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

Launched by NORTHWESTERN UNIVERSITY · Jan 3, 2023

Keywords

ClinConnect Summary

The DREAM trial is a research study looking at the outcomes of double lung transplants for patients with certain types of lung cancer or lung-related cancers. It focuses on individuals who have cancers that are only in the lungs and not spread to other parts of the body. The trial is aimed at patients who have not responded to standard treatments or for whom there are no effective treatment options available. To participate, patients need to be adults under the age of 80, in good overall health, and able to handle the physical and psychological challenges of a transplant.

Eligible participants may include those with specific types of lung cancer, metastatic cancers that have only affected the lungs, or those experiencing severe breathing problems related to past cancer diagnoses. Patients who join the study will help researchers learn more about how effective lung transplants can be for these conditions. It’s important to note that not all individuals with cancer will qualify—those with other serious health issues or who have certain types of cancer may be excluded. This study is currently recruiting participants, so if you think you might be eligible, it could be a good opportunity to discuss with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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:
• • 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