Pemetrexed Plus Gemcitabine as Front-Line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Clinical Trial

Eli Lilly and Company48 enrolled

Overview

The purposes of this study are to determine: 1. The safety of Pemetrexed plus Gemcitabine and any side effects that might be associated with the combination of these two drugs. 2. Whether Pemetrexed plus Gemcitabine can help patients with non-small cell lung cancer live longer. 3. Whether Pemetrexed plus Gemcitabine can make the tumor smaller or disappear, and for how long. 4. To see if patients feel better while taking Pemetrexed plus Gemcitabine.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Non-Small Cell Lung Cancer that can be treated with chemotherapy. * Have received no prior chemotherapy for Non-Small Cell Lung Cancer. * Have at least one measurable lesion. * Have an adequate performance status. * Sign an informed consent. Exclusion Criteria: * A female who is pregnant or breastfeeding. * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed. * Treatment with radiation therapy within the last 4 weeks. * Brain metastasis that is uncontrolled. * Active infection or other serious condition.

Locations (5)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559 or 317-615-4559) Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Palo Alto, California, United States

Columbia, Missouri, United States

Kansas City, Missouri, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Great Falls, Montana, United States

Seattle, Washington, United States

Outcomes

Primary Outcomes

To assess the objective tumor response rate of gemcitabine plus pemetrexed in patients with advanced or metastatic non-small-cell lung cancer.

Secondary Outcomes

To assess time to objective tumor response for responding patients

To assess duration of response for responding patients

To assess time to treatment failure for patients

To assess progression free survival of patients

To assess time to progressive disease for patients

To assess survival time for patients

To characterize the toxicities of gemcitabine plus pemetrexed in this patient population