Non Small Cell Lung CancerPhase 2NCT01573702
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
A Phase 2 study testing Stereotactic Radiosurgery and Erlotinib in people with Non Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
Trial summary
Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Stereotactic Radiosurgery and Erlotinib
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Dec 2012to 15 Mar 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate organ and marrow function
- Negative urine or serum pregnancy test for female patients
- Patients who can have children must agree to adequate contraception
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
STO Taussig Cancer Center; Cleveland Clinic
Cleveland, Ohio, 44195
East Carolina University
Greenville, North Carolina, 27834
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
University of California at San Francisco
San Francisco, California, 94115
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
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)
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy
Read the 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
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Stereotactic Radiosurgery, Erlotinib
- Keywords
- Non small cell lung cancer, EGFR mutant, Phase II, erlotinib, tarceva, cyberknife, Lineberger
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiosurgeryProcedure or surgery
Also called Cyberknife
21 Gy daily for 5 days
ErlotinibDrug
Also called Tarceva
150mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiosurgery Followed by Erlotinib | Other | Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib Receives: Procedure: Stereotactic Radiosurgery; Drug: Erlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression Free Survival
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.
Measured: 3 months after Initiation of Stereostatic Radiotherapy
Secondary outcomes (4)
Percentage of Participants With Local Control of Sites on Erlotinib Following Stereotactic Radiosurgery (SRS)
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.
Measured: 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
Median Overall Survival
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
Measured: up to 5 years after end of treatment
Toxicity Rate From Stereotactic Radiosurgery (SRS)
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.
Measured: From initiation to the end of SRS, up to 15 days
Toxicity Rate Attributed to Erlotinib
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.
Measured: from end of SRS to end of erlotinib treatment (median duration of 5.7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2012 (estimated)
- Study start11 Dec 2012
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Global Development, Inc.
- Responsible party
- Sponsor
- Investigators
- Jared Weiss, MD, Principal investigator, UNC at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573702
- Sponsor's protocol ID
- LCCC 1123
- Status last verified
- Dec 2020
- First submitted
- 5 Apr 2012
- Last updated
- 12 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01573702
- Acronym / sponsor ID
- LCCC 1123
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non small cell lung cancer, EGFR mutant, Phase II, erlotinib, tarceva, cyberknife, Lineberger
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma Global Development, Inc.
- Study start
- 11 Dec 2012 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 9 Apr 2012 (estimated)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiosurgery Followed by Erlotinib | Other | Procedure: Stereotactic Radiosurgery, Drug: ErlotinibStereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic RadiosurgeryAlso: Cyberknife21 Gy daily for 5 days | Procedure or surgery | Stereotactic Radiosurgery Followed by Erlotinib |
| ErlotinibAlso: Tarceva150mg once daily | Drug | Stereotactic Radiosurgery Followed by Erlotinib |
Primary outcome
Percentage of Participants With Progression Free Survival
Time frame: 3 months after Initiation of Stereostatic Radiotherapy
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.
4 secondary outcomes
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
Median Overall Survival
Time frame: up to 5 years after end of treatment
Toxicity Rate From Stereotactic Radiosurgery (SRS)
Time frame: From initiation to the end of SRS, up to 15 days
Toxicity Rate Attributed to Erlotinib
Time frame: from end of SRS to end of erlotinib treatment (median duration of 5.7 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Weiss, MD principal investigator
UNC at Chapel Hill
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Radiosurgery and Erlotinib in people with Non Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Progression Free Survival (time frame: 3 months after Initiation of Stereostatic Radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2021.