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NCT00385996 · ClinicalTrials.gov registry record · Phase 2

Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Weill Medical College of Cornell University.

Completed
Registry status
Phase 2
Development phase
22
Enrollment target

NCT00385996: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.

NCT00385996 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00385996, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.

COMPLETED
Registry status
Phase 2
Development phase
22 participants
Enrollment target

Study Summary

The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will measure the tumor by volume and by standard measurement (length and width). Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate.

Primary Outcome

High resolution CT scans for response assessment were obtained at baseline and within 1 week after completion of erlotinib treatment. Volumetric and maximum diameter (RECIST) response criteria was determined by a radiologist blinded to the sequence of treatment. Response rate (RR) is defined as the percentage of subjects achieving at least 50% tumor volume reduction.

Interventions

  • DRUG Tarceva (Erlotinib)

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2006-10
Est. Completion 2011-08
Phase Phase 2

What the finished NCT00385996 record still lists

NCT00385996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Tarceva (Erlotinib) is the first listed.

NCT00385996 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00385996 about?

NCT00385996 is a clinical study titled "Pilot Study of Preoperative Tarceva (Erlotinib) for Stages I/II Non-Small Cell Lung Cancer". The main purpose of this study is to see if Tarceva® (erlotinib) is effective in shrinking tumors. A high resolution CT scan (CT scanner that can view 3 dimensional images of the tumor) will be used to measure the tumor before and after treatment with Tarceva®(erlotinib) . This type of CT scan will ...

What is the current status of trial NCT00385996?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2006-10. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00385996?

The interventions under investigation include: Tarceva (Erlotinib) (DRUG).

Who is sponsoring clinical trial NCT00385996?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00385996's enrollment target sits among peer trials

22 1790th of 2000 higher than 207 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 NCT00385996, the US trial registry maintained by the National Library of Medicine. NCT00385996 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.