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NCT00950365 · ClinicalTrials.gov registry record · Phase 2

Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Albert Einstein College of Medicine.

Completed
Registry status
Phase 2
Development phase
79
Enrollment target

NCT00950365: Completed Phase 2 study, sponsored by Albert Einstein College of Medicine.

NCT00950365 is a Phase 2 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 79 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00950365, a Phase 2 study, has completed, sponsored by Albert Einstein College of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
79 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective with or without erlotinib hydrochloride in treating non-small cell lung cancer.

Primary Outcome

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Erlotinib Hydrochloride
  • DRUG Pemetrexed Disodium

Trial Details

FieldValue
Enrollment Target 79 participants
Start Date 2006-04
Est. Completion 2017-11-17
Phase Phase 2
Albert Einstein College of Medicine

175 total trials

What the finished NCT00950365 record still lists

NCT00950365 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (41% lower).

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

NCT00950365 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00950365 about?

NCT00950365 is a clinical study titled "Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer". This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tum...

What is the current status of trial NCT00950365?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2006-04. Estimated completion is 2017-11-17.

What interventions are being tested in trial NCT00950365?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Erlotinib Hydrochloride (DRUG), Pemetrexed Disodium (DRUG).

Who is sponsoring clinical trial NCT00950365?

This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00950365's enrollment target sits among peer trials

79 884th of 2000 higher than 1,117 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00950365, the US trial registry maintained by the National Library of Medicine. NCT00950365 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.