erlotinib
Keywords
IGR-1R, Non small cell lung cancer, CP-751, 871, Figitumumab
Medical subject headings
Carcinoma, Large Cell, Carcinoma, Non-Small-Cell Lung, Carcinoma, Squamous Cell, Carcinoma

What participants receive

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

  • CP 751,871 (Figitumumab)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.

  • ErlotinibDrug

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

  • ErlotinibDrug

    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.

Study groups in NCT00673049
Study groupRoleWhat they receive
Arm AExperimentalThe 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.
Receives: Drug: CP 751,871 (Figitumumab); Drug: Erlotinib
Arm BActive comparatorErlotinib (one tablet of 150 mg/day PO). Erlotinib will be taken at least one hour before or two hours after the ingestion of food)
Receives: Drug: Erlotinib

What is being measured

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

  1. 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.

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

Secondary outcomes (9)

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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

  3. Maximum Observed Plasma Concentration (Cmax) for Figitumumab

    Measured: 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

  4. Minimum Observed Plasma Trough Concentration (Cmin) for Figitumumab

    Measured: 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

  5. 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.

    Measured: 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

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

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

  7. 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.

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

  8. 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.

    Measured: 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)

  9. 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.

    Measured: 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)

Timeline

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

  1. First posted7 May 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2011
  4. Study completionApr 2012

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
583 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00673049
Sponsor's protocol ID
A4021018
Acronym
NSCLC
Status last verified
Jul 2013
First submitted
5 May 2008
Last updated
24 Jul 2013
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25395283

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CP 751,871 (Figitumumab) and Erlotinib in people with Carcinoma, Large Cell and Carcinoma, Non-Small-Cell Lung, run by Pfizer at 175 sites in 27 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 1 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 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Spain, France, Poland, Brazil and 22 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?

Yes. Results are posted in the registry (first posted 24 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Baseline, assessed every cycle until disease progression and then every 4 weeks until death, up to 30.65 months). 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 NCT00673049, which also lists 1 linked publication.

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 24 Jul 2013.

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