DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies

Inclusion criteria

• Any patient who is undergoing double lung transplantation as part of the clinical program, consents for this prospective observational trial, and has one of the following conditions will be eligible.
• Common Inclusion Criteria
• Adults of Age ≦ 80
• Resistant or refractory to or without available standard of care treatment options or experimental treatment options that are known to increase survival outcome
• Patients without any extrapulmonary disease
• Patients with good general health with an ability to withstand physiologic stressors and undergo psychosocial evaluation by the Stanford Integrated Psychosocial Assessment for Transplantation (SIPAT) or other assessment tools
• Patients to meet all other criteria for lung transplantation including insurance approval and United Network for Organ Sharing (UNOS) registration
• Inclusion Criteria for Cohort A
• Histologically confirmed selected lung non-small cell lung cancer including but not limited to:
• according to the International Association for the Study of Lung Cancer (IASLC)/American Thoracic Society (ATS)/European Respiratory Society (ERS) classification
• \- Lepidic dominant pattern
• Adenocarcinoma in situ
• Minimally invasive adenocarcinoma
• Non mucinous lepidic predominant invasive adenocarcinoma
• based on 2015 World Health Organization (WHO) classification of lung tumors including
• \- Invasive mucinous adenocarcinoma
• Mixed invasive mucinous and mucinous adenocarcinoma
• Colloid adenocarcinoma
• Enteric adenocarcinoma
• Minimally invasive adenocarcinoma
• Nonmucinous
• Mucinous
• \- Preinvasive lesions
• Atypical adenomatous hyperplasia
• Adenocarcinoma in situ
• Nonmucinous
• Mucinous
• based on the 2004 WHO classification of lung tumors including - Bronchioloalveolar carcinoma
• Nonmucinous
• Mucinous
• Mixed nonmucinous and mucinous or indeterminate
• Without any distant metastasis confirmed by standard staging work-up
• Without brain metastasis confirmed by brain imaging
• Without unidentified primary site of cancer
• Inclusion Criteria for Cohort B
• Metastatic cancers to lung alone - including but not limited to germ cell tumors, head \& neck tumors, colorectal tumors, renal cell tumors, testicular cancer
• Without any other distant metastasis confirmed by standard staging work-up
• Inclusion Criteria for Cohort C
• Respiratory failure with a history of cancer in the last 5 years - including, 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)
• Without any other distant metastasis confirmed by standard staging work-up

Exclusion criteria

• Exclusion criteria
• Adults unable or unwilling to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners
• Vulnerable Populations
• Presence of extrapulmonary disease or mediastinal nodal disease at the time of transplant referral
• Small Cell Cancers
• Unidentified primary site of cancer for Cohort A
• Progression of disease or confirmed distant metastases or mediastinal nodal disease at any point during transplantation work-up
• Medical ineligibility for lung transplantation after multidisciplinary assessment
• Not a suitable candidate according to the lung transplantation protocol for treatment of lung confined primary or metastatic tumors
• Body mass index more than 35 kg/m2
• Evidence of co-existing malignancies for Cohort A
• Untreatable significant dysfunction of another major organ system including heart, liver, kidney, or brain unless combined organ transplantation can be performed
• Uncorrected atherosclerotic disease with suspected or confirmed end-organ ischemia or dysfunction and/or coronary artery disease not amenable to revascularization
• Uncorrectable bleeding diathesis
• Evidence of active Mycobacterium tuberculosis infection
• Significant chest wall or spinal deformity expected to cause severe restriction after transplantation