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

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ClinicalTrials.gov Identifier: NCT01573702
Recruitment Status : Completed
First Posted : April 9, 2012
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Study Description
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Brief Summary:
- Progression free survival after locally ablative therapy and erlotinib in EGFR patients progressed after EGFR-TKI therapy

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Procedure: Stereotactic Radiosurgery Drug: Erlotinib Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 11, 2012
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Stereotactic Radiosurgery Followed by Erlotinib
Stereotactic Radiosurgery or Other Local Ablation Followed by Erlotinib
 Procedure: Stereotactic Radiosurgery
21 Gy daily for 5 days
Other Name: Cyberknife

Drug: Erlotinib
150mg once daily
Other Name: Tarceva


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Median Overall Survival [ Time Frame: up to 5 years after end of treatment ]
    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

  3. Toxicity Rate From Stereotactic Radiosurgery (SRS) [ Time Frame: From initiation to the end of SRS, up to 15 days ]
    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.

  4. Toxicity Rate Attributed to Erlotinib [ Time Frame: from end of SRS to end of erlotinib treatment (median duration of 5.7 months) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573702


Locations
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United States, California
University of California at San Francisco
San Francisco, California, United States, 94115
United States, Colorado
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
United States, North Carolina
Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
East Carolina University
Greenville, North Carolina, United States, 27834
United States, Ohio
STO Taussig Cancer Center; Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Astellas Pharma Global Development, Inc.
Investigators
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Principal Investigator: Jared Weiss, MD UNC at Chapel Hill
  Study Documents (Full-Text)

Documents provided by UNC Lineberger Comprehensive Cancer Center:
Study Protocol and Statistical Analysis Plan  [PDF] November 18, 2014

More Information
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Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01573702    
Other Study ID Numbers: LCCC 1123
First Posted: April 9, 2012    Key Record Dates
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021
Last Verified: December 2020
Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Non small cell lung cancer
EGFR mutant
Phase II
erlotinib
 tarceva
cyberknife
Lineberger
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action