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Lung AdenocarcinomaPhase 2NCT00334815

Combination Chemotherapy, Radiation Therapy, and Bevacizumab in Treating Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer That Cannot Be Removed by Surgery

A Phase 2 study testing Bevacizumab, Cisplatin and Docetaxel in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 61 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bevacizumab, Cisplatin and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
61 sitesUnited States
Study dates
15 Jun 2006to 22 Feb 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed single, primary, bronchogenic, non-small cell lung cancer (NSCLC)
  • Newly diagnosed disease
  • Unresectable disease
  • No more than 1 parenchymal lesions on same or opposite sides of the lungs
  • Meets 1 of the following stage criteria:
  • Stage IIIA (N2) disease meeting the following criteria:
Show all 85Show fewer
  • N2 mediastinal lymph nodes must be multiple and/or bulky on CT scan or x-ray so that the patient is not a candidate for induction chemotherapy or chemoradiotherapy followed by surgical resection
  • N2 status must be documented by ≥ 1 of the following methods:
  • Histologically or cytologically confirmed N2 disease by exploratory thoracotomy, thoracoscopy, mediastinoscopy, mediastinotomy, Chamberlain procedure, Wang needle biopsy (WNB), fine needle aspiration (FNA) under bronchoscopic or CT guidance, or any other method
  • Node positive by fludeoxyglucose-positron emission tomography (FDG-PET) scan
  • Nodes > 3 cm on CT scan
  • Paralyzed left true vocal cord with separate left lung primary distinct from anterior-posterior window nodes on CT scan
  • Stage IIIB disease meeting ≥ 1 of the following criteria:
  • Histologically or radiographically confirmed positive N3 nodes*, documented by ≥ 1 of the following methods:
  • FNA, core needle biopsy (CNB), or excisional biopsy of supraclavicular N3 nodes
  • Biopsy of contralateral mediastinal N3 nodes by mediastinoscopy, mediastinotomy, or thoracotomy
  • FNA, CNB, or WNB under CT or bronchoscopic fluoroscopic guidance of enlarged contralateral N3 mediastinal nodes
  • Contralateral mediastinal nodes > 3 cm on CT scan
  • Node positivity by FDG-PET scan
  • Right-sided primary with paralyzed left true vocal cord
  • T4 lesions of any size that invade the mediastinum, heart, great vessels, trachea, esophagus, vertebral body, or carina, documented by ≥ 1 of the following methods:
  • Written documentation of type of T4 extent if patient had a prior exploratory thoracotomy or thoracoscopy
  • T4 involvement of the trachea or carina by direct bronchoscopic visualization
  • T4 involvement of the heart, esophagus, aorta, or vertebral body by CT scan, MRI, or transesophageal ultrasound
  • T4 involvement of the mediastinum by CT scan or MRI if, in the absence of the above organ involvement, there is soft tissue extension directly into the mediastinal space**
  • Meets 1 of the following risk criteria:
  • Low risk disease, meeting the following criteria:
  • Non-squamous cell NSCLC, including adenocarcinoma, bronchoalveolar cell carcinoma, or large cell carcinoma
  • If mixed histology, the squamous cell carcinoma component must be < 50%
  • Histology or cytology from involved mediastinal or supraclavicular lymph nodes allowed if a separate distal primary lesion is clearly evident on radiographs (i.e., second biopsy not required)
  • No primary tumor with cavitation and/or tumor within 1 cm of a major vessel
  • No hemoptysis (i.e., bright red blood ≥ ½ teaspoon) in the past 28 days
  • High-risk* disease, meeting ≥ 1 of the following criteria:
  • Squamous cell NSCLC
  • If mixed histology, the squamous cell component must be ≥ 50%
  • Tumor with any histology that has cavitation or is located within 1 cm of a major vessel
  • No aortic involvement
  • Any histology and hemoptysis (i.e., bright red blood ≥ ½ teaspoon) within past 28 days
  • Measurable or nonmeasurable disease by CT scan or MRI
  • Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
  • No pleural effusion except for small pleural effusion visible on CT scan or MRI alone
  • No pericardial effusions
  • No metastatic disease involving the contralateral chest, liver, or adrenals confirmed by CT scan of the upper abdomen or by chest CT scan with complete liver and adrenals in the report
  • Patients must be offered participation in SWOG-S9925 (Lung Cancer Specimen Repository Protocol)
  • No brain metastases by CT scan or MRI
  • No evidence of cavitation
  • Creatinine normal
  • Creatinine clearance ≥ 50 mL/min
  • FEV_1 ≥ 2.0 liters OR predicted FEV_1 of the contralateral lung > 800 mL
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Urine protein: creatinine ratio ≤ 0.5 by urinalysis OR urine protein < 1,000 mg by 24-hour urine collection
  • INR < 1.5
  • Zubrod performance status 0-1
  • No sensory neuropathy > grade 1
  • No cerebrovascular accident within the past 6 months
  • No myocardial infarction or unstable angina within the past 6 months
  • No uncontrolled hypertension
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac arrhythmia requiring medication
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No pathologic condition other than lung cancer that carries a high risk of bleeding
  • No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No serious, nonhealing wound, ulcer, or bone fracture
  • No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer for which the patient is currently in complete remission, or other cancer for which the patient has been disease-free for 5 years
  • Not pregnant or nursing
  • No nursing during and for ≥ 6 months after the last dose of bevacizumab
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after the last dose of bevacizumab
  • Must have pre-treatment simulation demonstrating a V20 ≤ 35% with planned radiation dose of 6,480 cGy
  • No prior surgical resection
  • Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery allowed for diagnosing, staging, or determining potential resectability of lung tumor
  • No prior chemotherapy or radiotherapy for lung cancer
  • No prior radiotherapy to the neck or thorax
  • At least 4 weeks since prior thoracic or other major surgery (excluding mediastinoscopy) and recovered
  • More than 7 days since prior FNA, CNB, or mediastinoscopy
  • No other concurrent anticancer therapy, including chemotherapy, radiotherapy, or biologic agents
  • No other concurrent investigational drugs
  • No concurrent major surgical procedures
  • No concurrent full-dose anticoagulants (e.g., low-molecular weight and unfractionated heparin or warfarin)
  • Low-dose warfarin (i.e., 1 mg) is allowed to prevent clotting of an infusaport or central line
  • No concurrent brachytherapy, radiopharmaceuticals, high linear energy transfer radiation (i.e., fast neutrons), particle therapy (i.e., protons, carbon, or helium), and/or altered fractionation schemes
  • No concurrent intensity-modulated radiotherapy
  • No concurrent prophylactic contralateral hilar or supraclavicular lymph node radiotherapy

Who cannot join

None listed.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

United States61 sites

  • The Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Rocky Mountain Regional VA Medical Center

    Aurora, Colorado, 80045

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Dana-Farber Cancer Institute at Boston Medical Center - Brighton

    Brighton, Massachusetts, 02135

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Shaw Cancer Center

    Edwards, Colorado, 81632

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • HaysMed

    Hays, Kansas, 67601

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Hutchinson Regional Medical Center

    Hutchinson, Kansas, 67502

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Saint Bernards Regional Medical Center

    Jonesboro, Arkansas, 72401

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Cancer Centers of Central Florida PA

    Leesburg, Florida, 34788

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Providence Hospital

    Mobile, Alabama, 36608

  • Montrose Memorial Hospital

    Montrose, Colorado, 81401

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Ballad Health Cancer Care - Norton

    Norton, Virginia, 24273

  • Olathe Cancer Center

    Olathe, Kansas, 66061

  • Providence - Saint Peter Hospital

    Olympia, Washington, 98506-5166

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Highland Hospital

    Rochester, New York, 14620

  • University of Rochester

    Rochester, New York, 14642

  • Highlands Oncology Group - Rogers

    Rogers, Arkansas, 72758

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Audie L Murphy VA Hospital

    San Antonio, Texas, 78229

  • University Hospital

    San Antonio, Texas, 78229

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Providence Santa Rosa Memorial Hospital

    Santa Rosa, California, 95405

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • LSU Health Sciences Center at Shreveport

    Shreveport, Louisiana, 71103

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • MultiCare Allenmore Hospital

    Tacoma, Washington, 98405

  • Saint Joseph Medical Center

    Tacoma, Washington, 98405

  • University of Kansas Health System Saint Francis Campus

    Topeka, Kansas, 66606

  • Gene Upshaw Memorial Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Northbay Cancer Center

    Vacaville, California, 95687

  • Southeast Clinical Oncology Research Consortium NCORP

    Winston-Salem, North Carolina, 27104

Other trials in United States

About this study

Official title: A Pilot Trial of Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Docetaxel and the Addition of Bevacizumab (NSC-704865) in Three Cohorts of Patients With Inoperable Locally Advanced Stage III Non-small Cell Lung Cancer

This clinical trial studies combination chemotherapy, radiation therapy, and bevacizumab in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, work in different ways to stop the growth of [cancer/tumor] cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving more than one drug (combination chemotherapy) together with radiation therapy and bevacizumab may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the frequency and severity of toxic effects of induction therapy comprising cisplatin, etoposide, and radiotherapy with or without bevacizumab followed by consolidation therapy comprising docetaxel and bevacizumab, in terms of grade 4 or 5 hemorrhage, in patients with newly diagnosed, unresectable, stage III non-small cell lung cancer.

SECONDARY OBJECTIVES:

  1. Determine progression-free and overall survival of patients treated with these regimens.

II. Determine response (confirmed, unconfirmed, partial, and complete) in patients with measurable disease treated with these regimens.

OUTLINE: This is a pilot, multicenter study. Patients are stratified according to risk (high* vs low).

NOTE: *High-risk stratum closed to accrual as of 2/20/09.

INDUCTION THERAPY: Patients in each stratum are assigned to 1 of 3 sequential treatment groups.

GROUP 1: Patients receive cisplatin intravenously (IV) over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.

GROUP 2: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.

GROUP 3: Patients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.

CONSOLIDATION CHEMOTHERAPY: Beginning 3-6 weeks after completion of induction therapy, all patients receive consolidation chemotherapy comprising docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 2 and continuing until blood counts recover OR pegfilgrastim SC once on day 2.

Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to 4 years.

Medical subject headings
Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabBiological

    Also called ABP 215, ABP-215, ABP215, Alymsys

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • DocetaxelDrug

    Also called Docecad, RP 56976, RP-56976, RP56976

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • FilgrastimBiological

    Also called Filgrastim Biosimilar Filgrastim-sndz, Filgrastim Biosimilar Tbo-filgrastim, Filgrastim XM02, Filgrastim-aafi

    Given SC

  • PegfilgrastimBiological

    Also called Cegfila, Dulastin, Dyrupeg, Filgrastim SD-01

    Given SC

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo thoracic radiotherapy

Study groups in NCT00334815
Study groupRoleWhat they receive
Group 1 (cisplatin, etoposide, radiotherapy)ExperimentalPatients receive cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: Etoposide; Biological: Filgrastim; Biological: Pegfilgrastim; Radiation: Radiation Therapy
Group 2 (cisplatin, etoposide, radiotherapy, bevacizumab)ExperimentalPatients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 15, 36, and 57.
Receives: Biological: Bevacizumab; Drug: Cisplatin; Drug: Docetaxel; Drug: Etoposide; Biological: Filgrastim; Biological: Pegfilgrastim; Radiation: Radiation Therapy
Group 3 (cisplatin, etoposide, radiotherapy, bevacizumab)ExperimentalPatients receive cisplatin, etoposide, and thoracic radiotherapy as in group 1. Patients also receive bevacizumab IV over 30-90 minutes on days 1, 22, and 43.
Receives: Biological: Bevacizumab; Drug: Cisplatin; Drug: Docetaxel; Drug: Etoposide; Biological: Filgrastim; Biological: Pegfilgrastim; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Up to one year

Secondary outcomes (3)

  1. Progression-free Survival

    From date of registration to time of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression-free are censored at date of last contact.

    Measured: Disease assessments were performed every 10 weeks as long as the patient remained on protocol treatment, up to 4 years.

  2. Overall Survival

    From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

    Measured: Every week, up to 4 years

  3. Response Rate (Confirmed or Unconfirmed Partial Response)

    Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions.

    Measured: Response assessment occured at the end of CRT and docetaxel/bevacizumab and then every 2-3 months for 2 years and then every 6 months until 4 years after the initial registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2006 (estimated)
  2. Study start15 Jun 2006
  3. Primary completion1 Jul 2014
  4. Study completion22 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00334815
Sponsor's protocol ID
NCI-2009-01097
Other IDs
NCI-2009-01097, SWOG-S0533, CDR0000472907, S0533, S0533, U10CA180888, U10CA032102
Status last verified
Aug 2026
First submitted
7 Jun 2006
Last updated
26 Aug 2026

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Cisplatin and Docetaxel in people with Lung Adenocarcinoma and Lung Adenosquamous Carcinoma, run by National Cancer Institute (NCI) at 61 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 85 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: Up to one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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