Lung CancerDREAMNCT05671887
DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies
An observational study of Lung Cancer and Bilateral Cancer, run by Northwestern University at 1 site in United States.
Trial summary
This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Bilateral Cancer, Lung Transplant
- What is being tested?
- Double Lung Transplantation
- Type of treatment
- Surgery or procedure
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to Nov 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a prospective observational registration trial for patients who undergo lung transplantation using cadaveric organs for medically refractory cancers affecting the lungs alone and without extrapulmonary metastasis after meeting the inclusion criteria of the clinical program at Northwestern Medicine and participating centers. Essential Clinical 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
Who may be able to join
- 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
Show all 37Show fewer
- Patients to meet all other criteria for lung transplantation including insurance approval and United Network for Organ Sharing (UNOS) registration
- 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
- 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
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital) contact
United States1 site, 1 recruiting
- Recruiting
Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital)
Chicago, Illinois, 60611
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital), 312-695-5864, anne.oboye@nm.org
Liam Il-Young Chung, MD MPH, 312-472-6245, ilyoung.chung@northwestern.edu
About this study
Official title: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies (DREAM) - a Prospective Observational Registry Study for Patients Undergoing Lung Transplantation for Medically Refractory Cancers Confined to the Lungs
This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
Read the detailed description
Ever since human lung transplantation was first performed in a patient with advanced lung cancer in 1963 [1], it has emerged as a well-established treatment for patients suffering from a variety of end-stage pulmonary diseases. While lung transplant continues to be performed for refractory lung-limited malignancies that do not have extrapulmonary disease [2-6], given the perceived risks of tumor recurrence following transplantation and potentially reduced survival compared to patients with chronic end-stage lung diseases, transplants for cancer constitutes less than 0.5% of all such procedures (www.srtr.org). The need for lung transplantation is not only confined to patients with primary lung cancers. There are unmet needs for patients who have lung-limited metastasis after successful treatment for primary tumors such as sarcomas or colorectal cancer (CRC). Indeed, successful reports of lung transplantation for lung only metastasis that are refractory to standard of care treatment has been demonstrated [3] and proposed by international experts in highly selected patients [6]. Solid organ transplantation for both primary and metastatic cancers has been demonstrated in liver transplantation [7, 8]. While uncommonly performed, for patients with refractory lung cancer or those with concomitant respiratory failure, lung transplantation may be the only treatment option. The 5-year overall survival of patients in some prior reports who underwent double lung transplantation (DLT) for lung cancer was 39-57%[2, 9], compared to those with non-malignant diseases 50-59%[10, 11]. Indeed, lung transplants have been steadily increasing for cancers, as evident in the International Society of Lung Transplantation (ISHLT) [4-6]. However, the reported cases represent heterogeneity in the surgical technique, patient selection, and post-operative management.
This prospective observational registry aims to better understand the long-term outcomes in patients undergoing double lung transplantation for lung-limited cancers in the clinical programs at Northwestern Medicine and participating centers. We aim to study the impact of a standardized approach to patient selection, tumor staging, surgical technique, and post-operative management on the long-term survival following lung transplantation in patients with lung-limited malignancy. Specifically, this study aims to investigate the clinical outcomes of patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs without extrapulmonary metastases. Patients will undergo transplantation if they have failed standard of care treatments and do not have further curative treatment/trials options. Their clinical courses including overall survival, disease-free survival, and graft failure will be monitored as well as the molecular and genetic biomarkers to investigate the correlation with the prognosis.
- Conditions
- Lung Cancer, Bilateral Cancer, Lung Transplant
- Being tested
- Double Lung Transplantation
- Keywords
- Cancer, Lung Cancer, Bilateral Cancer, Lung Transplant, Double Lung Transplant, Bronchioloalveolar Carcinoma (BAC), Lepidic, Mucinous
- Medical subject headings
- Lung Neoplasms, Neoplasms, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Lung TransplantationProcedure or surgery
Also called Lung Transplantation
To evaluate outcomes among patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Primary lung cancers | - Examples include invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas Receives: Procedure: Double Lung Transplantation | |
| Cohort B: Metastatic cancers to the lung only | - Examples include germ cell tumors, head \& neck tumors, colorectal tumors, renal cell tumors Receives: Procedure: Double Lung Transplantation | |
| 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) Receives: Procedure: Double Lung Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS) rate
Measured: 30-day
overall survival (OS) rate
Measured: 90-day
disease-free survival (DFS) rate
Measured: 30-day
disease-free survival (DFS) rate
Measured: 90-day
allograft rejection (AR) rate
Measured: 30-day
allograft rejection (AR) rate
Measured: 90-day
allograft survival (AS) rate
Measured: 30-day
allograft survival (AS) rate
Measured: 90-day
Secondary outcomes (5)
overall survival (OS) rate
Measured: 6-month, 1-year, 3-year, and 5-year
disease-free survival (DFS) rate
Measured: 6-month, 1-year, 3-year, and 5-year
allograft rejection (AR) rate
Measured: 6-month, 1-year, 3-year, and 5-year
allograft survival (AS) rate
Measured: 6-month, 1-year, 3-year, and 5-year
Major post-transplantation morbidity (MPTM)
including acute kidney failure requiring continuous renal replacement therapy
Measured: 6-month, 1-year, 3-year, and 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start16 Nov 2022
- Primary completionNov 2032 (estimated)
- Study completionNov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Kwang Chae, Northwestern University
- Investigators
- Young Chae, MD MPH MBA, Principal investigator, Northwestern UniversityAnkit Bharat, MD, Principal investigator, Northwestern UniversityRade Tomic, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671887
- Sponsor's protocol ID
- STU00217958
- Other IDs
- NU 22L02
- Acronym
- DREAM
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2022
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bharat A, Machuca TN, Querrey M, Kurihara C, Garza-Castillon R Jr, Kim S, Manerikar A, Pelaez A, Pipkin M, Shahmohammadi A, Rackauskas M, Kg SR, Balakrishnan KR, Jindal A, Schaheen L, Hashimi S, Buddhdev B, Arjuna A, Rosso L, Palleschi A, Lang C, Jaksch P, Budinger GRS, Nosotti M, Hoetzenecker K. Early outcomes after lung transplantation for severe COVID-19: a series of the first consecutive cases from four countries. Lancet Respir Med. 2021 May;9(5):487-497. doi: 10.1016/S2213-2600(21)00077-1. Epub 2021 Mar 31.
PubMed 33811829Van Raemdonck D, Vos R, Yserbyt J, Decaluwe H, De Leyn P, Verleden GM. Lung cancer: a rare indication for, but frequent complication after lung transplantation. J Thorac Dis. 2016 Nov;8(Suppl 11):S915-S924. doi: 10.21037/jtd.2016.11.05.
PubMed 27942415Glanville AR, Wilson BE. Lung transplantation for non-small cell lung cancer and multifocal bronchioalveolar cell carcinoma. Lancet Oncol. 2018 Jul;19(7):e351-e358. doi: 10.1016/S1470-2045(18)30297-3. Epub 2018 Jun 29.
PubMed 30084382Feldman ER, Eagan RT, Schaid DJ. Metastatic bronchioloalveolar carcinoma and metastatic adenocarcinoma of the lung: comparison of clinical manifestations, chemotherapeutic responses, and prognosis. Mayo Clin Proc. 1992 Jan;67(1):27-32. doi: 10.1016/s0025-6196(12)60273-0.
PubMed 1310129Grover FL, Piantadosi S. Recurrence and survival following resection of bronchioloalveolar carcinoma of the lung--The Lung Cancer Study Group experience. Ann Surg. 1989 Jun;209(6):779-90. doi: 10.1097/00000658-198906000-00016.
PubMed 2543339Ahmad U, Wang Z, Bryant AS, Kim AW, Kukreja J, Mason DP, Bermudez CA, Detterbeck FC, Boffa DJ. Outcomes for lung transplantation for lung cancer in the United Network for Organ Sharing Registry. Ann Thorac Surg. 2012 Sep;94(3):935-40; discussion 940-1. doi: 10.1016/j.athoracsur.2012.04.069. Epub 2012 Jul 25.
PubMed 22835555Garver RI Jr, Zorn GL, Wu X, McGiffin DC, Young KR Jr, Pinkard NB. Recurrence of bronchioloalveolar carcinoma in transplanted lungs. N Engl J Med. 1999 Apr 8;340(14):1071-4. doi: 10.1056/NEJM199904083401403.
PubMed 10194236Paloyan EB, Swinnen LJ, Montoya A, Lonchyna V, Sullivan HJ, Garrity E. Lung transplantation for advanced bronchioloalveolar carcinoma confined to the lungs. Transplantation. 2000 Jun 15;69(11):2446-8. doi: 10.1097/00007890-200006150-00041.
PubMed 10868657Zorn GL Jr, McGiffin DC, Young KR Jr, Alexander CB, Weill D, Kirklin JK. Pulmonary transplantation for advanced bronchioloalveolar carcinoma. J Thorac Cardiovasc Surg. 2003 Jan;125(1):45-8. doi: 10.1067/mtc.2003.72.
PubMed 12538984de Perrot M, Chernenko S, Waddell TK, Shargall Y, Pierre AF, Hutcheon M, Keshavjee S. Role of lung transplantation in the treatment of bronchogenic carcinomas for patients with end-stage pulmonary disease. J Clin Oncol. 2004 Nov 1;22(21):4351-6. doi: 10.1200/JCO.2004.12.188.
PubMed 15514376Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
PubMed 25085497Dueland S, Grut H, Syversveen T, Hagness M, Line PD. Selection criteria related to long-term survival following liver transplantation for colorectal liver metastasis. Am J Transplant. 2020 Feb;20(2):530-537. doi: 10.1111/ajt.15682. Epub 2019 Nov 28.
PubMed 31674105Hernandez-Alejandro R, Ruffolo LI, Sasaki K, Tomiyama K, Orloff MS, Pineda-Solis K, Nair A, Errigo J, Dokus MK, Cattral M, McGilvray ID, Ghanekar A, Gallinger S, Selzner N, Claasen MPAW, Burkes R, Hashimoto K, Fujiki M, Quintini C, Estfan BN, Kwon CHD, Menon KVN, Aucejo F, Sapisochin G. Recipient and Donor Outcomes After Living-Donor Liver Transplant for Unresectable Colorectal Liver Metastases. JAMA Surg. 2022 Jun 1;157(6):524-530. doi: 10.1001/jamasurg.2022.0300.
PubMed 35353121
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Lung Transplant REgistry Aimed for Lung-limited Malignancies (DREAM) - a Prospective Observational Registry Study for Patients Undergoing Lung Transplantation for Medically Refractory Cancers Confined to the Lungs
- ClinicalTrials.gov ID
- NCT05671887
- Acronym / sponsor ID
- DREAM / STU00217958
- Conditions
- Lung Cancer, Bilateral Cancer, Lung Transplant
- Keywords
- Cancer, Lung Cancer, Bilateral Cancer, Lung Transplant, Double Lung Transplant, Bronchioloalveolar Carcinoma (BAC), Lepidic, Mucinous
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- Nov 2032 (estimated)
- Study completion
- Nov 2032 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.
Detailed description
Ever since human lung transplantation was first performed in a patient with advanced lung cancer in 1963 [1], it has emerged as a well-established treatment for patients suffering from a variety of end-stage pulmonary diseases. While lung transplant continues to be performed for refractory lung-limited malignancies that do not have extrapulmonary disease [2-6], given the perceived risks of tumor recurrence following transplantation and potentially reduced survival compared to patients with chronic end-stage lung diseases, transplants for cancer constitutes less than 0.5% of all such procedures (www.srtr.org). The need for lung transplantation is not only confined to patients with primary lung cancers. There are unmet needs for patients who have lung-limited metastasis after successful treatment for primary tumors such as sarcomas or colorectal cancer (CRC). Indeed, successful reports of lung transplantation for lung only metastasis that are refractory to standard of care treatment has been demonstrated [3] and proposed by international experts in highly selected patients [6]. Solid organ transplantation for both primary and metastatic cancers has been demonstrated in liver transplantation [7, 8]. While uncommonly performed, for patients with refractory lung cancer or those with concomitant respiratory failure, lung transplantation may be the only treatment option. The 5-year overall survival of patients in some prior reports who underwent double lung transplantation (DLT) for lung cancer was 39-57%[2, 9], compared to those with non-malignant diseases 50-59%[10, 11]. Indeed, lung transplants have been steadily increasing for cancers, as evident in the International Society of Lung Transplantation (ISHLT) [4-6]. However, the reported cases represent heterogeneity in the surgical technique, patient selection, and post-operative management.
This prospective observational registry aims to better understand the long-term outcomes in patients undergoing double lung transplantation for lung-limited cancers in the clinical programs at Northwestern Medicine and participating centers. We aim to study the impact of a standardized approach to patient selection, tumor staging, surgical technique, and post-operative management on the long-term survival following lung transplantation in patients with lung-limited malignancy. Specifically, this study aims to investigate the clinical outcomes of patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs without extrapulmonary metastases. Patients will undergo transplantation if they have failed standard of care treatments and do not have further curative treatment/trials options. Their clinical courses including overall survival, disease-free survival, and graft failure will be monitored as well as the molecular and genetic biomarkers to investigate the correlation with the prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Primary lung cancers | – | Procedure: Double Lung Transplantation- Examples include invasive mucinous/non-mucinous non-small cell lung cancers and multifocal carcinomas |
| Cohort B: Metastatic cancers to the lung only | – | Procedure: Double Lung Transplantation- Examples include germ cell tumors, head \& neck tumors, colorectal tumors, renal cell tumors |
| Cohort C: Respiratory failure with a history of cancer in the last 5 years | – | Procedure: Double Lung Transplantation- 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective observational registration trial for patients who undergo lung transplantation using cadaveric organs for medically refractory cancers affecting the lungs alone and without extrapulmonary metastasis after meeting the inclusion criteria of the clinical program at Northwestern Medicine and participating centers. Essential Clinical 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
Key inclusion criteria (37 listed)
- 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
- 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
- Adenocarcinoma in situ
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Double Lung TransplantationAlso: Lung TransplantationTo evaluate outcomes among patients who undergo lung transplantation for treatment of a select group of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis. | Procedure or surgery | Cohort A: Primary lung cancers, Cohort B: Metastatic cancers to the lung only, Cohort C: Respiratory failure with a history of cancer in the last 5 years |
Primary outcome
overall survival (OS) rate
Time frame: 30-day
overall survival (OS) rate
Time frame: 90-day
disease-free survival (DFS) rate
Time frame: 30-day
disease-free survival (DFS) rate
Time frame: 90-day
allograft rejection (AR) rate
Time frame: 30-day
allograft rejection (AR) rate
Time frame: 90-day
allograft survival (AS) rate
Time frame: 30-day
allograft survival (AS) rate
Time frame: 90-day
5 secondary outcomes
overall survival (OS) rate
Time frame: 6-month, 1-year, 3-year, and 5-year
disease-free survival (DFS) rate
Time frame: 6-month, 1-year, 3-year, and 5-year
allograft rejection (AR) rate
Time frame: 6-month, 1-year, 3-year, and 5-year
allograft survival (AS) rate
Time frame: 6-month, 1-year, 3-year, and 5-year
Major post-transplantation morbidity (MPTM)
Time frame: 6-month, 1-year, 3-year, and 5-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Background: PubMed 33811829Bharat A, Machuca TN, Querrey M, Kurihara C, Garza-Castillon R Jr, Kim S, Manerikar A, Pelaez A, Pipkin M, Shahmohammadi A, Rackauskas M, Kg SR, Balakrishnan KR, Jindal A, Schaheen L, Hashimi S, Buddhdev B, Arjuna A, Rosso L, Palleschi A, Lang C, Jaksch P, Budinger GRS, Nosotti M, Hoetzenecker K. Early outcomes after lung transplantation for severe COVID-19: a series of the first consecutive cases from four countries. Lancet Respir Med. 2021 May;9(5):487-497. doi: 10.1016/S2213-2600(21)00077-1. Epub 2021 Mar 31.
- Background: PubMed 27942415Van Raemdonck D, Vos R, Yserbyt J, Decaluwe H, De Leyn P, Verleden GM. Lung cancer: a rare indication for, but frequent complication after lung transplantation. J Thorac Dis. 2016 Nov;8(Suppl 11):S915-S924. doi: 10.21037/jtd.2016.11.05.
- Background: PubMed 30084382Glanville AR, Wilson BE. Lung transplantation for non-small cell lung cancer and multifocal bronchioalveolar cell carcinoma. Lancet Oncol. 2018 Jul;19(7):e351-e358. doi: 10.1016/S1470-2045(18)30297-3. Epub 2018 Jun 29.
- Background: PubMed 1310129Feldman ER, Eagan RT, Schaid DJ. Metastatic bronchioloalveolar carcinoma and metastatic adenocarcinoma of the lung: comparison of clinical manifestations, chemotherapeutic responses, and prognosis. Mayo Clin Proc. 1992 Jan;67(1):27-32. doi: 10.1016/s0025-6196(12)60273-0.
- Background: PubMed 2543339Grover FL, Piantadosi S. Recurrence and survival following resection of bronchioloalveolar carcinoma of the lung--The Lung Cancer Study Group experience. Ann Surg. 1989 Jun;209(6):779-90. doi: 10.1097/00000658-198906000-00016.
- Background: PubMed 22835555Ahmad U, Wang Z, Bryant AS, Kim AW, Kukreja J, Mason DP, Bermudez CA, Detterbeck FC, Boffa DJ. Outcomes for lung transplantation for lung cancer in the United Network for Organ Sharing Registry. Ann Thorac Surg. 2012 Sep;94(3):935-40; discussion 940-1. doi: 10.1016/j.athoracsur.2012.04.069. Epub 2012 Jul 25.
- Background: PubMed 10194236Garver RI Jr, Zorn GL, Wu X, McGiffin DC, Young KR Jr, Pinkard NB. Recurrence of bronchioloalveolar carcinoma in transplanted lungs. N Engl J Med. 1999 Apr 8;340(14):1071-4. doi: 10.1056/NEJM199904083401403.
- Background: PubMed 10868657Paloyan EB, Swinnen LJ, Montoya A, Lonchyna V, Sullivan HJ, Garrity E. Lung transplantation for advanced bronchioloalveolar carcinoma confined to the lungs. Transplantation. 2000 Jun 15;69(11):2446-8. doi: 10.1097/00007890-200006150-00041.
- Background: PubMed 12538984Zorn GL Jr, McGiffin DC, Young KR Jr, Alexander CB, Weill D, Kirklin JK. Pulmonary transplantation for advanced bronchioloalveolar carcinoma. J Thorac Cardiovasc Surg. 2003 Jan;125(1):45-8. doi: 10.1067/mtc.2003.72.
- Background: PubMed 15514376de Perrot M, Chernenko S, Waddell TK, Shargall Y, Pierre AF, Hutcheon M, Keshavjee S. Role of lung transplantation in the treatment of bronchogenic carcinomas for patients with end-stage pulmonary disease. J Clin Oncol. 2004 Nov 1;22(21):4351-6. doi: 10.1200/JCO.2004.12.188.
- Background: PubMed 25085497Weill D, Benden C, Corris PA, Dark JH, Davis RD, Keshavjee S, Lederer DJ, Mulligan MJ, Patterson GA, Singer LG, Snell GI, Verleden GM, Zamora MR, Glanville AR. A consensus document for the selection of lung transplant candidates: 2014--an update from the Pulmonary Transplantation Council of the International Society for Heart and Lung Transplantation. J Heart Lung Transplant. 2015 Jan;34(1):1-15. doi: 10.1016/j.healun.2014.06.014. Epub 2014 Jun 26.
- Background: PubMed 31674105Dueland S, Grut H, Syversveen T, Hagness M, Line PD. Selection criteria related to long-term survival following liver transplantation for colorectal liver metastasis. Am J Transplant. 2020 Feb;20(2):530-537. doi: 10.1111/ajt.15682. Epub 2019 Nov 28.
- Individual participant dataSharing planned: No
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Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital) contact
Young Chae, MD MPH MBA principal investigator
Northwestern University
Ankit Bharat, MD principal investigator
Northwestern University
Rade Tomic, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Bilateral Cancer, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lung Transplant Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital) (312-695-5864, anne.oboye@nm.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) rate (time frame: 30-day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671887, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.