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AzTrials

Lung CancerPhase 2NCT00085501

S0342: Paclitaxel, Carboplatin, and Cetuximab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 study testing cetuximab, carboplatin and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 163 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: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
cetuximab, carboplatin and paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
163 sitesUnited States
Study dates
Jul 2004to Jul 2011
Phase
Phase 2
Are there results?
None posted in the registry

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of one of the following stages:
  • Newly diagnosed selected stage IIIB disease (T4 lesion due to malignant pleural effusion, any N, M0)
  • Newly diagnosed stage IV disease (any T, any N, M1)
  • Recurrent stage IV disease after prior surgery or radiotherapy
  • The following subtypes are eligible:
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Large cell carcinoma
  • Unspecified
  • Measurable disease by CT scan, MRI, x-ray, or physical exam
  • Pleural effusions, ascites, or laboratory parameters are not acceptable as the only evidence of disease
  • Not within prior radiotherapy field unless a new lesion is present
  • Not within area of prior surgical resection
  • No known brain metastases by CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 mg/dL

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2 times ULN
  • Alkaline phosphatase ≤ 2 times ULN
  • No known acute hepatitis

Renal

  • Creatinine ≤ ULN
  • Creatinine clearance ≥ 50 mL/min

Cardiovascular

  • No significant cardiac disease
  • No uncontrolled hypertension
  • No unstable angina
  • No congestive heart failure

Other

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
  • No active or uncontrolled infection
  • No sensory neuropathy ≥ grade 2
  • No known human anti-mouse antibodies
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for NSCLC
  • No prior chimeric or murine monoclonal antibody therapy
  • No prior cetuximab

Chemotherapy

  • No prior systemic chemotherapy for NSCLC

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery

  • See Disease Characteristics
  • At least 2 weeks since prior thoracic or major surgery and recovered

Other

  • No prior gefitinib or other investigational agents that target the epidermal growth factor receptor pathway

Trial locations and contacts

163 sites in 1 country.

163 sites in 1 country

United States163 sites

  • Kapiolani Medical Center at Pali Momi

    ‘Aiea, Hawaii, 96701

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Saint Anthony's Hospital at Saint Anthony's Health Center

    Alton, Illinois, 62002

  • Alaska Regional Hospital

    Anchorage, Alaska, 99508

  • Rose Ramer Cancer Clinic at Anderson Area Medical Center

    Anderson, South Carolina, 29621

  • CCOP - Michigan Cancer Research Consortium

    Ann Arbor, Michigan, 48100

  • St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Arlington Cancer Center - Arlington

    Arlington, Texas, 76012

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • CCOP - Atlanta Regional

    Atlanta, Georgia, 30342

  • Northside Hospital Cancer Center

    Atlanta, Georgia, 30342

  • Saint Joseph's Hospital of Atlanta

    Atlanta, Georgia, 30342

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • WellStar Cobb Hospital

    Austell, Georgia, 30106

  • Cancer Care Center at Battle Creek Health System

    Battle Creek, Michigan, 49017

  • Bay Regional Medical Center

    Bay City, Michigan, 48708

  • St. Francis Hospital and Health Centers

    Beech Grove, Indiana, 46107

  • St. Joseph Hospital Community Cancer Center

    Bellingham, Washington, 98225

  • St. Charles Medical Center

    Bend, Oregon, 97701

  • Alta Bates Comprehensive Cancer Center

    Berkeley, California, 94705

  • Mecosta County General Hospital

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Cancer Research Center at Boston Medical Center

    Boston, Massachusetts, 02118

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • Peninsula Medical Center

    Burlingame, California, 94010

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Tri-Health Good Samaritan Hospital

    Cincinnati, Ohio, 45220

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Genesis Medical Center - West Campus

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital

    Dayton, Ohio, 45406

  • David L. Rike Cancer Center at Miami Valley Hospital

    Dayton, Ohio, 45409

  • Samaritan North Cancer Care Center

    Dayton, Ohio, 45415

  • Veterans Affairs Medical Center - Dayton

    Dayton, Ohio, 45428

  • CCOP - Dayton

    Dayton, Ohio, 45429

  • Charles B. Eberhart Cancer Center at DeKalb Medical Center

    Decatur, Georgia, 30033

  • St. Anthony Central Hospital

    Denver, Colorado, 80204

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center

    Denver, Colorado, 80217-3364

  • Veterans Affairs Medical Center - Denver

    Denver, Colorado, 80220

  • Josephine Ford Cancer Center at Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48532

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital

    Gape Girardeau, Missouri, 63701

  • Adirondack Cancer Care

    Glens Falls, New York, 12801

  • Legacy Mount Hood Medical Center

    Glesham, Oregon, 97030

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Mercy Medical Center

    Grand Rapids, Michigan, 49503

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metropolitan Hospital

    Grand Rapids, Michigan, 49506

  • Spectrum Health Hospital - Blodgett Campus

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute

    Great Falls, Montana, 59405

  • Marin Cancer Institute at Marin General Hospital

    Greenbrae, California, 94904

  • Sutter Health Western Division Cancer Research Group

    Greenbrae, California, 94904

  • Bon Secours St. Francis Health System

    Greenville, South Carolina, 29601

  • Greenville Hospital System Cancer Center

    Greenville, South Carolina, 29605

  • CCOP - Greenville

    Greenville, South Carolina, 29615

  • Saint Rose Hospital

    Hayward, California, 94545

  • Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Cancer Research Center of Hawaii

    Honolula, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Lusitana

    Honolulu, Hawaii, 96813

  • Queen's Cancer Institute at Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital, Incorporated

    Honolulu, Hawaii, 96813

  • OnCare Hawaii, Incorporated - Kuakini

    Honolulu, Hawaii, 96817

  • St. Francis Medical Center

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Community Oncology Group - Independence

    Independence, Ohio, 44131

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64804

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Keesler Medical Center - Keesler Air Force Base

    Kessler Air Force Base, Mississippi, 39534-2519

  • Charles F. Kettering Memorial Hospital

    Kettering, Ohio, 45429

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Gwinnett Medical Center

    Lawrenceville, Georgia, 30045

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Valley Memorial Hospital

    Livermore, California, 94550

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • UMC Southwest Cancer and Research Center

    Lubbock, Texas, 79415

  • MedCentral - Mansfield Hospital

    Mansfield, Ohio, 44903

  • Kennestone Cancer Center at Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • Memorial Hospital of Martinsville and Henry County

    Martinsville, Virginia, 24115

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Middletown Regional Hospital

    Middletown, Ohio, 45044

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Montrose Memorial Hospital Cancer Center

    Montrose, Colorado, 81401

  • Mount Clemens General Hospital

    Mount Clemens, Michigan, 48043

  • Cancer Care Center at Skagit Valley Hospital

    Mount Vernon, Washington, 98273

  • Hackley Hospital

    Muskegon, Michigan, 49443

  • Hematology Oncology Consultants Ltd.

    Naperville, Illinois, 60540

  • Edward Hospital Cancer Center

    Naperville, Illinois, 60566

  • Tulane Cancer Center

    New Orleans, Louisiana, 70112

  • Highland General Hospital

    Oakland, California, 94602

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • Comprehensive Cancer Center at Desert Regional Medical Center

    Palm Springs, California, 92262

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • St. Joseph Mercy Hospital

    Pontiac, Michigan, 48341-2985

  • Comprehensive Cancer Center at Legacy Good Samaritan Hospital & Medical Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Institute of Oncology at Vilnius University

    Portland, Oregon, 97227

  • Valley Hospital - Ridgewood

    Ridgewood, New Jersey, 07450

  • Southern Regional Medical Center

    Riverdale, Georgia, 30274

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

    Rochester, New York, 14642

  • Sutter Roseville Medical Center

    Roseville, California, 95661

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Mercy General Hospital

    Sacramento, California, 95819

  • Seton Cancer Institute - Saginaw

    Saginaw, Michigan, 48601

  • Salem Hospital Regional Cancer Center

    Salem, Oregon, 97309

  • Salina Regional Health Center

    Salina, Kansas, 67401

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • California Pacific Medical Center - California Campus

    San Francisco, California, 94118

  • J.C. Robinson, M.D. Regional Cancer Center

    San Pablo, California, 94806

  • CCOP - Santa Rosa Memorial Hospital

    Sana Rosa, California, 95405

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31403

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

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

    Seattle, Washington, 98114

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195

  • Cancer Treatment Center at Christus Schumpert St. Mary Place

    Shreveport, Louisiana, 71101

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29304

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Providence Cancer Center at Holy Family Hospital

    Spokane, Washington, 99207

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • CCOP - St. Louis-Cape Girardeau

    St Louis, Missouri, 63141

  • David C. Pratt Cancer Center at St. John's Mercy

    St Louis, Missouri, 63141

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • UVMC Cancer Care Center at Upper Valley Medical Center

    Troy, Ohio, 45373

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Pearlman Comprehensive Cancer Center at South Georgia Medical Center

    Valdosta, Georgia, 31603

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • St. John Macomb Hospital

    Warren, Michigan, 48903

  • Central Washington Hospital

    Wenatchee, Washington, 98801

  • Wenatchee Valley Clinic

    Wenatchee, Washington, 98801

  • St. Anthony North Hospital

    Westminster, Colorado, 80030

  • Exempla Lutheran Medical Center

    Wheat Ridge, Colorado, 80033

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • United States Air Force Medical Center Wright-Patterson

    Wright-Patterson AFB, Ohio, 45433-5529

  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital

    Xenia, Ohio, 45385

  • North Star Lodge Cancer Center

    Yakima, Washington, 98902

  • Washington Hematology - Oncology Specialists

    Yakima, Washington, 98902

Other trials in United States

About this study

Official title: Phase II Selection Design Trial Of Concurrent Chemotherapy + Cetuximab Vs. Chemotherapy Followed By Cetuximab In Advanced Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with a monoclonal antibody may kill more tumor cells. It is not yet known whether cetuximab is more effective when given at the same time as chemotherapy or following chemotherapy.

PURPOSE: This randomized phase II trial is studying how well giving cetuximab at the same time as combination chemotherapy works compared to giving cetuximab after combination chemotherapy in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Compare overall survival of patients with selected stage IIIB or stage IV non-small cell lung cancer treated with concurrent vs sequential paclitaxel, carboplatin, and cetuximab.

Secondary

  • Compare response rates (confirmed and unconfirmed, complete and partial) in patients treated with these regimens.
  • Compare the toxic effects of these regimens in these patients.
  • Correlate epidermal growth factor receptor polymorphisms and downstream biomarkers with response to cetuximab in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I (concurrent cetuximab): Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days 1, 8, and 15 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 8. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour once weekly in the absence of disease progression or unacceptable toxicity.
  • Arm II (sequential cetuximab): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for a total of 4 courses (12 weeks) in the absence of disease progression or unacceptable toxicity. Beginning on week 13, patients receive single-agent cetuximab IV over 1 hour (over 2 hours on week 13 only) once weekly in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 9 months.

Conditions
Lung Cancer
Keywords
recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, large cell lung cancer
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.

  • cetuximabDrug

    Arm 1: 400 mg/m2 (Initial dose), 2 hour IV infusion on Day 1, Week 1 only. 250 mg/m2 (Subsequent doses), 1 hour IV infusion, on Day 1 weekly starting at Week 2.

    Arm 2: 400 mg/m2 (Initial dose), 2 hour IV infusion on Week 13 ONLY 250 mg/m2 (Subsequent doses), 1 hour IV infusion, weekly starting at Week 14.

  • carboplatinDrug

    Arm 1: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 2

    Arm 2: AUC=6 30 minute IV infusion immediately following paclitaxel on Day 1 q 21 days x 4 starting at Week 1

  • paclitaxelDrug

    Arm 1: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 4.

    Arm 2: 225 mg/m2 3 hour IV infusion 1 hour following cetuximab on Day 1, q 21 days x 4 Starting at Week 1.

Study groups in NCT00085501
Study groupRoleWhat they receive
1Active comparatorNot described
Receives: Drug: cetuximab; Drug: carboplatin; Drug: paclitaxel
2Active comparatorNot described
Receives: Drug: cetuximab; Drug: carboplatin; Drug: paclitaxel

What is being measured

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

  1. Select a regimen based on overall survival

    To select a regimen based on overall survival via a Phase II selection design of chemotherapy in conjunction with cetuximab (concurrent vs. sequential) for Phase III testing against chemotherapy alone in Stage IIIB and Stage IV non-small cell lung cancer.

    Measured: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

  2. Response rate (confirmed and unconfirmed, complete and partial response)

    To evaluate response rates (confirmed and unconfirmed, complete and partial) of patients with selected Stage IIIB and Stage IV NSCLC treated with paclitaxel and carboplatin with concurrent cetuximab or paclitaxel and carboplatin followed by cetuximab.

    Measured: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

  3. Toxicities

    To evaluate the toxicities of the two treatment regimens in patients with selected Stage IIIB and Stage IV NSCLC.

    Measured: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years

Secondary outcomes (2)

  1. Correlation of epidermal growth factor receptor polymorphisms and downstream biomarkers with response

    To conduct exploratory molecular correlative studies of the EGFR-HER signaling pathways examining activated phosphoproteins, oncogenic mutations and rates of proliferation and apoptosis in patient tissues (see S9925 for details).

    Measured: At prestudy

  2. Evaluate EGFR polymorphisms

    To evaluate EGFR polymorphisms as a potential correlate for response to cetuximab (see S9925 for details).

    Measured: At prestudy and week 5

Timeline

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

  1. First posted11 Jun 2004 (estimated)
  2. Study startJul 2004
  3. Primary completionAug 2007
  4. Study completionJul 2011

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00085501
Sponsor's protocol ID
CDR0000370806
Other IDs
S0342, U10CA032102
Status last verified
Oct 2012
First submitted
10 Jun 2004
Last updated
1 Nov 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Franklin WA, Gandara DR, Kim ES, et al.: SWOG S0342 and S0536: expression of EGFR protein and markers of epithelial-mesenchymal transformation (EMT) in cetuximab/chemotherapy-treated non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-11076, 2009.

  • Mack PC, Holland WS, Redman M, et al.: KRAS mutation analysis in cetuximab-treated advanced stage non-small cell lung cancer (NSCLC): SWOG experience with S0342 and S0536. [Abstract] J Clin Oncol 27 (Suppl15): A-8022, 2009.

  • Hirsch FR, Herbst RS, Olsen C, Chansky K, Crowley J, Kelly K, Franklin WA, Bunn PA Jr, Varella-Garcia M, Gandara DR. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small-cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008 Jul 10;26(20):3351-7. doi: 10.1200/JCO.2007.14.0111.

    PubMed 18612151

  • Herbst RS, Chansky K, Kelly K, et al.: A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. [Abstract] J Clin Oncol 25 (Suppl 18): A-7545, 395s, 2007.

  • Kelly K, Herbst RS, Crowley JJ, et al.: Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer (NSCLC): a randomized phase II selectional trial SWOG 0342. [Abstract] J Clin Oncol 24 (Suppl 18): A-7015, 367s, 2006.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab, carboplatin and paclitaxel in people with Lung Cancer, run by SWOG Cancer Research Network at 163 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 1 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Select a regimen based on overall survival (time frame: From date of registration until the date of progression or date of death from any cause, whichever came first, assessed up to 3 years). The study lists 3 primary outcomes in all. 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 NCT00085501, which also lists 5 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 1 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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