Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC
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|ClinicalTrials.gov Identifier: NCT03667820|
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : March 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC)||Drug: Osimertinib Radiation: SABR||Phase 2|
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 , 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Osimertinib in Combination With Stereotactic Ablative Radiation (SABR) in EGFR Mutant Advanced Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||September 26, 2018|
|Estimated Primary Completion Date :||April 1, 2021|
|Estimated Study Completion Date :||April 1, 2022|
Osimertinib in combination with Stereotactic Ablative Radiation (SABR)
Osimertinib 80mg tablet to be taken once daily.
Stereotactic Ablative Radiation (SABR)
- Determine efficacy of Osimertinib plus SABR in patients with EGFR mutant lung cancer measured by Progression-Free Survival (PFS) [ Time Frame: Every 8 weeks from the time of first dose of study medication until subject death from any cause, assessed up to 150 weeks. ]Progression-Free Survival (PFS) as determined by RECIST 1.1 or death (in the absence of progression).
- Determine the impact of Osimertinib plus SABR on survival [ Time Frame: 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 [ Time Frame: Every 8 weeks from time of first dose of study medication until disease progression or death from any cause, assessed up to 150 weeks. ]Duration of response (DoR) defined as the time from documentation of tumor response to disease progression.
- Determine the impact of Osimertinib plus SABR on the length of time until next therapy needed [ Time Frame: Every 8 Weeks from time of first dose of study medication until subsequent SABR, discontinuation, or disease progression, assessed up to 150 weeks. ]Time to subsequent SABR (2nd, 3rd, etc), initiation of new therapy, or death.
- Determine the impact of Osimertinib plus SABR on tumor response [ Time Frame: Every 8 weeks from time of first study medication dose until discontinuation or subject death from any cause, assessed up to 150 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 [ Time Frame: Every 8 weeks from time of first study medication dose until disease progression, discontinuation or subject death from any cause, up to 150 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 [ Time Frame: 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.
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): NCT03667820
|Contact: Jessica Saltarskifirstname.lastname@example.org|
|Contact: Sawsan Rashdan, MD||214-648-7097||Sawsan.Rashdan@UTSouthwestern.edu|
|United States, California|
|City of Hope Medical Center||Recruiting|
|Duarte, California, United States, 91010|
|Contact: Sagus Sampath, MD 626-256-4673|
|Contact: Hiary (Holly) Weisbuch, MS,CCRP 626-256-4919 email@example.com|
|United States, Texas|
|University of Texas Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jessica Saltarski 214-648-7097 firstname.lastname@example.org|
|Principal Investigator:||Sawsan Rashdan, MD||University of Texas Southwestern Medical Center|