AzTrials
AzTrials

Recurrent Non-Small Cell Lung CarcinomaPhase 2NCT00698815

Pemetrexed and/or Sunitinib as Second-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

A Phase 2 study testing Laboratory Biomarker Analysis, Pemetrexed Disodium and Sunitinib Malate in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIB Non-Small Cell Lung Cancer AJCC v7, run by National Cancer Institute (NCI) at 129 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

This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Pemetrexed Disodium and Sunitinib Malate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
129 sitesUnited States
Study dates
15 Apr 2008to 1 Dec 2011
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

  • Histologic documentation: histologic or cytologic documentation of NSCLC
  • Stage: IIIB/IV with evidence of disease progression following first-line therapy
  • Tumor site: lung (non-small cell)
  • No cavitary lesions
  • Only one prior chemotherapy regimen in the first-line stage IIIB/IV setting is allowed; this could have been either a platinum- or non-platinum-based regimen
  • First-line therapy must be completed >= 28 days before registration
Show all 43Show fewer
  • Prior adjuvant therapy is allowed provided the patient had one previous regimen in the advanced stage IIIB/IV setting
  • At least 28 days from prior major surgery and at least 14 days from any prior radiotherapy before registration
  • No prior inhibitors of VEGF receptor (VEGFR) (e.g., SU5416, SU6668, AZ6474, SU11248, PTK787, AZD2171, AEE-788, sorafenib); prior treatment with epidermal growth factor receptor (EGFR) inhibitors and bevacizumab is allowed, provided at least 4 weeks has elapsed
  • No prior pemetrexed
  • Patients must have measurable or non-measurable disease
  • Measurable disease
  • Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral computed tomography (CT) scan
  • Non-measurable disease
  • All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions
  • Lesions that are considered non-measurable include the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Lymphangitis cutis/pulmonis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Pregnant or nursing mothers are not eligible for this study; patients in their child bearing years must have a baseline negative pregnancy test (in the case of females); males and females must practice appropriate contraceptive measures during the period of protocol therapy and for 6 months after completion of protocol therapy; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives (Norplant), or double barrier method (diaphragm plus condom)
  • No ongoing cardiac dysrhythmias, atrial fibrillation, or history of corrected QT interval (QTc interval) > 500 msec (within 2 years prior to registration); the use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide) is not recommended while on protocol therapy
  • Patients with class I New York Heart Association (NYHA) heart failure are eligible; patients with a history of class II NYHA heart failure are eligible, provided they meet at least one of the following criteria:
  • Patients with a history of class II heart failure who are asymptomatic on treatment
  • Patients with prior anthracycline exposure
  • Patients who have received central thoracic radiation that included the heart in the radiotherapy port
  • Patients with a history of symptomatic congestive heart failure within 12 months prior to entry are not eligible
  • No myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft or stenting, cerebrovascular accident or transient ischemic attack within the last year
  • Patients with hypertension that cannot be controlled by medications (> 150/100 mmHg despite optimal medical therapy) are not eligible
  • Patients who require use of therapeutic anticoagulation for thromboembolic disease are not eligible; Note: low doses of Coumadin (up to 2 mg daily) are permitted for prophylaxis of thrombosis
  • No history of venous thrombosis, pulmonary embolism, or hypercoagulopathy syndrome
  • No history of pulmonary hemorrhage, bleeding diathesis, or evidence of hemoptysis; patients with blood-tinged or blood-streaked sputum will be permitted on study if the hemoptysis amounts to less than 5 mL of blood per episode and less than 10 mL of blood per 24-hour period in the best estimate of the investigator
  • Patients with a history of hypothyroidism or hyperthyroidism are eligible, provided they are currently euthyroid
  • None of the following within 28 days of beginning treatment: abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, serious or non-healing wound, ulcer, or bone fracture
  • The use of the following specific inhibitors and inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) is not permitted; the following inhibitors of CYP3A4 are prohibited within 7 days before and during treatment with sunitinib: azole antifungals (ketoconazole, itraconazole), diltiazem, clarithromycin, erythromycin, verapamil, delavirdine, and human immunodeficiency virus (HIV) protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir); the following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib: rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's Wort, efavirenz, tipranavir
  • Other inhibitors and inducers of CYP3A4 may be used if necessary, but their use is discouraged
  • No symptomatic or untreated central nervous system (CNS) metastases; patients with CNS metastases must be asymptomatic, must have received definitive therapy (>= 6 weeks since resection or >= 2 weeks since radiotherapy) for brain metastases, and be off steroids or on a stable dose for 2 weeks prior to registration
  • No chronic daily treatment with aspirin (> 325 mg/day) or non-steroidal antiinflammatory agents known to inhibit platelet function; treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and/or cilostazol (Pletal) is not allowed
  • No pleural effusions or ascites that are detectable on physical exam

Who cannot join

None listed.

Trial locations and contacts

129 sites in 1 country.

129 sites in 1 country

United States129 sites

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92807

  • Arroyo Grande Community

    Arroyo Grande, California, 93420

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Harold Alfond Center for Cancer Care

    Augusta, Maine, 04330

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • University of Vermont College of Medicine

    Burlington, Vermont, 05405

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Jesse Brown Veterans Affairs Medical Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Exeter Hospital

    Exeter, New Hampshire, 03833

  • McLeod Regional Medical Center

    Florence, South Carolina, 29506

  • Kaiser Permanente Hospital

    Fontana, California, 92335

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Kaiser Permanente - Harbor City

    Harbor City, California, 90710

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Saint Mary's Medical Center

    Huntington, West Virginia, 25702

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Iowa City VA Healthcare System

    Iowa City, Iowa, 52246

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Jupiter Medical Center

    Jupiter, Florida, 33458

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente-Cadillac

    Los Angeles, California, 90034

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Contra Costa Regional Medical Center

    Martinez, California, 94553-3156

  • Memorial Hospital Of Martinsville

    Martinsville, Virginia, 24115

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • Middlesex Hospital

    Middletown, Connecticut, 06457

  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

    Milford, Massachusetts, 01757

  • University of Minnesota/Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • El Camino Hospital

    Mountain View, California, 94040

  • Long Island Jewish Medical Center

    New Hyde Park, New York, 11040

  • Northwell Health/Center for Advanced Medicine

    New Hyde Park, New York, 11040

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Newton-Wellesley Hospital

    Newton, Massachusetts, 02462

  • Lakeland Community Hospital

    Niles, Michigan, 49120

  • Great Plains Regional Medical Center

    North Platte, Nebraska, 69103

  • Norwalk Hospital

    Norwalk, Connecticut, 06856

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Alegent Health Immanuel Medical Center

    Omaha, Nebraska, 68122

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • PCR Oncology

    Pismo Beach, California, 93449

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • University of California San Diego

    San Diego, California, 92103

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92069

  • Doctors Medical Center- JC Robinson Regional Cancer Center

    San Pablo, California, 94806

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Missouri Baptist Medical Center

    St Louis, Missouri, 63131

  • Center for Cancer Care and Research

    St Louis, Missouri, 63141

  • Comprehensive Cancer Care PC

    St Louis, Missouri, 63141

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • State University of New York Upstate Medical University

    Syracuse, New York, 13210

  • Syracuse Veterans Administration Medical Center

    Syracuse, New York, 13210

  • Marion L Shepard Cancer Center at Vidant Beaufort Hospital

    Washington, North Carolina, 27889

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina, 28401

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Kaiser Permanente

    Woodland Hills, California, 91367

Other trials in United States

About this study

Official title: A Randomized Phase II Study to Assess the Efficacy of Pemetrexed or Sunitinib (NSC # 736511) or Pemetrexed Plus Sunitinib in the Second-Line Treatment of Advanced Non-small Cell Lung Cancer

This randomized phase II trial studies pemetrexed disodium and sunitinib malate to compare how well they work when given alone or together as second-line therapy in treating patients with stage IIIB or stage IV non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether pemetrexed disodium and sunitinib malate are more effective when given alone or together in treating non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate the 18 week progression-free survival rate of pemetrexed (pemetrexed disodium) alone (Arm I), sunitinib (sunitinib malate) alone (Arm II) and pemetrexed plus sunitinib (Arm III) in the second-line setting of advanced non-small cell lung cancer (NSCLC).

SECONDARY OBJECTIVES:

  1. To compare the progression-free survival of the three arms. II. To estimate the response rate, duration of response, rate of stable disease, overall survival and to characterize the toxicity profiles of the three arms.

III. To estimate the response rate, duration of response, rate of stable disease, overall survival and toxicity of sunitinib in those patients on Arm I that receive this regimen in the third line setting.

IV. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer.

  1. To test change in tumor size at 6 weeks (after 2 cycles of therapy, typically the first evaluation point in this type of study) as an early predictor of therapeutic activity in second-line treatment of non-small cell lung cancer.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive pemetrexed disodium intravenously (IV) over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.

ARM II: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.

ARM III: Patients receive pemetrexed disodium IV over 10 minutes on day 1 and sunitinib malate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.

After completion of study treatment, patients are followed up every 6 weeks until disease progression and then every 6 months for 2 years.

Being tested
Laboratory Biomarker Analysis, Pemetrexed Disodium, Sunitinib Malate
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pemetrexed DisodiumDrug

    Also called Alimta, 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

    Given IV

  • Sunitinib MalateDrug

    Also called SU011248, SU11248, sunitinib, Sutent

    Given PO

Study groups in NCT00698815
Study groupRoleWhat they receive
Arm I (pemetrexed)ExperimentalPatients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive sunitinib malate as in Arm II as third-line therapy.
Receives: Other: Laboratory Biomarker Analysis; Drug: Pemetrexed Disodium
Arm II (sunitinib)ExperimentalPatients receive sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive pemetrexed disodium as in Arm I as third-line therapy.
Receives: Other: Laboratory Biomarker Analysis; Drug: Sunitinib Malate
Arm III (pemetrexed and sunitinib)ExperimentalPatients receive pemetrexed disodium 500 mg/m^2 IV over 10 minutes on day 1 and sunitinib malate at 37.5 mg PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with documented disease progression may then receive third-line therapy at the discretion of the treating physician.
Receives: Other: Laboratory Biomarker Analysis; Drug: Pemetrexed Disodium; Drug: Sunitinib Malate

What is being measured

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

  1. 18 Week Progression-free Survival (PFS) Rate

    The 18 week progression-free survival rate was defined as the proportion of patients that were alive and progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.

    Measured: At 18 weeks

Secondary outcomes (3)

  1. PFS

    PFS was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.

    Measured: Time from randomization to disease progression and death of any cause, whichever comes first (up to 3 years)

  2. Overall Response Rate

    The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

    Measured: Duration of treatment (up to 3 years)

  3. Overall Survival (OS)

    OS is defined as the time from patient randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

    Measured: Time from randomization to death (up to 3 years)

Timeline

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

  1. First posted17 Jun 2008 (estimated)
  2. Study start15 Apr 2008
  3. Primary completion1 Dec 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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00698815
Sponsor's protocol ID
NCI-2009-00471
Other IDs
NCI-2009-00471, CDR0000589102, CALGB 30704, CALGB-30704, U10CA180821, U10CA031946
Status last verified
Jan 2022
First submitted
14 Jun 2008
Last updated
8 Feb 2022

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis, Pemetrexed Disodium and Sunitinib Malate in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIB Non-Small Cell Lung Cancer AJCC v7, run by National Cancer Institute (NCI) at 129 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 43 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: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 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 19 Mar 2015). 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?

18 Week Progression-free Survival (PFS) Rate (time frame: At 18 weeks). 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 NCT00698815.

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 8 Feb 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in