Actively Recruiting

Age: 18Years +
All Genders
NCT07008742

Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer

Led by Royal Marsden NHS Foundation Trust · Updated on 2025-06-15

100

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

R

Royal Marsden NHS Foundation Trust

Lead Sponsor

F

Francis Crick Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study aims to determine if it is feasible to collect samples of blood and viable lung cancer tissue in patients with either: * Stage IV mutation-driven NSCLC * Stage II-III NSCLC undergoing neoadjuvant immunotherapy prior to surgery Viable tissue has been defined by the collaborating pathology department as the presence of viable tumour cells, in accordance with recommendations from the International Association or the Study of Lung Cancer. In patients with stage IV NSCLC, obtaining adequate samples of viable tissue for advanced testing can be challenging, as sites of cancer that are accessible by biopsy are often small, and contain few viable cancer cells. If obtained, however, viable blood and tissue specimens can be utilised for genetic and other analyses aimed at identifying cancer markers that may offer prognostic information, or that may potentially lead to development of therapies that target these markers in the future. In patients with stage II-III NSCLC, the use of immunotherapy prior to surgery has been shown to affect the proportion of viable tumour tissue at the time of surgery, although this needs to be further studied. There is a need to better understand the genetic basis of these tumours to improve response rates to immunotherapy prior to surgery. The study will be open for four years in total. The first three years will consist of recruitment and participant follow up, and the fourth year will consist of follow up only. Data analysis will occur in the fifth year when the study is closed.

CONDITIONS

Official Title

Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed locally advanced or metastatic NSCLC for Cohort 1
  • ECOG performance score 0-2 for Cohort 1
  • Tier 1 ASCO/AMP NSCLC oncogenic variant identified through routine clinical methods for Cohort 1
  • Planned to begin targeted therapy (any line) including bispecific antibodies and antibody-drug conjugates for Cohort 1
  • Regular follow-up and monitoring for cancer recurrence planned at enrolling site for Cohort 1
  • Provided written informed consent to participate for Cohort 1
  • Age 18 years or older for Cohort 2
  • Histologically confirmed stage II/III operable NSCLC for Cohort 2
  • Planned to receive neoadjuvant CPI-based therapy for Cohort 2
  • Provided written informed consent to participate for Cohort 2
Not Eligible

You will not qualify if you...

  • Patient too medically unstable to commit to the required sampling for the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Royal Marsden NHS Foundation Trust

London, United Kingdom, United Kingdom, SW3 6JJ

Actively Recruiting

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Research Team

A

Ashling Henderson, Senior Clinical Trial Manager

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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