Pemetrexed and Gemcitabine in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Eli Lilly and Company48 enrolled

Overview

This is a Phase 2 study of pemetrexed and gemcitabine chemotherapy given once every 14 days to patients with advanced stage non-small cell lung cancer. This treatment is for patients that have not received any prior chemotherapy treatment for lung cancer. The primary goal is to find out if the tumor gets smaller or disappears with this treatment.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lung Neoplasms

Interventions

pemetrexedDRUG

gemcitabineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Have a diagnosis of advanced stage non-small cell lung cancer. 2. Are able to be active at home and/or work. 3. Have not received chemotherapy for this cancer disease. 4. Have good organ function (for example, most blood work is normal). 5. Have completed any prior radiation treatment at least 4 weeks ago. Exclusion Criteria: 1. Have been treated with an investigational/research drug within the last month. 2. Have cancer that has spread to the brain and is causing symptoms. 3. Have an active infection or other serious medical condition. 4. Have a second cancer in addition to non-small cell lung cancer. 5. Can not stop taking aspirin or other anti-inflammatory agents for 5-8 days.

Locations (5)

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.

Fort Myers, Florida, United States

Marshfield, Minnesota, United States

Outcomes

Primary Outcomes

To find out how often tumors become smaller or disappear in patients with advanced NSCLC treated with gemcitabine followed by pemetrexed once every 14 days. Chemotherapy treatment will be given for up to 12 times or until the cancer disease increases.

Secondary Outcomes

To measure the effects of chemotherapy treatment on:

time until the cancer becomes less;time to cancer re-appears or becomes larger;length of time there is no increase in the amount of cancer;length of time patients survive;

To measure the side-effects from this chemotherapy as given once every 14 days.

Data from ClinicalTrials.gov

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