Phase II Study to Evaluate the Impact of SBRT (Stereotactic Body Radiation Therapy) and/or SRS (Stereotactic Radiosurgery) on Oligoresidual Disease in EGFR Mutation Patients Treated with Osimertinib as First-Line Systemic Intervention. All candidates must exhibit a partial response after 12 weeks of treatment with the third-generation tyrosine kinase inhibitor (alone or in combination with chemotherapy) and a maximum of five (5) residual lesions in a maximum of two (2) organs. The primary outcome will be progression-free survival (PFS), and secondary outcomes will include overall survival (OS), proportion of patients without progression at months 12 and 36, safety, and overall response rate (ORR). Additionally, an exploratory analysis will be conducted on the prognostic value of liquid biopsy (supplementary information), considering baseline presence of mutations (determined by Next Generation Sequencing tests) and reduction or negativization of allelic fraction (AF).
Be older than 18 years of age.
Be capable of giving informed consent to participate in the study.
Have histological confirmation compatible with EGFR mutant non-small cell lung cancer (NSCLC) and metastatic disease (with or without histological confirmation of metastatic lesions).
Have confirmation of the presence of common EGFR mutations (exon 19 deletion, L858R/exon 21, or G719X) through any locally and internationally accepted standard tests.
Severe comorbidities contraindicating radiation therapy.
Bone metastases in the femur with a high risk of fracture.
Complete response to Osimertinib treatment (no oligoresidual disease for ablative treatment).
Inability to treat all oligoresidual lesions with ablative intent.
Single group
Stereotactic Body Radiation Therapy SBRT
RadiationThis is a non-randomized Phase II study in which all patients receive the experimental treatment with Stereotactic Ablative Radiotherapy (SABR) to residual tumor lesions (up to 5 residual metastatic lesions in a maximum of 2 organs) following 12 weeks of systemic treatment with Osimertinib. The study aims to enroll 35 patients diagnosed and treated at CTIC Centro de Tratamiento e Investigación Sobre Cáncer Luis Carlos Sarmiento Angulo.
Progression-Free Survival
Time from the initiation of systemic treatment (Osimertinib) to disease progression or death. This outcome is not influenced by second-line interventions and allows for the estimation of the relative efficacy of the treatment and its Hazard Ratio (HR)
Overall Response Rate (ORR)
Proportion of patients with partial or complete response following the implementation of SBRT. This measurement does not include stable disease
Overall Survival (OS)
Time from diagnosis, the first day of systemic treatment, and implementation of SBRT to death from any cause or last follow-up
Progression-Free Time (PFT)
Time from the execution of SBRT to objective tumor progression, excluding death
Adverse Events and Safety
Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5 from the National Cancer Institute (NCI) US
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