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Lung CancerPhase 2NCT00445848

S0636: Erlotinib and Bevacizumab in Never-Smokers With Stage IIIB or Stage IV Primary Non-Small Cell Lung Cancer

A Phase 2 study testing bevacizumab and erlotinib hydrochloride in people with Lung Cancer, run by SWOG Cancer Research Network at 153 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Lung Cancer
What is being tested?
bevacizumab and erlotinib hydrochloride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
153 sitesUnited States
Study dates
Jul 2007to Jan 2014
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
  • Adenocarcinoma
  • No component of squamous cell carcinoma present
  • Incompletely resected or unresectable disease
  • Stage IIIB or IV disease as defined below:
  • Selected stage IIIB disease
  • T4 (cytologically confirmed malignant pleural effusion OR pleural tumor foci that are separate from direct pleural invasion by the primary tumor)
  • Any N
  • M0
  • Stage IV disease
  • Any T
  • Any N
  • M1 (distant metastases present)
  • Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease
  • New lesions occurring ≥ 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer
  • Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI
  • Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port
  • Measurable disease must be assessed within the past 28 days
  • Nonmeasurable disease must be assessed within the past 42 days
  • Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
  • Must be a lifelong nonsmoker (< 100 cigarettes in lifetime)
  • Treated brain metastases allowed provided the patient is asymptomatic and do not require steroids

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin normal
  • SGOT or SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Alkaline phosphatase ≤ 2.5 times ULN (5 times ULN if bone metastases present)
  • Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 50 mL/min
  • Urine protein:creatinine ratio ≤ 0.5 OR urine protein < 1,000 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Hypertension allowed if controlled on medication prior to study enrollment
  • Must be willing to provide prior smoking history
  • No immediate life-threatening complications from malignancies
  • No prior major medical condition, psychological condition, or social situation that would preclude study treatment
  • No hemoptysis ≥ ½ teaspoon within the past 28 days
  • No clinical history of pulmonary or upper respiratory hemorrhage ≥ grade 2 within the past 6 months or grade 1 within the past 28 days
  • No history of either thrombosis or hemorrhage, including hemorrhagic or thrombotic stroke, or other CNS bleeding
  • No serious nonhealing wound, ulcer, or bone fracture
  • No other prior malignancy except for the following:
  • Adequately treated basal cell or squamous cell skin cancer
  • Adequately treated stage I or II cancer from which the patient is currently in complete remission
  • In situ cervical cancer
  • Any other cancer from which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 7 days since prior fine-needle aspiration or core biopsy
  • At least 28 days since prior radiotherapy (14 days for palliative radiotherapy) and recovered
  • At least 28 days since prior surgery (e.g., thoracic or other major surgeries) and recovered
  • At least 28 days since prior systemic chemotherapy
  • Prior biologic therapy allowed
  • No prior gefitinib, erlotinib hydrochloride, bevacizumab, or other targeted therapies against the epidermal growth factor receptor or vascular endothelial growth factor axes
  • Concurrent stable, therapeutic anticoagulation therapy allowed (e.g., warfarin or low molecular weight heparin), provided the patient has no history of bleeding complications on anticoagulation or an inability to establish a stable therapeutic regimen for anticoagulation
  • No concurrent surgery
  • No other concurrent nonprotocol treatment (including chemotherapy, hormonal therapy, biological therapy, or radiotherapy) directed at this cancer

Trial locations and contacts

153 sites in 1 country.

153 sites in 1 country

United States153 sites

  • Saint Joseph Mercy Cancer Center

    Ann Arbor, Michigan, 48106-0995

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente - Deer Valley

    Antioch, California, 94531

  • Randolph Hospital

    Asheboro, North Carolina, 27203-5400

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342-1611

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342-1701

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • University of Colorado Cancer Center at UC Health Sciences Center

    Aurora, Colorado, 80045

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Alta Bates Summit Comprehensive Cancer Center

    Berkeley, California, 94704

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare Cancer Care Services

    Billings, Montana, 59101

  • Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Bozeman Deaconess Cancer Center

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Peninsula Medical Center

    Burlingame, California, 94010

  • St. James Healthcare Cancer Care

    Butte, Montana, 59701

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • John B. Amos Cancer Center

    Columbus, Georgia, 31904

  • Oakwood Cancer Center at Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48123-2500

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Center of Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Kaiser Permanente - Denver

    Denver, Colorado, 80205

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Shaw Regional Cancer Center

    Edwards, Colorado, 81632

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Kaiser Permanente - Fremont

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Big Sky Oncology

    Great Falls, Montana, 59405-5309

  • Great Falls Clinic - Main Facility

    Great Falls, Montana, 59405

  • Sletten Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Moses Cone Regional Cancer Center at Wesley Long Community Hospital

    Greensboro, North Carolina, 27403-1198

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Northern Montana Hospital

    Havre, Montana, 59501

  • Kaiser Permanente Medical Center - Hayward

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Kaiser Permanente - Moanalua Medical Center and Clinic

    Honolulu, Hawaii, 96819

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Foote Memorial Hospital

    Jackson, Michigan, 49201

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology at KRMC

    Kalispell, Montana, 59901

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

  • Columbia Basin Hematology

    Kennewick, Washington, 99336

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Kaiser Permanente - Lafayette

    Lafayette, Colorado, 80026

  • Sparrow Regional Cancer Center

    Lansing, Michigan, 48912-1811

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Cancer Center of Kansas, PA - Liberal

    Liberal, Kansas, 67905

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP

    Marysville, California, 95901

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

    Missoula, Montana, 59807

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Mercy General Health Partners

    Muskegon, Michigan, 49443

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60540

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Kaiser Permanente Medical Center - Oakland

    Oakland, California, 94611

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Regional Cancer Center at Singing River Hospital

    Pascagoula, Mississippi, 39581

  • Valley Medical Oncology Consultants - Pleasanton

    Pleasanton, California, 94588

  • St. Joseph Mercy Oakland

    Pontiac, Michigan, 48341-2985

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • Adventist Medical Center

    Portland, Oregon, 97216

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Harrison Poulsbo Hematology and Onocology

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Kaiser Permanente Medical Center - Redwood City

    Redwood City, California, 94063

  • Annie Penn Cancer Center

    Reidsville, North Carolina, 27320

  • Kaiser Permanente Medical Center - Richmond

    Richmond, California, 94801

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274-2600

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Harbin Clinic Cancer Center - Medical Oncology

    Rome, Georgia, 30165

  • Kaiser Permanente Medical Center - Roseville

    Roseville, California, 95661

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • South Sacramento Kaiser-Permanente Medical Center

    Sacramento, California, 95823

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67401

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Kaiser Permanente Medical Center - San Francisco Geary Campus

    San Francisco, California, 94115

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • Kaiser Permanente Medical Center - Santa Teresa

    San Jose, California, 95119

  • Kaiser Foundation Hospital - San Rafael

    San Rafael, California, 94903

  • Sutter Health - Western Division Cancer Research Group

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara Kiely Campus

    Santa Clara, California, 95051

  • Kaiser Permanente Medical Center - Santa Rosa

    Santa Rosa, California, 95403

  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

    Savannah, Georgia, 31405

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Kaiser Permanente Medical Center - South San Francisco

    South San Francisco, California, 94080

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Evergreen Hematology and Oncology, PS

    Spokane, Washington, 99218

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Kaiser Permanente Medical Facility - Stockton

    Stockton, California, 95210

  • Cotton-O'Neil Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Tahoe Forest Cancer Center

    Truckee, California, 96161

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Kaiser Permanente Medical Center - Walnut Creek

    Walnut Creek, California, 94596

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Central Dupage Cancer Center

    Winfield, Illinois, 60190

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (RHUMAB VEGF; NSC 704865) in Never-Smokers With Stage IIIB and IV Primary NSCLC Adenocarcinomas

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving erlotinib together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving erlotinib together with bevacizumab works in treating patients with stage IIIB or stage IV primary non-small cell lung cancer who have never smoked.

Read the detailed description

OBJECTIVES:

Primary

  • Assess overall survival of patients with stage IIIB or IV primary non-small cell lung adenocarcinoma who have never smoked and are treated with erlotinib hydrochloride and bevacizumab.

Secondary

  • Assess progression-free survival of patients treated with this regimen.
  • Assess the response rate (confirmed and unconfirmed, complete and partial) in a subset of patients with measurable disease treated with this regimen.
  • Evaluate the frequency and severity of toxicities associated with this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral erlotinib hydrochloride daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Conditions
Lung Cancer
Being tested
bevacizumab, erlotinib hydrochloride
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

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

Study groups in NCT00445848
Study groupRoleWhat they receive
Erlotinib and BevacizumabExperimentalNot described
Receives: Biological: bevacizumab; Drug: erlotinib hydrochloride

What is being measured

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

  1. 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: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

Secondary outcomes (3)

  1. Progression-free Survival

    From date of registration to date 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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v 1.0), as a 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, or unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided) or appearance of any new lesion/site, or death due to disease without prior documentation of progression and without symptomatic deterioration.

    Measured: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

  2. Response Rate (Complete and Partial)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    All target measurable lesions must be assessed using the same techniques as baseline.

    Measured: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.

  3. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Any CTCAE 3.0 event of Grade 3 (serious), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.

    Measured: Toxicity assessment was evaluated after each cycle (21 days) while on protocol therapy.

Timeline

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

  1. First posted9 Mar 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionAug 2013
  4. Study completionJan 2014

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00445848
Sponsor's protocol ID
CDR0000531056
Other IDs
S0636, U10CA032102
Status last verified
Feb 2020
First submitted
7 Mar 2007
Last updated
5 Mar 2020
Data monitoring committee
No

Publications

  • West HJ, Moon J, Hirsch FR, et al.: SWOG S0635 and S0636: Phase II trials in advanced-stage NSCLC of erlotinib (OSI-774) and bevacizumab in bronchioloalveolar carcinoma (BAC) and adenocarcinoma with BAC features (adenoBAC), and in never-smokers with primary NSCLC adenocarcinoma (adenoCa). [Abstract] J Clin Oncol 30 (Suppl 15): A-7517, 2012.

  • Mack PC, Moon J, West HJ, et al.: Molecular marker analysis of SWOG S0636, a phase II trial of erlotinib and bevacizumab in never-smokers with advanced NSCLC. [Abstract] J Clin Oncol 30 (Suppl 15): A-7552, 2012.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bevacizumab and erlotinib hydrochloride in people with Lung Cancer, run by SWOG Cancer Research Network at 153 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?

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: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 153 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 7 Sep 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?

Overall Survival (time frame: Disease assessment is performed every 6 weeks for 18 weeks, then every 9-12 weeks until progression up to 2 years. After disease progression, patients must be followed every 3 months for 1 year and then every 6 months for a maximum of 3 years.). 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 NCT00445848, which also lists 2 linked publications.

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 5 Mar 2020.

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