Lung Cancer, Non-small CellNCT05628376
TRAcking Thoracic Cancer Evolution Through Therapy (Rx) EVO
An observational study of Lung Cancer, Non-small Cell and Small Cell Lung Cancer, run by University College, London at 1 site in United Kingdom.
Trial summary
TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pleural mesothelioma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Non-small Cell, Small Cell Lung Cancer, Pleural Mesothelioma
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2023to Jun 2034
- Phase
- Observational
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: I-IIIC or de novo metastatic (stage IV) Non-small cell lung cancer, stage I-IV Small cell lung cancer, pleural mesothelioma.
Who may be able to join
- Cohort A, B and C :
- Written Informed consent
- Agreement to be followed up (including on-study assessments and sample collection) every 3 months in the first 2 years and then 6 monthly.
- Agreement to be followed up at a TRACERx EVO site
- Cohort A:
- Participants ≥18 years of age, with early stage I-IIIB NSCLC disease who are eligible for primary surgery
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- Histopathologically confirmed NSCLC, or a strong suspicion of cancer on lung imaging necessitating surgery (e.g., diagnosis determined from frozen section in theatre)
- Primary surgery in keeping with NICE guidelines (lobectomy, either open or thoracoscopic), lung parenchymal-sparing operations (segmentectomy or wedge resection) if a complete resection can be achieved, extensive surgery (bronchoangioplastic surgery, bilobectomy, pneumonectomy) if necessary to obtain clear margins, hilar and mediastinal lymph node sampling or en bloc resection)
- For participants proceeding with upfront primary surgery (i.e. no neoadjuvant therapy), a minimum tumour diameter of at least 15mm on imaging to allow for tissue sampling of at least two tumour regions; this can either be two fresh tissue samples or one fresh tissue sample plus one representative diagnostic FFPE block (to be requested at a later date according to trial specific procedures)
- Participants undergoing neoadjuvant treatment must have at least 1 region of fresh frozen or FFPE surgical or diagnostic biopsy tissue.
- Considered sufficiently fit for upfront standard of care primary surgery or neoadjuvant therapy if indicated
- Performance status 0 to 2
- Cohort B:
- Participants ≥18 years of age, with late-stage unresectable stage IIIB and above NSCLC disease (TNM 8th edition) or presenting with stage IV de novo metastatic disease.
- Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
- Deemed to be fit for anti-cancer treatment
- Performance status 0 to 2 Participants who were initially consented into Cohort A who are found to have more advanced disease pre- or immediately post operatively (e.g. locally advanced/inoperable or stage IV disease) could be included in Cohort B.
- Cohort C:
- Participants ≥18 years of age, with any stage SCLC or pleural mesothelioma.
- Sufficient tissue (at least 1 region/biopsy), either FFPE or fresh frozen
- Deemed to be fit for anti-cancer treatment
- Performance status 0 to 2
Who cannot join
- Cohort A, B and C:
- Any other active or current malignancy and/or systemic treatment (excluding hormone therapy) for that malignancy in the last 12 months (i.e., participant must be cancer free for the last 12 months, and if on therapy it can only be hormone therapy).
- Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer, or for Cohort C, cases of NSCLC that have transformed to SCLC, or for Cohort A another synchronous lung cancer.
- Psychological condition that would preclude informed consent
- Diagnosis other than NSCLC, SCLC or pleural mesothelioma confirmed following surgery or biopsy
- Confirmed diagnosis of known high-risk infections (e.g., Human Immunodeficiency Virus) (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection, tuberculosis and Creutzfeldt-Jacob disease) unless participant case is of a particular scientific interest and agreed in advance with research staff, local mortuary staff and pathologist.
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- Contra-indicated severe co-morbid conditions
- Cohort A:
- Positive margins, incomplete resection or insufficient nodal sampling
- Insufficient tissue, i.e., for participants having upfront surgery and not having neoadjuvant therapy, a minimum of two tumour regions unlikely to be obtained for the study based on pre-operative imaging, or for participants having neoadjuvant therapy at least one tissue biopsy unable to be obtained prior to neoadjuvant therapy (Fresh Frozen or FFPE).
- Participant found to have pre-invasive lesions rather than invasive cancer following surgery, such as adenocarcinoma in situ or minimally invasive lesions will be withdrawn. However, the surgical tissue and baseline blood already collected will be sent to the central laboratory. These participants will not be followed-up in the study or required to provide any further blood samples. If these participants subsequently develop invasive cancer, the date of diagnosis and the tumour histology will be reported on the electronic data capture system.
- Cohort B/C:
- Insufficient tissue, i.e., at least one tissue biopsy unable to be obtained (Fresh Frozen or FFPE)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospitals NHS Foundation Trust
London, NW1 2PG
About this study
TRACERx EVO is a programme of work using a prospective observational cohort study of participants with early- and late-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pleural mesothelioma.
Read the detailed description
TRACERx EVO is a programme of work linked to an observational cohort study that consists of early and late-stage lung cancer and pleural mesothelioma. Participants will receive anti-cancer therapies (systemic therapies, radiotherapy and surgery, as per local and national guidelines). This study involves collecting a large amount of data, covering demographic and clinical characteristics, data throughout their follow up from the time of baseline/surgery, genomics and all other laboratory results using their blood, tissue, urine, saliva and stool samples. Data would also be retrieved from participant medical records. As such, there will be a wide range of analyses
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Mesothelioma, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | 300 participants with early stage resectable I-IIIB NSCLC | |
| Cohort B | 200 participants with unresectable late stage IIIB-IIIC or de novo metastatic (stage IV) NSCLC. | |
| Cohort C | 50-100 participants with stage I-IV SCLC or pleural mesothelioma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
DFS; recurrence or death from any cause): Cohorts A \& C
Measured: 5 years
Progression Free Survival
PFS; first disease progression or death from any cause): Cohorts B \& C
Measured: 5 years
Overall Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2022
- Study start20 Oct 2023
- Primary completion20 Oct 2030 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Non-small CellStudies of the same condition, open and under way.
- More trials run by University College, LondonThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628376
- Sponsor's protocol ID
- UCL - 151927
- Status last verified
- Jul 2026
- First submitted
- 16 Nov 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No