A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone
SUN1058
Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer
1 other identifier
interventional
162
8 countries
32
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Longer than P75 for phase_2
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2005
CompletedFirst Posted
Study publicly available on registry
December 14, 2005
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedResults Posted
Study results publicly available
June 10, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 6, 2013
January 1, 2013
3.6 years
December 12, 2005
January 21, 2011
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to \[≥\]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Secondary Outcomes (62)
Percentage of Participants With Objective Response
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Time to Tumor Progression (TTP)
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Duration of Response (DR)
From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)
Overall Survival (OS)
From randomization until death (up to Month 17)
Percentage of Participants Surviving at 1 Year
From randomization until death (up until Month 17)
- +57 more secondary outcomes
Other Outcomes (4)
VEGF-C Ratio to Baseline at Each Timepoint
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
VEGFR-2 Ratio to Baseline at Each Timepoint
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
VEGFR-3 Ratio to Baseline at Each Timepoint
Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)
- +1 more other outcomes
Study Arms (2)
A
EXPERIMENTALB
ACTIVE COMPARATORInterventions
erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- Patients with locally advanced/metastatic non-small cell lung cancer
- Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen
You may not qualify if:
- Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
- History of or known brain metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (32)
Pfizer Investigational Site
Birmingham, Alabama, 35233, United States
Pfizer Investigational Site
Birmingham, Alabama, 35294, United States
Pfizer Investigational Site
Mobile, Alabama, 36604, United States
Pfizer Investigational Site
Antioch, California, 94531, United States
Pfizer Investigational Site
Palm Springs, California, 92262-4885, United States
Pfizer Investigational Site
Pleasant Hill, California, 94523, United States
Pfizer Investigational Site
San Leandro, California, 94578, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
City of Saint Peters, Missouri, 63376, United States
Pfizer Investigational Site
Creve Coeur, Missouri, 63141, United States
Pfizer Investigational Site
St Louis, Missouri, 63110-1094, United States
Pfizer Investigational Site
St Louis, Missouri, 63110, United States
Pfizer Investigational Site
Chapel Hill, North Carolina, 27599-7600, United States
Pfizer Investigational Site
Clinton, North Carolina, 28328, United States
Pfizer Investigational Site
Goldsboro, North Carolina, 27534, United States
Pfizer Investigational Site
Wilson, North Carolina, 27893, United States
Pfizer Investigational Site
Cleveland, Ohio, 44106, United States
Pfizer Investigational Site
Houston, Texas, 77030, United States
Pfizer Investigational Site
Edmonton, Alberta, T6G 1Z2, Canada
Pfizer Investigational Site
Hamilton, Ontario, L8V 5C2, Canada
Pfizer Investigational Site
Budapest, 1525, Hungary
Pfizer Investigational Site
Törökbálint, 2045, Hungary
Pfizer Investigational Site
Genova, 16132, Italy
Pfizer Investigational Site
Monteforte Irpino, AV, 83024, Italy
Pfizer Investigational Site
Amsterdam, 1066 CX, Netherlands
Pfizer Investigational Site
Groningen, 9713 GZ, Netherlands
Pfizer Investigational Site
Bydgoszcz, 85-796, Poland
Pfizer Investigational Site
Gdansk, 80-952, Poland
Pfizer Investigational Site
Cluj-Napoca, Cluj, 400015, Romania
Pfizer Investigational Site
Bucharest, Sector 2, 022328, Romania
Pfizer Investigational Site
Bucharest, 30171, Romania
Pfizer Investigational Site
Santander, Cantabria, 39008, Spain
Related Publications (1)
Groen HJ, Socinski MA, Grossi F, Juhasz E, Gridelli C, Baas P, Butts CA, Chmielowska E, Usari T, Selaru P, Harmon C, Williams JA, Gao F, Tye L, Chao RC, Blumenschein GR Jr. A randomized, double-blind, phase II study of erlotinib with or without sunitinib for the second-line treatment of metastatic non-small-cell lung cancer (NSCLC). Ann Oncol. 2013 Sep;24(9):2382-9. doi: 10.1093/annonc/mdt212. Epub 2013 Jun 20.
PMID: 23788751DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to rounding some percentages will not equal 100%
Results Point of Contact
- Title
- Pfizer Clinical Trials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 12, 2005
First Posted
December 14, 2005
Study Start
June 1, 2006
Primary Completion
January 1, 2010
Study Completion
January 1, 2012
Last Updated
February 6, 2013
Results First Posted
June 10, 2011
Record last verified: 2013-01