Pemetrexed Plus Gemcitabine for Patients With Locally Advanced or Metastatic NSCLC Who Have Not Had Previous Chemotherapy.

Lilly

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: gemcitabine; Drug: pemetrexed

Study type: Interventional

Funder types: Industry

Identifiers

NCT00061464

7211

H3E-US-JMFX

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed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 1-2 weeks
• Brain metastasis that is uncontrolled
• Active infection or other serious condition

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)