Abstract CT234: [DREAM] Double lung transplant registry aimed for lung-limited malignancies - A prospective registry study for medically refractory cancers

Abstract Background: 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). Five studies have reported on lung transplantation in carefully selected subsets of patients with multifocal lung adenocarcinoma. The 5-year survival rate of bilateral sequential lung transplantation was estimated at over 50% in patients with multifocal BAC, invasive adenocarcinoma, and NSCLC. Moreover, there is an unmet need for patients who have lung-limited metastasis after successful treatment for primary tumors such as sarcomas or colorectal cancer (CRC). As with liver transplantation for CRC patients who have liver-confined metastases, the applicability of lung transplantation in lung-limited metastatic patients should be explored. There is also an unmet need for patients with respiratory failure with a history of cancer in the last 5 years. Methods: 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 studied. The study duration will be 10 years including surveillance. The goal is to enroll 125 participants through the Northwestern Medicine Clinical Programs. Essential Criteria: 1. The tumor should be without any extrapulmonary metastasis as determined by standard of care diagnostic and staging workup. 2. All standard of care or experimental oncological treatments known to improve survival should have failed or deemed infeasible 3. 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) Clinical trial registry number : NCT05671887. Enrollment began November 16, 2022. Trial is open and continues to enroll participants as of December 23, 2024. Citation Format: Young Kwang Chae, Liam Il-Young Chung, Tarik Demir, Carolyn Moloney, Brooke Sanson, Rose Dwyer, Chan Mi Jung, Rade Tomic, Ankit Bharat. [DREAM] Double lung transplant registry aimed for lung-limited malignancies - A prospective registry study for medically refractory cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT234.