Artificial Intelligence to Help Non-Small Cell Lung Cancer Patients: Measure Lung Cancer Biology and Treatment Response Via Imaging
Trial ID: NCT05254132
Status: UNKNOWN
Study type: OBSERVATIONAL
Start date: 2022-07-01
Completion date: 2025-06-30
Sponsor: OncoRadiomics
Collaborators: University Hospital, Antwerp
Conditions: Non Small Cell Lung Cancer
Interventions: Liquid biopsy
Enrollment: 1000
Age range: 18 Years - None
Sex: ALL

Summary:
SALMON is a prospective, multi-center, multi-country, biomarker validation study that synergizes an extensive non-interventional biomarker discovery study on diagnostic images and tissue biopsies of non-small cell lung cancer NSCLC (rATLAS) with a smaller biomarker minimally interventional study on patients with metastases who undergo liquid biopsy and imaging follow-up for 2 years (aRECIST). A total of 1120 patients will be screened to get 1000 participants enrolled in rATLAS, and a subset of 250 participants will be screened to then recruit 150 participants also for aRECIST. The study will end after one visit for participants in rATLAS while there is a 2-years follow-up period for participants in aRECIST. Participants will not receive any treatment specific for this study, but might receive standard of care therapy or investigational products in the framework of another clinical study following the baseline visit.

The objectives of optimizing AI based tools for the assessment of EGFR status (rATLAS) and automated Response Evaluation Criteria in Solid Tumours 1.1 (RECIST 1.1) (aRECIST) will be achieved using a trial design that combines a biomarker discovery study design (cross-sectional for rATLAS) with a reader study design (follow-up study in aRECIST). Medical treatments in the aRECIST cohort are not dictated by study protocol, rather determined by the clinicians in line with standard clinical practice.

Eligibility criteria:
Inclusion Criteria:

* Participant must be aged at least 18 years
* Willing and able to comply with clinic visits and study-related procedures.
* Willing and able to provide signed informed consent.
* Participant must be at first diagnosis of NSCLC and have the largest diameter of the primary tumor equal or greater than 2 cm.
* Participant must be treatment naïve (includes radiotherapy).
* Participant must have received a CT scan for the diagnosis of NSCLC according to "Imaging Protocol" document (Appendix 1).
* Participant with confirmed availability of representative tumor specimens in formalin-fixed, paraffin-embedded (FFPE) blocks or ≥25 unstained slides (at least 10 unstained slides). Participant without adequate archival tumor specimens cannot be included

Additional inclusion criteria specific to aRECIST cohort:

* Participant must be diagnosed with NSCLC Stage IV.
* Participant must have a life expectancy ≥ 3 months.
* Participant must have at least one lesion that is suitable for accurate repeated assessment (according to RECIST criteria).
* Participant must be able to comply with standard of care visits for imaging purposes to follow-up on treatment response.
* Participant must need to agree to undergo a liquid biopsy at baseline and at follow-up visits.
* Participant must undergo either chemotherapy or immunotherapy after baseline visit, according to SoC.

Exclusion Criteria:

* Pregnant or breast-feeding participants (to avoid radiation exposure)
* Participant is either an employee of Radiomics or the investigational center or an immediate relative of an employee of Radiomics or the investigational center.
* Participant with total body CT scan already performed at a different site with acquisition parameters different from those reported in the Imaging Protocol

Additional inclusion criteria specific to aRECIST cohort:

• Participant who previously underwent or are planned for curable cancer surgery (lobectomy, wedge resection, pneumonectomy) or ablative radiotherapy on metastases.

Outcomes:
Equivalence between aRECIST and manual RECIST in the evaluation of target lesions at time of study enrolment; Equivalence between aRECIST and manual RECIST in the evaluation of target lesions at month 3; Equivalence between aRECIST and manual RECIST in the evaluation of target lesions at month 6; Equivalence between aRECIST and manual RECIST in the evaluation of target lesions at month 12; Equivalence between aRECIST and manual RECIST in the evaluation of target lesions at month 24; Identification of imaging biomarkers that discriminate EGFR status in patients with NSCLC with a minimum area under the curve of 0.65