CClinicalTrials.gg
Sign In
CompletedNCT00324805Updated Jun 23, 2026Results posted

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

A Phase 3 interventional study of Bevacizumab and Cisplatin in Stage IB Lung Non-Small Cell Carcinoma AJCC v7, Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 and Stage IIB Lung Non-Small Cell Carcinoma AJCC v7, sponsored by National Cancer Institute (NCI). Completed at 1,169 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,501
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate overall survival with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

I. To evaluate disease-free survival and toxicity with chemotherapy with or without bevacizumab used in the adjuvant setting in patients with resected stage IB (>= 4 cm) - IIIA NSCLC.

CORRELATIVE OBJECTIVES:

I. To perform analyses of tissue and blood to establish factors that predict clinical outcome in patients receiving chemotherapy, with or without bevacizumab, for resected early stage NSCLC.

II. To determine whether smoking status is linked to outcome for patients with resected stage IB (>= 4 cm) - IIIA NSCLC treated with chemotherapy with or without bevacizumab in the adjuvant setting.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I (adjuvant chemotherapy without bevacizumab): Patients receive 1 of 4 chemotherapy regimens.

REGIMEN 1: Patients receive vinorelbine ditartrate intravenously (IV) over 10 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following vinorelbine ditartrate administration.

REGIMEN 2: Patients receive docetaxel IV over 1 hour on day 1 and cisplatin over 1 hour on day 1 immediately following docetaxel administration.

REGIMEN 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 60 minutes on day 1 immediately following gemcitabine administration.

REGIMEN 4 (non-squamous histology only): Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 1 hour on day 1 immediately following pemetrexed disodium administration.

In all regimens, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

ARM II (adjuvant chemotherapy with bevacizumab): 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.

After completion of study treatment, patients are followed up periodically for 10 years.

02

Conditions studied

  • 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
03

In context

Carcinoma, Non-Small-Cell Lung

6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.

This study's enrollment of 1,501 is above the median of 62 across 5,211 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • In order to be eligible for this trial, patients must have undergone complete resection of their non-small cell lung cancer (NSCLC) [stage IB (>= 4 cm)] - [IIIA (T2-3N0, T1-3N1, T1-3N2] prior to enrollment; accepted types of resection will consist of lobectomy, sleeve lobectomy, bi-lobectomy or pneumonectomy; resections by segmentectomy or wedge resection will not be accepted; mediastinal lymph node sampling at specified levels is required pre-operatively (mediastinoscopy) or intraoperatively (level 7 and 4 for right sided tumors or level 7 and 5 and/or 6 for left sided tumors)
  • Patients must be no less than 6 weeks (42 days) and no more than 12 weeks (84 days) post-thoracotomy at the time of randomization and must be adequately recovered from surgery
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

  • Patients must not have received the following:

    • Prior systemic chemotherapy at any time; methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 2 weeks prior to date of registration will be allowed; other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required
    • Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of randomization; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is now considered cured is acceptable)
  • Patients must not have any history of cancer within 5 years from randomization, with the exception of in-situ carcinoma of the cervix or completely resected non-melanoma skin cancer
  • Absolute neutrophil count (ANC) >= 1500 mm\^3
  • Platelets >= 100,000/mm\^3

  • Prothrombin time/international normalized ratio (INR) =\< 1.5

    • Or, if patient is on therapeutic anticoagulation, prothrombin time/INR =\< 3.0
  • Partial thromboplastin time (PTT) =\< institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be =\< 1.5 x ULN
  • Total bilirubin =\< 1.5 mg/dL
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) \< 5 x upper limit of normal (ULN)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) \< 5 x upper limit of normal (ULN)
  • Serum creatinine =\< 1.5 x institutional upper limit of normal (ULN)
  • Urine protein should be screened by urine analysis for urine protein creatinine (UPC) ratio; for UPC ratio > 0.5, 24-hour urine protein must be obtained and the level must be \< 1000 mg (1 g) for patient enrollment
  • Patients with a known history of myocardial infarction or other evidence of arterial thrombotic disease (angina) will be allowed on study only if they have had no evidence of active disease for at least 12 months prior to randomization
  • Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA) will not be allowed on trial

  • Women must not be pregnant or breast-feeding

    • All females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy
  • Both fertile men and women must agree to use adequate contraceptive measures during study treatment and for at least 6 months after completion of bevacizumab
  • Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients must have no history of bleeding diathesis or coagulopathy
  • All patients must have a documented blood pressure (BP) with systolic =\< 150 and diastolic =\< 90 within 28 days of registration; patients with known hypertension must be on a stable regimen of anti-hypertensive therapy
  • Patients receiving daily treatment with aspirin or non-steroidal anti-inflammatory agents (NSAIDS) are eligible; treatment with dipyridamole (Persantine), ticlopine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed; patients must have stopped taking any of these agents at least 7 days prior to randomization
  • Patients must not have serious non-healing wound, ulcer, bone fracture, or have undergone a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization OR core biopsy within 7 days prior to randomization
  • Patients must not have a history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to randomization
  • Patients must not have any anticipated major surgical procedure(s) during the course of the study
  • Patients must not have known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Patients may be on a stable regimen of therapeutic anticoagulation or may be receiving prophylactic anticoagulation of venous access devices, provided that coagulation studies meet entry criteria above; caution must be exercised for patients requiring anticoagulation, including treatment with low dose heparin or low molecular weight heparin for deep vein thrombosis (DVT) prophylaxis while on study
  • Patients with ongoing post-operative hemoptysis (defined as bright red blood of 1/2 teaspoon or more) are not eligible; patients with pre-operative hemoptysis that has resolved post-operatively are eligible

  • Patients who will receive pemetrexed (pemetrexed disodium)/cisplatin therapy must also meet the following criteria:

    • Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology
    • Calculated creatinine clearance must be obtained within 2 weeks of randomization and calculated creatinine clearance (CrCl) must be >= 45 mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method ([51]chromium-labeled ethylenediaminetetraacetic acid [51-CrEDTA] or technetium 99m diethylenetriamine-pentaacetic acid [Tc99m-DTPA]) must be used to calculate CrCl
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,501 participants (actual)

Study arms

  • Active comparator
    Arm I (chemotherapy)

    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

    Drug: Cisplatin · Drug: Docetaxel · Drug: Gemcitabine Hydrochloride · Other: Laboratory Biomarker Analysis · Drug: Pemetrexed Disodium · Other: Questionnaire Administration · Drug: Vinorelbine Tartrate

  • Experimental
    Arm II (chemotherapy, bevacizumab)

    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.

    Biological: Bevacizumab · Drug: Cisplatin · Drug: Docetaxel · Drug: Gemcitabine Hydrochloride · Other: Laboratory Biomarker Analysis · Drug: Pemetrexed Disodium · Other: Questionnaire Administration · Drug: Vinorelbine Tartrate

Interventions

  • BiologicalBevacizumab

    Given IV

    Also known as: ABP 215, ABP-215, ABP215, Alymsys, Anti-VEGF, Anti-VEGF Humanized Monoclonal Antibody, Anti-VEGF Monoclonal Antibody SIBP04, Anti-VEGF rhuMAb, Avastin, Avzivi, Aybintio, BAT 1706, BAT-1706, BAT1706, BAT1706 Biosimilar, Bevacizumab awwb, Bevacizumab Biosimilar ABP 215, Bevacizumab Biosimilar BAT1706, Bevacizumab Biosimilar BEVZ92, Bevacizumab Biosimilar BI 695502, Bevacizumab Biosimilar CBT 124, Bevacizumab Biosimilar CT-P16, Bevacizumab Biosimilar FKB238, Bevacizumab Biosimilar GB-222, Bevacizumab Biosimilar HD204, Bevacizumab Biosimilar HLX04, Bevacizumab Biosimilar IBI305, Bevacizumab Biosimilar LY01008, Bevacizumab Biosimilar MB02, Bevacizumab Biosimilar MIL60, Bevacizumab Biosimilar Mvasi, Bevacizumab Biosimilar MYL-1402O, Bevacizumab Biosimilar QL 1101, Bevacizumab Biosimilar QL1101, Bevacizumab Biosimilar RPH-001, Bevacizumab Biosimilar SCT501, Bevacizumab Biosimilar Zirabev, Bevacizumab-adcd, Bevacizumab-awwb, Bevacizumab-aybi, Bevacizumab-bvzr, Bevacizumab-equi, Bevacizumab-maly, Bevacizumab-onbe, Bevacizumab-tnjn, BP102, BP102 Biosimilar, CT P16, CT-P16, CTP16, Equidacent, FKB 238, FKB-238, FKB238, HD204, Immunoglobulin G1 (Human-Mouse Monoclonal rhuMab-VEGF Gamma-Chain Anti-Human Vascular Endothelial Growth Factor), Disulfide With Human-Mouse Monoclonal rhuMab-VEGF Light Chain, Dimer, MB 02, MB-02, MB02, Mvasi, MYL-1402O, Onbevzi, Oyavas, PF 06439535, PF-06439535, PF06439535, QL1101, Recombinant Humanized Anti-VEGF Monoclonal Antibody, rhuMab-VEGF, SCT501, SIBP 04, SIBP-04, SIBP04, Vegzelma, Zirabev

  • DrugCisplatin

    Given IV

    Also known as: Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin

  • DrugDocetaxel

    Given IV

    Also known as: Docecad, RP 56976, RP-56976, RP56976, Taxotere, Taxotere Injection Concentrate

  • DrugGemcitabine Hydrochloride

    Given IV

    Also known as: dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemcitabine HCI, Gemzar, LY 188011, LY-188011, LY188011

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • DrugPemetrexed Disodium

    Given IV

    Also known as: Alimta, Almita, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

  • OtherQuestionnaire Administration

    Ancillary studies

  • DrugVinorelbine Tartrate

    Given IV

    Also known as: Biovelbin, Eunades, KW 2307, KW-2307, KW2307, Navelbine, Navelbine Ditartrate, NVB, Vinorelbine Ditartrate

06

What researchers measure

Primary outcomes

  1. Overall Survival

    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

Secondary outcomes

  1. Disease-free Survival

    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

Other outcomes

  1. Toxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

    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

  2. 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.

    Time frame: From registration to death, up to 10 years

  3. 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.

    Time frame: From registration to death, up to 10 years

07

Results

Posted Feb 14, 2018

Participant flow

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.

Participant flow — Overall Study
MilestoneArm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)
Started749752
Started assigned therapy737735
Completed599269
Not completed150483
Withdrew: Adverse event62203
Withdrew: Progression735
Withdrew: Withdrawal by subject51174
Withdrew: Death69
Withdrew: Alternative therapy48
Withdrew: Other complicating disease19
Withdrew: Other reasons726
Withdrew: Other02
Withdrew: Did not start therapy1217

Outcome measures

PrimaryOverall Survival

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
Reported as:
Median · months
Overall Survival
monthsArm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)
Overall SurvivalNA (NA to NA)85.8 (74.9 to NA)
Statistical analysis
  • Arm I (Chemotherapy) vs Arm II (Chemotherapy, Bevacizumab) · Regression, Cox · p = 0.90 · Hazard ratio (hr): 0.99 · 95% CI 0.82 to 1.19Arm II versus Arm I
SecondaryDisease-free Survival

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
Reported as:
Median · months
Disease-free Survival
monthsArm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)
Disease-free Survival42.9 (36.7 to 57.0)40.6 (35.5 to 49.5)
Statistical analysis
  • Arm I (Chemotherapy) vs Arm II (Chemotherapy, Bevacizumab) · Regression, Cox · p = 0.95 · Hazard ratio (hr): 0.99 · 95% CI 0.86 to 1.15Arm II vs. Arm I
Other pre-specifiedToxicity Rates as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

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

Results for this outcome have not been posted.

Other pre-specifiedPerform 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.
Time frame:
From registration to death, up to 10 years

No measurements were reported for this outcome.

Other pre-specifiedTo 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.
Time frame:
From registration to death, up to 10 years

No measurements were reported for this outcome.

Adverse events

Collected over Assessed every 3 weeks while on treatment and for 30 days after the end of treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I (Chemotherapy)—424/738 (57.5%)474/738 (64.2%)
Arm II (Chemotherapy, Bevacizumab)—563/735 (76.6%)509/735 (69.3%)
Most frequent serious events
Showing 10 of 158
Most frequent serious events
EventArm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)
Neutrophil count decreasedInvestigations237/738273/735
HypertensionVascular disorders19/738200/735
FatigueGeneral disorders66/73892/735
NauseaGastrointestinal disorders63/73874/735
HyponatremiaMetabolism and nutrition disorders44/73866/735
AnemiaBlood and lymphatic system disorders52/73840/735
VomitingGastrointestinal disorders38/73847/735
DehydrationMetabolism and nutrition disorders40/73845/735
Platelet count decreasedInvestigations30/73844/735
Febrile neutropeniaBlood and lymphatic system disorders31/73843/735
Most frequent other events
Most frequent other events
EventArm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)
AnemiaBlood and lymphatic system disorders256/738183/735
Creatinine increasedInvestigations169/738247/735
Neutrophil count decreasedInvestigations220/738236/735
FatigueGeneral disorders62/73868/735
Peripheral sensory neuropathyNervous system disorders53/73858/735
HypertensionVascular disorders2/73850/735
Platelet count decreasedInvestigations48/73849/735
ProteinuriaRenal and urinary disorders3/73848/735

Baseline characteristics

All randomized patients

Age, Continuous
Age, Continuous(years)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Mean60.7 ± 9.060.8 ± 8.760.8 ± 8.8
Sex: Female, Male
Sex: Female, Male(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Female374381755
Male375371746
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Hispanic or Latino192948
Not Hispanic or Latino6806881368
Unknown or Not Reported503585
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
American Indian or Alaska Native156
Asian221638
Native Hawaiian or Other Pacific Islander325
Black or African American7457131
White6426601302
More than one race000
Unknown or Not Reported71219
Chemotherapy
Chemotherapy(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Cisplatin/Vinorelbine187190377
Cisplatin/Docetaxel172171343
Cisplatin/Gemcitabine142141283
Cisplatin/Pemetrexed248249497
Unknown/Missing011
Histology
Histology(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Squamous216206422
Adenocarcinoma424450874
Large cell221638
Bronchioloalveolar carcinoma (BAC)8513
Not otherwise specified (NOS)241640
Combined/mixed454893
Other101020
Unknown/missing011
Performance Status
Performance Status(Participants)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Fully active439440879
Ambulatory310310620
Unknown/missing022
Urine protein:creatinine (UPC) ratio
Urine protein:creatinine (UPC) ratio(ratio)Arm I (Chemotherapy)Arm II (Chemotherapy, Bevacizumab)Total
Mean0.31 ± 3.100.18 ± 0.920.25 ± 2.28

1 further baseline measures are reported on the registry.

08

Study locations

1,169 sites
  • Northeast Alabama Regional Medical Center
    Anniston, Alabama 36202, United States
  • Clearview Cancer Institute
    Huntsville, Alabama 35805, United States
  • Providence Hospital
    Mobile, Alabama 36608, United States
  • University of South Alabama Mitchell Cancer Institute
    Mobile, Alabama 36688, United States
  • Alaska Regional Hospital
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Mayo Clinic in Arizona
    Scottsdale, Arizona 85259, United States
  • University of Arizona Cancer Center-Orange Grove Campus
    Tucson, Arizona 85704, United States
  • Banner University Medical Center - Tucson
    Tucson, Arizona 85719, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
  • Mercy Hospital Fort Smith
    Fort Smith, Arkansas 72903, United States
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
    Jonesboro, Arkansas 72401, United States
  • NEA Baptist Memorial Hospital
    Jonesboro, Arkansas 72401, United States
  • Saint Bernards Regional Medical Center
    Jonesboro, Arkansas 72401, United States
  • John L McClellan Memorial Veterans Hospital
    Little Rock, Arkansas 72205, United States
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92806, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • PCR Oncology
    Arroyo Grande, California 93420, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Mills-Peninsula Medical Center
    Burlingame, California 94010, United States
  • East Bay Radiation Oncology Center
    Castro Valley, California 94546, United States
  • Eden Hospital Medical Center
    Castro Valley, California 94546, United States
  • Valley Medical Oncology Consultants-Castro Valley
    Castro Valley, California 94546, United States
  • Adventist Health Cancer Care Center Chico
    Chico, California 95973, United States
  • Community Cancer Institute
    Clovis, California 93611, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Bay Area Breast Surgeons Inc
    Emeryville, California 94608, United States
  • Epic Care Partners in Cancer Care
    Emeryville, California 94608, United States
  • Kaiser Permanente-Fontana
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Valley Medical Oncology Consultants-Fremont
    Fremont, California 94538, United States
  • California Cancer Associates for Research and Excellence (cCare)
    Fresno, California 93720, United States
  • Kaiser Permanente-Fresno
    Fresno, California 93720, United States
  • Saint Jude Medical Center
    Fullerton, California 92835, United States
  • Glendale Memorial Hospital and Health Center
    Glendale, California 91204, United States
  • Marin Cancer Care Inc
    Greenbrae, California 94904, United States
  • Marin General Hospital
    Greenbrae, California 94904, United States
  • Kaiser Permanente South Bay
    Harbor City, California 90710, United States
  • Saint Rose Hospital
    Hayward, California 94545, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
  • Long Beach Memorial Medical Center-Todd Cancer Institute
    Long Beach, California 90806, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Los Angeles General Medical Center
    Los Angeles, California 90033, United States
  • USC / Norris Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • Kaiser Permanente West Los Angeles
    Los Angeles, California 90034, United States
  • Contra Costa Regional Medical Center
    Martinez, California 94553-3156, United States
  • Fremont - Rideout Cancer Center
    Marysville, California 95901, United States
  • Mercy Cancer Center
    Merced, California 95340, United States
  • Memorial Medical Center
    Modesto, California 95355, United States
  • Kaiser Permanente-Modesto
    Modesto, California 95356, United States
  • Community Hospital of Monterey Peninsula
    Monterey, California 93940, United States
  • El Camino Hospital
    Mountain View, California 94040, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California 94040, United States
  • Sutter Cancer Research Consortium
    Novato, California 94945, United States
  • Highland General Hospital
    Oakland, California 94602, United States
  • Alta Bates Summit Medical Center - Summit Campus
    Oakland, California 94609, United States
  • Bay Area Tumor Institute
    Oakland, California 94609, United States
  • Hematology and Oncology Associates-Oakland
    Oakland, California 94609, United States
  • Tom K Lee Inc
    Oakland, California 94609, United States
  • Kaiser Permanente Oakland-Broadway
    Oakland, California 94611, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Saint Joseph Hospital - Orange
    Orange, California 92868, United States
  • UC Irvine Health/Chao Family Comprehensive Cancer Center
    Orange, California 92868, United States
  • Desert Regional Medical Center
    Palm Springs, California 92262, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California 94301, United States
  • Stanford Cancer Institute Palo Alto
    Palo Alto, California 94304, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Valley Care Health System - Pleasanton
    Pleasanton, California 94588, United States
  • Valley Medical Oncology Consultants
    Pleasanton, California 94588, United States
  • Pomona Valley Hospital Medical Center
    Pomona, California 91767, United States
  • Kaiser Permanente-Rancho Cordova Cancer Center
    Rancho Cordova, California 95670, United States
  • Eisenhower Medical Center
    Rancho Mirage, California 92270, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Rohnert Park Cancer Center
    Rohnert Park, California 94928, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
  • The Permanente Medical Group-Roseville Radiation Oncology
    Roseville, California 95678, United States
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Mercy General Hospital
    Sacramento, California 95819, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • South Sacramento Cancer Center
    Sacramento, California 95823, United States
  • Kaiser Permanente Sacramento Medical Center
    Sacramento, California 95825, United States
  • Salinas Valley Memorial
    Salinas, California 93901, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • Zuckerberg San Francisco General Hospital
    San Francisco, California 94110, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • UCSF Medical Center-Mount Zion
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92078, United States

Showing the first 100 of 1,169 sites across 5 countries.

09

References and documents

Publications

  • Wang Y, Sun Z, Sridhar A, Ramalingam SS, Wakelee HA, Gerber DE. Participation in lung cancer biospecimen studies: an analysis of the ECOG-ACRIN phase 3 E1505 and E5508 clinical trials. Lung Cancer. 2026 Apr;214:109304. doi: 10.1016/j.lungcan.2026.109304. Epub 2026 Feb 7. PubMed 41666849 ↗
  • 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. PubMed 29129443 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00324805
Lead sponsor
National Cancer Institute (NCI)
Collaborators
Cancer and Leukemia Group B, NCIC Clinical Trials Group, North Central Cancer Treatment Group, SWOG Cancer Research Network
Responsible party
Sponsor
First posted
May 11, 2006
Start date
Jul 19, 2007
Primary completion
Oct 20, 2015
Completion
Jan 31, 2025
Results posted
Feb 14, 2018
Last update
Jun 23, 2026

Study contacts

Heather A Wakelee
principal investigator · ECOG-ACRIN Cancer Research Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Carcinoma, Non-Small-Cell Lung→

Other studies from this sponsor

National Cancer Institute (NCI)

Start the discussion