Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Metastases EGFR Gene Mutation EGF-R Positive Non-Small Cell Lung Cancer Non-small Cell Lung Cancer NSCLC

Keywords

nsclcnon-small cell lung cancerEGFR Gene MutationEGF-R Positive Non-Small Cell Lung CancerEGFRBrain MetastasesosimertinibtagrissoSRSstereotactic radiosurgery

Outcome Measures

Primary Outcomes (1)

Brain control: CNS-PFS
Lesions that did not disappear after two months of Osimertinib treatment will be better controlled with SRS
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
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
Change in patient cognitive function will be followed and assessed at screen, Randomization, 2 month after Randomization, then every 3 month

Study Arms (2)

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

Radiation: Stereotactic surgery

SoC Tagrisso treatment only

ACTIVE COMPARATOR

continuation of osimertinib alone

Radiation: Stereotactic surgery

Interventions

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.

Early SRS treatment with SoCSoC Tagrisso treatment only

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 120 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Hadassah Medical Organization
Otherlead

Study Sites (1)

Hadassah Ein Kerem Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Amichay Meirovitz, MD, MBACONTACT972-26776735 amichaym@hadassah.org.il

Philip Blumenfeld, MDCONTACTphilipb@hadassah.org.il

Related Publications (15)

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.
PMID: 31912902BACKGROUND
Chen 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.
PMID: 25056707BACKGROUND
Wu 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungBrain Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsBrain DiseasesCentral Nervous System Diseases

Central Study Contacts

Amichay Meirovitz, MD, MBA

CONTACT

972-2-6776735 amichaym@hadassah.org.il

Philip Blumenfeld, MD

CONTACT

philipb@hadassah.org.il

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principle investigator, oncologist and radiation specialist

Study Record Dates

First Submitted

July 4, 2021

First Posted

September 5, 2021

Study Start

March 9, 2021

Actual (reported)

Primary Completion

December 31, 2024

Estimated (date passed)

You may not qualify if:

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.
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.
b. Systemic progression under Osimertinib treatment between screen and randomization systemic scan, per RECIST1.1.
c. 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.
f. 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.
g. 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.
h. 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.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Early SRS treatment with SoC

SoC Tagrisso treatment only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (15)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Early SRS treatment with SoC

SoC Tagrisso treatment only

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (15)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations