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

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · May 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how well we can collect blood and tissue samples from patients with different stages of non-small cell lung cancer (NSCLC) that is driven by specific genetic changes, known as oncogenes. The trial focuses on two groups of patients: those with advanced stage IV NSCLC and those with early-stage (stage II-III) NSCLC who are receiving immunotherapy before surgery. The main goal is to see if we can gather enough viable (living) cancer cells from these samples to learn more about the cancer and potentially develop new treatments in the future.

To join this study, participants must be at least 18 years old and have a confirmed diagnosis of NSCLC. In the first group, they should have advanced cancer with specific genetic changes and be starting targeted therapy. In the second group, they need to have operable cancer and plan to receive immunotherapy before surgery. Participants will be required to give their consent to take part, and over the course of four years, the study will involve collecting samples and monitoring their progress. This research is important because it may help scientists understand how to improve treatments for lung cancer.

Gender

ALL

Eligibility 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