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

ALIMTA Plus Gemcitabine as Front-line Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer: A Phase II Clinical Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00061451

Enrollment

Registered

2003-05-29

Start date

2002-12-31

Completion date

2006-09-30

Last updated

2010-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

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.

Interventions

DRUGPemetrexed

DRUGGemcitabine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating Pemetrexed.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 4 weeks. * Brain metastasis that is uncontrolled. * Active infection or other serious condition.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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 objective tumor response for responding patients	—
To assess survival time for patients	—
To characterize the toxicities of gemcitabine plus pemetrexed in this patient population	—
To assess time to progressive disease for patients	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026