Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Interventions
- Radiation: SABR
- Registration Number
- NCT03667820
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
This study evaluates the combination of two well-tolerated therapies, osimertinib and Stereotactic Ablative Radiation (SABR).
- Detailed Description
Patients with EGFR mutant non-small cell lung cancer will receive the current optimal therapy with osimertinib. After 8 weeks of targeted therapy, there will likely be some persisting lesions that would not have completely regressed. These persisting lesions would likely consist of cells that are less sensitive to targeted therapy. From the data summarized above \[14\], these persisting lesions are most to subsequently develop resistance and demonstrate progression.
To delay the onset of clinical progression, lesions that persist after 8 weeks of osimertinib therapy and are amenable to stereotactic ablative radiation will be radiated. Osimertinib will be held for 3 days before the first dose of radiation and resumed 3 days after the last dose.
After radiation, all patients will continue osimertinib therapy. If subsequently there is any evidence of progression, there will be an assessment of whether a repeat course of radiation is feasible. If it is feasible to repeat SABR to sites of progression, this will be performed and osimertinib resumed. If SABR is not possible, then a change in systemic therapy will be required.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 41
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Osimertinib Osimertinib Osimertinib in combination with Stereotactic Ablative Radiation (SABR) Osimertinib SABR Osimertinib in combination with Stereotactic Ablative Radiation (SABR)
- Primary Outcome Measures
Name Time Method Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS) Every 8 weeks from the time of first dose of study medication until subject death from any cause, assessed up to 300 weeks. Progression-Free Survival (PFS) as determined by RECIST 1.1 or death (in the absence of progression).
- Secondary Outcome Measures
Name Time Method Determine the impact of Osimertinib plus SABR on the length of time until next therapy needed Every 8 Weeks from time of first dose of study medication until subsequent SABR, discontinuation, or disease progression, assessed up to 300 weeks. Time to subsequent SABR (2nd, 3rd, etc), initiation of new therapy, or death.
Determine the impact of Osimertinib plus SABR on tumor response Every 8 weeks from time of first study medication dose until discontinuation or subject death from any cause, assessed up to 300 weeks. Objective response rate (ORR) defined as the proportion of patients with measurable disease who had a response after receiving at least one cycle of therapy.
Determine the impact of Osimertinib plus SABR on the duration of time while on Osimertinib Every 8 weeks from time of first study medication dose until disease progression, discontinuation or subject death from any cause, up to 300 weeks. Impact defined as time from initiation of Osimertinib to evidence of disease progression by RECIST 1.1, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason.
Number and type of adverse events related to Osimertinib plus SABR as assessed by CTCAE v4.0 From time of first study medication dose through treatment period and including the follow-up period every 3 months following last dose of study medication, until subject death from any cause, up to 48 months. Defined as the risk to patients by using Osimertinib plus SABR and the degree to which overt adverse events of the Osimertinib plus SABR can be tolerated.
Determine the impact of Osimertinib plus SABR on survival From time of first dose of study medication until subject death from any cause, up to 300 weeks. Overall survival defined as time from the date of initiation of Osimertinib until death of any cause.
Determine the impact of Osimertinib plus SABR on length of response Every 8 weeks from time of first dose of study medication until disease progression or death from any cause, assessed up to 300 weeks. Duration of response (DoR) defined as the time from documentation of tumor response to disease progression.
Trial Locations
- Locations (2)
City of Hope Medical Center
🇺🇸Duarte, California, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States