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

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

NCT00061464

Enrollment

Registered

2003-05-29

Start date

2003-02-28

Completion date

2006-02-28

Last updated

2007-01-26

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is pregnant or breastfeeding * Treatment with an investigational drug within the last 30 days, previously completed or withdrawn from this study or any other study investigating pemetrexed * Treatment with radiation therapy within the last 1-2 weeks * Brain metastasis that is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

Design outcomes

Primary

Measure	Time frame
To determine the tumor response rate for pemetrexed plus gemcitabine in patients with locally advanced or metastatic (Stage IIIB or IV) Non-Small Cell Lung Cancer (NSCLC).	—

Secondary

Measure	Time frame
progression-free survival	—
To measure time-to-event efficacy variables including:	—
time to objective tumor response for responding patients	—
time to progressive disease	—
time to treatment failure	—
overall survival	—
To characterize the quantitative and qualitative toxicities of pemetrexed plus gemcitabine in this patient population.	—
duration of response for responding patients	—

Countries

United States

Outcome results

None listed

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