Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Completed · Phase 2
Conditions studied: Non Small Cell Lung Cancer
In brief
\- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Key facts
- Study ID
- NCT01573702
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 32
- Starts
- 2012-12-11
- Expected to finish
- 2019-03-15
- Last updated by the study team
- 2021-01-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California at San Francisco — San Francisco, California, United States
- University of Colorado Cancer Center — Aurora, Colorado, United States
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States
- East Carolina University — Greenville, North Carolina, United States
- STO Taussig Cancer Center; Cleveland Clinic — Cleveland, Ohio, United States
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Swedish Cancer Institute — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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