At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Royal Marsden NHS Foundation Trust, is looking at whether it is possible to collect tissue and blood samples from people with non-small cell lung cancer (NSCLC). It includes two groups: people whose cancer is driven by a known gene change (sometimes called 'oncogene-addicted') and who are due to start targeted treatment, and people with stage 2 or 3 operable NSCLC who are due to have treatment before surgery that helps the immune system fight cancer.
Who can take part
- Aged 18 or over
- Group 1: non-small cell lung cancer (NSCLC) that is locally advanced or has spread, confirmed by tissue testing, with a known gene change such as EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2 or NTRK found through routine testing
- Group 1: able to carry out day-to-day activities at least some of the time (performance score 0-2)
- Group 1: due to start targeted therapy (any time during treatment), including newer medicines such as bispecific antibodies and antibody-drug conjugates
- Group 1: planned regular check-ups and monitoring for cancer coming back at the hospital running the study
- Group 2: stage 2 or 3 NSCLC that can be operated on, confirmed by tissue testing
- Group 2: due to have treatment before surgery that helps the immune system fight cancer (neoadjuvant CPI-based therapy)
- Both groups: willing and able to give written consent to take part
Who may not be able to
- Too unwell to safely manage the extra tissue and blood samples the study needs
What taking part involves
- • Providing tissue and blood samples for the study
- • Not stated — ask the trial team about exactly what samples are taken and when
Time commitment: Taking part involves giving tissue and blood samples; the number of visits and how long the study lasts are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2025-06-04
- Last checked
- 2025-06
Plain English Summary
What is this study?
- • Testing a new treatment for oncogene-addicted non small cell lung cancer
- • Clinical study - 100 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with oncogene-addicted non small cell lung cancer
Where?
- • London - The Royal Marsden NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Rationale Benchmarking the proportion of patients who are able to provide paired samples of blood and viable tumour tissue is important in oncogene-addicted metastatic NSCLC patients as investigators have now entered the era of genotype-guided post-progression targeted therapies. In the early-stage operable NSCLC context, benchmarking the feasibility of paired samples is of interest as neoadjuvant CPI-based therapy has recently emerged as a new standard of care strategy. As such, investigators have defined the following cohorts within our study: Cohort 1: Oncogene-addicted NSCLC, due to commence new line of targeted therapy * Sub-cohort 1A: treatment naïve, oncogene-addicted NSCLC * Sub-cohort 1B: pre-treated, oncogene-addicted NSCLC, received prior targeted therapy * Sub-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 Primary aim To estimate the feasibility of collecting paired samples of blood and viable tissue in patients 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. Secondary aims To estimate the feasibility of obtaining viable tissue samples at: * Baseline (sub-cohort 1B) * PD (Cohort 1) * Surgery (Cohort 2) Exploratory aims * To identify genes/proteins associated with disease progression on targeted therapy (Cohort 1) * To measure levels of tumour cell-recognising antibodies in patients on targeted therapy (Cohort 1) * To identify genes/proteins associated with tumour regression (Cohort 2)
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Who cannot take part
- ✗Patient too medically unstable to commit to sampling required for the study
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
How to Get in Touch
Ashling Henderson, Senior Clinical Trial Manager
Sponsor contactCONTACT