NCT00762034

Brief Summary

This study will compare overall survival in participants with Stage IIIB or IV nonsquamous non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
939

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline
Completed

Started Dec 2008

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach
1 country

67 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 28, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 21, 2015

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

September 26, 2008

Results QC Date

March 28, 2013

Last Update Submit

November 16, 2015

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Overall survival (OS) is the duration from date of randomization to date of death from any cause. Participants were censored at the date they were last known to be alive.

    Baseline to date of death from any cause (up to 37.06 months)

Secondary Outcomes (27)

  • Percentage of Participants With a Complete Response (CR) and Partial Response (PR) (Overall Response Rate)

    Baseline to measured progressive disease (up to 37.06 months)

  • Percentage of Participants With a Complete Response (CR), Partial Response (PR), and Stable Disease (SD) (Disease Control Rate)

    Baseline to measured progressive disease (up to 37.06 months)

  • Progression Free Survival Time

    Baseline to measured progressive disease or date of death from any cause (up to 33.54 months)

  • Time to Progressive Disease

    Baseline to measured progressive disease (up to 37.06 months)

  • Safety and Toxicity Profile of Study Treatments

    Baseline to study endpoint (up to 37.06 months)

  • +22 more secondary outcomes

Study Arms (2)

Pem/Carbo/Bev

EXPERIMENTAL

Pemetrexed (Pem), carboplatin (Carbo) and bevacizumab (Bev) followed by pemetrexed and bevacizumab

Drug: PemetrexedDrug: CarboplatinBiological: Bevacizumab

Pac/Carbo/Bev

ACTIVE COMPARATOR

Paclitaxel (Pac), carboplatin (Carbo) and bevacizumab (Bev) followed by bevacizumab

Drug: PaclitaxelDrug: CarboplatinBiological: Bevacizumab

Interventions

PemetrexedDRUG

Induction therapy 500 milligram per meter squared (mg/m\^2) intravenously (IV) every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days

Also known as: Alimta, LY231514
Pem/Carbo/Bev
PaclitaxelDRUG

Induction therapy 200 mg/m\^2 IV every 21 days (with carboplatin and bevacizumab) for up to 4 cycles of 21 days

Pac/Carbo/Bev
CarboplatinDRUG

Induction therapy area under the concentration curve (AUC) 6 IV every 21 days for up to 4 cycles of 21 days

Pac/Carbo/BevPem/Carbo/Bev
BevacizumabBIOLOGICAL

Induction therapy 15 milligrams per kilogram (mg/kg) IV every 21 days for up to 4 cycles of 21 days

Pac/Carbo/BevPem/Carbo/Bev

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • You must sign an informed consent document for clinical research.
  • You must have Stage IIIB or Stage IV nonsquamous non-small cell lung cancer.
  • You must not have received any prior treatment for your disease.
  • Prior radiation therapy is allowed to \< 25% of the bone marrow; however, prior radiation to the whole pelvis is not allowed. If you have had radiation therapy to the chest, you are not eligible to participate.
  • You must be at least 18 years of age or older.
  • You must have measureable tumor lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) or disease can be evaluated on computed tomography (CT) scan.
  • Your test results assessing the function of blood forming tissue, kidneys and liver must be satisfactory.
  • Women must be sterile, postmenopausal or on contraception and men must be sterile (for example post-vasectomy) or on contraception.

You may not qualify if:

  • You cannot have clinically significant third-space fluid collections (e.g. ascites or pleural effusions that cannot be controlled by drainage or other procedures).
  • You cannot have Non-small Cell Lung Carcinoma (NSCLC) of predominantly squamous cell histology.
  • You cannot have known central nervous system (CNS) disease, other than stable, treated brain metastasis.
  • You cannot have undergone a surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days of starting the study treatment, or have an anticipated need for major surgery during the study.
  • You cannot have a history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
  • You are currently receiving ongoing treatment with full-dose warfarin or equivalent.
  • You cannot have significant vascular disease, serious cardiac conditions (such as heart attack), stroke or transient ischemic attack within 6 months of the trial.
  • You cannot have evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
  • You cannot have inadequately controlled hypertension, or a history of hypertensive crisis or hypertensive encephalopathy.
  • You cannot have a serious, nonhealing wound, active ulcer, or untreated bone fracture.
  • You cannot have another form of cancer, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
  • You cannot have received an investigational treatment within 30 days prior to the trial.
  • You cannot have previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab.
  • You cannot be pregnant or breast-feeding.
  • You cannot have a known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (67)

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Fayetteville, Arkansas, 72703, United States

Location

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Jonesboro, Arkansas, 72401, United States

Location

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Alhambra, California, 91801, United States

Location

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Bakersfield, California, 93309, United States

Location

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Duarte, California, 91010, United States

Location

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Fountain Valley, California, 92708, United States

Location

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Fullerton, California, 92835, United States

Location

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La Verne, California, 91750, United States

Location

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Long Beach, California, 90813, United States

Location

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Los Angeles, California, 90095, United States

Location

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Northridge, California, 91325, United States

Location

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Rancho Mirage, California, 92270, United States

Location

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Redondo Beach, California, 90277, United States

Location

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Santa Barbara, California, 93105, United States

Location

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Santa Maria, California, 93454, United States

Location

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Santa Rosa, California, 95403, United States

Location

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Grand Junction, Colorado, 81501, United States

Location

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Boca Raton, Florida, 33486, United States

Location

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Coral Springs, Florida, 33065, United States

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Fort Myers, Florida, 33916, United States

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Jacksonville, Florida, 32256, United States

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Lake Worth, Florida, 33467, United States

Location

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Melbourne, Florida, 32901, United States

Location

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Orlando, Florida, 32804, United States

Location

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Pembroke Pines, Florida, 33028, United States

Location

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Port Saint Lucie, Florida, 34952, United States

Location

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Stuart, Florida, 34994, United States

Location

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Athens, Georgia, 30607, United States

Location

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Augusta, Georgia, 30901, United States

Location

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Fort Gordon, Georgia, 30905, United States

Location

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Chicago, Illinois, 60612, United States

Location

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Gurnee, Illinois, 60031, United States

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Skokie, Illinois, 60077, United States

Location

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New Albany, Indiana, 47150, United States

Location

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Wichita, Kansas, 67214, United States

Location

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Louisville, Kentucky, 40205, United States

Location

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Baton Rouge, Louisiana, 70809, United States

Location

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Baltimore, Maryland, 21237, United States

Location

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Bethesda, Maryland, 20817, United States

Location

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Chevy Chase, Maryland, 20815, United States

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Frederick, Maryland, 21701, United States

Location

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Rockville, Maryland, 20850, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Framingham, Massachusetts, 01701, United States

Location

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Lambertville, Michigan, 48144, United States

Location

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Duluth, Minnesota, 55805, United States

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Minneapolis, Minnesota, 55417, United States

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St Louis, Missouri, 63110, United States

Location

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Reno, Nevada, 89502, United States

Location

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Stony Brook, New York, 11794, United States

Location

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The Bronx, New York, 10467, United States

Location

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Chapel Hill, North Carolina, 27514, United States

Location

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Cincinnati, Ohio, 45242, United States

Location

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Columbus, Ohio, 43219, United States

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Oklahoma City, Oklahoma, 73120, United States

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Tulsa, Oklahoma, 74136, United States

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Kittanning, Pennsylvania, 16201, United States

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Willow Grove, Pennsylvania, 19090, United States

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Columbia, South Carolina, 29210, United States

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Knoxville, Tennessee, 37920, United States

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Memphis, Tennessee, 38120, United States

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San Antonio, Texas, 78229, United States

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The Woodlands, Texas, 77380, United States

Location

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Abingdon, Virginia, 24211, United States

Location

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Richmond, Virginia, 23230, United States

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Tacoma, Washington, 98405, United States

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Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (4)

  • Spigel DR, Patel JD, Reynolds CH, Garon EB, Hermann RC, Govindan R, Olsen MR, Winfree KB, Chen J, Liu J, Guba SC, Socinski MA, Bonomi P. Quality of life analyses from the randomized, open-label, phase III PointBreak study of pemetrexed-carboplatin-bevacizumab followed by maintenance pemetrexed-bevacizumab versus paclitaxel-carboplatin-bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Thorac Oncol. 2015 Feb;10(2):353-9. doi: 10.1097/JTO.0000000000000277.

    PMID: 25611228DERIVED

  • Reynolds CH, Patel JD, Garon EB, Olsen MR, Bonomi P, Govindan R, Pennella EJ, Liu J, Guba SC, Li S, Spigel DR, Hermann RC, Socinski MA, Obasaju CK. Exploratory Subset Analysis of African Americans From the PointBreak Study: Pemetrexed-Carboplatin-Bevacizumab Followed by Maintenance Pemetrexed-Bevacizumab Versus Paclitaxel-Carboplatin-Bevacizumab Followed by Maintenance Bevacizumab in Patients With Stage IIIB/IV Nonsquamous Non-Small-Cell Lung Cancer. Clin Lung Cancer. 2015 May;16(3):200-8. doi: 10.1016/j.cllc.2014.11.004. Epub 2014 Nov 18.

    PMID: 25516338DERIVED

  • Patel JD, Socinski MA, Garon EB, Reynolds CH, Spigel DR, Olsen MR, Hermann RC, Jotte RM, Beck T, Richards DA, Guba SC, Liu J, Frimodt-Moller B, John WJ, Obasaju CK, Pennella EJ, Bonomi P, Govindan R. PointBreak: a randomized phase III study of pemetrexed plus carboplatin and bevacizumab followed by maintenance pemetrexed and bevacizumab versus paclitaxel plus carboplatin and bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013 Dec 1;31(34):4349-57. doi: 10.1200/JCO.2012.47.9626. Epub 2013 Oct 21.

    PMID: 24145346DERIVED

  • Patel JD, Bonomi P, Socinski MA, Govindan R, Hong S, Obasaju C, Pennella EJ, Girvan AC, Guba SC. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer. 2009 Jul;10(4):252-6. doi: 10.3816/CLC.2009.n.035.

    PMID: 19632943DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

PemetrexedPaclitaxelCarboplatinBevacizumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination ComplexesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMC - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2008

First Posted

September 30, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2012

Study Completion

December 1, 2014

Last Updated

December 21, 2015

Results First Posted

November 28, 2013

Record last verified: 2015-11

Locations

US(67)