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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-Small Cell Lung Cancer
• Intervention / Treatment: Other: Will look for immune infiltration

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

• Study Type: Observational
• Enrollment (Actual): 865

Contacts and Locations

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense Universitetshospital
  • København Ø
    • København, København Ø, Denmark, 2100
      • Rigshospitalet
• Norway
  • Oslo, Norway, 0379
    • Oslo University Hospital
  • Tromsø, Norway, 9038
    • University Hospital of North Norway
  • Trondheim, Norway, 7006
    • St.Olav Hospital, University Hospital of Trondheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Pasients coming for resection of primary NSCLC with a curative intent

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
NSCLC patients; Resected NSCLC patients with curative intent	Other: Will look for immune infiltration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Collaborators: Odense University Hospital; Oslo University Hospital; Rigshospitalet, Denmark; University of Tromso; St. Olavs Hospital; Norwegian Cancer Society; Northern Health Authority
• Investigators: Principal Investigator: Lill-Tove R Busund, MD, PhD, University Hospital of North Norway; Principal Investigator: Sigve Andersen, MD,PhD, University Hospital of North Norway; Principal Investigator: Tom Dønnem, MD,PhD, University Hospital of North Norway

Publications and helpful links

General Publications

• Donnem 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.
• 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, 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 2016/714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No