MedTrace Logo

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

NCT05998993 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-08-21

No results posted yet for this study

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).

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

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.

Sponsors & Collaborators

  • Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

    lead OTHER

Principal Investigators

  • Luis Rojas, MD · Centro de Tratamiento e Investigación sobre Cáncer, Luis Carlos Sarmiento Angulo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2026-11-30
Completion
2028-11-30

Countries

  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998993 on ClinicalTrials.gov