Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
Recruiting · NCT07008742 · Observational (researchers observe without assigning treatment) · Lead sponsor: Royal Marsden NHS Foundation Trust
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- Cohort 1):
- 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)
- 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
- Inclusion Criteria (Cohort 2)
- 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
Exclusion criteria
- Patient too medically unstable to commit to sampling required for the study
Where it is running
1 location listed.
- The Royal Marsden NHS Foundation Trust - London, United Kingdom, United Kingdom