Collecting blood and viable tumor samples from people with oncogene-driven or neoadjuvantly treated non-small cell lung cancer.
Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Cancer
This project will try to see if paired blood and viable tumor samples can be reliably collected from adults with oncogene-driven advanced NSCLC starting targeted therapy and from adults with stage II–III NSCLC receiving neoadjuvant immunotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | amivantamab, trastuzumab, immunotherapy, chemotherapy |
| Locations | 1 site (London, United Kingdom) |
| Trial ID | NCT07008742 on ClinicalTrials.gov |
What this trial studies
This observational feasibility project enrolls two main cohorts: patients with oncogene-addicted locally advanced or metastatic NSCLC who are about to start a new line of targeted therapy, and patients with stage II–III operable NSCLC planned for neoadjuvant checkpoint inhibitor-based therapy. Investigators will attempt to collect paired blood and viable tumor tissue, with viable tissue defined by preserved tumor cells per pathology guidelines. The primary goal is to benchmark how often adequate paired samples can be obtained for downstream genetic and molecular analyses. Results will inform the practicality of routine paired sampling for genotype-guided care and for research into biomarkers and targeted treatments.
Who should consider this trial
Good fit: Adults (≥18) with histologically confirmed oncogene-addicted locally advanced/metastatic NSCLC about to start a new targeted therapy, or adults with stage II–III operable NSCLC planned for neoadjuvant checkpoint inhibitor therapy, who can consent and attend the enrolling site.
Not a fit: Patients who are medically unstable, lack accessible viable tumor for biopsy, or do not meet the oncogene or neoadjuvant therapy criteria are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this work could improve the ability to obtain high-quality blood and tissue samples that enable molecular testing and support development of targeted therapies.
How similar studies have performed: While blood and tissue collection for molecular testing is established, systematically benchmarking paired-sample feasibility in oncogene-addicted metastatic and neoadjuvantly treated early-stage NSCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (Cohort 1): 1. Age \>/= 18. 2. Histologically confirmed locally advanced or metastatic NSCLC 3. ECOG performance score 0-2 4. Tier 1 ASCO/AMP NSCLC oncogenic variant identified through routine clinical methods, e.g. EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, HER2, NTRK 5. 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) 6. Regular follow-up and monitoring for cancer recurrence per standard of care planned at the enrolling site 7. Provided written informed consent to participate in the study Inclusion Criteria (Cohort 2) 1. Age \>/= 18. 2. Histologically confirmed stage II/III operable NSCLC 3. Planned to undergo neoadjuvant CPI-based therapy 4. Provided written informed consent to participate in the study Exclusion Criteria: • Patient too medically unstable to commit to sampling required for the study
Where this trial is running
London, United Kingdom
- The Royal Marsden NHS Foundation Trust — London, United Kingdom, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Professor Sanjay Popat, Consultant Medical Oncologist — Royal Marsden NHS Foundation Trust
- Study coordinator: Ashling Henderson, Senior Clinical Trial Manager
- Email: Festival@rmh.nhs.uk
- Phone: +44 2031865916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.