Description:
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients
progressed after EGFR-TKI therapy
Title
- Brief Title: Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
- Official Title: Phase II Study of Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib for Patients With Epidermal Growth Factor Receptor(EGFR) Mutation Who Have Previously Progressed on an Epidermal Growth Factor Receptor-tyrosine Kinase Inhibitor (EGFR-TKI)
Clinical Trial IDs
- ORG STUDY ID:
LCCC 1123
- NCT ID:
NCT01573702
Conditions
- Non Small Cell Lung Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Erlotinib | Tarceva | Stereotactic Radiosurgery Followed by Erlotinib |
Purpose
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients
progressed after EGFR-TKI therapy
Detailed Description
Primary Objectives
- To estimate progression free survival (PFS) after locally ablative therapy and erlotinib in
EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
Secondary Objectives
- To evaluate local control of sites previously progressive on erlotinib following
stereotactic radiosurgery (SRS) followed by erlotinib
- To estimate overall survival (OS) after locally ablative therapy and erlotinib in
EGFR-mutant NSCLC patients who progressed on prior EGFR-TKI therapy
- To characterize the toxicity of SRS
- To characterize the toxicity of erlotinib when preceded by SRS
Exploratory Objectives
- To explore if VeriStrat results at initial progression are associated with longer PFS or
OS after study treatment
- To explore if VeriStrat results following completion of SRS are associated with longer
PFS or OS after re-initiation of erlotinib
- To explore whether "poor" VeriStrat signatures ever turn to "good" signatures with the
study therapy, and to explore PFS and OS of patients whose signature changes
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Stereotactic Radiosurgery Followed by Erlotinib | Other | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Percentage of Participants With Progression Free Survival |
| Time Frame: | 3 months after Initiation of Stereostatic Radiotherapy |
| Safety Issue: | |
| Description: | Progression free survival (PFS) after locally ablative therapy and erlotinib in EGFR-mutant NSCLC patients who progressed on prior EGFR-tyrosine kinase inhibitor (TKI) therapy reported as percentage of participants who are alive and without progressive disease at 3 months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or the appearance of new lesions. |
Secondary Outcome Measures
| Measure: | Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS) |
| Time Frame: | Initiation of Stereotactic Radiotherapy every 6 to 12 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months |
| Safety Issue: | |
| Description: | Count of subjects who had local control of sites previously progressive on erlotinib following SRS followed by erlotinib. Using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), local control is defined as Complete Response (CR), Disappearance of all target lesions; or Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; in sites ablated by SRS. |
| Measure: | Median Overall Survival |
| Time Frame: | up to 5 years after end of treatment |
| Safety Issue: | |
| Description: | To estimate overall survival (OS) after locally ablative therapy and erlotinib in EGFR-mutant, NSCLC patients who progressed on prior EGFR-TKI therapy measured as length of time from start of treatment until date of death from any cause |
| Measure: | Toxicity Rate From Stereotactic Radiosurgery (SRS) |
| Time Frame: | From initiation to the end of SRS, up to 15 days |
| Safety Issue: | |
| Description: | Toxicity of SRS will be measured by NCI CTCAE version 4 following completion of SRS, but prior to erlotinib re-initiation. The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| Measure: | Toxicity Rate Attributed to Erlotinib |
| Time Frame: | from end of SRS to end of erlotinib treatment (median duration of 5.7 months) |
| Safety Issue: | |
| Description: | Toxicity of erlotinib will be graded using the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE version 4) which is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Completed |
| Lead Sponsor: | UNC Lineberger Comprehensive Cancer Center |
Trial Keywords
- Non small cell lung cancer
- EGFR mutant
- Phase II
- erlotinib
- tarceva
- cyberknife
- Lineberger
Last Updated
January 12, 2021
