Study to Evaluate SBRT for EGFR Mutant NSCLC Patients Receiving Osimertinib (CULTRO)

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).

NCT Number	NCT05998993
Lead Sponsor	Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo
Conditions	EGF-R Positive Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer, EGFR Exon 19 Deletion, EGFR Exon 21 Mutation, EGFR G719X
Enrollment	35 participants
Start Date	2023-11
Primary Completion	2026-11 (estimated)
Study Completion	2028-11 (estimated)
Updated on ClinicalTrials.gov	2023-08-21