Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT03603002
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
* Age \> 18 year
* Confirmed non-small cell lung cancer after initial biopsies
* Patient with accessible tumor for biopsy
* Patient is to have sufficient initial core biopsy samples for tissue analyses
* Stage I lung cancer
* Adequate normal organ and marrow function
* Patient with tumor amenable to SABR treatment as determined by a radiation oncologist
* Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
* Post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
Exclusion Criteria:
* Primary tumors not amenable to serial core biopsies.
* Prior thoracic radiation in the region that will be treated by SABR.
* Patient may not be receiving any other concurrent investigational agents or chemotherapy.
* Patient may not be receiving or received immunotherapy.
* Patients may not be on or use steroids within 14 days before radiation, and from the duration of radiation to the time of the post-SABR biopsies and blood samples.
* Female patients who are pregnant from screening to completion of SABR
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03603002
Study Brief:
Protocol Section:
NCT03603002