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NCT00085839 · ClinicalTrials.gov registry record · Phase 2

Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2

A Phase 2 study, sponsored by OSI Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
103
Enrollment target

NCT00085839: Completed Phase 2 study, sponsored by OSI Pharmaceuticals.

NCT00085839 is a Phase 2 study that has completed, run by OSI Pharmaceuticals. The registered enrollment target is 103 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00085839, a Phase 2 study, has completed, sponsored by OSI Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
103 participants
Enrollment target

Study Summary

The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The study will also evaluate the safety of single-agent erlotinib in this patient population.

Primary Outcome

Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.

Interventions

  • DRUG Tarceva (Trademark) (erlotinib HCl, OSI-774)
  • DRUG Combination carboplatin and paclitaxel

Trial Details

FieldValue
Enrollment Target 103 participants
Start Date 2004-02
Est. Completion 2007-03
Phase Phase 2
OSI Pharmaceuticals

16 total trials

What the finished NCT00085839 record still lists

NCT00085839 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (23% lower).

The record links to 0 conditions, and to 2 interventions - of which Tarceva (Trademark) (erlotinib HCl, OSI-774) is the first listed.

NCT00085839 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00085839 about?

NCT00085839 is a clinical study titled "Erlotinib vs. Standard Chemotherapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) and Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 2". The purpose of this noncomparative study is to obtain preliminary estimates of the efficacy of erlotinib and standard chemotherapy in patients with advanced, previously untreated nonsmall cell lung cancer (NSCLC) and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2. The stud...

What is the current status of trial NCT00085839?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 103 participants. The study started on 2004-02. Estimated completion is 2007-03.

What interventions are being tested in trial NCT00085839?

The interventions under investigation include: Tarceva (Trademark) (erlotinib HCl, OSI-774) (DRUG), Combination carboplatin and paclitaxel (DRUG).

Who is sponsoring clinical trial NCT00085839?

This trial is sponsored by OSI Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00085839's enrollment target sits among peer trials

103 664th of 2000 higher than 1,333 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 NCT00085839, the US trial registry maintained by the National Library of Medicine. NCT00085839 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.