NCT07008742Recruiting
Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 15 May 2025
- Start date
- 4 Jun 2025
- Primary completion date
- 1 Jun 2029
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Diseases
- Lung cancer
- NCT number
- NCT07008742
What you commit to
- Study type: Observational
- Planned participants: 100
- From 4 Jun 2025 to the primary completion date, 1 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patient too medically unstable to commit to sampling required for the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Marsden NHS Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.