Phase 2
N=25
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01573702 ↗Enrolled (actual)
25
Serious AEs
4.0%
Results posted
Jan 2021
Primary outcome: Primary: Percentage of Participants With Progression Free Survival — 64 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Stereotactic Radiosurgery (Procedure); Erlotinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Progression Free Survival |
64 | — |
| SECONDARY Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS) |
7 | — |
| SECONDARY Median Overall Survival |
29 | — |
| SECONDARY Toxicity Rate From Stereotactic Radiosurgery (SRS) |
4; 0; 21; 2; 1; 22 | — |
| SECONDARY Toxicity Rate Attributed to Erlotinib |
5; 2; 2; 16; 2; 1 | — |
Summary
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01573702). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.