An observational study in Non-small Cell Lung Cancer (NSCLC), sponsored by Hellenic Cooperative Oncology Group. Recruiting at 20 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Hellenic Cooperative Oncology Group · Observational
This is a non-interventional translational research study aiming to comprehensively characterize the genomic and transcriptomic landscape of patients with non-small cell lung cancer (NSCLC). The study will employ whole-exome sequencing (WES) and RNA sequencing (RNA-seq) on tumor tissue samples and matched germline DNA to identify genomic alterations, mutational signatures, and transcriptomic profiles associated with prognosis and response to immunotherapy.
A total of approximately 300 patients with histologically confirmed NSCLC will be included, comprising both metastatic and early-stage disease. Formalin-fixed paraffin-embedded (FFPE) tumor tissue and, where available, fresh frozen samples will be analyzed. Peripheral blood samples will also be collected for germline DNA assessment. The study aims to identify clinically actionable genomic alterations, measure tumor mutational burden (TMB), characterize immune-related gene expression signatures, and investigate associations between molecular findings and clinical outcomes.
In addition, a pilot sub-study will evaluate circulating tumor DNA (ctDNA) dynamics in approximately 20 patients with unresectable stage III NSCLC treated with concurrent chemoradiation followed by durvalumab maintenance therapy. Longitudinal plasma samples will be collected at predefined timepoints to assess minimal residual disease (MRD), ctDNA kinetics, and correlations with clinical outcomes including progression-free survival (PFS) and overall survival (OS).
The results of this study are expected to improve understanding of tumor biology and immune landscape in NSCLC and support the identification of prognostic and predictive biomarkers for immunotherapy and other treatment strategies.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 300 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Hellenic Cooperative Oncology Group is the lead sponsor of 62 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The EXPLORE study will enroll approximately 300 patients with histologically confirmed Non-Small Cell Lung Cancer (NSCLC) who have received immunotherapy as part of standard care. Participants will provide tumor tissue, either formalin-fixed paraffin-embedded (FFPE) blocks or fresh-frozen samples, along with peripheral blood samples for germline DNA analysis. Tissue samples will be used for Whole Exome Sequencing (WES) and RNA sequencing (RNA-seq), enabling comprehensive characterization of genomic alterations, transcriptomic profiles, tumor mutational burden, and immune-related features.
A sub-study will include approximately 20 patients with unresectable stage III NSCLC receiving concurrent chemoradiation (cCRT) followed by Durvalumab maintenance according to standard of care. For these patients, longitudinal blood samples will be collected at baseline (pre-cCRT) and at multiple timepoints during Durvalumab treatment to evaluate circulating tumor DNA (ctDNA) dynamics, minimal
Main Study:
Diagnosis: confirmed Non-Small Cell Lung Cancer (NSCLC). Age: ≥18 years. Consent: Signed for participation in the study.
Patient Cohorts:
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 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).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with histologically confirmed non-small cell lung cancer providing tumor tissue and blood samples for genomic and transcriptomic analyses, including whole-exome sequencing, RNA sequencing, and ctDNA analysis in a subset of patients.
Prevalence of genomic alterations, TMB levels, and mRNA-based immune subtypes
Percentage of Greek NSCLC patients presenting with specific oncogenic drivers, clinically actionable mutations, germline pathogenic/likely pathogenic variants, Tumor Mutational Burden (TMB) signatures, and distinct transcriptomic mRNA-based immune subtypes.
Time frame: Baseline
Plan to share: No
Started Dec 2021 (actual). Primary completion is estimated for Dec 2026, 60 months after the start.
Of 355 non-industry observational studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 126. This study's planned 60 months is close to that.
Counting every sponsor, half of 497 studies reached it within 55 months; a quarter within 35 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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