Completed

A Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy

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What is being tested

pemetrexed

Drug
Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2003
See protocol details

Summary

Principal SponsorEli Lilly and Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

The purposes of this study are to determine: * the safety of pemetrexed and any side effects that might be associated with it * how much pemetrexed should be given to patients. It is possible that information collected during this study will be analyzed by the Sponsor in the future to evaluate pemetrexed for other possible uses or for other medical or scientific purposes other than those currently proposed. Although pemetrexed has been shown to be effective in some patients with non-small-cell lung cancer, pemetrexed might not have beneficial effects for all patients.

Official TitleA Randomized Phase 3 Study of Two Doses of Alimta in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed a Prior Platinum-Containing Chemotherapy 
NCT00078260
Principal SponsorEli Lilly and Company
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

589 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

Inclusion Criteria: * Diagnosis of locally advanced or metastatic (Stage III or IV at entry) non-small cell lung cancer (NSCLC) that is not amenable to curative therapy. * Patients must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease. Patients are also eligible if they have received one platinum-based chemotherapy regimen as neoadjuvant or adjuvant chemotherapy, but must have received an additional chemotherapy regimen upon recurrence. * No more than two prior systemic anti-cancer therapies will be allowed. * Prior radiation therapy is allowed to less than 25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment. Exclusion Criteria: * Pregnancy. * Breast-feeding. * Second primary malignancy that is clinically detectable at the time of consideration for study enrollment. * Inability to interrupt aspirin, or other nonsteroidal anti-inflammatory agents for a 5-day period. * Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

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.

Ankara, TurkeySee the location
Suspended

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.

Gaziantep, Turkey
Completed2 Study Centers