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NCT00102804 · ClinicalTrials.gov registry record · Phase 3

Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
663
Enrollment target

NCT00102804: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00102804 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 663 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00102804, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
663 participants
Enrollment target

Study Summary

This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment) into this trial.

Primary Outcome

PFS time was the elapsed time from the date of randomization to the first date of objective progression of disease or death from any cause. PFS was censored at the date of the participant's last tumor assessment for participants who were not known to have died or to have PD as of the data-inclusion cut-off date for analysis. PD, defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0), was at least a 20% increase in the sum of longest diameter (LD) of target lesions t

Interventions

  • DRUG Placebo
  • DRUG Pemetrexed
  • OTHER Best Supportive Care

Trial Details

FieldValue
Enrollment Target 663 participants
Start Date 2005-03
Est. Completion 2013-12
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00102804 record still lists

NCT00102804 is an interventional study that assigns participants to a tested intervention. The registered 663 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT00102804 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00102804 about?

NCT00102804 is a clinical study titled "Pemetrexed and Best Supportive Care Versus Placebo and Best Supportive Care in Non-Small Cell Lung Cancer (NSCLC)". This study is a randomized Phase 3, double-blind study of maintenance pemetrexed plus best supportive care versus placebo plus best supportive care in NSCLC. Participants must have received 1 of 6 induction regimens for 4 cycles and did not have progressive disease prior to randomization (enrollment...

What is the current status of trial NCT00102804?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 663 participants. The study started on 2005-03. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00102804?

The interventions under investigation include: Placebo (DRUG), Pemetrexed (DRUG), Best Supportive Care (OTHER).

Who is sponsoring clinical trial NCT00102804?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00102804's enrollment target sits among peer trials

663 553rd of 2000 higher than 1,447 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00102804, the US trial registry maintained by the National Library of Medicine. NCT00102804 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.