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A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer


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

Thank you

Trial Information

A Phase 3, Double-Blind, Placebo-Controlled Study of Maintenance Pemetrexed Plus Best Supportive Care Versus Best Supportive Care Immediately Following Induction Treatment for Advanced Non-Small Cell Lung Cancer


Inclusion Criteria:



- Histologic or cytologic diagnosis of NSCLC Stage IIIB (with pleural effusion and/or
positive supraclavicular lymph nodes) or Stage IV prior to induction therapy.

- Patients must have had one of the following induction therapies for treatment for
Stage IIIB (with pleural effusion and/or positive supraclavicular lymph nodes) or IV
NSCLC: Gemcitabine plus carboplatin, paclitaxel plus carboplatin, or docetaxel plus
carboplatin, gemcitabine plus cisplatin, paclitaxel plus cisplatin or docetaxel plus
cisplatin.

- Patients must have received only one chemotherapeutic doublet lasting precisely four
cycles.

- Induction regimens must be based on 21-day cycles.

- Documented evidence of a tumor response of CR, PR or SD. Tumor assessment must occur
between Cycle 4 (Day 1) of induction therapy and the date of randomization. This
response does not have to be confirmed in order for the patient to be randomized.
(Positron emission tomography (PET) scans and ultrasounds may not be used for lesion
measurements for response determination.

Exclusion Criteria:

- With the exception of those chemotherapies listed as inclusion criterion, patients
will not be included if they have received prior systemic anticancer therapy
(including adjuvant early-stage treatment for NSCLC) or any systemic treatment for
any other cancer.

- Have received treatment within the last 30 days with a drug that has not received
regulatory approval for any indication at the time of study entry.

- Inability to comply with protocol or study procedures.

- A serious concomitant systemic disorder that would compromise the patient's ability
to complete the study.

- A serious cardiac condition, such as myocardial infarction within 6 months, angina,
or heart disease, as defined by the New York Heart Association Class III or IV.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival time (PFS)

Outcome Time Frame:

baseline to measured progressive disease

Safety Issue:

No

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:

5122

NCT ID:

NCT00102804

Start Date:

March 2005

Completion Date:

December 2014

Related Keywords:

  • Non Small Cell 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.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.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.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.Portsmouth, New Hampshire  03801
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.Marshfield, Wisconsin  54449