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TerminatedPhase 2NCT00791336
Official study title

Study to Evaluate Using Nelfinavir With Chemoradiation for Non-small Cell Lung Cancer

Study summary

This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNelfinavir

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 28, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Iowa

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
University of Iowa
Interventions being studied
Drug: Nelfinavir
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Treatment approach
Chemotherapy→Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Histological diagnosis of non-small cell lung cancer that is Stage III (T1-3, pN2, M0) NSCLC in whom neoadjuvant therapy is recommended.
  • Must have had a mediastinoscopy to determine nodal status and potential resectability
  • Must have enough tissue from the biopsy for tissue marker determination for correlative studies
  • Negative metastatic work up (FDG PET/CT, brain CT or MRI)
  • No prior thoracic radiotherapy will be permitted
  • Age 18 years or greater
  • ECOG performance status 0-1 (Karnofsky at least 70%)
  • Normal organ and marrow function
  • No known HIV infection
  • Not pregnant
  • Ability to understand and the willingness to sign an informed consent document
Reasons someone may not be able to joinExclusion criteria
  • Patients requiring a pneumonectomy
  • Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study, or who have not recovered from adverse events due to agents administered earlier.
  • Prior thoracic radiation
  • Treatment with any other investigational agents.
  • Known metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV
  • Patients receiving drugs contraindicated with NFV will be excluded.
  • Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study compliance.
  • Pregnant or lactating women
  • HIV-positive patients on combination antiretroviral therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • The University of Iowa Department of Radiation OncologyIowa City, Iowa

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 28, 2017. Always confirm current availability with the study team.

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