Clinical trial · Observational
Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
NCT03299478CI-TRIAL-00077851TNM-Iactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Will look for immune infiltration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NSCLC patients
- description
- Resected NSCLC patients with curative intent
- interventionNames
- Other: Will look for immune infiltration
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 5 year follow-up
- description
- Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Secondary outcomes (2)
- measure
- TTR
- timeFrame
- 5 year follow-up
- description
- Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDDonnem T, Kilvaer TK, Andersen S, Richardsen E, Paulsen EE, Hald SM, Al-Saad S, Brustugun OT, Helland A, Lund-Iversen M, Solberg S, Gronberg BH, Wahl SG, Helgeland L, Flotten O, Pohl M, Al-Shibli K, Sandanger TM, Pezzella F, Busund LT, Bremnes RM. Strategies for clinical implementation of TNM-Immunoscore in resected nonsmall-cell lung cancer. Ann Oncol. 2016 Feb;27(2):225-32. doi: 10.1093/annonc/mdv560. Epub 2015 Nov 16. PMID 26578726
- RESULTRakaee 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, Gronberg BH, Fjellbirkeland L, Helland A, Pohl M, Kwiatkowski DJ, Donnem T. Machine learning-based immune phenotypes correlate with STK11/KEAP1 co-mutations and prognosis in resectable NSCLC: a sub-study of the TNM-I trial. Ann Oncol. 2023 Jul;34(7):578-588. doi: 10.1016/j.annonc.2023.04.005. Epub 2023 Apr 24. PMID 37100205