Carcinoma, Non-Small Cell LungPhase 3NCT00457392

A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

A Phase 3 study testing erlotinib and sunitinib in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 204 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Non-Small Cell Lung
What is being tested?: erlotinib and sunitinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 960 participants
Where: 204 sitesin 26 countries
Study dates: Jul 2007to Dec 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

Patients with locally advanced/metastatic non-small cell lung cancer
Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Who cannot join

Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
History of or known brain metastases

Trial locations and contacts

204 sites in 26 countries.

Country

City, postcode or hospital

204 sites in 26 countries

United States63 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48106
Pfizer Investigational Site
Antioch, California, 94531
Pfizer Investigational Site
Athens, Georgia, 30607
Pfizer Investigational Site
Aurora, Illinois, 60504
Pfizer Investigational Site
Baton Rouge, Louisiana, 70809
Pfizer Investigational Site
Beaumont, Texas, 77701
Pfizer Investigational Site
Bethesda, Maryland, 20817
Pfizer Investigational Site
Bountiful, Utah, 84010
Pfizer Investigational Site
Brooksville, Florida, 34613
Pfizer Investigational Site
Burbank, California, 91505-4866
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376
Pfizer Investigational Site
Cocoa Beach, Florida, 32931
Pfizer Investigational Site
Columbus, Mississippi, 39705
Pfizer Investigational Site
Corinth, Mississippi, 38834
Pfizer Investigational Site
Council Bluffs, Iowa, 51503
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Downey, California, 90241
Pfizer Investigational Site
Fairfield, Connecticut, 06824
Pfizer Investigational Site
Florence, Alabama, 35630
Pfizer Investigational Site
Fort Lauderdale, Florida, 33308
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Goshen, Indiana, 46526
Pfizer Investigational Site
Grapevine, Texas, 76051
Pfizer Investigational Site
Hot Springs, Arkansas, 71913
Pfizer Investigational Site
Indianapolis, Indiana, 46260-2082
Pfizer Investigational Site
Irving, Texas, 75063
Pfizer Investigational Site
Jamaica, New York, 11432
Pfizer Investigational Site
Kennewick, Washington, 99336
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
La Jolla, California, 92037
Pfizer Investigational Site
La Jolla, California, 92093-0987
Pfizer Investigational Site
Lafayette, Louisiana, 70503
Pfizer Investigational Site
Lancaster, Pennsylvania, 17605
Pfizer Investigational Site
Las Vegas, Nevada, 89102
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Layton, Utah, 84041
Pfizer Investigational Site
Merritt Island, Florida, 32952
Pfizer Investigational Site
Montebello, California, 90640
Pfizer Investigational Site
Murray, Utah, 84157
Pfizer Investigational Site
Muscle Shoals, Alabama, 35661
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
Omaha, Nebraska, 68105
Pfizer Investigational Site
Pleasant Hill, California, 94523
Pfizer Investigational Site
Provo, Utah, 84604
Pfizer Investigational Site
Rockledge, Florida, 32955
Pfizer Investigational Site
Salt Lake City, Utah, 84102
Pfizer Investigational Site
Salt Lake City, Utah, 84106
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Leandro, California, 94578
Pfizer Investigational Site
Sandy City, Utah, 84094
Pfizer Investigational Site
Scottsdale, Arizona, 85258
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
Titusville, Florida, 32796
Pfizer Investigational Site
Troy, Michigan, 48085
Pfizer Investigational Site
Tulsa, Oklahoma, 74014
Pfizer Investigational Site
Tulsa, Oklahoma, 74104
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Tupelo, Mississippi, 38801
Pfizer Investigational Site
West Valley City, Utah, 84102
Pfizer Investigational Site
Whittier, California, 90606

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Germany13 sites

Pfizer Investigational Site
Bad Berka, 99437
Pfizer Investigational Site
Berlin, 12203
Pfizer Investigational Site
Dresden, 01307
Pfizer Investigational Site
Ebensfeld, 96250
Pfizer Investigational Site
Essen, 45122
Pfizer Investigational Site
Gauting, 82131
Pfizer Investigational Site
Großhansdorf, 22927
Pfizer Investigational Site
Halle, 06120
Pfizer Investigational Site
Heidelberg, 69126
Pfizer Investigational Site
Homburg, 66424
Pfizer Investigational Site
Mainz, 55131
Pfizer Investigational Site
Tübingen, 72076
Pfizer Investigational Site
Wiesbaden, 65199

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United Kingdom12 sites

Pfizer Investigational Site
Bebington, Wirral, CH63 4JY
Pfizer Investigational Site
Cambridge, CB2 0QQ
Pfizer Investigational Site
Derby, DE1 2QY
Pfizer Investigational Site
Dundee, DD1 9SY
Pfizer Investigational Site
Keighley, West Yorkshire, BD20 6TD
Pfizer Investigational Site
London, NW1 2PG
Pfizer Investigational Site
London, NW3 2QG
Pfizer Investigational Site
Peterborough, PE3 6DA
Pfizer Investigational Site
Rhyl, Denbigshire, LL18 5UJ
Pfizer Investigational Site
Sheffield, S10 2SJ
Pfizer Investigational Site
Southampton, SO16 6YD
Pfizer Investigational Site
Yeovil, Somerset, BA21 4AT

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Italy11 sites

Pfizer Investigational Site
Catania, 95122
Pfizer Investigational Site
Grosseto, 58100
Pfizer Investigational Site
Mantua, 46100
Pfizer Investigational Site
Milan, 20132
Pfizer Investigational Site
Milan, 20162
Pfizer Investigational Site
Monza (MI), 20052
Pfizer Investigational Site
Novara, 28100
Pfizer Investigational Site
Orbassano (TO), 10043
Pfizer Investigational Site
Parma, 43100
Pfizer Investigational Site
Roma, 00152
Pfizer Investigational Site
Rozzano (MI), 20089

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Canada10 sites

Pfizer Investigational Site
Greenfield Park, Quebec, J4V 2H1
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Kingston, Ontario, K7L 5P9
Pfizer Investigational Site
Lévis, Quebec, G6V 3Z1
Pfizer Investigational Site
Oshawa, Ontario, L1G 2B9
Pfizer Investigational Site
Québec, Quebec, G1J 1Z4
Pfizer Investigational Site
Rimouski, Quebec, G5L 5T1
Pfizer Investigational Site
Saskatoon, Saskatchewan, S7N 4H4
Pfizer Investigational Site
Toronto, Ontario, M4N 3M5
Pfizer Investigational Site
Toronto, Ontario, M5G 2M9

Other trials in Canada

Spain10 sites

Pfizer Investigational Site
A Coruña, La Coruña, 15006
Pfizer Investigational Site
Barcelona, Barcelona, 08036
Pfizer Investigational Site
Dos Hermanas, Sevilla, 41700
Pfizer Investigational Site
Madrid, Madrid, 28046
Pfizer Investigational Site
Málaga, Malaga, 29010
Pfizer Investigational Site
Palma de Mallorca, Balearic Islands, 07198
Pfizer Investigational Site
Sabadell, Barcelona, 08208
Pfizer Investigational Site
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38320
Pfizer Investigational Site
Seville, Sevilla, 41013
Pfizer Investigational Site
Valencia, Valencia, 46015

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Czechia9 sites

Pfizer Investigational Site
České Budějovice, 370 87
Pfizer Investigational Site
Nová Ves pod Pleší, 262 04
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Ostrava-Poruba, 708 52
Pfizer Investigational Site
Prague, 128 08
Pfizer Investigational Site
Prague, 180 81
Pfizer Investigational Site
Pribram V, 261 95
Pfizer Investigational Site
Tábor, 390 03
Pfizer Investigational Site
Ústí nad Labem, 401 13

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Netherlands8 sites

Pfizer Investigational Site
's-Hertogenbosch, 5211 RW
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Arnhem, 6815 AD
Pfizer Investigational Site
Enschede, Overijssel, 7513 ER
Pfizer Investigational Site
Harderwijk, 3844 DG
Pfizer Investigational Site
Maastricht, 6229 HX
Pfizer Investigational Site
Rotterdam, 3075 EA
Pfizer Investigational Site
Rotterdam, 3097 DZ

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Hungary6 sites

Pfizer Investigational Site
Budapest, H-1529
Pfizer Investigational Site
Deszk, 6772
Pfizer Investigational Site
Gyula, 5703
Pfizer Investigational Site
Mátraháza, H-3233
Pfizer Investigational Site
Székesfehérvár, 8000
Pfizer Investigational Site
Zalaegerszeg-Pozva, H-8900

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Poland6 sites

Pfizer Investigational Site
Lodz, 93-509
Pfizer Investigational Site
Opole, 45-060
Pfizer Investigational Site
Otwock, 05-400
Pfizer Investigational Site
Warsaw, 01-138
Pfizer Investigational Site
Warsaw, 02-781
Pfizer Investigational Site
Zielona Góra, 65-046

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Brazil5 sites

Pfizer Investigational Site
Barretos, São Paulo, 14784-400
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90840-440
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
São Paulo, São Paulo, 01308-050

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Norway5 sites

Pfizer Investigational Site
Kristiansand, 4604
Pfizer Investigational Site
Oslo, 0379
Pfizer Investigational Site
Stavanger, 4011
Pfizer Investigational Site
Tromsø, 9038
Pfizer Investigational Site
Trondheim, 7030

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Slovakia5 sites

Pfizer Investigational Site
Bratislava, 826 06
Pfizer Investigational Site
Košice, 041 90
Pfizer Investigational Site
Kvetnica Pri Poprade, 058 87
Pfizer Investigational Site
Nitra-Zobor, 949 88
Pfizer Investigational Site
Žilina, 012 07

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Argentina4 sites

Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., C1094AAD
Pfizer Investigational Site
Buenos Aires, Buenos Aires F.D., C1122AAL
Pfizer Investigational Site
Buenos Aires, C1034ACO
Pfizer Investigational Site
Córdoba, Córdoba Province, 5000

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Denmark4 sites

Pfizer Investigational Site
Herlev, 2730
Pfizer Investigational Site
Hilleroed, 3400
Pfizer Investigational Site
Koebenhavn OE, 2100
Pfizer Investigational Site
Odense, 5000

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Greece4 sites

Pfizer Investigational Site
Alexandroupoli, 68100
Pfizer Investigational Site
Athens, 11527
Pfizer Investigational Site
Heraklion, Crete, 71 110
Pfizer Investigational Site
Kifisia, Athens, 145 64

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Russia4 sites

Pfizer Investigational Site
Moscow, 115478
Pfizer Investigational Site
Moscow, 143423
Pfizer Investigational Site
Saint Petersburg, 194044
Pfizer Investigational Site
Saint Petersburg, 197022

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South Korea4 sites

Pfizer Investigational Site
Seoul, 120-725
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 138-736

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Austria3 sites

Pfizer Investigational Site
Grimmenstein, A-2840
Pfizer Investigational Site
Innsbruck, A-6020
Pfizer Investigational Site
Linz, A-4010

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Belgium3 sites

Pfizer Investigational Site
Brussels, 1070
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000

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Chile3 sites

Pfizer Investigational Site
Independencia, Santiago, RM, 8380456
Pfizer Investigational Site
Providencia, Santiago, RM, 7500921
Pfizer Investigational Site
Santiago, Chile

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Hong Kong3 sites

Pfizer Investigational Site
Kowloon
Pfizer Investigational Site
Shatin, NT
Pfizer Investigational Site
Tuenmen

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Taiwan3 sites

Pfizer Investigational Site
Gwei Shan Township, Taoyuan County, 333
Pfizer Investigational Site
Taichung, 40705
Pfizer Investigational Site
Tainan, 704

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Thailand3 sites

Pfizer Investigational Site
Amphoe Mueang, Chiang Mai, 50200
Pfizer Investigational Site
Bangkok, 10700
Pfizer Investigational Site
Pathumwan, Bangkok, 10330

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Colombia2 sites

Pfizer Investigational Site
Medellín, Antioquia, 0
Pfizer Investigational Site
Medellín, Antioquia

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Switzerland1 site

Pfizer Investigational Site
Genolier, 1272

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib

Conditions: Carcinoma, Non-Small Cell Lung
Being tested: erlotinib, sunitinib, placebo
Keywords: Non-small cell lung cancer, sunitinib, erlotinib, Phase 3
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

erlotinibDrug
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
sunitinibDrug
Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
erlotinibDrug
plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity
placeboDrug
Placebo daily by oral capsules in a continuous regimen

Study groups in NCT00457392
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: erlotinib; Drug: sunitinib
2	Active comparator	Not described Receives: Drug: erlotinib; Drug: placebo

What is being measured

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

Overall Survival (OS)
Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.
Measured: Baseline to death or 28 days after last dose for the last participant

Secondary outcomes (5)

Progression-Free Survival (PFS)
Time in weeks from assignment to study medication to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Measured: Baseline to disease progression or death due to any cause or 28 days after last dose
Percentage of Participants With Objective Response (OR)
Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. Confirmed response are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all lesions (target and/or non target). PR are those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Measured: Baseline to disease progression or discontinuation from study or 28 days after last dose
Duration of Response (DR)
Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7.
Measured: Baseline to disease progression or death or discontinuation from study or 28 days after last dose
One-year Survival Probability
The 1 year survival probability was defined as the probability of survival at one year after the date of the start of the study treatment based on the Kaplan Meier estimate.
Measured: Baseline until death or until 28 days after last dose for the last participant
EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score
EQ-5D: 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 (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in total score range -0.594 to 1.000; higher score indicates better health state.
Measured: Baseline and End of Treatment (EOT) or Withdrawal

Timeline

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

Jul 2007Dec 2012

First posted6 Apr 2007 (estimated)
Study startJul 2007
Primary completionJul 2010
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Non-Small Cell LungStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 960 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00457392
Sponsor's protocol ID: A6181087
Other IDs: SUN1087
Status last verified: Sep 2013
First submitted: 4 Apr 2007
Last updated: 29 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer

All Carcinoma, Non-Small Cell Lung trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Controlled Phase 3, Efficacy And Safety Study Of Sunitinib (SU011248) In Patients With Advanced/Metastatic Non-Small Cell Lung Cancer Treated With Erlotinib
ClinicalTrials.gov ID: NCT00457392
Acronym / sponsor ID: A6181087
Conditions: Carcinoma, Non-Small Cell Lung
Keywords: Non-small cell lung cancer, sunitinib, erlotinib, Phase 3
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 960 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2007
Primary completion: Jul 2010 (actual)
Study completion: Dec 2012 (actual)
First posted: 6 Apr 2007 (estimated)
Results: Posted 2 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: erlotinib, Drug: sunitinib
2	Active comparator	Drug: erlotinib, Drug: placebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients with locally advanced/metastatic non-small cell lung cancer
Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Key exclusion criteria (2 listed)

Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
History of or known brain metastases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
erlotinibplus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity	Drug	1
sunitinibSunitinib 37.5 mg daily by oral capsules in a continuous regimen	Drug	1
erlotinibplus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity	Drug	2
placeboPlacebo daily by oral capsules in a continuous regimen	Drug	2

Primary outcome

Overall Survival (OS)
Time frame: Baseline to death or 28 days after last dose for the last participant
Overall survival is the duration from assignment to study medication to death. For participants who are alive, overall survival is censored at the last contact.

5 secondary outcomes

Progression-Free Survival (PFS)
Time frame: Baseline to disease progression or death due to any cause or 28 days after last dose
Percentage of Participants With Objective Response (OR)
Time frame: Baseline to disease progression or discontinuation from study or 28 days after last dose
Duration of Response (DR)
Time frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose
One-year Survival Probability
Time frame: Baseline until death or until 28 days after last dose for the last participant
EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score
Time frame: Baseline and End of Treatment (EOT) or Withdrawal

Results and safety

Results posted to the registry on 2 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sunitinib + Erlotinib	480	0
Erlotinib	480	0

Primary outcome: Overall Survival (OS)

Time frame: Baseline to death or 28 days after last dose for the last participant. Median (95% Confidence Interval). Unit: Months

Measure	Sunitinib + Erlotinib n = 480	Erlotinib n = 480
Value	9.0 (8.4 to 10.2)	8.5 (7.4 to 9.8)

Sunitinib + Erlotinib vs Erlotinib: Hazard Ratio (HR): 0.942 (95% CI 0.822 to 1.079), p = 0.1933, Log Rank

Population analysed: The Full Analysis (FA) set included all participants who were randomized, with study drug assignment designated according to actual randomization, regardless of whether participants received study drug according to the randomization schedule, or received a different drug from that to which they were randomized.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sunitinib + Erlotinib	207 of 473 (43.8%)	463 of 473 (97.9%)	Not reported
Erlotinib	181 of 477 (37.9%)	461 of 477 (96.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Carcinoma, Non-Small Cell Lung

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

204 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib and sunitinib in people with Carcinoma, Non-Small Cell Lung, run by Pfizer at 204 sites in 26 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States, Germany, United Kingdom, Italy, Canada and 21 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 2 Aug 2011). 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 (OS) (time frame: Baseline to death or 28 days after last dose for the last participant). 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 NCT00457392.

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 29 Oct 2013.