Collecting blood and viable tumor samples from people with oncogene-driven or neoadjuvantly treated non-small cell lung cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• PF-08634404 plus chemotherapy versus pembrolizumab-based chemotherapy for advanced non-small cell lung cancer

  This will test whether PF-08634404 combined with chemotherapy works better than pembrolizumab plus chemotherapy for adults with locally advanced or metastatic non-small cell lung cancer who have not received prior treatment for their advanced disease.

  Recruiting at 464 sites Phase 3 Pfizer · Bullhead City, Arizona and 483 other locations · NCT07222566

• Firmonertinib versus standard EGFR drugs as first treatment for advanced NSCLC with EGFR PACC mutations

  This trial tests whether daily firmonertinib works better than standard EGFR drugs (osimertinib or afatinib) as the first treatment for people with advanced NSCLC that has EGFR PACC mutations.

  Recruiting at 141 sites Phase 3 ArriVent BioPharma, Inc. · Fullerton, California and 140 other locations · NCT07185997

• Ubamatamab with or without REGN7075 for adults with advanced or metastatic non-small cell lung cancer

  This trial will try ubamatamab alone and with REGN7075 in adults with advanced or metastatic non-small cell lung cancer to see if they control the cancer and will try sarilumab to manage immune-related side effects.

  Recruiting at 18 sites Phase 2 Regeneron Pharmaceuticals · Birmingham, Alabama and 17 other locations · NCT07154290

• Reduced chemotherapy and immunotherapy for older adults with advanced lung cancer

  This study is testing a lower dose of chemotherapy combined with immunotherapy to see if it's safe and tolerable for older adults over 70 with advanced lung cancer who can’t have curative treatment.

  Recruiting at 2 sites Phase 2 Virginia Commonwealth University · Richmond, Virginia and 1 other locations · NCT06731413

• Evaluating BBO-8520 for treating KRAS G12C non-small cell lung cancer

  This study is testing a new drug called BBO-8520 to see if it can safely help adults with a specific type of lung cancer that has a KRAS G12C mutation, both on its own and when combined with another treatment.

  Recruiting at 38 sites Phase 1 TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics) · Birmingham, Alabama and 37 other locations · NCT06343402

• Investigating OBX-115 for advanced solid tumors

  This study is testing a new treatment called OBX-115 to see if it can help adults with advanced solid tumors like metastatic melanoma and non-small cell lung cancer feel better and live longer.

  Recruiting at 13 sites Phase 1/2 Obsidian Therapeutics, Inc. · Tucson, Arizona and 13 other locations · NCT06060613

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.