Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00100854 · ClinicalTrials.gov registry record · Phase 2

Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Translational Oncology Research International.

Completed
Registry status
Phase 2
Development phase
108
Enrollment target

NCT00100854: Completed Phase 2 study, sponsored by Translational Oncology Research International.

NCT00100854 is a Phase 2 study that has completed, run by Translational Oncology Research International. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00100854, a Phase 2 study, has completed, sponsored by Translational Oncology Research International.

COMPLETED
Registry status
Phase 2
Development phase
108 participants
Enrollment target

Study Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes. Giving erlotinib together with fulvestrant may kill more tumor cells. It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Interventions

  • DRUG fulvestrant
  • DRUG erlotinib hydrochloride

Trial Details

FieldValue
Enrollment Target 108 participants
Start Date 2004-10-28
Est. Completion 2018-09-05
Phase Phase 2

What the finished NCT00100854 record still lists

NCT00100854 is an interventional study that assigns participants to a tested intervention. The registered 108 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 (19% lower).

The record links to 0 conditions, and to 2 interventions - of which fulvestrant is the first listed.

NCT00100854 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00100854 about?

NCT00100854 is a clinical study titled "Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer". RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of non-small cell lung cancer cells. Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes....

What is the current status of trial NCT00100854?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2004-10-28. Estimated completion is 2018-09-05.

What interventions are being tested in trial NCT00100854?

The interventions under investigation include: fulvestrant (DRUG), erlotinib hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00100854?

This trial is sponsored by Translational Oncology Research International, which has 11 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00100854's enrollment target sits among peer trials

108 640th of 2000 higher than 1,355 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02703207 · 108 participants · NA

    Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD

  • NCT02744677 · 108 participants · NA

    COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

  • NCT02781883 · 108 participants · Phase 2

    Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

  • NCT03848663 · 108 participants · NA

    Visual Remapping to Aid Reading With Field Loss

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT00100854, the US trial registry maintained by the National Library of Medicine. NCT00100854 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.