Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
Cancer Research UK
Chief Investigator:
Prof. Charles Swanton
Recruitment target:
Cohort A-300; Cohort B-200; Cohort C-50-100
EudraCT number:
Contact details:
Lay summary:
TRAcking thoracic Cancer Evolution through therapy (Rx) EVO

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. There will be 3 distinct sub-cohorts for recruitment in this study: 

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. 


Treatment: There is no treatment intervention or specification in this observational study. Participants will have standard of care treatment as dictated by their treating clinicians

Key inclusion/exclusion criteria:
Key inclusion criteria
Cohort A:
  • Participants must be over 18, have early stage I-IIIB NSCLC and be eligible for primary surgery in accordance with NICE guidelines.
  • Participants must be sufficiently fit for upfront SOC primary surgery and have a tumour diameter of 15mm to allow sampling of at least two tumour regions. 
  • Participants undergoing neoadjuvant therapy must have at least one region of fresh frozen surgical or diagnostic biopsy tissue
Cohort B
  • Participants must be over18 and present with late stage IIIB and above unresectable NSCLC or de novo stage IV metastases
  • Participants must be sufficiently fit for anti cancer therapy and must have at least one region of fresh frozen biopsy tissue
Cohort C
  • Participants should present with any stage SCLC or pleural mesothelioma. 
  • Participants must be sufficiently fit for anti cancer therapy and must have at least one region of fresh frozen biopsy tissue
Key exclusion criteria

All Cohorts:
  • Participants cannot have any other current malignancy or malignancy diagnosed or relapsed at any time, which is currently being treated (including hormonal therapy). 
  • Participants cannot have any other current malignancy or malignancy diagnosed or relapsed within the past 3 years (other than non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer). 
  • Participants cannot have confirmed diagnosis of high-risk infections (e.g., HIV, HBV, HCV and syphilis).
Cohort A
  • If there is insufficient tissue (either FF or FFPE per biopsy)
  • the operative criteria are not met (e.g. incomplete resection or insufficient nodal sampling)
Cohort B/C
  • If there is no sufficient tissue (either FF or FFPE per biopsy)
Duration of recruitment: Recruitment is expected to take up to 4 years


TRACERx EVO aims to accelerate our understanding of lung cancer evolution, drug resistance, metastasis, immune evasion and their combined impact on the patient's metabolism and body composition. Participants will receive standard of care anti-cancer therapies for their lung cancer as dictated by their treating team (for example: systemic therapies, radiotherapy and surgery, as per local and national guidelines). Participants who consent to the study will be approached for cancer tissue samples, blood and other samples (such as urine, stool, saliva, and nasal epithelial samples). Data on the participant’s demographics, treatment plans, imaging results and outcomes will also be collected. Using the collected tissue, blood and other samples, we hope to build a well curated data set to better understand how cancers spread, why they become resistant to treatments, and why severe weight loss is seen in patients with cancer. Multiple types of analyses will be performed, including, but not limited to, genetic, metabolism, immune cell analyses, as well as mouse model and cell line analyses. By building on the work performed in the original study, TRACERx, we hope that TRACERx EVO will further improve our understanding of lung cancer, and lead to improvements in patient care in the future.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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