CompletedPhase 2NCT01573702

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

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

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

StatusCompleted
PhasePhase 2
U.S. locations8
SponsorUNC Lineberger Comprehensive Cancer Center
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

Inclusion 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 Exclusion 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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