SBRT Combined With Osimertinib Compared With Osimertinib for Stage IV NSCLC

Launched by LI ZHANG · Oct 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with stage IV non-small cell lung cancer (NSCLC) that has a specific mutation in the epidermal growth factor receptor (EGFR). The study will compare two treatment options: one group will receive a combination of Stereotactic Body Radiation Therapy (SBRT) along with Osimertinib, while the other group will receive only Osimertinib, which is a targeted therapy that many patients with this type of cancer already take. The goal is to see if adding radiation therapy can improve treatment outcomes for patients whose cancer has not progressed after three months of Osimertinib.

To be eligible for this trial, participants should be between 18 and 75 years old, have a confirmed diagnosis of metastatic NSCLC, and have been stable on Osimertinib for at least three months. They should also have a limited number of cancer spots and meet certain health criteria. If someone joins the study, they will receive regular check-ups and monitoring to assess how well the treatment is working. It’s important to note that patients who have previously received radiation treatment to the same area or who are pregnant cannot participate. This trial is not yet recruiting, but it represents a hopeful step in exploring better treatments for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients must have biopsy proven metastatic NSCLC (Stage IV).
• • 2. Patients receiving first-line Osimertinib for EGFR mutant-positive for 3 months and achieved stable disease or partial response.
• • 3. Age 18 to 75 years old.
• • 4. Patients must have measurable disease at baseline.
• • 5. The amount of metastatic focus \<5.
• • 6. ECOG score 0-2 7 Adequate normal organ and marrow function for TKI treatment and radiotherapy.
• • 8. Patients must has sensitizing EGFR mutation (e.g. exon 19 deletion or exon 21 L858R) 9. Patients must provide written informed consent to participate in the study.
• Exclusion Criteria:
• • 1. Patients who previously received radiotherapy to the primary site.
• • 2. Patient can't tolerate radiotherapy or targeted therapy;
• • 3. Pregnant or nursing women