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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Non-Small Cell Lung Cancer

Thank you

Trial Information

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


This is a multicenter, randomized, open-label, Phase III trial. Eligible patients 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.
Patients randomized to Pemetrexed + Carboplatin + Pemetrexed will receive folic acid,
vitamin B12, and dexamethasone as stated in the pemetrexed label. Before administration of
paclitaxel, patients randomized to Paclitaxel + Carboplatin + Bevacizumab will receive
premedication (dexamethasone, diphenhydramine, and cimetidine or ranitidine) as recommended
in the paclitaxel label.


Inclusion Criteria:



- a histologic or cytologic diagnosis of advanced 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. Patients 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 patient'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 . Patients with M1a disease with
pleural effusions are eligible if the effusions can be adequately controlled.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival without grade 4 toxicity as measured by the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.

Outcome Time Frame:

Baseline to measured progressive disease or treatment discontinuation, assessed at 3 years.

Safety Issue:

Yes

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

13258

NCT ID:

NCT00948675

Start Date:

September 2009

Completion Date:

June 2013

Related Keywords:

  • Advanced Non-Small Cell Lung Cancer
  • Advanced Non-Small Cell Lung Cancer of Nonsquamous Histology
  • Advanced Lung Cancer
  • Non-Small Cell Lung Cancer
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

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.Iowa City, Iowa  
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.Durham, North Carolina  
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.Phoenix, Arizona  85012
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.Greenbrae, California  94904
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.Jacksonville, Florida  32256
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.Athens, Georgia  30607
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.Chicago, Illinois  60674
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.Indianapolis, Indiana  46227
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.Kalamazoo, Michigan  49048
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.Minneapolis, Minnesota  55404
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.St Joseph, Missouri  64507
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.Billings, Montana  59101
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.Cincinnati, Ohio  45267
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.Tulsa, Oklahoma  74136
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.Dunmore, Pennsylvania  18512
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.Greenville, South Carolina  29605
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.Memphis, Tennessee  38138
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.Bedford, Texas  76022
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.Salt Lake City, Utah  84106
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.Norfolk, Virginia  23502
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.Seattle, Washington  98133
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.Albuquerque, New Mexico  87106
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.Lexington, Kentucky  40536
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.Coeur D'Alene, Idaho  83814
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.Fargo, North Dakota  58122