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

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung	Drug: erlotinib Drug: sunitinib Drug: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib Sunitinib malate Sunitinib

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Overall Survival (OS) [ Time Frame: Baseline to death or 28 days after last dose for the last participant ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Progression-Free Survival (PFS) [ Time Frame: Baseline to disease progression or death due to any cause or 28 days after last dose ] [ Designated as safety issue: No ]
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").
Percentage of Participants With Objective Response (OR) [ Time Frame: Baseline to disease progression or discontinuation from study or 28 days after last dose ] [ Designated as safety issue: No ]
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.
Duration of Response (DR) [ Time Frame: Baseline to disease progression or death or discontinuation from study or 28 days after last dose ] [ Designated as safety issue: No ]
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.
One-year Survival Probability [ Time Frame: Baseline until death or until 28 days after last dose for the last participant ] [ Designated as safety issue: No ]
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.
EuroQol 5-Dimension Questionnaire (EQ-5D)- Health State Profile Utility Score [ Time Frame: Baseline and End of Treatment (EOT) or Withdrawal ] [ Designated as safety issue: No ]
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.

Enrollment:	960
Study Start Date:	July 2007
Study Completion Date:	December 2012
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: erlotinib plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity Drug: sunitinib Sunitinib 37.5 mg daily by oral capsules in a continuous regimen
Active Comparator: 2	Drug: erlotinib plus erlotinib 150 mg daily by tablets in a continuous regimen until progression or unacceptable toxicity Drug: placebo Placebo daily by oral capsules in a continuous regimen

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457392

Show 204 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00457392 History of Changes
Other Study ID Numbers:	A6181087, SUN1087
Study First Received:	April 4, 2007
Results First Received:	July 6, 2011
Last Updated:	February 13, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Non-small cell lung cancer
sunitinib
erlotinib
Phase 3

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases

Erlotinib
Sunitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013