CompletedPhase 2NCT01573702
Official study title

Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)

Study summary

\- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedStereotactic Radiosurgery and Erlotinib

The study team can explain what participation involves.

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

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 12, 2021 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?8 U.S. locations

Locations may change over time.

Who runs it?UNC Lineberger Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
UNC Lineberger Comprehensive Cancer Center
Interventions being studied
Procedure: Stereotactic Radiosurgery; Drug: Erlotinib
02
Explore related studies

How this study is categorized

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

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
  • Written informed consent
  • 18 years of age or older
  • Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC
  • History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria
  • Progressive disease following EGFR-TKI therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate organ and marrow function
  • Negative urine or serum pregnancy test for female patients
  • Patients who can have children must agree to adequate contraception
Reasons someone may not be able to joinExclusion criteria
  • Unresolved chronic toxicities greater than 2, measured by CTCAE v4
  • Treatment with any FDA approved or experimental cancer treatment following progression on EGFR-TKI
  • Any history of previous greater than grade 3 toxicity attributable to erlotinib
  • Pregnant or lactating female
  • Any previous radiation to sites of planned Stereostatic Radiosurgery
  • History of another malignancy
  • Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)
  • Evidence of severe or uncontrolled systemic diseases
  • Known hypersensitivity reaction or idiosyncrasy to erlotinib
  • Psychological, familial, sociological, or geographical conditions
  • Any other condition in investigator's opinion jeopardize compliance with protocol

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

  • University of California at San FranciscoSan Francisco, California
  • University of Colorado Cancer CenterAurora, Colorado
  • Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina
  • East Carolina UniversityGreenville, North Carolina
  • STO Taussig Cancer Center; Cleveland ClinicCleveland, Ohio
  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania
  • University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
  • Swedish Cancer InstituteSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 12, 2021. Always confirm current availability with the study team.

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