NSCLCNCT05033691
A Study to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases
A study testing Stereotactic surgery in people with NSCLC and EGFR Gene Mutation, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- NSCLC, EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer
- What is being tested?
- Stereotactic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Mar 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed metastatic NSCLC, not amenable to curative surgery or curative radiotherapy.
- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be sensitive to Osimertinib - These include exon 19 del; L858R (exon 21); G719X (exon 18); L861G (exon 21); S768I (exon 20) and T790M (exon 20) NOTE: Mutation analysis is to be done as per local practice.
- An MRI showing brain metastases. At randomization, number of brain lesions is under 20. Patients with over 20 brain lesions at randomization MRI will be suitable for whole brain radiation, and will not be randomized.
- Brain metastases are asymptomatic or with minor symptoms (ECOG≤2) at study randomization.
- ECOG performance status ≤2 and a minimum life expectancy of at least 6 months
- Must be eligible and receive Osimertinib as their anti EGFR TKI at time of randomization.
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- Must be eligible for SRS treatment at time of randomization.
- Provided written informed consent.
- Be male or female and at least 18 years of age on the day of signing informed consent.
- Female patients:
- Willing to use adequate contraceptive measures until 6 weeks after the final dose of study treatment
- Not breast feeding
- Have a negative pregnancy test prior to the start of dosing if of childbearing potential or have evidence of non-childbearing potential by fulfilling one of the following criteria at screening:
- Post-menopausal, defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments ii. Women under 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with Luteinizing Hormone (LH) and Follicle-Stimulating Hormone (FSH) levels in the post-menopausal range for the institution iii. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation
- Male patients who are willing to use barrier contraception (i.e. condoms) until 4 months after the final dose of study treatment.
Who cannot join
- a. Prior treatment with:
- Anti EGFR TKI treatment.
- Checkpoint inhibitors immunotherapy for metastatic NSCLC.
- Whole brain radiation (WBRT) and/or Stereotactic Radiosurgery (SRS).
- Medications or herbal supplements known to be potent inducers of CYP3A4 and are unable to stop use within the recommended wash out period prior to receiving the first dose of Osimertinib.
- An investigational drug within five half-lives of the compound.
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- Any other cytotoxic chemotherapy, investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of entry to the study.
- Systemic progression under Osimertinib treatment between screen and randomization systemic scan, per RECIST1.1.
- Spinal cord compression unless asymptomatic and stable. d. Leptomeningeal disease. e. Moderate or severe symptomatic brain metastases defined as per Radiation Therapy Oncology Group acute morbidity grade 3 to 4.
- NOTE: Grade 3 refers to neurological findings requiring hospitalization for initial management. Grade 4 refers to serious neurological impairment including paralysis, coma or seizures more than three times per week despite medication and requires hospitalization.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
- Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of Osimertinib.
- Involvement in the planning and conduct of the study i. Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Philip Blumenfeld, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hadassah Ein Kerem Medical Center
Jerusalem, 9112001
Amichay Meirovitz, MD, MBA, 972-26776735, amichaym@hadassah.org.il
Philip Blumenfeld, MD, philipb@hadassah.org.il
About this study
Official title: A Multi-center, Open-label, Randomized, Two-arm Study, to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases.
This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib, a small molecule that penetrates the blood brain barrier (BBB) well and controls majority, but not all, of the brain metastases. We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment, LUNG- will improve long term brain control, cognitive abilities and potentially overall survival. Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months. Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start. Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms. Arm A patients will be treated with SRS while continuing Osimertinib, while arm B patients will continue with Osimertinib alone. Patients will be assessed based on brain and whole body progression by RECIST. Patients will also be assessed for CNS-PFS and body-PFS, cognitive function, Quality of life and overall survival status via routine follow-up tests.
- Conditions
- NSCLC, EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, Non-small Cell Lung Cancer, Brain Metastases
- Being tested
- Stereotactic surgery
- Keywords
- nsclc, non-small cell lung cancer, EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, EGFR, Brain Metastases, osimertinib, tagrisso, SRS, stereotactic radiosurgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic surgeryRadiation
At two month (8 weeks) post Osimertinib start, patients will be randomized into one of the two study arms. Arm A patients will be treated with stereotactic surgery (SRS). In both arms Osimertinib treatment will continue.
| Study group | Role | What they receive |
|---|---|---|
| Early SRS treatment with SoC | Experimental | Stereotactic surgery (SRS) to the brain metastases and continuation of Osimertinib, at 2 month (8 weeks) post Osimertinib start Receives: Radiation: Stereotactic surgery |
| SoC Tagrisso treatment only | Active comparator | continuation of osimertinib alone Receives: Radiation: Stereotactic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain control: CNS-PFS
Lesions that did not disappear after two months of Osimertinib treatment will be better controlled with SRS
Measured: Change in lesion size in the CNS will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Secondary outcomes (5)
whole body PFS
Whole body progression will be delayed when Osimertinib is combined with early treatment of SRS
Measured: Change in lesion size in the whole body will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Cognitive function
Patient cognitive function will improve after SRS treatment
Measured: Change in patient cognitive function will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Quality of life (QOL)
Patient QOL will improve after SRS treatment
Measured: Change in patient quality of life will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Time to whole brain radiation
Time until whole brain radiation will be given will prolong for patients who receive early SRS treatment
Measured: Status will be checked at every visit and follow up
Overall survival (OS)
Patient OS will improve after SRS treatment
Measured: Status will be checked at every visit and follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start9 Mar 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MEIRROVITZ AMICHAY, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033691
- Sponsor's protocol ID
- LUNG-OSIME-SRS
- Status last verified
- Aug 2021
- First submitted
- 4 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Data for individual participants will be collected anonymously via the study CRF, data will be analyzed statistically and published.
Publications
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902Chen Z, Fillmore CM, Hammerman PS, Kim CF, Wong KK. Non-small-cell lung cancers: a heterogeneous set of diseases. Nat Rev Cancer. 2014 Aug;14(8):535-46. doi: 10.1038/nrc3775.
PubMed 25056707Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.
PubMed 24439929Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
PubMed 25589191Teijeira S, Navarro C. [Dystrophinopathies: concept and diagnostic methodology]. Neurologia. 1994 May;9(5):191-7. No abstract available. Spanish.
PubMed 8024825Martinez P, Mak RH, Oxnard GR. Targeted Therapy as an Alternative to Whole-Brain Radiotherapy in EGFR-Mutant or ALK-Positive Non-Small-Cell Lung Cancer With Brain Metastases. JAMA Oncol. 2017 Sep 1;3(9):1274-1275. doi: 10.1001/jamaoncol.2017.1047.
PubMed 28520828Magnuson WJ, Lester-Coll NH, Wu AJ, Yang TJ, Lockney NA, Gerber NK, Beal K, Amini A, Patil T, Kavanagh BD, Camidge DR, Braunstein SE, Boreta LC, Balasubramanian SK, Ahluwalia MS, Rana NG, Attia A, Gettinger SN, Contessa JN, Yu JB, Chiang VL. Management of Brain Metastases in Tyrosine Kinase Inhibitor-Naive Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer: A Retrospective Multi-Institutional Analysis. J Clin Oncol. 2017 Apr 1;35(10):1070-1077. doi: 10.1200/JCO.2016.69.7144. Epub 2017 Jan 23.
PubMed 28113019Duggirala KB, Lee Y, Lee K. Chronicles of EGFR Tyrosine Kinase Inhibitors: Targeting EGFR C797S Containing Triple Mutations. Biomol Ther (Seoul). 2022 Jan 1;30(1):19-27. doi: 10.4062/biomolther.2021.047.
PubMed 34074804Wang C, Lu X, Lyu Z, Bi N, Wang L. Comparison of up-front radiotherapy and TKI with TKI alone for NSCLC with brain metastases and EGFR mutation: A meta-analysis. Lung Cancer. 2018 Aug;122:94-99. doi: 10.1016/j.lungcan.2018.05.014. Epub 2018 May 18.
PubMed 30032853Wang J, Xia TY, Wang YJ, Li HQ, Li P, Wang JD, Chang DS, Liu LY, Di YP, Wang X, Wu WZ. Prospective study of epidermal growth factor receptor tyrosine kinase inhibitors concurrent with individualized radiotherapy for patients with locally advanced or metastatic non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e59-65. doi: 10.1016/j.ijrobp.2010.12.035. Epub 2011 Feb 23.
PubMed 21345607Du XJ, Pan SM, Lai SZ, Xu XN, Deng ML, Wang XH, Yao DC, Wu SX. Upfront Cranial Radiotherapy vs. EGFR Tyrosine Kinase Inhibitors Alone for the Treatment of Brain Metastases From Non-small-cell Lung Cancer: A Meta-Analysis of 1465 Patients. Front Oncol. 2018 Dec 12;8:603. doi: 10.3389/fonc.2018.00603. eCollection 2018.
PubMed 30619745Chang WS, Kim HY, Chang JW, Park YG, Chang JH. Analysis of radiosurgical results in patients with brain metastases according to the number of brain lesions: is stereotactic radiosurgery effective for multiple brain metastases? J Neurosurg. 2010 Dec;113 Suppl:73-8. doi: 10.3171/2010.8.GKS10994.
PubMed 21121789Mohammadi AM, Recinos PF, Barnett GH, Weil RJ, Vogelbaum MA, Chao ST, Suh JH, Marko NF, Elson P, Neyman G, Angelov L. Role of Gamma Knife surgery in patients with 5 or more brain metastases. J Neurosurg. 2012 Dec;117 Suppl:5-12. doi: 10.3171/2012.8.GKS12983.
PubMed 23205782Grandhi R, Kondziolka D, Panczykowski D, Monaco EA 3rd, Kano H, Niranjan A, Flickinger JC, Lunsford LD. Stereotactic radiosurgery using the Leksell Gamma Knife Perfexion unit in the management of patients with 10 or more brain metastases. J Neurosurg. 2012 Aug;117(2):237-45. doi: 10.3171/2012.4.JNS11870. Epub 2012 May 25.
PubMed 22631694Gerstenecker A, Nabors LB, Meneses K, Fiveash JB, Marson DC, Cutter G, Martin RC, Meyers CA, Triebel KL. Cognition in patients with newly diagnosed brain metastasis: profiles and implications. J Neurooncol. 2014 Oct;120(1):179-85. doi: 10.1007/s11060-014-1543-x. Epub 2014 Jul 18.
PubMed 25035099
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Two-arm Study, to Evaluate the Efficacy of Osimertinib With Early Intervention SRS Treatment Compared to the Continuation of Osimertinib Alone, in Patients With EGFR Mutated NSCLC and Asymptomatic Brain Metastases.
- ClinicalTrials.gov ID
- NCT05033691
- Acronym / sponsor ID
- LUNG-OSIME-SRS
- Conditions
- NSCLC, EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, Non-small Cell Lung Cancer, Brain Metastases
- Keywords
- nsclc, non-small cell lung cancer, EGFR Gene Mutation, EGF-R Positive Non-Small Cell Lung Cancer, EGFR, Brain Metastases, osimertinib, tagrisso
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study involves patients with EGFR-mutated NSCLC and asymptomatic brain metastases. This is an open-label, randomized study, comparing the continuation of Osimertinib treatment alone to Osimertinib treatment combined with early intervention stereotactic radiosurgery (SRS). The current first line of care for EGFR-mutated NSCLC is administration of Osimertinib, a small molecule that penetrates the blood brain barrier (BBB) well and controls majority, but not all, of the brain metastases. We hypothesize that relatively early intervention with SRS to brain metastases that are still visualized by MRI 2 months-post initiation of Osimertinib treatment, LUNG- will improve long term brain control, cognitive abilities and potentially overall survival. Patients with EGFR-mutated NSCLC and asymptomatic brain metastases will be treated with Osimertinib for 2 months. Brain MRI scans will be collected pre-Osimertinib and 2 months after treatment start. Patients with asymptomatic brain metastases present after 2 months of Osimertinib will be randomized into one of two study arms. Arm A patients will be treated with SRS while continuing Osimertinib, while arm B patients will continue with Osimertinib alone. Patients will be assessed based on brain and whole body progression by RECIST. Patients will also be assessed for CNS-PFS and body-PFS, cognitive function, Quality of life and overall survival status via routine follow-up tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early SRS treatment with SoC | Experimental | Radiation: Stereotactic surgeryStereotactic surgery (SRS) to the brain metastases and continuation of Osimertinib, at 2 month (8 weeks) post Osimertinib start |
| SoC Tagrisso treatment only | Active comparator | Radiation: Stereotactic surgerycontinuation of osimertinib alone |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Newly diagnosed metastatic NSCLC, not amenable to curative surgery or curative radiotherapy.
- Documented EGFR mutation (at any time since the initial diagnosis of NSCLC) known to be sensitive to Osimertinib - These include exon 19 del; L858R (exon 21); G719X (exon 18); L861G (exon 21); S768I (exon 20) and T790M (exon 20) NOTE: Mutation analysis is to be done as per local practice.
- An MRI showing brain metastases. At randomization, number of brain lesions is under 20. Patients with over 20 brain lesions at randomization MRI will be suitable for whole brain radiation, and will not be randomized.
- Brain metastases are asymptomatic or with minor symptoms (ECOG≤2) at study randomization.
- ECOG performance status ≤2 and a minimum life expectancy of at least 6 months
Key exclusion criteria (13 listed)
- a. Prior treatment with:
- NOTE: Grade 3 refers to neurological findings requiring hospitalization for initial management. Grade 4 refers to serious neurological impairment including paralysis, coma or seizures more than three times per week despite medication and requires hospitalization.
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 surgeryAt two month (8 weeks) post Osimertinib start, patients will be randomized into one of the two study arms. Arm A patients will be treated with stereotactic surgery (SRS). In both arms Osimertinib treatment will continue. | Radiation | Early SRS treatment with SoC, SoC Tagrisso treatment only |
Primary outcome
Brain control: CNS-PFS
Time frame: Change in lesion size in the CNS will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Lesions that did not disappear after two months of Osimertinib treatment will be better controlled with SRS
5 secondary outcomes
whole body PFS
Time frame: Change in lesion size in the whole body will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Cognitive function
Time frame: Change in patient cognitive function will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Quality of life (QOL)
Time frame: Change in patient quality of life will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month
Time to whole brain radiation
Time frame: Status will be checked at every visit and follow up
Overall survival (OS)
Time frame: Status will be checked at every visit and follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 25056707Chen Z, Fillmore CM, Hammerman PS, Kim CF, Wong KK. Non-small-cell lung cancers: a heterogeneous set of diseases. Nat Rev Cancer. 2014 Aug;14(8):535-46. doi: 10.1038/nrc3775.
- Background: PubMed 24439929Wu YL, Zhou C, Hu CP, Feng J, Lu S, Huang Y, Li W, Hou M, Shi JH, Lee KY, Xu CR, Massey D, Kim M, Shi Y, Geater SL. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Feb;15(2):213-22. doi: 10.1016/S1470-2045(13)70604-1. Epub 2014 Jan 15.
- Background: PubMed 25589191Yang JC, Wu YL, Schuler M, Sebastian M, Popat S, Yamamoto N, Zhou C, Hu CP, O'Byrne K, Feng J, Lu S, Huang Y, Geater SL, Lee KY, Tsai CM, Gorbunova V, Hirsh V, Bennouna J, Orlov S, Mok T, Boyer M, Su WC, Lee KH, Kato T, Massey D, Shahidi M, Zazulina V, Sequist LV. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015 Feb;16(2):141-51. doi: 10.1016/S1470-2045(14)71173-8. Epub 2015 Jan 12.
- Background: PubMed 8024825Teijeira S, Navarro C. [Dystrophinopathies: concept and diagnostic methodology]. Neurologia. 1994 May;9(5):191-7. No abstract available. Spanish.
- Background: PubMed 28520828Martinez P, Mak RH, Oxnard GR. Targeted Therapy as an Alternative to Whole-Brain Radiotherapy in EGFR-Mutant or ALK-Positive Non-Small-Cell Lung Cancer With Brain Metastases. JAMA Oncol. 2017 Sep 1;3(9):1274-1275. doi: 10.1001/jamaoncol.2017.1047.
- Background: PubMed 28113019Magnuson WJ, Lester-Coll NH, Wu AJ, Yang TJ, Lockney NA, Gerber NK, Beal K, Amini A, Patil T, Kavanagh BD, Camidge DR, Braunstein SE, Boreta LC, Balasubramanian SK, Ahluwalia MS, Rana NG, Attia A, Gettinger SN, Contessa JN, Yu JB, Chiang VL. Management of Brain Metastases in Tyrosine Kinase Inhibitor-Naive Epidermal Growth Factor Receptor-Mutant Non-Small-Cell Lung Cancer: A Retrospective Multi-Institutional Analysis. J Clin Oncol. 2017 Apr 1;35(10):1070-1077. doi: 10.1200/JCO.2016.69.7144. Epub 2017 Jan 23.
- Background: PubMed 34074804Duggirala KB, Lee Y, Lee K. Chronicles of EGFR Tyrosine Kinase Inhibitors: Targeting EGFR C797S Containing Triple Mutations. Biomol Ther (Seoul). 2022 Jan 1;30(1):19-27. doi: 10.4062/biomolther.2021.047.
- Background: PubMed 30032853Wang C, Lu X, Lyu Z, Bi N, Wang L. Comparison of up-front radiotherapy and TKI with TKI alone for NSCLC with brain metastases and EGFR mutation: A meta-analysis. Lung Cancer. 2018 Aug;122:94-99. doi: 10.1016/j.lungcan.2018.05.014. Epub 2018 May 18.
- Background: PubMed 21345607Wang J, Xia TY, Wang YJ, Li HQ, Li P, Wang JD, Chang DS, Liu LY, Di YP, Wang X, Wu WZ. Prospective study of epidermal growth factor receptor tyrosine kinase inhibitors concurrent with individualized radiotherapy for patients with locally advanced or metastatic non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):e59-65. doi: 10.1016/j.ijrobp.2010.12.035. Epub 2011 Feb 23.
- Background: PubMed 30619745Du XJ, Pan SM, Lai SZ, Xu XN, Deng ML, Wang XH, Yao DC, Wu SX. Upfront Cranial Radiotherapy vs. EGFR Tyrosine Kinase Inhibitors Alone for the Treatment of Brain Metastases From Non-small-cell Lung Cancer: A Meta-Analysis of 1465 Patients. Front Oncol. 2018 Dec 12;8:603. doi: 10.3389/fonc.2018.00603. eCollection 2018.
- Background: PubMed 21121789Chang WS, Kim HY, Chang JW, Park YG, Chang JH. Analysis of radiosurgical results in patients with brain metastases according to the number of brain lesions: is stereotactic radiosurgery effective for multiple brain metastases? J Neurosurg. 2010 Dec;113 Suppl:73-8. doi: 10.3171/2010.8.GKS10994.
- Grambsch, P. M., \& Therneau, T. M. (1994). Proportional hazards tests and diagnostics based on weighted residuals. Biometrika, 81(3), 515-526Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Data for individual participants will be collected anonymously via the study CRF, data will be analyzed statistically and published.
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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.
Philip Blumenfeld, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic surgery in people with NSCLC and EGFR Gene Mutation, run by Hadassah Medical Organization at 1 site in Israel.
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 15 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amichay Meirovitz, MD, MBA (972-2-6776735, amichaym@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain control: CNS-PFS (time frame: Change in lesion size in the CNS will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05033691, which also lists 15 linked publications.
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 5 Sep 2021.