Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT00324805

Recruitment Status : Active, not recruiting

First Posted : May 11, 2006

Results First Posted : February 14, 2018

Last Update Posted : April 17, 2024

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Sponsor:

Collaborators:

Cancer and Leukemia Group B

NCIC Clinical Trials Group

North Central Cancer Treatment Group

SWOG Cancer Research Network

Information provided by (Responsible Party):

National Cancer Institute (NCI)

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7
Interventions	Biological: Bevacizumab Drug: Cisplatin Drug: Docetaxel Drug: Gemcitabine Hydrochloride Other: Laboratory Biomarker Analysis Drug: Pemetrexed Disodium Other: Questionnaire Administration Drug: Vinorelbine Tartrate
Enrollment	1501

Participant Flow

Recruitment Details	Patients were recruited between June 1, 2007 and September 20, 2013 from ECOG-ACRIN, SWOG, RTOG, CALGB, NCCTG, NCIC-CTG, NSABP, ACOSOG, and CTSU sites.
Pre-assignment Details


Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 intravenously (IV) on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
Period Title: Overall Study
Started	749	752
Started Assigned Therapy	737	735
Completed	599	269
Not Completed	150	483
Reason Not Completed
Adverse Event	62	203
Progression	7	35
Withdrawal by Subject	51	174
Death	6	9
Alternative therapy	4	8
Other complicating disease	1	9
Other reasons	7	26
Other	0	2
Did not start therapy	12	17

Baseline Characteristics

Arm/Group Title		Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)	Total
Arm/Group Description		Patients receive one of the followi...	Patients receive chemotherapy as in...	Total of all reporting groups
Arm/Group Description		Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Total of all reporting groups
Overall Number of Baseline Participants		749	752	1501
Baseline Analysis Population Description		...
Baseline Analysis Population Description		All randomized patients
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	749 participants	752 participants	1501 participants
		60.7 (9.0)	60.8 (8.7)	60.8 (8.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	Female	374 49.9%	381 50.7%	755 50.3%
	Male	375 50.1%	371 49.3%	746 49.7%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	Hispanic or Latino	19 2.5%	29 3.9%	48 3.2%
	Not Hispanic or Latino	680 90.8%	688 91.5%	1368 91.1%
	Unknown or Not Reported	50 6.7%	35 4.7%	85 5.7%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	American Indian or Alaska Native	1 0.1%	5 0.7%	6 0.4%
	Asian	22 2.9%	16 2.1%	38 2.5%
	Native Hawaiian or Other Pacific Islander	3 0.4%	2 0.3%	5 0.3%
	Black or African American	74 9.9%	57 7.6%	131 8.7%
	White	642 85.7%	660 87.8%	1302 86.7%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	7 0.9%	12 1.6%	19 1.3%
Chemotherapy Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	Cisplatin/Vinorelbine	187 25.0%	190 25.3%	377 25.1%
	Cisplatin/Docetaxel	172 23.0%	171 22.7%	343 22.9%
	Cisplatin/Gemcitabine	142 19.0%	141 18.8%	283 18.9%
	Cisplatin/Pemetrexed	248 33.1%	249 33.1%	497 33.1%
	Unknown/Missing	0 0.0%	1 0.1%	1 0.1%
Histology Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	Squamous	216 28.8%	206 27.4%	422 28.1%
	Adenocarcinoma	424 56.6%	450 59.8%	874 58.2%
	Large cell	22 2.9%	16 2.1%	38 2.5%
	Bronchioloalveolar carcinoma (BAC)	8 1.1%	5 0.7%	13 0.9%
	Not otherwise specified (NOS)	24 3.2%	16 2.1%	40 2.7%
	Combined/mixed	45 6.0%	48 6.4%	93 6.2%
	Other	10 1.3%	10 1.3%	20 1.3%
	Unknown/missing	0 0.0%	1 0.1%	1 0.1%
Performance Status Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	749 participants	752 participants	1501 participants
	Fully active	439 58.6%	440 58.5%	879 58.6%
	Ambulatory	310 41.4%	310 41.2%	620 41.3%
	Unknown/missing	0 0.0%	2 0.3%	2 0.1%
Urine protein:creatinine (UPC) ratio Mean (Standard Deviation) Unit of measure: Ratio
	Number Analyzed	749 participants	752 participants	1501 participants
		0.31 (3.10)	0.18 (0.92)	0.25 (2.28)
Urine protein Mean (Standard Deviation) Unit of measure: mg/dL
	Number Analyzed	749 participants	752 participants	1501 participants
		95.26 (32.28)	100.25 (32.28)	97.79 (41.86)

Outcome Measures

1.Primary Outcome


Title	Overall Survival
Description	Overall survival (OS) was defined as the time from randomization to de...
Description	Overall survival (OS) was defined as the time from randomization to death from any cause, and patients who were thought to be alive at the time of final analysis were censored at the last date of contact. The study failed to meet its primary endpoint.
Time Frame	From registration to death, up to 10 years

Outcome Measure Data

Analysis Population Description

All enrolled patients


Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description:	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description:	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
Overall Number of Participants Analyzed	749	752
Median (95% Confidence Interval) Unit of Measure: months
	NA ^[1] (NA to NA)	85.8 ^[2] (74.9 to NA)

[1]

The median overall survival and corresponding 95% confidence interval were not calculable because an insufficient number of participants reached the event at the final time point for assessment, i.e. a median has not been reached

[2]

The upper limit of the 95% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Chemotherapy), Arm II (Chemotherapy, Bevacizumab)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.90
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% 0.82 to 1.19
	Estimation Comments	Arm II versus Arm I

2.Secondary Outcome


Title	Disease-free Survival
Description	Disease-free survival (DFS) was defined as the time from randomization...
Description	Disease-free survival (DFS) was defined as the time from randomization to an event. Events include disease recurrence, new primary of lung cancer, second primaries or death, whichever occurred first; however, it should be noted that patients with new primaries at other non-lung sites should have continued followup for recurrence of the original cancer. Patients that have not had an event reported at analysis were censored at their last date of disease assessment.
Time Frame	From registration to death, up to 10 years

Outcome Measure Data

Analysis Population Description

All enrolled patients


Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description:	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description:	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
Overall Number of Participants Analyzed	749	752
Median (95% Confidence Interval) Unit of Measure: months
	42.9 (36.7 to 57.0)	40.6 (35.5 to 49.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm I (Chemotherapy), Arm II (Chemotherapy, Bevacizumab)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.95
	Comments	[Not Specified]
	Method	Regression, Cox
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95% 0.86 to 1.15
	Estimation Comments	Arm II vs. Arm I

3.Other Pre-specified Outcome


Title	Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Description	If the difference in the rate of a particular category of toxicities b...
Description	If the difference in the rate of a particular category of toxicities between the 2 arms (N=750 per arm) is at least 5% (4% vs. 9%), 96% power can be attained assuming a significance level of 5% (two-sided Chi Square test) and that the lower toxicity rate for one arm is 4%. A difference in the rates of grade 3-5 arterial thromboembolic events and bleeding events will be monitored and assessed between the treatment arms.
Time Frame	Up to 1 year post-treatment

Outcome Measure Data Not Reported

4.Other Pre-specified Outcome


Title	Perform Analyses of Tissue and Blood to Establish Factors That Predict for Clinical Outcome in Patients Receiving Chemotherapy, With or Without Bevacizumab, for Resected Early Stage NSCLC.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From registration to death, up to 10 years

Outcome Measure Data

Analysis Population Description

Data for these studies were not collected


Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description:	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description:	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

5.Other Pre-specified Outcome


Title	To Determine Whether Smoking Status is Linked to Outcome for Patients With Resected Stage IB - IIIA NSCLC Treated With Chemotherapy With or Without Bevacizumab in the Adjuvant Setting.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	From registration to death, up to 10 years

Outcome Measure Data

Analysis Population Description

Data were not collected


Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description:	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description:	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

Adverse Events

Time Frame	Assessed every 3 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description	One patient who did not start treatment submitted an adverse event report

Arm/Group Title	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
Arm/Group Description	Patients receive one of the followi...	Patients receive chemotherapy as in...
Arm/Group Description	Patients receive one of the following. For all, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. REGIMEN 1: Vinorelbine ditartrate 30 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV over 60 minutes on day 1 REGIMEN 2: Docetaxel 75 mg/m2 IV and cisplastin 75 mg/m2 IV on day 1 REGIMEN 3: Gemcitabine hydrochloride 1200 mg/m2 IV on days 1 and 8, cisplatin 75 mg/m2 IV on day 1 REGIMEN 4 (non-squamous histology only): Pemetrexed disodium 500mg/m2 IV and cisplatin 75 mg/m2 IV on day 1 Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV	Patients receive chemotherapy as in Arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab repeats every 21 days for up to 1 year. Bevacizumab: Given IV Cisplatin: Given IV Docetaxel: Given IV Gemcitabine Hydrochloride: Given IV Pemetrexed Disodium: Given IV Vinorelbine: Given IV
All-Cause Mortality
	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events Serious Adverse Events
	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	424/738 (57.45%)	563/735 (76.60%)
Blood and lymphatic system disorders
Anemia ^† 1	52/738 (7.05%)	40/735 (5.44%)
Febrile neutropenia ^† 1	31/738 (4.20%)	43/735 (5.85%)
Cardiac disorders
Acute coronary syndrome ^† 1	0/738 (0.00%)	1/735 (0.14%)
Atrial fibrillation ^† 1	2/738 (0.27%)	2/735 (0.27%)
Atrial flutter ^† 1	0/738 (0.00%)	1/735 (0.14%)
Cardiac arrest ^† 1	0/738 (0.00%)	1/735 (0.14%)
Chest pain - cardiac ^† 1	0/738 (0.00%)	1/735 (0.14%)
Heart failure ^† 1	0/738 (0.00%)	3/735 (0.41%)
Left ventricular systolic dysfunction ^† 1	1/738 (0.14%)	1/735 (0.14%)
Myocardial infarction ^† 1	1/738 (0.14%)	7/735 (0.95%)
Sinus tachycardia ^† 1	0/738 (0.00%)	2/735 (0.27%)
Cardiac disorders - Other, specify ^† 1	1/738 (0.14%)	0/735 (0.00%)
Ear and labyrinth disorders
Hearing impaired ^† 1	6/738 (0.81%)	2/735 (0.27%)
Tinnitus ^† 1	4/738 (0.54%)	4/735 (0.54%)
Eye disorders
Blurred vision ^† 1	1/738 (0.14%)	1/735 (0.14%)
Photophobia ^† 1	0/738 (0.00%)	1/735 (0.14%)
Retinal detachment ^† 1	0/738 (0.00%)	1/735 (0.14%)
Gastrointestinal disorders
Abdominal distension ^† 1	0/738 (0.00%)	2/735 (0.27%)
Abdominal pain ^† 1	5/738 (0.68%)	22/735 (2.99%)
Cheilitis ^† 1	1/738 (0.14%)	0/735 (0.00%)
Colitis ^† 1	5/738 (0.68%)	2/735 (0.27%)
Colonic hemorrhage ^† 1	0/738 (0.00%)	2/735 (0.27%)
Colonic obstruction ^† 1	0/738 (0.00%)	1/735 (0.14%)
Colonic perforation ^† 1	1/738 (0.14%)	1/735 (0.14%)
Constipation ^† 1	8/738 (1.08%)	5/735 (0.68%)
Diarrhea ^† 1	15/738 (2.03%)	31/735 (4.22%)
Duodenal perforation ^† 1	0/738 (0.00%)	1/735 (0.14%)
Dyspepsia ^† 1	1/738 (0.14%)	1/735 (0.14%)
Dysphagia ^† 1	1/738 (0.14%)	2/735 (0.27%)
Enterocolitis ^† 1	1/738 (0.14%)	1/735 (0.14%)
Esophageal pain ^† 1	1/738 (0.14%)	0/735 (0.00%)
Gastric hemorrhage ^† 1	0/738 (0.00%)	1/735 (0.14%)
Gastritis ^† 1	1/738 (0.14%)	2/735 (0.27%)
Gastroesophageal reflux disease ^† 1	1/738 (0.14%)	0/735 (0.00%)
Gastrointestinal pain ^† 1	1/738 (0.14%)	0/735 (0.00%)
Ileus ^† 1	3/738 (0.41%)	3/735 (0.41%)
Mucositis oral ^† 1	4/738 (0.54%)	12/735 (1.63%)
Nausea ^† 1	63/738 (8.54%)	74/735 (10.07%)
Pancreatitis ^† 1	1/738 (0.14%)	0/735 (0.00%)
Rectal hemorrhage ^† 1	0/738 (0.00%)	2/735 (0.27%)
Small intestinal obstruction ^† 1	1/738 (0.14%)	1/735 (0.14%)
Stomach pain ^† 1	1/738 (0.14%)	1/735 (0.14%)
Toothache ^† 1	0/738 (0.00%)	1/735 (0.14%)
Vomiting ^† 1	38/738 (5.15%)	47/735 (6.39%)
Gastrointestinal disorders - Other ^† 1	1/738 (0.14%)	2/735 (0.27%)
General disorders
Fatigue ^† 1	66/738 (8.94%)	92/735 (12.52%)
Fever ^† 1	0/738 (0.00%)	2/735 (0.27%)
Infusion site extravasation ^† 1	0/738 (0.00%)	1/735 (0.14%)
Multi-organ failure ^† 1	0/738 (0.00%)	1/735 (0.14%)
Non-cardiac chest pain ^† 1	3/738 (0.41%)	6/735 (0.82%)
Pain ^† 1	2/738 (0.27%)	1/735 (0.14%)
Sudden death NOS ^† 1	0/738 (0.00%)	1/735 (0.14%)
Hepatobiliary disorders
Cholecystitis ^† 1	0/738 (0.00%)	1/735 (0.14%)
Immune system disorders
Allergic reaction ^† 1	0/738 (0.00%)	1/735 (0.14%)
Anaphylaxis ^† 1	7/738 (0.95%)	6/735 (0.82%)
Autoimmune disorder ^† 1	1/738 (0.14%)	0/735 (0.00%)
Cytokine release syndrome ^† 1	0/738 (0.00%)	1/735 (0.14%)
Serum sickness ^† 1	0/738 (0.00%)	1/735 (0.14%)
Infections and infestations
Anorectal infection ^† 1	1/738 (0.14%)	0/735 (0.00%)
Bladder infection ^† 1	0/738 (0.00%)	1/735 (0.14%)
Bronchial infection ^† 1	3/738 (0.41%)	1/735 (0.14%)
Catheter related infection ^† 1	0/738 (0.00%)	3/735 (0.41%)
Device related infection ^† 1	1/738 (0.14%)	0/735 (0.00%)
Enterocolitis infectious ^† 1	2/738 (0.27%)	2/735 (0.27%)
Esophageal infection ^† 1	0/738 (0.00%)	1/735 (0.14%)
Gum infection ^† 1	2/738 (0.27%)	0/735 (0.00%)
Lung infection ^† 1	8/738 (1.08%)	11/735 (1.50%)
Pleural infection ^† 1	0/738 (0.00%)	2/735 (0.27%)
Sepsis ^† 1	4/738 (0.54%)	5/735 (0.68%)
Skin infection ^† 1	2/738 (0.27%)	1/735 (0.14%)
Tooth infection ^† 1	0/738 (0.00%)	1/735 (0.14%)
Upper respiratory infection ^† 1	1/738 (0.14%)	4/735 (0.54%)
Urinary tract infection ^† 1	4/738 (0.54%)	5/735 (0.68%)
Infections and infestations - Other ^† 1	10/738 (1.36%)	18/735 (2.45%)
Injury, poisoning and procedural complications
Vascular access complication ^† 1	2/738 (0.27%)	3/735 (0.41%)
Wound dehiscence ^† 1	0/738 (0.00%)	4/735 (0.54%)
Investigations
Alanine aminotransferase increased ^† 1	2/738 (0.27%)	0/735 (0.00%)
Alkaline phosphatase increased ^† 1	1/738 (0.14%)	0/735 (0.00%)
Aspartate aminotransferase increased ^† 1	2/738 (0.27%)	0/735 (0.00%)
Cardiac troponin I increased ^† 1	1/738 (0.14%)	0/735 (0.00%)
Creatinine increased ^† 1	6/738 (0.81%)	9/735 (1.22%)
INR increased ^† 1	0/738 (0.00%)	1/735 (0.14%)
Lipase increased ^† 1	1/738 (0.14%)	1/735 (0.14%)
Lymphocyte count decreased ^† 1	7/738 (0.95%)	11/735 (1.50%)
Neutrophil count decreased ^† 1	237/738 (32.11%)	273/735 (37.14%)
Platelet count decreased ^† 1	30/738 (4.07%)	44/735 (5.99%)
Weight loss ^† 1	1/738 (0.14%)	1/735 (0.14%)
White blood cell decreased ^† 1	41/738 (5.56%)	42/735 (5.71%)
Investigations - Other, specify ^† 1	1/738 (0.14%)	1/735 (0.14%)
Metabolism and nutrition disorders
Acidosis ^† 1	0/738 (0.00%)	2/735 (0.27%)
Anorexia ^† 1	9/738 (1.22%)	19/735 (2.59%)
Dehydration ^† 1	40/738 (5.42%)	45/735 (6.12%)
Hypercalcemia ^† 1	1/738 (0.14%)	0/735 (0.00%)
Hyperglycemia ^† 1	11/738 (1.49%)	9/735 (1.22%)
Hyperkalemia ^† 1	4/738 (0.54%)	1/735 (0.14%)
Hypoalbuminemia ^† 1	1/738 (0.14%)	3/735 (0.41%)
Hypocalcemia ^† 1	3/738 (0.41%)	6/735 (0.82%)
Hypoglycemia ^† 1	0/738 (0.00%)	1/735 (0.14%)
Hypokalemia ^† 1	20/738 (2.71%)	13/735 (1.77%)
Hypomagnesemia ^† 1	5/738 (0.68%)	4/735 (0.54%)
Hyponatremia ^† 1	44/738 (5.96%)	66/735 (8.98%)
Hypophosphatemia ^† 1	0/738 (0.00%)	4/735 (0.54%)
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	3/738 (0.41%)	5/735 (0.68%)
Back pain ^† 1	0/738 (0.00%)	1/735 (0.14%)
Bone pain ^† 1	0/738 (0.00%)	1/735 (0.14%)
Chest wall pain ^† 1	0/738 (0.00%)	1/735 (0.14%)
Generalized muscle weakness ^† 1	6/738 (0.81%)	7/735 (0.95%)
Muscle weakness lower limb ^† 1	0/738 (0.00%)	1/735 (0.14%)
Myalgia ^† 1	4/738 (0.54%)	2/735 (0.27%)
Neck pain ^† 1	0/738 (0.00%)	1/735 (0.14%)
Pain in extremity ^† 1	1/738 (0.14%)	1/735 (0.14%)
Nervous system disorders
Ataxia ^† 1	1/738 (0.14%)	3/735 (0.41%)
Cognitive disturbance ^† 1	1/738 (0.14%)	1/735 (0.14%)
Dizziness ^† 1	4/738 (0.54%)	12/735 (1.63%)
Dysphasia ^† 1	1/738 (0.14%)	1/735 (0.14%)
Headache ^† 1	5/738 (0.68%)	18/735 (2.45%)
Intracranial hemorrhage ^† 1	1/738 (0.14%)	1/735 (0.14%)
Ischemia cerebrovascular ^† 1	0/738 (0.00%)	1/735 (0.14%)
Memory impairment ^† 1	0/738 (0.00%)	1/735 (0.14%)
Neuralgia ^† 1	0/738 (0.00%)	1/735 (0.14%)
Peripheral motor neuropathy ^† 1	2/738 (0.27%)	1/735 (0.14%)
Peripheral sensory neuropathy ^† 1	5/738 (0.68%)	5/735 (0.68%)
Reversible posterior leukoencephalopathy ^† 1	0/738 (0.00%)	3/735 (0.41%)
Seizure ^† 1	1/738 (0.14%)	3/735 (0.41%)
Stroke ^† 1	1/738 (0.14%)	0/735 (0.00%)
Syncope ^† 1	8/738 (1.08%)	10/735 (1.36%)
Nervous system disorders - Other ^† 1	0/738 (0.00%)	5/735 (0.68%)
Psychiatric disorders
Anxiety ^† 1	1/738 (0.14%)	0/735 (0.00%)
Confusion ^† 1	1/738 (0.14%)	4/735 (0.54%)
Depression ^† 1	3/738 (0.41%)	0/735 (0.00%)
Insomnia ^† 1	0/738 (0.00%)	2/735 (0.27%)
Renal and urinary disorders
Acute kidney injury ^† 1	6/738 (0.81%)	6/735 (0.82%)
Chronic kidney disease ^† 1	1/738 (0.14%)	3/735 (0.41%)
Hematuria ^† 1	0/738 (0.00%)	1/735 (0.14%)
Proteinuria ^† 1	2/738 (0.27%)	17/735 (2.31%)
Urinary retention ^† 1	1/738 (0.14%)	0/735 (0.00%)
Reproductive system and breast disorders
Testicular pain ^† 1	1/738 (0.14%)	0/735 (0.00%)
Respiratory, thoracic and mediastinal disorders
Aspiration ^† 1	2/738 (0.27%)	1/735 (0.14%)
Bronchopleural fistula ^† 1	0/738 (0.00%)	2/735 (0.27%)
Bronchopulmonary hemorrhage ^† 1	0/738 (0.00%)	3/735 (0.41%)
Cough ^† 1	2/738 (0.27%)	6/735 (0.82%)
Dyspnea ^† 1	8/738 (1.08%)	17/735 (2.31%)
Epistaxis ^† 1	2/738 (0.27%)	4/735 (0.54%)
Hoarseness ^† 1	0/738 (0.00%)	1/735 (0.14%)
Hypoxia ^† 1	0/738 (0.00%)	5/735 (0.68%)
Laryngeal edema ^† 1	0/738 (0.00%)	1/735 (0.14%)
Pleural effusion ^† 1	1/738 (0.14%)	2/735 (0.27%)
Pneumonitis ^† 1	3/738 (0.41%)	1/735 (0.14%)
Pulmonary hypertension ^† 1	1/738 (0.14%)	1/735 (0.14%)
Respiratory failure ^† 1	0/738 (0.00%)	1/735 (0.14%)
Respiratory thoracic mediastinal - Other ^† 1	1/738 (0.14%)	1/735 (0.14%)
Skin and subcutaneous tissue disorders
Rash maculo-papular ^† 1	1/738 (0.14%)	3/735 (0.41%)
Stevens-Johnson syndrome ^† 1	0/738 (0.00%)	1/735 (0.14%)
Vascular disorders
Hematoma ^† 1	0/738 (0.00%)	1/735 (0.14%)
Hypertension ^† 1	19/738 (2.57%)	200/735 (27.21%)
Hypotension ^† 1	7/738 (0.95%)	11/735 (1.50%)
Peripheral ischemia ^† 1	0/738 (0.00%)	1/735 (0.14%)
Thromboembolic event ^† 1	12/738 (1.63%)	33/735 (4.49%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 4.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm I (Chemotherapy)	Arm II (Chemotherapy, Bevacizumab)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	474/738 (64.23%)	509/735 (69.25%)
Blood and lymphatic system disorders
Anemia ^† 1	256/738 (34.69%)	183/735 (24.90%)
General disorders
Fatigue ^† 1	62/738 (8.40%)	68/735 (9.25%)
Investigations
Creatinine increased ^† 1	169/738 (22.90%)	247/735 (33.61%)
Neutrophil count decreased ^† 1	220/738 (29.81%)	236/735 (32.11%)
Platelet count decreased ^† 1	48/738 (6.50%)	49/735 (6.67%)
Nervous system disorders
Peripheral sensory neuropathy ^† 1	53/738 (7.18%)	58/735 (7.89%)
Renal and urinary disorders
Proteinuria ^† 1	3/738 (0.41%)	48/735 (6.53%)
Vascular disorders
Hypertension ^† 1	2/738 (0.27%)	50/735 (6.80%)
† Indicates events were collected by systematic assessment 1 Term from vocabulary, CTCAE 4.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Study Statistician
Organization:	ECOG-ACRIN Statistical Center
Phone:	617-632-3012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wakelee HA, Dahlberg SE, Keller SM, Tester WJ, Gandara DR, Graziano SL, Adjei AA, Leighl NB, Aisner SC, Rothman JM, Patel JD, Sborov MD, McDermott SR, Perez-Soler R, Traynor AM, Butts C, Evans T, Shafqat A, Chapman AE, Kasbari SS, Horn L, Ramalingam SS, Schiller JH; ECOG-ACRIN. Adjuvant chemotherapy with or without bevacizumab in patients with resected non-small-cell lung cancer (E1505): an open-label, multicentre, randomised, phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1610-1623. doi: 10.1016/S1470-2045(17)30691-5. Epub 2017 Nov 9.

Layout table for additonal information

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00324805
Other Study ID Numbers:	NCI-2009-00509 NCI-2009-00509 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 09-0404 E1505 CDR0000475774 ECOG-E1505 E1505 ( Other Identifier: ECOG-ACRIN Cancer Research Group ) E1505 ( Other Identifier: CTEP ) U10CA180820 ( U.S. NIH Grant/Contract ) U10CA021115 ( U.S. NIH Grant/Contract )
First Submitted:	May 10, 2006
First Posted:	May 11, 2006
Results First Submitted:	January 12, 2018
Results First Posted:	February 14, 2018
Last Update Posted:	April 17, 2024

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