NSCLC biomarker study using tumor and blood samples to link genetics with prognosis and immunotherapy response

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 translational study analyzes tumor tissue (FFPE and, when available, fresh frozen) and matched germline DNA from NSCLC patients to map genomic alterations and gene expression profiles. Whole exome sequencing and RNA sequencing will identify mutational signatures, tumor mutational burden, and immune-related gene expression patterns. The goal is to find clinically actionable biomarkers that correlate with prognosis and response to immunotherapy across metastatic and early-stage disease, with subgroups including resectable cases receiving adjuvant immunotherapy. Peripheral blood will be collected for germline analysis, and a sub-study includes patients with unresectable Stage III NSCLC undergoing concurrent chemoradiation. Participation requires confirmed NSCLC, age 18 or older, consent, and availability of suitable tissue and blood samples.

Why it matters

Who can join: the full rules

Main Study:

Diagnosis: Histologically confirmed Non-Small Cell Lung Cancer (NSCLC). Age: ≥18 years. Consent: Signed informed consent for participation in the study.

Patient Cohorts:

Metastatic NSCLC (Stage IV): 150 patients. Must have received immunotherapy from the date of study amendment. Early-stage NSCLC (Stage I-IIIB): 150 patients. Must have received immunotherapy from the date of study amendment. At least 50 patients must be resectable (Stages I, II, selected Stage III) and treated with adjuvant immunotherapy.

Biological Material:

Availability of FFPE tumor tissue collected ≤6 months before study entry. Availability of peripheral blood for germline DNA extraction. Molecular Analysis: Sufficient DNA and RNA for Whole Exome Sequencing (WES) and RNA sequencing (RNA-seq).

Sub - Study:

Participants must be enrolled in the main EXPLORE study. Diagnosis: Histologically confirmed, unresectable Stage III NSCLC. Treatment Plan: Scheduled to receive concurrent chemoradiation (cCRT) followed by Durvalumab maintenance as per standard of care.

Age: ≥18 years. Consent: Signed informed consent for ctDNA sub-study participation. Biospecimens: Willingness to provide longitudinal blood samples (baseline, during Durvalumab cycles, per protocol).

Where it's running

• German Oncology Center
  Limassol, Cyprus Recruiting
• Euroclinic Athens
  Athens, Greece Recruiting
• 401 General Military Hospital of Athens
  Athens, Greece Recruiting
• Henry Dunant Hospital Center
  Athens, Greece Recruiting
• Alexandra General Hospital
  Athens, Greece Recruiting
• Alexandra General Hospital
  Athens, Greece Recruiting

Study contacts

• Study coordinator: Elefteria Tsolaki
• Email: hecogoff@otenet.gr
• Phone: +30 21 0691 2520

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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.