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Study of Participants With Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00948675
Recruitment Status : Completed
First Posted : July 29, 2009
Results First Posted : April 2, 2014
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to compare the regimens of pemetrexed, carboplatin with pemetrexed maintenance and paclitaxel, carboplatin, bevacizumab with bevacizumab maintenance in participants with Stage IV nonsquamous non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Advanced Non-Small Cell Lung Cancer Drug: Pemetrexed Drug: Carboplatin Drug: Paclitaxel Biological: Bevacizumab Phase 3

Detailed Description:
This is a multicenter, randomized, open-label, Phase III trial. Eligible participants will be randomized in a 1:1 ratio to receive pemetrexed and carboplatin followed by pemetrexed or paclitaxel, carboplatin, and bevacizumab followed by bevacizumab as their study treatment. Participants randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid, vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of paclitaxel, participants randomized to Paclitaxel + Carboplatin + Bevacizumab will receive premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended in the paclitaxel label.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 361 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Pemetrexed Plus Carboplatin Followed by Maintenance Pemetrexed vs Paclitaxel Plus Carboplatin and Bevacizumab Followed by Maintenance Bevacizumab in Patients With Advanced NCSLC of Nonsquamous Histology
Actual Study Start Date : September 1, 2009
Actual Primary Completion Date : January 31, 2013
Actual Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pemetrexed + Carboplatin + Pemetrexed
Pemetrexed and Carboplatin followed by Pemetrexed
 Drug: Pemetrexed
Induction therapy: 500 milligrams/square meter (mg/m²) given intravenously every 21 days for 4 cycles. Maintenance therapy: 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation.
Other Name: ALIMTA, LY231514

Drug: Carboplatin
Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.
Active Comparator: Paclitaxel + Carboplatin + Bevacizumab
Paclitaxel, Carboplatin, and Bevacizumab followed by Bevacizumab
 Drug: Carboplatin
Induction Therapy (every 21 days for 4 cycles): Area Under the Curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes.

Drug: Paclitaxel
Induction Therapy (every 21 days for 4 cycles): 200 mg/m² intravenously infused over 3 hours

Biological: Bevacizumab
Induction therapy: 15 milligrams/kilogram (mg/kg) given intravenously every 21 days for 4 cycles. Maintenance therapy: 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation.


Outcome Measures
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Primary Outcome Measures :
  1. Progression Free Survival Without Grade 4 Toxicity (G4PFS) as Measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 [ Time Frame: Randomization to measured progressive disease or treatment discontinuation up to 39.49 months ]
    G4PFS was defined as the duration from the date of randomization to the earliest occurrence date of one of the following three events: Common Terminology Criteria (CTC) grade 4 adverse events (G4AEs), or progressive disease (PD) or death from any cause, whichever occurred earlier. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD is ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no G4AEs, or PD, or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Randomization to measured progressive disease up to 39.49 months ]
    PFS was defined as the duration from the date of randomization to the date of progressive disease (PD) or death from any cause. PD was determined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. PD was ≥20% increase in sum of longest diameter of target lesions or the appearance of new lesions. For participants who had no PD or death at the time of the data inclusion cutoff, PFS was censored at their last objective progression-free disease assessment prior to the cutoff date or the date of initiation of subsequent systemic anticancer therapy.

  2. Overall Survival (OS) [ Time Frame: Randomization to date of death from any cause up to 39.49 months ]
    OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive at the time of the data inclusion cutoff, OS was censored at the last date the participant was known to be alive.

  3. Percentage of Participants With Complete Response or Partial Response (Overall Tumor Response Rate) [ Time Frame: Baseline to date of objective progressive disease up to 39.49 months ]
    Overall Response rate (ORR) was the percentage of participants with a confirmed complete response (CR) or partial response (PR), as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesions. ORR was calculated as a total number of participants with CR or PR from the start of study treatment until disease progression or recurrence divided by the total number of participants treated, then multiplied by 100.

  4. Disease Control Rates Defined as Complete Response (CR), Partial Response (PR), and Stable Disease (SD) [ Time Frame: Baseline to date of objective progressive disease up to 39.49 months ]
    Disease control rate was the percentage of participants with a confirmed CR, PR or SD, as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.0. CR was the disappearance of all target and non-target lesions; PR was a ≥30% decrease in sum of longest diameter of target lesions without new lesion and progression of non-target lesion; SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Disease control rate was calculated as a total number of participants with CR or PR or SD divided by the total number of participants treated, then multiplied by 100.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a histologic or cytologic diagnosis of advanced non-small cell lung cancer (NSCLC) [Stage IV from the American Joint Committee on Cancer Staging Criteria (AJCC) staging system, version 7.0, including both M1a and M1b], other than predominantly squamous cell histology, that is not amenable to curative therapy. Participants may not have received any prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy, including adjuvant therapy, for any stage of NSCLC.
  • prior radiation therapy is allowed to < 25% of the bone marrow; however, prior radiation to the whole pelvis not allowed.
  • good performance status.
  • adequate organ function.
  • estimated life expectancy of at least 12 weeks.

Exclusion Criteria:

  • known central nervous system (CNS) disease, other than treated brain metastasis.
  • major surgical procedure, open biopsy, open pleurodesis, or significant traumatic injury within 28 days prior to study or have an anticipated need for major surgery during the study.
  • core biopsy or other minor surgical procedure, excluding placement of vascular access device, closed pleurodesis, thoracentesis, and mediastinoscopy, within 7 days prior to study.
  • history of gastrointestinal fistula, perforation, or abscess, inflammatory bowel disease, or diverticulitis.
  • currently receiving ongoing treatment with full-dose warfarin or equivalent
  • significant vascular disease within 6 months prior to Day 1 of Cycle 1.
  • evidence of bleeding diathesis or coagulopathy.
  • serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol.
  • serious cardiac condition, such as myocardial infarction, angina, or heart disease.
  • inadequately controlled hypertension.
  • any prior history of hypertensive crisis or hypertensive encephalopathy.
  • serious, nonhealing wound, active ulcer, or untreated bone fracture.
  • another active malignancy, other than superficial basal cell and superficial squamous (skin) cell, or carcinoma in situ of the cervix within the last 5 years.
  • previously received treatment with paclitaxel, carboplatin, pemetrexed, or bevacizumab (prior intravitreal administration of bevacizumab does not preclude study participation).
  • pregnant or breast-feeding.
  • history of stroke or transient ischemic attack within 6 months prior to study.
  • known sensitivity to any component of paclitaxel, carboplatin, pemetrexed, or bevacizumab.
  • history of hemoptysis within 3 months prior to randomization.
  • unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • unwilling to take folic acid or vitamin B12 supplementation.
  • clinically significant third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage. Participants with M1a disease with pleural effusions are eligible if the effusions can be adequately controlled.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948675


Locations
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United States, Arizona
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Scottsdale, Arizona, United States, 85259
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Tucson, Arizona, United States, 85715
United States, California
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Mission Hills, California, United States, 91345
United States, Florida
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Aventura, Florida, United States, 33180
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Daytona Beach, Florida, United States, 32114
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Fort Myers, Florida, United States, 33916
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Gainesville, Florida, United States, 32610
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Jacksonville, Florida, United States, 32256
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Port Saint Lucie, Florida, United States, 34952
United States, Georgia
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Athens, Georgia, United States, 30607
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Augusta, Georgia, United States, 30901
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Macon, Georgia, United States, 31201
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Marietta, Georgia, United States, 30060
United States, Idaho
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Post Falls, Idaho, United States, 83854
United States, Illinois
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Gurnee, Illinois, United States, 60031
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Joliet, Illinois, United States, 60435
United States, Indiana
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Goshen, Indiana, United States, 46526
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New Albany, Indiana, United States, 47150
United States, Iowa
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Sioux City, Iowa, United States, 51101
United States, Kentucky
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Mount Sterling, Kentucky, United States, 40353
United States, Michigan
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Ann Arbor, Michigan, United States, 48106
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Lansing, Michigan, United States, 48910
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Southfield, Michigan, United States, 48075
United States, Minnesota
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Rochester, Minnesota, United States, 55905
United States, Missouri
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Branson, Missouri, United States, 65616
United States, Montana
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Billings, Montana, United States, 59107
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Great Falls, Montana, United States, 59405
United States, New Mexico
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Albuquerque, New Mexico, United States, 87106
United States, North Carolina
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Burlington, North Carolina, United States, 27215
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High Point, North Carolina, United States, 27262
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
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Fargo, North Dakota, United States, 58122
United States, Ohio
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Cincinnati, Ohio, United States, 45242
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
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DuBois, Pennsylvania, United States, 15801
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Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
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Columbia, South Carolina, United States, 29210
United States, Tennessee
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Chattanooga, Tennessee, United States, 37404
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Memphis, Tennessee, United States, 38119
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Nashville, Tennessee, United States, 37203
United States, Texas
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Fort Worth, Texas, United States, 76104
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Houston, Texas, United States, 77030
United States, Utah
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Salt Lake City, Utah, United States, 84106
United States, Virginia
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Richmond, Virginia, United States, 23230
United States, Washington
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Kennewick, Washington, United States, 99336
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00948675    
Other Study ID Numbers: 13258
H3E-US-S130 ( Other Identifier: Eli Lilly and Company )
First Posted: July 29, 2009    Key Record Dates
Results First Posted: April 2, 2014
Last Update Posted: October 29, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
Advanced Lung Cancer
Non-Small Cell Lung Cancer
Lung Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Bevacizumab
Carboplatin
Pemetrexed
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors