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Compares treatment options for NSCLC
Official title 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
ClinicalTrials.gov ID: NCT05033691
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120
You may be able to join 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...
- An MRI showing brain metastases. At randomization, number of brain lesions is under 20. Patients with over 20 brain lesions at randomization MRI will...
- 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
You likely can't join 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...
- An investigational drug within five half-lives of the compound.
See the full eligibility criteria
- 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...
- 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 assigned by...
- 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.
- 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...
- Male patients who are willing to use barrier contraception (i.e. condoms) until 4 months after the final dose of study treatment.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Jerusalem, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jerusalem, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.