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AzTrials

NSCLC (Non-small Cell Lung Cancer)GEMA-proNNCT06876402

Gene Molecular Alterations as Disease Prognostic Markers in Patients With Non-small Cell Lung Cancer (NSCLC)

An observational study of NSCLC (Non-small Cell Lung Cancer), run by Hellenic Cooperative Oncology Group at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

GEMA-proN is an observational, multicenter, single cohort, retrospective clinical trial. The aim of the trial is to assess the prevalence, and prognostic value of genetic molecular alterations and investigate correlations with clinicopathological features in unselected patients with histologically confirmed non-small… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC (Non-small Cell Lung Cancer)
How many people
367 participants
Where
1 siteGreece
Study dates
9 Sep 2013to 15 Jul 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients diagnosed with non-small cell lung cancer (NSCLC) regardless of disease stage, between 2000 and 2020, who received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece. Variables under investigation; * ECOG performance status (categorical), * Sex (categorical) * Age (continuous) * Smoking status (categorical) * Histology type (categorical) * Stage (categorical) * Type of surgery in resected disease (categorical) * Pathogenic/ likely pathogenic SNVs (categorical) * CNAs (categorical) * Translocations (categorical) * Co-mutations (categorical) * PD-L1 expression (categorical) * TILs expression (categorical) * Immunotherapy in the 1st line setting (categorical) * Overall survival (OS) (continuous) * PFS (progression-free survival) * DFS (disease-free survival)

Who may be able to join

  • Age 18 and above.
  • Histologically confirmed non-small cell lung cancer (NSCLC).
  • Adequate, and suitable tissue for the testing of somatic genetic alterations.

Who cannot join

  • Patients with personal medical history of malignancy, other than non-small cell lung cancer (NSCLC), with the exclusion of completely resected non-melanoma skin cancers, in situ carcinomas of the cervix uteri, in situ bladder carcinomas, in situ ductal breast carcinoma, and other cancers treated with curative intent with no evidence of disease recurrence for 5 years.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Hellenic Cooperative Oncology Group (HeCOG)

    Athens, 11526

Other trials in Greece

About this study

Official title: Assessment of the Prevalence and Prognostic Value of Gene Molecular Alterations and Association With Clinicopathological Factors in Patients With Non-small Cell Lung Cancer (NSCLC)

GEMA-proN is an observational, multicenter, single cohort, retrospective clinical trial. The aim of the trial is to assess the prevalence, and prognostic value of genetic molecular alterations and investigate correlations with clinicopathological features in unselected patients with histologically confirmed non-small cell lung cancer (NSCLC).

Read the detailed description

This a non- interventional, multicenter, retrospective one arm trial assessing patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC). Patients received treatment in 18 Hellenic Cooperative Oncology Group (HeCOG)- affiliated centers in Greece between 2000 and 2020. Molecular genetic alterations, including single nucleotide variants, copy number alterations, and translocations, are detected with next generation sequencing using the ForeSENTIA® NSCLC panel developed by NIPD Genetics. The aim of the trial is to assess the prevalence and prognostic value of molecular alterations in the study population.

Keywords
NSCLC, Non-small cell lung cancer, Early stage non-small cell lung cancer, Metastatic non-small cell lung cancer, Mutations, Copy number alterations, Translocations, CNA, PD-L1 expression, Tumor infiltrating lymphocytes, TILs, Pathogenic single nucleotide variants
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06876402
Study groupRoleWhat they receive
Patients with histologically confirmed diagnosis of non-small cell lung cancer (NSCLC).Assessment of tumor molecular profile in patients with histologically confirmed early stage or metastatic non-small cell lung cancer (NSCLC). Identification of gene somatic alterations including single nucleotide variants (SNVs), small insertions and deletions (indels), copy number alterations (CNAs), and rearrangements with the use of next generation sequencing (NGS) with a custom tumor profile gene assay developed by NIPD Genetics.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. OS (overall survival) in whole cohort.

    Overall survival is defined from the date of initial diagnosis until death or last contact.

    Measured: Through study completion, 3 years.

Secondary outcomes (2)

  1. Progression-free survival (PFS) in patients who received 1st line treatment for metastatic non-small cell ling cancer (NSCLC).

    Progression-free survival is defined from the date of 1st line treatment initiation until the date of radiologically confirmed disease progression (PD), following 1st line treatment.

    Measured: Through study completion, 3 years.

  2. Recurrence-free survival (RFS) in patients who underwent surgical treatment for non-small cell lung cancer (NSCLC).

    Recurrence-free survival is defined from the date of initial surgical diagnosis until the date of radiologically confirmed disease recurrence, following surgical resection.

    Measured: Through study completion, 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start9 Sep 2013
  3. Primary completion13 Oct 2024
  4. Study completion15 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06876402
Sponsor's protocol ID
HE_2TR/13
Acronym
GEMA-proN
Status last verified
Oct 2026
First submitted
10 Mar 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cancer Genome Atlas Research Network. Comprehensive molecular profiling of lung adenocarcinoma. Nature. 2014 Jul 31;511(7511):543-50. doi: 10.1038/nature13385. Epub 2014 Jul 9.

    PubMed 25079552

  • Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012 Sep 27;489(7417):519-25. doi: 10.1038/nature11404. Epub 2012 Sep 9.

    PubMed 22960745

  • Skoulidis F, Heymach JV. Co-occurring genomic alterations in non-small-cell lung cancer biology and therapy. Nat Rev Cancer. 2019 Sep;19(9):495-509. doi: 10.1038/s41568-019-0179-8. Epub 2019 Aug 12.

    PubMed 31406302

  • Hendry S, Salgado R, Gevaert T, Russell PA, John T, Thapa B, Christie M, van de Vijver K, Estrada MV, Gonzalez-Ericsson PI, Sanders M, Solomon B, Solinas C, Van den Eynden GGGM, Allory Y, Preusser M, Hainfellner J, Pruneri G, Vingiani A, Demaria S, Symmans F, Nuciforo P, Comerma L, Thompson EA, Lakhani S, Kim SR, Schnitt S, Colpaert C, Sotiriou C, Scherer SJ, Ignatiadis M, Badve S, Pierce RH, Viale G, Sirtaine N, Penault-Llorca F, Sugie T, Fineberg S, Paik S, Srinivasan A, Richardson A, Wang Y, Chmielik E, Brock J, Johnson DB, Balko J, Wienert S, Bossuyt V, Michiels S, Ternes N, Burchardi N, Luen SJ, Savas P, Klauschen F, Watson PH, Nelson BH, Criscitiello C, O'Toole S, Larsimont D, de Wind R, Curigliano G, Andre F, Lacroix-Triki M, van de Vijver M, Rojo F, Floris G, Bedri S, Sparano J, Rimm D, Nielsen T, Kos Z, Hewitt S, Singh B, Farshid G, Loibl S, Allison KH, Tung N, Adams S, Willard-Gallo K, Horlings HM, Gandhi L, Moreira A, Hirsch F, Dieci MV, Urbanowicz M, Brcic I, Korski K, Gaire F, Koeppen H, Lo A, Giltnane J, Rebelatto MC, Steele KE, Zha J, Emancipator K, Juco JW, Denkert C, Reis-Filho J, Loi S, Fox SB. Assessing Tumor-Infiltrating Lymphocytes in Solid Tumors: A Practical Review for Pathologists and Proposal for a Standardized Method from the International Immuno-Oncology Biomarkers Working Group: Part 2: TILs in Melanoma, Gastrointestinal Tract Carcinomas, Non-Small Cell Lung Carcinoma and Mesothelioma, Endometrial and Ovarian Carcinomas, Squamous Cell Carcinoma of the Head and Neck, Genitourinary Carcinomas, and Primary Brain Tumors. Adv Anat Pathol. 2017 Nov;24(6):311-335. doi: 10.1097/PAP.0000000000000161.

    PubMed 28777143

  • Tuminello S, Sikavi D, Veluswamy R, Gamarra C, Lieberman-Cribbin W, Flores R, Taioli E. PD-L1 as a prognostic biomarker in surgically resectable non-small cell lung cancer: a meta-analysis. Transl Lung Cancer Res. 2020 Aug;9(4):1343-1360. doi: 10.21037/tlcr-19-638.

    PubMed 32953509

Questions about this trial

What is this clinical trial studying?

An observational study of NSCLC (Non-small Cell Lung Cancer), run by Hellenic Cooperative Oncology Group at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

OS (overall survival) in whole cohort. (time frame: Through study completion, 3 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06876402, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.

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