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

NCT07008742 | Recruiting DMC

• 3 other identifiers: CCR595233653124/LO/0791
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Oncogene-addicted Non Small Cell Lung Cancer; Early-stage Operable Non Small Cell Lung Cancer; Non Small Cell Lung Cancer; Metastatic Non Small Cell Lung Cancer; Locally Advanced NSCLC - Non-Small Cell Lung Cancer; Stage 2/3 Operable Non Small Cell Lung Cancer

Keywords

tissue; blood; feasibility study

Outcome Measures

Primary Outcomes (1)

• The number of participants with paired samples of blood and viable tissue

  The number of participants with paired samples of blood and viable tissue with: * Oncogene-addicted metastatic NSCLC commencing new line of targeted therapy at progression (Cohort 1), and * Early-stage operable NSCLC undergoing neoadjuvant CPI-based therapy (Cohort 2) Viable tissue is defined by the presence of viable tumour cells. Viable tumour cells are defined by those with well-preserved architectural and cytological features, in line with the latest recommendation from the International Association for the Study of Lung Cancer (IASLC), evaluated by a specialist pulmonary pathologist using a haematoxylin \& eosin (H\&E) stained slide.

  5 years

Secondary Outcomes (1)

• The number of patients with viable tissue samples

  5 years

Other Outcomes (1)

• Exploratory aims

  5 years

Study Arms (4)

Cohort 1A

Treatment naïve, oncogene-addicted NSCLC

Cohort 1B

Pre-treated, oncogene-addicted NSCLC, received prior targeted therapy

Cohort 1C

Pre-treated, oncogene-addicted NSCLC, no prior targeted therapy (can have received chemotherapy/CPI/chemo-CPI)

Cohort 2

Early-stage operable NSCLC undergoing neoadjuvant CPI therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Royal Marsden NHS Foundation patients

You may qualify if:

• Age \>/= 18.
• Histologically confirmed locally advanced or metastatic NSCLC
• ECOG performance score 0-2
• Tier 1 ASCO/AMP NSCLC oncogenic variant identified through routine clinical methods, e.g. EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2, NTRK
• Planned to commence targeted therapy (any line of therapy)
• o This includes bispecific antibodies (e.g. amivantamab), and antibody-drug conjugates (e.g. trastuzumab-deruxtecan)
• Regular follow-up and monitoring for cancer recurrence per standard of care planned at the enrolling site
• Provided written informed consent to participate in the study
• Age \>/= 18.
• Histologically confirmed stage II/III operable NSCLC
• Planned to undergo neoadjuvant CPI-based therapy
• Provided written informed consent to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Francis Crick Institute: collaborator
• University of Cambridge: collaborator
• Royal Brompton & Harefield NHS Foundation Trust: collaborator
• Institute of Cancer Research, United Kingdom: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, United Kingdom, SW3 6JJ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Archival tissue, fresh surgical tissue, blood

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Professor Sanjay Popat, Consultant Medical Oncologist

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashling Henderson, Senior Clinical Trial Manager

CONTACT

+44 2031865916; Festival@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 6, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

GB (1)