NCT05998993

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

Phase II Study to Evaluate the Efficacy and Safety of SBRT as an Adjunctive Intervention for Oligoresidual Disease in EGFR Mutant NSCLC With First-Line Osimertinib Treatment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

Phase II study with a single-stage Fleming design based on a normal approximation to the binomial distribution, with a one-sided type I error of 10% and a power of 90% to detect 30 events related to disease progression. Under the alternative hypothesis to detect a 35% improvement in PFS, 35 patients are required to be recruited over 22 months, with a minimum median follow-up of 14 months. An interim analysis will be conducted to determine early termination of the study using a Lan-DeMets monitoring boundary and an O'Brien-Fleming stopping rule. The interim analysis will be performed when 20 out of the expected 30 events have been observed. Employing the O'Brien-Fleming statistic, the critical value for the Z-score in the interim analysis (to stop and reject the null hypothesis) will be 1.054, and the critical value for the Z-score to stop and reject the alternative (futility) will be -0.204.

Conditions

• EGF-R Positive Non-Small Cell Lung Cancer
• Non Small Cell Lung Cancer
• EGFR Exon 19 Deletion
• EGFR Exon 21 Mutation
• EGFR G719X

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy SBRT	This 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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2026-11-01
• Completion: 2028-11-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

1 site across 1 country: Colombia