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A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone (SUN1058)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

erlotinib

sunitinib

erlotinib

placebo

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung focused on measuring Non-small cell lung cancer, sunitinib, erlotinib, Phase 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors History of or known brain metastases

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With Objective Response

Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.

Time to Tumor Progression (TTP)

TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Duration of Response (DR)

DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.

Overall Survival (OS)

OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

Percentage of Participants Surviving at 1 Year

Percentage of participants alive at 1 year after date of first administration of study medication.

Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib

AUC(0-24) of Sunitinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib

AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)

AUC(0-24) of Total Drug (Sunitinib + SU-012662)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)

Maximum Observed Plasma Concentration (Cmax) of Erlotinib

Cmax of Sunitinib

Cmax of SU-012662 (Metabolite of Sunitinib)

Cmax of Total Drug (Sunitinib + SU-012662)

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib

AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC[0-t]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC[t-inf])

AUC(0-inf) for Sunitinib

AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)

AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)

AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)

AUC(0-inf) for Total Drug (Sunitinib + SU-012662)

AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)

Plasma Decay Half-life (t1/2) of Erlotinib

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Plasma Decay Half-life (t1/2) of Sunitinib

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Erlotinib Clearance at Steady State After Oral Administration (CL/F)

Sunitinib Clearance at Steady State After Oral Administration (CL/F)

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib

Tmax for Sunitinib

Tmax for SU-012662 (Metabolite of Sunitinib)

Tmax for Total Drug (Sunitinib + SU-012662)

Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.

Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.

Percentage of Participants With EGFR Gene Copy Number Increase

The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.

PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.

Percentage of Participants With EGFR Gene Amplification

The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

PFS in Subgroups That Were Defined by EGFR Gene Amplification

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Percentage of Participants With EGFR Gene Mutation

Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.

PFS in Subgroups That Were Defined by EGFR Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.

PFS in Subgroups That Were Defined by KRAS Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.

PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.

Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.

PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.

Percentage of Participants by Tumor VEGFR Mutation

Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts

A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

PFS in Subgroups That Were Defined by RNA Expression Profile

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.

EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes [min]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP >150 mmHg/diastolic BP >100 mmHg at any timepoint postbaseline.

Number of Participants With BP Greater Than 200/110 mmHg

Number of Participants on Anti-hypertensive Medications

Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.

Plasma Concentration of VEGF-C at Baseline

Plasma Concentration of Soluble VEGFR-2 at Baseline

Plasma Concentration of Soluble VEGFR-3 at Baseline

Plasma Concentration of Soluble KIT (sKIT) at Baseline

Full Information

NCT ID

NCT00265317

First Posted

December 12, 2005

Last Updated

January 31, 2013

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00265317

Brief Title

A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Acronym

SUN1058

Official Title

Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancer, sunitinib, erlotinib, Phase 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

erlotinib

Intervention Description

erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

sunitinib

Other Intervention Name(s)

Sutent

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

erlotinib

Intervention Description

erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Secondary Outcome Measure Information:

Title

Percentage of Participants With Objective Response

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Time to Tumor Progression (TTP)

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Duration of Response (DR)

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Overall Survival (OS)

Description

Time Frame

From randomization until death (up to Month 17)

Title

Percentage of Participants Surviving at 1 Year

Description

Percentage of participants alive at 1 year after date of first administration of study medication.

Time Frame

From randomization until death (up until Month 17)

Title

Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

Description

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib

Time Frame

Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

AUC(0-24) of Sunitinib

Description

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

Description

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

AUC(0-24) of Total Drug (Sunitinib + SU-012662)

Description

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

Maximum Observed Plasma Concentration (Cmax) of Erlotinib

Time Frame

Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

Cmax of Sunitinib

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Cmax of SU-012662 (Metabolite of Sunitinib)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Cmax of Total Drug (Sunitinib + SU-012662)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib

Description

Time Frame

Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)

Title

AUC(0-inf) for Sunitinib

Description

AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Title

AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)

Description

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Title

AUC(0-inf) for Total Drug (Sunitinib + SU-012662)

Description

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Title

Plasma Decay Half-life (t1/2) of Erlotinib

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time Frame

Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

Plasma Decay Half-life (t1/2) of Sunitinib

Description

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Erlotinib Clearance at Steady State After Oral Administration (CL/F)

Time Frame

Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

Sunitinib Clearance at Steady State After Oral Administration (CL/F)

Time Frame

Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib

Time Frame

Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Title

Tmax for Sunitinib

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Tmax for SU-012662 (Metabolite of Sunitinib)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Tmax for Total Drug (Sunitinib + SU-012662)

Time Frame

Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Title

Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Title

Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Title

Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Title

Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Title

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Title

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Description

Time Frame

predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Title

Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

Description

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With EGFR Gene Copy Number Increase

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With EGFR Gene Amplification

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by EGFR Gene Amplification

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With EGFR Gene Mutation

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by EGFR Gene Mutation

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by KRAS Gene Mutation

Description

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

Description

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

Description

Time Frame

From randomization until death (up to Month 17)

Title

Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

Description

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

Description

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Percentage of Participants by Tumor VEGFR Mutation

Description

Time Frame

Baseline

Title

Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts

Description

Time Frame

Baseline (Day 1, Cycle 1)

Title

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

Description

Time Frame

Baseline

Title

PFS in Subgroups That Were Defined by RNA Expression Profile

Description

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time Frame

From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Title

Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

Description

Time Frame

Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1

Title

EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

Description

Time Frame

Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)

Title

Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Description

Time Frame

Randomization up until Month 17

Title

Number of Participants With BP Greater Than 200/110 mmHg

Description

Time Frame

Randomization up until Month 17

Title

Number of Participants on Anti-hypertensive Medications

Description

Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.

Time Frame

Randomization to Day 28 of Cycle 18

Title

Plasma Concentration of VEGF-C at Baseline

Time Frame

Baseline (Cycle 1, Day 1)

Title

Plasma Concentration of Soluble VEGFR-2 at Baseline

Time Frame

Baseline (Cycle 1, Day 1)

Title

Plasma Concentration of Soluble VEGFR-3 at Baseline

Time Frame

Baseline (Cycle 1, Day 1)

Title

Plasma Concentration of Soluble KIT (sKIT) at Baseline

Time Frame

Baseline (Cycle 1, Day 1)

Other Pre-specified Outcome Measures:

Title

VEGF-C Ratio to Baseline at Each Timepoint

Description

Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)

Time Frame

Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Title

VEGFR-2 Ratio to Baseline at Each Timepoint

Description

Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)

Time Frame

Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Title

VEGFR-3 Ratio to Baseline at Each Timepoint

Description

Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)

Time Frame

Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Title

sKIT Ratio to Baseline at Each Timepoint

Description

Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)

Time Frame

Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35233

Country

United States

Facility Name

Pfizer Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Pfizer Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36604

Country

United States

Facility Name

Pfizer Investigational Site

City

Antioch

State/Province

California

ZIP/Postal Code

94531

Country

United States

Facility Name

Pfizer Investigational Site

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262-4885

Country

United States

Facility Name

Pfizer Investigational Site

City

Pleasant Hill

State/Province

California

ZIP/Postal Code

94523

Country

United States

Facility Name

Pfizer Investigational Site

City

San Leandro

State/Province

California

ZIP/Postal Code

94578

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Pfizer Investigational Site

City

Creve Coeur

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110-1094

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Pfizer Investigational Site

City

St. Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

Pfizer Investigational Site

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599-7600

Country

United States

Facility Name

Pfizer Investigational Site

City

Clinton

State/Province

North Carolina

ZIP/Postal Code

28328

Country

United States

Facility Name

Pfizer Investigational Site

City

Goldsboro

State/Province

North Carolina

ZIP/Postal Code

27534

Country

United States

Facility Name

Pfizer Investigational Site

City

Wilson

State/Province

North Carolina

ZIP/Postal Code

27893

Country

United States

Facility Name

Pfizer Investigational Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Pfizer Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Pfizer Investigational Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8V 5C2

Country

Canada

Facility Name

Pfizer Investigational Site

City

Budapest

ZIP/Postal Code

1525

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Torokbalint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

Pfizer Investigational Site

City

Genova

ZIP/Postal Code

16132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Monteforte Irpino, AV

ZIP/Postal Code

83024

Country

Italy

Facility Name

Pfizer Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Pfizer Investigational Site

City

Bydgoszcz

ZIP/Postal Code

85-796

Country

Poland

Facility Name

Pfizer Investigational Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Pfizer Investigational Site

City

Cluj-Napoca

State/Province

Cluj

ZIP/Postal Code

400015

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

State/Province

Sector 2

ZIP/Postal Code

022328

Country

Romania

Facility Name

Pfizer Investigational Site

City

Bucuresti

ZIP/Postal Code

30171

Country

Romania

Facility Name

Pfizer Investigational Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

23788751

Citation

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.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181058&StudyName=A%20Study%20In%20Patients%20With%20Non-Small%20Cell%20Lung%20Cancer%20Testing%20If%20Erlotinib%20Plus%20SU011248%20%28sunitinib%29%20Is%20Better%20Than%20Erlotinib%20Alone

Description

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Learn more about this trial

A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

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A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone (SUN1058)

Carcinoma, Non-Small-Cell Lung

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial