255TiP DREAM Double lung transplant registry aimed for lung-limited malignancies: A prospective registry study for medically refractory cancers

Adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are listed as 'special circumstances' for lung transplantation according to a consensus document from the International Society for Heart and Lung Transplantation (ISHLT) (Weill D et al., 2015). There is an unmet need for lung transplantation in patients who have lung-limited malignancies. This is a prospective registration trial to evaluate outcomes of patients who undergo double lung transplantation for the treatment of the select groups of medically refractory cancers (primary lung cancers or metastatic cancers in lungs). Overall survival (OS), disease-free survival (DFS), allograft rejection (AR) and allograft survival (AS) as well as molecular and genetic biomarkers will be monitored to investigate the correlation with prognosis. The study duration will be 10 years including surveillance. Recruitment is to occur during the first 5 years of the study. The goal is to enroll 125 participants through the Northwestern Medicine Clinical Programs. Essential Criteria: The tumor should be without any extrapulmonary metastasis as determined by standard of care diagnostic and staging workup. All standard of care or experimental oncological treatments known to improve survival should have failed or deemed infeasible Patients should meet the general criteria for lung transplant evaluation and listing Study cohorts: Cohort A: Primary lung cancers - Examples include, but not limited to, invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas. Cohort B: Metastatic cancers to the lung only - Examples include, but not limited to, germ cell tumors, head & neck tumors, colorectal tumors, renal cell tumors, testicular cancers. Cohort C: Respiratory failure with a history of cancer in the last 5 years- Examples include, but not limited to interstitial lung disease (ILD), pulmonary fibrosis (idiopathic or secondary), advanced chronic obstructive pulmonary disease (COPD), bronchiectasis, emphysema, cystic fibrosis (CF), emphysema due to alpha-1 antitrypsin deficiency, and pulmonary arterial hypertension (PAH). Study is open to enroll participants as of Jan 8, 2024. NCT05671887. Northwestern University. Has not received any funding.