Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer

Conditions

Non-Small Cell Lung Cancer

Brief summary

The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.

Detailed description

The main aim is to validate the most promising T-cell marker candidates from earlier studies in a prospective multicenter study to establish a prognostic TNM-Immunoscore. The investigators will include around 1000 stage I-IIIA patients from various centers in Scandinavia. The investigators will also collect demographic and clinicopathological data, blood and tissues in a database and biobank. Candidate T-cell markers will be analyzed by immunohistochemistry for validation and by other methods for exploration of their impact on prognosis

Mehrdad Rakaee, Per Niklas Waaler, Falah Jabar, Krinio Giannikou, Elio Adib et al. (19 authors)

Cancer Research2025-04-21

10.1158/1538-7445.am2025-5366

Machine learning-based immune phenotypes correlate with STK11/KEAP1 co-mutations and prognosis in resectable NSCLC: a sub-study of the TNM-I trial.

Rakaee M, Andersen S, Giannikou K, Paulsen EE, Kilvaer TK, Busund LR, Berg T, Richardsen E, Lombardi AP, Adib E, Pedersen MI, Tafavvoghi M, Wahl SGF, Petersen RH, Bondgaard AL, Yde CW, Baudet C, Licht P, Lund-Iversen M, Grønberg BH, Fjellbirkeland L, Helland Å, Pøhl M, Kwiatkowski DJ, Donnem T.

2023-04-2418 citations

10.1016/j.annonc.2023.04.005

Interventions

OTHERWill look for immune infiltration

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* resectable NSCLC * Age 18 and above * no other malignancy last 5 years * informed consent

Exclusion criteria

* multiple tumor foci * preoperative chemo- or radiotherapy * non-NSCLC histology * no tissue available for study * metastasis

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	5 year follow-up	Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Secondary

Measure	Time frame	Description
TTR	5 year follow-up	Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Disease-specific survival	5 year follow-up	Disease specific survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.

Countries

Denmark, Norway

Outcome results

None listed