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:
o 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
o 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:
- 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