TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

Non-small Cell Lung Cancer Clinical Trial

— TRACERx  

Official title:

TRAcking Non-small Cell Lung Cancer Evolution Through Therapy (Rx)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01888601
• Other study ID #: UCL/12/0279
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the NSCLC evolutionary genomic landscape between primary and metastatic sites and the dynamics of intratumour heterogeneity over time combined with detailed clinical, histopathological and cancer phenotypic annotation for each patient, in order to significantly improve the outcomes of NSCLC patients (e.g. reduce their chance of recurrence and improve survival).

Description:

The importance of intratumour genetic and functional heterogeneity is increasingly recognised as a driver of cancer progression and survival outcome. Understanding how tumour clonal heterogeneity impacts upon therapeutic outcome, however, is still an area of unmet clinical and scientific need. TRACERx (TRAcking non-small cell lung Cancer Evolution through therapy [Rx]), a prospective study of patients with primary non-small cell lung cancer (NSCLC), aims to define the evolutionary trajectories of lung cancer in both space and time through multiregion and longitudinal tumour sampling and genetic analysis. By following cancers from diagnosis to relapse, tracking the evolutionary trajectories of tumours in relation to therapeutic interventions, and determining the impact of clonal heterogeneity on clinical outcomes, TRACERx may help to identify novel therapeutic targets for NSCLC and may also serve as a model applicable to other cancer types.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 814
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written Informed consent

• Patients =18 years of age, with early stage IIA-IIIB disease (according to TNM 8th edition) who are eligible for primary surgery. Patients with a radiological staging of IB (N0) who could be upstaged to IIA-IIIB following surgery (due to the presence of possible nodal involvement on the pre-operative scan) may also be included, but will be withdrawn if post-surgical staging remains IB.

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 planned (see section 9.3)

• Agreement to be followed up at a TRACERx site

• Performance status 0 or 1

• Minimum tumour diameter at least 15mm to allow for sampling of at least two tumour regions (if 15mm, a high likelihood of nodal involvement on pre-operative imaging required to meet eligibility according to stage, i.e. T1N1-3)

Exclusion Criteria:

• Any other* malignancy diagnosed or relapsed at any time, which is currently being treated (including by hormonal therapy).

• Any other* current malignancy or malignancy diagnosed or relapsed within the past 3 years**.

*Exceptions are: non-melanomatous skin cancer, stage 0 melanoma in situ, and in situ cervical cancer

**An exception will be made for malignancies diagnosed or relapsed more than 2, but less than 3, years ago only if a pre-operative biopsy of the lung lesion has confirmed a diagnosis of NSCLC.

• Psychological condition that would preclude informed consent

• Treatment with neo-adjuvant therapy for current lung malignancy deemed necessary

• Post-surgery staging is not IIA-IIIB

• Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or syphilis infection.

• Sufficient tissue, i.e. a minimum of two tumour regions, is unlikely to be obtained for the study based on pre-operative imaging

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
United Kingdom	Grampian Health Board	Aberdeen
United Kingdom	Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Cardiff and Vale University Health Board	Cardiff
United Kingdom	Ashford and St Peter's Hospitals NHS Foundation Trust	Chertsey	Surrey
United Kingdom	NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	The Princess Alexandra Hospital NHS Trust	Harlow	Essex
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Liverpool Heart and Chest Hospital	Liverpool
United Kingdom	Barts Health NHS Trust	London
United Kingdom	North Middlesex University Hospital NHS Trust	London
United Kingdom	Royal Brompton & Harefield NHS Foundation Trust	London
United Kingdom	Royal Free Hospital	London
United Kingdom	Royal Free London NHS Foundation Trust - Barnet Hospital	London
United Kingdom	The Whittington Hospital NHS Trust, trading as Whittington Health	London
United Kingdom	University College London Hospitals NHS Foundation Trust	London	Select Region
United Kingdom	University Hospital of South Manchester NHS Foundation Trust	Manchester
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	University Hospital Southampton NHS Foundation Trust	Southampton	Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intratumour heterogeneity	• Define the relationship between intratumour heterogeneity and clinical outcome following surgery and adjuvant therapy (including relationships between intratumour heterogeneity and clinical disease stage and histological subtypes of NSCLC).	Year 5