Trial Outcomes & Findings for A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer (NCT NCT00113516)

Last Updated: 2010-05-18

Results Overview

Proportion of those surviving at the end of one year from the first dose of study treatment. In the absence of confirmation of death, survival time was censored at the last date the subject was known to be alive. Patients lacking data beyond the day of first dose had their survival time censored at Day 1 of treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

From start of treatment until 1 year or death

Results posted on

2010-05-18

Participant Flow

During Part 1, subjects received carboplatin plus paclitaxel 172-225 mg/m2. Those same subjects were eligible for continuation in Part 2 where they received sunitinib 50 mg. 66 subjects continued in Part 2.

Participant milestones

Participant milestones
Measure	Carboplatin Plus Paclitaxel Carboplatin Plus Paclitaxel 172-225 mg/m2	Sunitinib Sunitinib 50 mg
Part 1 STARTED	84	0
Part 1 COMPLETED	0	0
Part 1 NOT COMPLETED	84	0
Part 2 STARTED	0	66
Part 2 COMPLETED	0	0
Part 2 NOT COMPLETED	0	66

Reasons for withdrawal

Reasons for withdrawal
Measure	Carboplatin Plus Paclitaxel Carboplatin Plus Paclitaxel 172-225 mg/m2	Sunitinib Sunitinib 50 mg
Part 1 Adverse Event	6	0
Part 1 Death	3	0
Part 1 Other	3	0
Part 1 Withdrawal by Subject	2	0
Part 1 Lack of Efficacy	2	0
Part 1 Did Not Meet Entrance Criteria	1	0
Part 1 Laboratory Abnormality	1	0
Part 1 Ongoing	1	0
Part 1 Missing	65	0
Part 2 Adverse Event	0	16
Part 2 Death	0	5
Part 2 Lack of Efficacy	0	37
Part 2 Withdrawal by Subject	0	3
Part 2 Other	0	3
Part 2 Laboratory Abnormality	0	1
Part 2 Ongoing	0	1

Baseline Characteristics

A Study Of SU011248 As Therapy In Patients With Locally Advanced Or Metastatic Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Age, Customized < 65 years	53 participants n=5 Participants
Age, Customized > = 65 years	31 participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants

PRIMARY outcome

Timeframe: From start of treatment until 1 year or death

Population: Intent-to-treat (ITT) population = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Proportion of Subjects Surviving at One Year	0.405 proportion

SECONDARY outcome

Timeframe: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death

Population: ITT

PFS was defined as the time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Progression-free Survival (PFS)	23.1 weeks Interval 21.4 to 28.2

SECONDARY outcome

Timeframe: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)

Population: ITT

TTP was defined as the time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date - first paclitaxel/carboplatin dose date +1)/7.02.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Time to Tumor Progression (TTP)	23.6 weeks Interval 22.6 to 29.3

SECONDARY outcome

Timeframe: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib) or death

Population: ITT. DR was calculated for the subgroup of subjects with objective response. 23 subjects reported CR or PR response and were analyzed for DR.

DR=time from the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) that was subsequently confirmed to first documentation of objective disease progression or death due to any cause, whichever was first. CR=disappearance of all target lesions. PR=a \> = 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions. If tumor progression data included more than 1 date, first date was used. DR (in weeks) was calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.02.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=23 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Duration of Response (DR)	27.3 weeks Interval 16.3 to 40.1

SECONDARY outcome

Timeframe: From start of treatment until Day 21 of Cycles 2 and 4 (Carboplatin plus Paclitaxel), Day 28 of Cycles 1, 2, 3, 4, and even cycles thereafter (Sunitinib)

Population: ITT

Objective disease response = subjects with confirmed CR or PR according to the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.0). A CR was defined as the disappearance of all target lesions. A PR was defined as a ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Number of Subjects With Overall Confirmed Objective Disease Response	23 participants

SECONDARY outcome

Timeframe: From start of study treatment until death

Population: ITT

OS was defined as the time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death - date of paclitaxel/carboplatin first dose +1)/30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of paclitaxel/carboplatin had their survival time censored at Day 1 of paclitaxel/carboplatin treatment.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Overall Survival (OS)	10.4 months Interval 8.1 to 12.2

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: Pharmacokinetic (PK) = all subjects enrolled in the study who received at least 1 dose of carboplatin/paclitaxel or sunitinib. Subjects with plasma values below limit of quantification were excluded.

Ctrough = the plasma concentration prior to study drug administration. On Day 28, this parameter provided and idea of the concentration at steady state since no big fluctuation was expected in a 24 hour interval.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Trough Plasma Concentration (Ctrough) of Sunitinib Cycle 1, Day 28 (n=51)	57.69 nanograms (ng)/milliliter (mL) Standard Deviation 29.37
Trough Plasma Concentration (Ctrough) of Sunitinib Cycle 2, Day 28 (n=36)	50.88 nanograms (ng)/milliliter (mL) Standard Deviation 33.67
Trough Plasma Concentration (Ctrough) of Sunitinib Cycle 3, Day 28 (n=16)	41.55 nanograms (ng)/milliliter (mL) Standard Deviation 24.28
Trough Plasma Concentration (Ctrough) of Sunitinib Cycle 5, Day 28 (n=6)	38.57 nanograms (ng)/milliliter (mL) Standard Deviation 21.83

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: PK. Subjects with plasma values below limit of quantification were excluded.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 1, Day 28 (n=51)	27.54 ng/mL Standard Deviation 15.10
Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 2, Day 28 (n=36)	23.47 ng/mL Standard Deviation 20.99
Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 3, Day 28 (n=16)	18.37 ng/mL Standard Deviation 9.05
Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 5, Day 28 (n=6)	15.67 ng/mL Standard Deviation 7.12

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: PK. Subjects with plasma values below limit of quantification were excluded.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 1, Day 28 (n=51)	85.23 ng/mL Standard Deviation 42.22
Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 2, Day 28 (n=36)	74.35 ng/mL Standard Deviation 51.60
Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 3, Day 28 (n=16)	59.92 ng/mL Standard Deviation 30.72
Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 5, Day 28 (n=6)	54.24 ng/mL Standard Deviation 27.90

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: PK. Subjects with plasma values below limit of quantification were excluded.

Ctrough = the plasma concentration prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. This was determined due to potential dose changes throughout the study in different subjects. It was calculated as the observed values multiplied by the reference dose (50 mg) divided by the actual dose. For dose-corrected trough concentration, only trough concentration values from subjects who received sunitinib during at least the last 10 consecutive days of dosing at the same dose level were included.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Dose-Corrected Ctrough of Sunitinib Cycle 1, Day 28 (n=39)	64.10 ng/mL Standard Deviation 26.84
Dose-Corrected Ctrough of Sunitinib Cycle 2, Day 28 (n=28)	59.85 ng/mL Standard Deviation 40.45
Dose-Corrected Ctrough of Sunitinib Cycle 3, Day 28 (n=13)	49.59 ng/mL Standard Deviation 21.86
Dose-Corrected Ctrough of Sunitinib Cycle 5, Day 28 (n=5)	54.51 ng/mL Standard Deviation 13.67

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: PK. Subjects with plasma values below limit of quantification were excluded.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 1, Day 28 (n=39)	27.90 ng/mL Standard Deviation 14.66
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 2, Day 28 (n=28)	27.37 ng/mL Standard Deviation 30.55
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 3, Day 28 (n=13)	20.64 ng/mL Standard Deviation 9.97
Dose-Corrected Ctrough of SU-012662 (Sunitinib's Metabolite) Cycle 5, Day 28 (n=5)	22.29 ng/mL Standard Deviation 8.35

SECONDARY outcome

Timeframe: predose on Day 28 of Cycles 1, 2, 3, and 5 of Part 2

Population: PK. Subjects with plasma values below limit of quantification were excluded.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=66 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 1, Day 28 (n=39)	92.00 ng/mL Standard Deviation 40.31
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 2, Day 28 (n=28)	87.22 ng/mL Standard Deviation 68.28
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 3, Day 28 (n=13)	70.24 ng/mL Standard Deviation 28.71
Dose-Corrected Ctrough of Total Drug (Sunitinib + SU-012662) Cycle 5, Day 28 (n=5)	76.80 ng/mL Standard Deviation 20.13

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: Modified ITT population (MITT) = all subjects enrolled in the study who received at least 1 dose of paclitaxel/carboplatin and at least 1 dose of Sunitinib.

Concentration of VEGFR3 at baseline.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=60 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Concentration at Baseline	30382.83 picograms (pg)/milliliter (mL) Standard Deviation 19134.12

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.

VEGFR3 concentration at each time point divided by VEGFR3 concentration at baseline (ratio to baseline).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=46 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGFR3 Ratio to Baseline at Each Time Point Cycle 1, Day 28 (n=46)	0.39 ratio Standard Deviation 0.201
VEGFR3 Ratio to Baseline at Each Time Point Cycle 2, Day 1 (n=40)	0.74 ratio Standard Deviation 0.255
VEGFR3 Ratio to Baseline at Each Time Point Cycle 2, Day 28 (n=29)	0.36 ratio Standard Deviation 0.165
VEGFR3 Ratio to Baseline at Each Time Point Cycle 3, Day 1 (n=21)	0.70 ratio Standard Deviation 0.288
VEGFR3 Ratio to Baseline at Each Time Point Cycle 3, Day 28 (n=12)	0.31 ratio Standard Deviation 0.111
VEGFR3 Ratio to Baseline at Each Time Point Cycle 5, Day 28 (n=4)	0.31 ratio Standard Deviation 0.163

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: MITT. Number of participants analyzed = number of subjects with VEGF-C data at Baseline.

Concentration of VEGF-C at baseline.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=59 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGF-C Concentration at Baseline	793.19 pg/mL Standard Deviation 323.770

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point.

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

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=46 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGF-C Ratio to Baseline at Each Time Point Cycle 1, Day 28 (n=46)	0.81 ratio Standard Deviation 0.342
VEGF-C Ratio to Baseline at Each Time Point Cycle 2, Day 1 (n=39)	0.90 ratio Standard Deviation 0.396
VEGF-C Ratio to Baseline at Each Time Point Cycle 2, Day 28 (n=30)	0.91 ratio Standard Deviation 0.577
VEGF-C Ratio to Baseline at Each Time Point Cycle 3, Day 1 (n=20)	1.00 ratio Standard Deviation 0.460
VEGF-C Ratio to Baseline at Each Time Point Cycle 3, Day 28 (n=12)	0.91 ratio Standard Deviation 0.340
VEGF-C Ratio to Baseline at Each Time Point Cycle 5, Day 28 (n=4)	0.89 ratio Standard Deviation 0.269

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: MITT. Number of participants analyzed = number of subjects with soluble E-Selectin data at Baseline.

Concentration of soluble E-Selectin at baseline.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=53 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Soluble E-Selectin at Baseline	27.06 nanograms (ng)/mL Standard Deviation 11.474

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. At Cycle 4, Day 28, median and/or standard deviation were not able to be estimated.

Soluble E-Selectin concentration at each time point divided by soluble E-Selectin concentration at baseline (ratio to baseline).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=34 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 1, Day 28 (n=34)	0.83 ratio Standard Deviation 0.222
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 2, Day 1 (n=29)	0.89 ratio Standard Deviation 0.287
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 2, Day 28 (n=22)	0.77 ratio Standard Deviation 0.246
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 3, Day 1 (n=16)	0.81 ratio Standard Deviation 0.224
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 3, Day 28 (n=8)	0.69 ratio Standard Deviation 0.126
Soluble E-Selectin Ratio to Baseline at Each Time Point Cycle 5, Day 28 (n=3)	0.76 ratio Standard Deviation 0.354

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Median concentration of VEGFR3 at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=45 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (CR or PR or SD, n=21)	21660.00 pg/mL
VEGFR3 at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (PD, n=24)	27740.00 pg/mL

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.

Median VEGFR3 concentration at each time point divided by median VEGFR3 concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=36 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (CR or PR or SD, n=16)	0.34 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (PD, n=20)	0.35 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (CR or PR or SD, n=19)	0.75 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (PD, n=16)	0.84 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (CR or PR or SD, n=15)	0.32 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (PD, n=12)	0.38 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (CR or PR or SD, n=15)	0.57 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (PD, n=5)	0.92 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (CR or PR or SD, n=11)	0.38 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (pd, n=1)	0.43 ratio
VEGFR3 Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 5, Day 28 (CR or PR or SD, n=4)	0.30 ratio

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Median concentration of VEGF-C at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=44 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (PD, n=24)	766.45 pg/mL
VEGF-C at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (CR or PR or SD, n=20)	704.80 pg/mL

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 5, Day 28.

Median VEGF-C concentration at each time point divided by median VEGF-C concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=36 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (CR or PR or SD, n=16)	0.73 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (PD, n=20)	0.81 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (CR or PR or SD, n=18)	0.87 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (PD, n=16)	0.85 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (CR or PR or SD, n=16)	0.89 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (PD, n=12)	0.69 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (CR or PR or SD, n=14)	0.89 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (PD, n=5)	0.78 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (CR or PR or SD, n=11)	0.85 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (PD, n=1)	0.90 ratio
VEGF-C Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 5, Day 28 (CR or PR or SD, n=4)	0.78 ratio

SECONDARY outcome

Timeframe: Baseline (Cycle 1, Day 1) of Part 2

Population: MITT. n=number of subjects with levels of soluble protein biomarkers and tumor response at baseline.

Median concentration of soluble E-selectin at baseline stratified by tumor response (CR or PR or \[SD \> = 6 Weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a nonparametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=38 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (CR or PR or SD, n=17)	26.40 pg/mL
Soluble E-Selectin at Baseline Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 1 (PD, n=21)	27.40 pg/mL

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. No subjects had PD at Cycle 4, Day 28 and Cycle 5, Day 28.

Median soluble E-selectin concentration at each time point divided by median soluble E-selectin concentration at baseline (ratio to baseline) for subjects with tumor response (CR or PR or \[SD \> = 6 weeks\] or PD). A measure of dispersion is not included because the Wilcoxon rank sum test is a non-parametric test that makes no assumptions about the distribution of the data (eg, normality).

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=26 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (CR or PR or SD, n=10)	0.84 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 1, Day 28 (PD, n=16)	0.84 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (CR or PR or SD, n=13)	0.84 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 1 (PD, n=12)	0.76 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (CR or PR or SD, n=10)	0.86 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 2, Day 28 (PD, n=10)	0.64 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (CR or PR or SD, n=10)	0.74 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 1 (PD, n=5)	0.77 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (CR or PR or SD, n=7)	0.67 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 3, Day 28 (PD, n=1)	0.78 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 4, Day 28 (CR or PR or SD, n=1)	1.13 ratio
Soluble E-Selectin Ratio to Baseline at Each Time Point Stratified by Tumor Response (CR or PR or [SD > = 6 Weeks] or PD) Cycle 5, Day 28 (CR or PR or SD, n=3)	0.64 ratio

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint) and Cycle 5, Day 28 (\> = median cutpoint), median and/or CI were not able to be estimated.

PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1)divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after Stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=60 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=30)	13.1 weeks Interval 10.11 to 32.91
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	10.3 weeks Interval 9.12 to 16.1
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	15.8 weeks Interval 9.97 to 32.91
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	10.3 weeks Interval 6.84 to 16.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=20)	22.5 weeks Interval 15.81 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	11.1 weeks Interval 10.83 to 16.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=14)	16.8 weeks Interval 10.83 to 32.91
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	16.1 weeks Interval 10.97 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=10)	32.9 weeks Interval 22.51 to 45.87
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=11)	16.1 weeks Interval 9.97 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=6)	32.9 weeks Interval 21.79 to 45.73
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 5, Day 28 (< Median Cutpoint, n=2)	38.3 weeks Interval 30.77 to 45.87

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint) and Cycle 5, Day 28 (\< median cutpoint), median and/or CI were not able to be estimated.

PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=59 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=29)	16.1 weeks Interval 10.97 to 32.91
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	10.1 weeks Interval 8.97 to 15.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	12.4 weeks Interval 8.97 to 43.3
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	11.0 weeks Interval 9.97 to 16.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=19)	13.1 weeks Interval 10.11 to 22.51
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	16.1 weeks Interval 10.97 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=15)	10.8 weeks Interval 10.11 to 16.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	31.8 weeks Interval 16.1 to 45.73
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=10)	19.7 weeks Interval 10.11 to 45.87
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=10)	30.8 weeks Interval 15.81 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=6)	32.9 weeks Interval 30.77 to 45.73
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 5, Day 28 (> = Median Cutpoint, n=2)	37.0 weeks Interval 30.77 to 43.3

SECONDARY outcome

Timeframe: [Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 2, Day 28 (\> = median cutpoint), Cycle 3, Day 28 (\< median cutpoint), and Cycles 4 and 5, Day 28 (\< median cutpoint, \> = median cutpoint), median and/or CI were not able to be estimated.

PFS = time from start of study treatment to first documentation of objective disease progression or to death on study due to any cause, whichever was first. If tumor progression data included more than 1 date, the first date was used. PFS (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=53 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=26)	11.1 weeks Interval 9.12 to 22.51
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=27)	11.0 weeks Interval 9.97 to 21.79
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=17)	11.0 weeks Interval 9.26 to 21.79
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=17)	10.1 weeks Interval 6.84 to 16.1
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=14)	11.0 weeks Interval 10.11 to 45.87
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=15)	16.1 weeks Interval 10.11 to 33.9
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=11)	11.0 weeks Interval 10.11 to 16.81
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=8)	33.8 weeks Interval 9.97 to 45.87
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=8)	22.5 weeks Interval 10.11 to 43.3
Comparison of Kaplan-Meier PFS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=4)	43.3 weeks Interval 16.1 to 43.3

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from baseline in VEGFR3 at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=60 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=30)	15.8 weeks Interval 10.83 to 32.91
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	11.0 weeks Interval 9.26 to 21.79
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	15.8 weeks Interval 9.97 to 32.91
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	12.4 weeks Interval 9.97 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=20)	30.8 weeks Interval 15.81 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	11.1 weeks Interval 10.83 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=14)	16.8 weeks Interval 10.83 to 32.91
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	16.1 weeks Interval 10.97 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=10)	32.9 weeks Interval 30.77 to 45.87
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=11)	16.1 weeks Interval 9.97 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=6)	32.9 weeks Interval 21.79 to 45.73
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline and Changes From Baseline Cycle 5, Day 28 (< Median Cutpoint, n=2)	38.3 weeks Interval 30.77 to 45.87

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\< median cutpoint), and Cycle 5, Day 28 (\< median cutpoint, \> = median cutpoint), median and/or CI were not able to be estimated.

TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=59 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=29)	16.1 weeks Interval 10.97 to 32.91
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	10.3 weeks Interval 9.26 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	15.8 weeks Interval 9.12 to 43.3
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	11.0 weeks Interval 9.97 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=19)	13.1 weeks Interval 10.11 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	16.1 weeks Interval 10.97 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=15)	10.8 weeks Interval 10.11 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	31.8 weeks Interval 16.1 to 45.73
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=10)	16.8 weeks Interval 10.11 to 45.87
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=10)	30.8 weeks Interval 15.81 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=6)	32.9 weeks Interval 30.77 to 45.73
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 5, Day 28 (> = Median Cutpoint, n=2)	37.0 weeks Interval 30.77 to 43.3

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2

TTP = time from start of study treatment to first documentation of objective disease progression. If tumor progression data included more than 1 date, the first date was used. TTP (in weeks) was calculated as (first event date minus first sunitinib dose date +1) divided by 7.02. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=53 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=26)	11.1 weeks Interval 9.97 to 43.3
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=27)	12.4 weeks Interval 10.11 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=17)	11.0 weeks Interval 9.26 to 21.79
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=17)	10.1 weeks Interval 9.12 to 43.3
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=14)	11.0 weeks Interval 10.11 to 45.87
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=15)	16.1 weeks Interval 10.11 to 33.9
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=11)	11.0 weeks Interval 10.11 to 16.81
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=8)	33.8 weeks Interval 9.97 to 45.87
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint n=8)	33.9 weeks Interval 10.11 to 43.3
Comparison of Kaplan-Meier TTP Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=4)	43.3 weeks Interval 16.1 to 43.3

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (\< median cutpoint), median and/or CI were not able to be estimated.

OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1)divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGFR3 at Baseline and after stratification by \< or \> = median changes from Baseline in VEGFR3 at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=60 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=30)	8.7 months Interval 6.55 to 20.53
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	6.1 months Interval 4.51 to 9.67
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	14.7 months Interval 5.23 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	7.1 months Interval 4.41 to 11.15
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=20)	13.7 months Interval 6.12 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	8.8 months Interval 6.55 to 24.47
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=14)	11.2 months Interval 7.11 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	13.3 months Interval 8.82 to 26.09
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=11)	7.4 months Interval 5.07 to 13.26
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 3, Day 28 (< Median Cutpoint, n=6)	17.7 months Interval 13.65 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 5, Day 28 (< Median Cutpoint, n=2)	17.1 months Interval 13.65 to 20.53
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGFR3 at Baseline Changes From Baseline Cycle 5, Day 28 (> = Median Cutpoint, n=2)	13.8 months Interval 12.66 to 14.84

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 28 (\> = median cutpoint), median and/or CI were not able to be estimated.

OS = time from start of study treatment to death due to any cause. OS (in months) was calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring, their survival times were censored at the last date of known contact they were known to be alive. Subjects lacking data beyond the day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of VEGF-C at Baseline and after stratification by \< or \> = median changes from Baseline in VEGF-C at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=59 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=29)	8.5 months Interval 6.32 to 15.76
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=30)	5.2 months Interval 4.41 to 12.66
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=23)	8.5 months Interval 5.07 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=23)	8.8 months Interval 4.41 to 20.53
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=19)	9.7 months Interval 5.2 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=20)	12.7 months Interval 6.55 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=15)	8.0 months Interval 4.41 to 24.47
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=15)	14.8 months Interval 13.26 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (< Median Cutpoint, n=10)	10.2 months Interval 5.2 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=10)	15.8 months Interval 13.26 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 3, Day 28 (< Median Cutpoint, n=6)	14.2 months Interval 12.66 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 5, Day 28 (< Median Cutpoint, n=2)	14.2 months Interval 13.65 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of VEGF-C at Baseline and Changes From Baseline Cycle 5, Day 28 (> = Median Cutpoint, n=2)	16.6 months Interval 12.66 to 20.53

SECONDARY outcome

Timeframe: Baseline to Cycle 1 (Day 28), Cycle 2 (Days 1, 28), Cycle 3 (Days 1, 28), Cycle 4 (Day 28), Cycle 5 (Day 28) of Part 2

Population: MITT. n=number of subjects with soluble protein biomarkers at baseline and at the specified time point. At Cycle 3, Day 1 (\< median cutpoint), Cycle 4, Day 28 (\< median cutpoint, \> = median cutpoint)and Cycle 5, Day 28 (\< median cutpoint), median and/or CI were not able to be estimated.

OS=time from start of study treatment to death due to any cause. OS (in months) calculated as (date of death minus date of sunitinib first dose +1) divided by 30.4. For subjects not expiring their survival times were censored at last date of known contact they were known to be alive. Subjects lacking data beyond day of first dose of sunitinib had their survival time censored at Day 1 of sunitinib treatment. Groups are defined by \< or \> = median levels of soluble E-selectin at Baseline and after stratification by \< or \> = median changes from Baseline in soluble E-selectin at each time point.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=53 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 1 (< Median Cutpoint, n=26)	6.5 months Interval 4.24 to 12.66
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 1 (> = Median Cutpoint, n=27)	8.0 months Interval 4.51 to 13.65
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 28 (< Median Cutpoint, n=17)	8.7 months Interval 4.57 to 24.47
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 1, Day 28 (> = Median Cutpoint, n=17)	6.5 months Interval 3.95 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 1 (< Median Cutpoint, n=14)	11.2 months Interval 4.51 to 24.47
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 1 (> = Median Cutpoint, n=15)	8.5 months Interval 5.23 to 13.26
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 28 (< Median Cutpoint, n=11)	8.0 months Interval 4.41 to 24.47
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 2, Day 28 (> = Median Cutpoint, n=11)	14.8 months Interval 12.66 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 3, Day 1 (> = Median Cutpoint, n=8)	12.7 months Interval 5.07 to 14.84
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 3, Day 28 (> = Median Cutpoint, n=4)	15.3 months Interval 12.66 to 22.89
Comparison of Kaplan-Meier OS Curves After Stratification by < or > = Median Levels of Soluble E-Selectin at Baseline and Changes From Baseline Cycle 5, Day 28 (> = Median Cutpoint, n=2)	13.8 months Interval 12.66 to 14.84

SECONDARY outcome

Timeframe: Screening

Population: Samples were collected and stained from a subset of subjects. Due to the small sample size, no correlative analyses with clinical outcome were conducted.

Previously collected tumor paraffin block (or 12-20 10-micron slides prepared for the paraffin block) for correlative laboratory analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Within 7 days of Day 1

Population: c-Kit, Flt-3 and c-Fms to safety of Sunitinib samples were collected and analyzed. However, there was no statistics performed since power was insufficient.

A blood sample (6 mL) was collected and used to isolate DNA. These samples were not anonymized.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2

Population: ITT. Number of participants analyzed = number of subjects with EORTC response (defined as having at least 1 item response on the EORTC). n=number of subjects with EORTC scale score at baseline and each specified time point. Data in cycles with less than 9 subjects are not reported due to lack of statistical reliability.

EORTC QLQ-C30 scales: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much, global/QOL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms. Change: score at each visit in Part 2 minus baseline score in Part 1.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Financial Difficulties (n=54)	5.56 scores on a scale Standard Error 2.607
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Financial Difficulties (n=42)	2.38 scores on a scale Standard Error 2.381
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Financial Difficulties (n=34)	5.88 scores on a scale Standard Error 4.331
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Financial Difficulties (n=21)	6.35 scores on a scale Standard Error 5.453
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Financial Difficulties (n=14)	11.90 scores on a scale Standard Error 7.500
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Financial Difficulties (n=10)	13.33 scores on a scale Standard Error 10.184
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Financial Difficulties (n=10)	13.33 scores on a scale Standard Error 10.184
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Global Health Status /QoL (n=54)	-1.54 scores on a scale Standard Error 3.580
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Global Health Status /QoL (n=42)	-9.13 scores on a scale Standard Error 3.964
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Global Health Status /QoL (n=35)	-2.62 scores on a scale Standard Error 3.361
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Global Health Status /QoL (n=21)	-9.13 scores on a scale Standard Error 4.704
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Global Health Status /QoL (n=14)	0.60 scores on a scale Standard Error 7.175
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Global Health Status /QoL (n=10)	-2.50 scores on a scale Standard Error 8.056
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Global Health Status /QoL (n=10)	7.50 scores on a scale Standard Error 4.883
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Physical Functioning (n=54)	-6.79 scores on a scale Standard Error 2.806
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Physical Functioning (n=42)	-9.68 scores on a scale Standard Error 2.363
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Physical Functioning (n=35)	-7.43 scores on a scale Standard Error 2.941
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Physical Functioning (n=22)	-12.42 scores on a scale Standard Error 4.771
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Physical Functioning (n=15)	-5.78 scores on a scale Standard Error 3.178
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Physical Functioning (n=10)	-9.33 scores on a scale Standard Error 7.647
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Physical Functioning (n=10)	-2.00 scores on a scale Standard Error 5.072
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Role Functioning (n=54)	-16.05 scores on a scale Standard Error 4.641
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Role Functioning (n=42)	-20.63 scores on a scale Standard Error 5.383
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Role Functioning (n=35)	-13.81 scores on a scale Standard Error 4.950
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Role Functioning (n=22)	-28.03 scores on a scale Standard Error 8.234
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Role Functioning (n=15)	-16.67 scores on a scale Standard Error 7.968
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Role Functioning (n=10)	-15.00 scores on a scale Standard Error 13.017
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Role Functioning (n=10)	8.33 scores on a scale Standard Error 11.180
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Emotional Functioning (n=54)	-2.16 scores on a scale Standard Error 3.512
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Emotional Functioning (n=42)	3.57 scores on a scale Standard Error 3.139
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Emotional Functioning (n=35)	1.90 scores on a scale Standard Error 3.649
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Emotional Functioning (n=21)	1.98 scores on a scale Standard Error 4.668
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Emotional Functioning (n=14)	13.10 scores on a scale Standard Error 3.571
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Emotional Functioning (n=10)	12.50 scores on a scale Standard Error 4.348
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Emotional Functioning (n=10)	24.17 scores on a scale Standard Error 5.038
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Cognitive Functioning (n=54)	-8.95 scores on a scale Standard Error 3.138
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Cognitive Functioning (n=42)	-3.57 scores on a scale Standard Error 3.704
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Cognitive Functioning (n=35)	-10.00 scores on a scale Standard Error 3.817
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Cognitive Functioning (n=21)	-10.32 scores on a scale Standard Error 5.573
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Cognitive Functioning (n=14)	1.19 scores on a scale Standard Error 3.692
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Cognitive Functioning (n=10)	-1.67 scores on a scale Standard Error 4.615
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Cognitive Functioning (n=10)	5.00 scores on a scale Standard Error 5.000
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Social Functioning (n=53)	-11.64 scores on a scale Standard Error 4.250
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Social Functioning (n=41)	-10.98 scores on a scale Standard Error 5.417
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Social Functioning (n=34)	-9.31 scores on a scale Standard Error 5.228
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Social Functioning (n=20)	-25.00 scores on a scale Standard Error 7.204
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Social Functioning (n=14)	-7.14 scores on a scale Standard Error 5.980
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Social Functioning (n=10)	-8.33 scores on a scale Standard Error 11.453
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Social Functioning (n=10)	1.67 scores on a scale Standard Error 7.222
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Fatigue (n=54)	13.48 scores on a scale Standard Error 3.411
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Fatigue (n=42)	16.40 scores on a scale Standard Error 3.921
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Fatigue (n=35)	8.25 scores on a scale Standard Error 4.083
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Fatigue (n=22)	19.70 scores on a scale Standard Error 6.025
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Fatigue (n=15)	8.15 scores on a scale Standard Error 6.548
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Fatigue (n=10)	22.22 scores on a scale Standard Error 11.355
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Fatigue (n=10)	-1.11 scores on a scale Standard Error 7.490
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Nausea and Vomiting (n=54)	5.56 scores on a scale Standard Error 2.988
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Nausea and Vomiting (n=42)	11.90 scores on a scale Standard Error 3.822
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Nausea and Vomiting (n=35)	6.67 scores on a scale Standard Error 4.491
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Nausea and Vomiting (n=22)	6.82 scores on a scale Standard Error 4.608
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Nausea and Vomiting (n=15)	5.56 scores on a scale Standard Error 5.789
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Nausea and Vomiting (n=10)	11.67 scores on a scale Standard Error 7.049
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Nausea and Vomiting (n=10)	1.67 scores on a scale Standard Error 6.310
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Pain (n=54)	3.09 scores on a scale Standard Error 4.228
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Pain (n=42)	-0.79 scores on a scale Standard Error 3.766
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Pain (n=35)	5.24 scores on a scale Standard Error 4.572
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Pain (n=22)	0.76 scores on a scale Standard Error 5.748
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Pain (n=15)	5.56 scores on a scale Standard Error 6.640
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Pain (n=10)	-1.67 scores on a scale Standard Error 8.767
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Pain (n=10)	-3.33 scores on a scale Standard Error 7.778
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Dyspnea (n=54)	2.47 scores on a scale Standard Error 3.396
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Dyspnea (n=42)	1.59 scores on a scale Standard Error 3.760
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Dyspnea (n=35)	-4.76 scores on a scale Standard Error 4.352
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Dyspnea (n=22)	-13.64 scores on a scale Standard Error 6.454
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Dyspnea (n=15)	-8.89 scores on a scale Standard Error 3.940
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Dyspnea (n=10)	0.00 scores on a scale Standard Error 8.607
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Dyspnea (n=10)	-13.33 scores on a scale Standard Error 7.370
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Insomnia (n=54)	-3.09 scores on a scale Standard Error 5.006
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Insomnia (n=42)	-5.56 scores on a scale Standard Error 5.671
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Insomnia (n=35)	-2.86 scores on a scale Standard Error 5.529
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Insomnia (n=22)	6.06 scores on a scale Standard Error 8.672
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Insomnia (n=15)	-2.22 scores on a scale Standard Error 6.057
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Insomnia (n=10)	6.67 scores on a scale Standard Error 10.887
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Insomnia (n=10)	-20.00 scores on a scale Standard Error 7.370
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Appetite Loss (n=54)	11.11 scores on a scale Standard Error 5.138
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Appetite Loss (n=42)	20.63 scores on a scale Standard Error 5.898
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Appetite Loss (n=35)	13.33 scores on a scale Standard Error 7.633
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Appetite Loss (n=22)	10.61 scores on a scale Standard Error 7.068
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Appetite Loss (n=15)	2.22 scores on a scale Standard Error 7.606
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Appetite Loss (n=10)	13.3 scores on a scale Standard Error 12.373
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Appetite Loss (n=10)	-6.67 scores on a scale Standard Error 10.887
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Constipation (n=54)	5.56 scores on a scale Standard Error 4.109
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Constipation (n=42)	-0.79 scores on a scale Standard Error 5.266
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Constipation (n=35)	13.33 scores on a scale Standard Error 4.965
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Constipation (n=22)	-4.55 scores on a scale Standard Error 6.317
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Constipation (n=15)	-4.44 scores on a scale Standard Error 6.397
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Constipation (n=10)	-6.67 scores on a scale Standard Error 6.667
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Constipation (n=10)	-10.00 scores on a scale Standard Error 5.092
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 1 Diarrhea (n=54)	-3.09 scores on a scale Standard Error 2.206
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 1, Day 28 Diarrhea (n=41)	13.01 scores on a scale Standard Error 5.058
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 1 Diarrhea (n=35)	11.43 scores on a scale Standard Error 4.916
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 2, Day 28 Diarrhea (n=21)	7.94 scores on a scale Standard Error 5.589
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1 Diarrhea (n=14)	16.67 scores on a scale Standard Error 6.767
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 28 Diarrhea (n=10)	26.67 scores on a scale Standard Error 9.686
Change From Baseline in Health Related Quality of Life (HRQOL) and Lung Cancer Related Symptoms as Assessed With the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 4, Day 1 Diarrhea (n=10)	0.00 scores on a scale Standard Error 9.938

SECONDARY outcome

Timeframe: Baseline (Part 1) to Cycle1 (Days 1 [baseline], 28), Cycles 2 and 3 (Days 1, 28), and Cycle 4 (Day 1) in Part 2

QLQ-LC13 assessed lung cancer symptoms (dyspnea, coughing, dysphasia, hemoptysis, sore mouth, peripheral neuropathy, alopecia, chest pain, arm pain, shoulder pain, and pain in other parts). 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. Change: score at each visit in Part 2 minus baseline score in Part 1.

Outcome measures

Outcome measures
Measure	First Carboplatin Plus Paclitaxel, Then Sunitinib n=84 Participants Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Dyspnea (n=49)	3.40 scores on a scale Standard Error 3.008
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Dyspnea (n=37)	4.80 scores on a scale Standard Error 3.030
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Dyspnea (n=31)	4.30 scores on a scale Standard Error 4.112
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Dyspnea (n=21)	1.59 scores on a scale Standard Error 4.490
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Dyspnea (n=14)	-1.59 scores on a scale Standard Error 3.466
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Dyspnea (n=9)	4.94 scores on a scale Standard Error 6.705
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Dyspnea (n=9)	0.00 scores on a scale Standard Error 3.208
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Coughing (n=53)	-14.47 scores on a scale Standard Error 5.120
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Coughing (n=40)	-14.17 scores on a scale Standard Error 5.048
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Coughing (n=34)	-12.75 scores on a scale Standard Error 5.077
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Coughing (n=21)	-15.87 scores on a scale Standard Error 7.496
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Coughing (n=14)	-9.52 scores on a scale Standard Error 5.445
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Coughing (n=10)	-13.33 scores on a scale Standard Error 7.370
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Coughing (n=9)	-11.11 scores on a scale Standard Error 7.857
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Hemoptysis (n=53)	0.63 scores on a scale Standard Error 1.678
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Hemoptysis (n=39)	5.13 scores on a scale Standard Error 3.362
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Hemoptysis (n=33)	2.02 scores on a scale Standard Error 1.406
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Hemoptysis (n=21)	-1.59 scores on a scale Standard Error 2.795
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Hemoptysis (n=14)	-2.38 scores on a scale Standard Error 2.381
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Hemoptysis (n=10)	0.00 scores on a scale Standard Error 0.000
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Hemoptysis (n=9)	-3.70 scores on a scale Standard Error 3.704
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Sore Mouth (n=53)	-5.66 scores on a scale Standard Error 3.782
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Sore Mouth (n=40)	20.00 scores on a scale Standard Error 7.141
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Sore Mouth (n=34)	9.80 scores on a scale Standard Error 7.111
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Sore Mouth (n=21)	12.70 scores on a scale Standard Error 6.289
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Sore Mouth (n=14)	0.00 scores on a scale Standard Error 3.494
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Sore Mouth (n=10)	10.00 scores on a scale Standard Error 13.194
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Sore Mouth (n=9)	-11.11 scores on a scale Standard Error 7.857
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Dysphasia (n=53)	-0.63 scores on a scale Standard Error 3.298
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Dysphasia (n=40)	7.50 scores on a scale Standard Error 4.697
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Dysphasia (n=34)	2.94 scores on a scale Standard Error 5.145
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Dysphasia (n=21)	-1.59 scores on a scale Standard Error 2.795
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Dysphasia (n=14)	-4.76 scores on a scale Standard Error 4.762
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Dysphasia (n=10)	-10.00 scores on a scale Standard Error 5.092
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Dysphasia (n=9)	-11.11 scores on a scale Standard Error 5.556
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Peripheral Neuropathy (n=53)	42.14 scores on a scale Standard Error 5.012
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Peripheral Neuropathy (n=40)	32.50 scores on a scale Standard Error 5.402
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Peripheral Neuropathy (n=34)	28.43 scores on a scale Standard Error 5.825
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Peripheral Neuropathy (n=21)	26.98 scores on a scale Standard Error 7.841
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Peripheral Neuropathy (n=14)	23.81 scores on a scale Standard Error 10.145
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Peripheral Neuropathy (n=10)	20.00 scores on a scale Standard Error 10.184
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Peripheral Neuropathy (n=9)	7.41 scores on a scale Standard Error 7.407
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Alopecia (n=53)	63.52 scores on a scale Standard Error 5.407
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Alopecia (n=40)	40.83 scores on a scale Standard Error 7.009
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Alopecia (n=34)	30.39 scores on a scale Standard Error 7.627
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Alopecia (n=20)	11.67 scores on a scale Standard Error 7.752
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Alopecia (n=14)	0.00 scores on a scale Standard Error 0.000
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Alopecia (n=10)	0.00 scores on a scale Standard Error 0.000
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Alopecia (n=9)	0.00 scores on a scale Standard Error 0.000
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Pain in Chest (n=53)	-8.18 scores on a scale Standard Error 3.581
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Pain in Chest (n=40)	-4.17 scores on a scale Standard Error 3.415
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Pain in Chest (n=34)	-0.98 scores on a scale Standard Error 3.850
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Pain in Chest (n=21)	0.00 scores on a scale Standard Error 3.984
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Pain in Chest (n=14)	4.76 scores on a scale Standard Error 5.906
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Pain in Chest (n=10)	0.00 scores on a scale Standard Error 7.027
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Pain in Chest (n=9)	7.41 scores on a scale Standard Error 9.259
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Pain in Arm or Shoulder (n=51)	-1.31 scores on a scale Standard Error 4.171
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Pain in Arm or Shoulder (n=39)	0.85 scores on a scale Standard Error 4.497
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Pain in Arm or Shoulder (n=34)	3.92 scores on a scale Standard Error 6.257
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Pain in Arm or Shoulder (n=21)	3.17 scores on a scale Standard Error 4.545
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Pain in Arm or Shoulder (n=14)	2.38 scores on a scale Standard Error 4.228
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Pain in Arm or Shoulder (n=10)	-6.67 scores on a scale Standard Error 11.967
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Pain in Arm or Shoulder (n=9)	-11.11 scores on a scale Standard Error 11.111
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 1 Pain in Other Parts (n=47)	3.55 scores on a scale Standard Error 6.431
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 1, Day 28 Pain in Other Parts (n=35)	-6.67 scores on a scale Standard Error 5.925
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 1 Pain in Other Parts (n=27)	12.35 scores on a scale Standard Error 7.368
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 2, Day 28 Pain in Other Parts (n=17)	13.73 scores on a scale Standard Error 8.603
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 1 Pain in Other Parts (n=14)	11.90 scores on a scale Standard Error 8.274
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 3, Day 28 Pain in Other Parts (n=9)	-11.11 scores on a scale Standard Error 9.623
Change From Baseline in HRQOL and Lung Cancer Related Symptoms as Assessed With the EORTC QLQ Lung Cancer Module (QLQ-LC13) Cycle 4, Day 1 Pain in Other Parts (n=9)	0.00 scores on a scale Standard Error 9.623

Adverse Events

Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)

Serious events: 29 serious events

Other events: 82 other events

Deaths: 0 deaths

Sunitinib 50 mg (Part 2)

Serious events: 29 serious events

Other events: 60 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \< 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \< 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Measure	Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1) n=84 participants at risk	Sunitinib 50 mg (Part 2) n=66 participants at risk
Blood and lymphatic system disorders Anaemia	33.3% 28/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	18.2% 12/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Blood and lymphatic system disorders Neutropenia	23.8% 20/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Blood and lymphatic system disorders Thrombocytopenia	10.7% 9/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	19.7% 13/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Constipation	27.4% 23/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Diarrhoea	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	36.4% 24/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Nausea	42.9% 36/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	31.8% 21/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Vomiting	25.0% 21/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	18.2% 12/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Asthenia	16.7% 14/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	25.8% 17/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Chest pain	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Chills	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	10.6% 7/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Fatigue	32.1% 27/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	31.8% 21/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Mucosal inflammation	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	12.1% 8/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Oedema peripheral	14.3% 12/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	10.6% 7/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Pain	6.0% 5/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	3.0% 2/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
General disorders Pyrexia	20.2% 17/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Investigations Weight decreased	11.9% 10/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Metabolism and nutrition disorders Anorexia	11.9% 10/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	24.2% 16/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Musculoskeletal and connective tissue disorders Arthralgia	27.4% 23/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Musculoskeletal and connective tissue disorders Back pain	10.7% 9/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	7.6% 5/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Musculoskeletal and connective tissue disorders Myalgia	26.2% 22/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	3.0% 2/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 12/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Dysgeusia	6.0% 5/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	15.2% 10/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Hypoaesthesia	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	3.0% 2/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Neuropathy peripheral	28.6% 24/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Paraesthesia	9.5% 8/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	3.0% 2/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Peripheral sensory neuropathy	6.0% 5/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	0.00% 0/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Psychiatric disorders Anxiety	10.7% 9/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	0.00% 0/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Psychiatric disorders Insomnia	13.1% 11/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	0.00% 0/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Respiratory, thoracic and mediastinal disorders Cough	13.1% 11/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Respiratory, thoracic and mediastinal disorders Dyspnoea	19.0% 16/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	18.2% 12/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 6/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Respiratory, thoracic and mediastinal disorders Hiccups	6.0% 5/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	0.00% 0/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Alopecia	47.6% 40/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	0.00% 0/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Rash	9.5% 8/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Blood and lymphatic system disorders Leukopenia	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Abdominal pain	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	10.6% 7/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Dyspepsia	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Infections and infestations Upper respiratory tract infection	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	9.1% 6/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	7.6% 5/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Dizziness	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Nervous system disorders Headache	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	10.6% 7/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	10.6% 7/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	6.1% 4/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.
Vascular disorders Hypertension	0.00% 0/84 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.	13.6% 9/66 Part 1 = adverse events (AEs) reported occurred during chemotherapy treatment. Part 2 = AEs reported occurred on or after the first dose of sunitinib.