Non-Small Cell Lung CancerTNM-INCT03299478
Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
An observational study of Non-Small Cell Lung Cancer, run by University Hospital of North Norway at 5 sites in 2 countries.
Trial summary
The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Will look for immune infiltration
- How many people
- 865 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 28 Nov 2016to 1 Feb 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Pasients coming for resection of primary NSCLC with a curative intent
Who may be able to join
- resectable NSCLC
- Age 18 and above
- no other malignancy last 5 years
- informed consent
Who cannot join
- multiple tumor foci
- preoperative chemo- or radiotherapy
- non-NSCLC histology
- no tissue available for study
- metastasis
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Norway3 sites
Oslo University Hospital
Oslo, 0379
University Hospital of North Norway
Tromsø, 9038
St.Olav Hospital, University Hospital of Trondheim
Trondheim, 7006
Denmark2 sites
Rigshospitalet
Copenhagen, København Ø, 2100
Odense Universitetshospital
Odense, 5000
About this study
The purpose of this study is to validate TNM-Immunoscore in resected non-small cell lung cancer.
Read the 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
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Will look for immune infiltration
- 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.
Will look for immune infiltrationOther
| Study group | Role | What they receive |
|---|---|---|
| NSCLC patients | Resected NSCLC patients with curative intent Receives: Other: Will look for immune infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Measured: 5 year follow-up
Secondary outcomes (2)
TTR
Time to recurrence in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
Measured: 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.
Measured: 5 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start28 Nov 2016
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective
- Enrolment
- 865 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Cancer Society, Northern Health Authority, St. Olavs Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Oslo University Hospital, University of Tromso
- Responsible party
- Sponsor
- Investigators
- Lill-Tove R Busund, MD, PhD, Principal investigator, University Hospital of North NorwaySigve Andersen, MD,PhD, Principal investigator, University Hospital of North NorwayTom Dønnem, MD,PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299478
- Sponsor's protocol ID
- 2016/714
- Acronym
- TNM-I
- Status last verified
- May 2024
- First submitted
- 27 Sep 2017
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26578726Rakaee 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.
PubMed 37100205
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Implementation of TNM-immunoscore in Resected Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03299478
- Acronym / sponsor ID
- TNM-I / 2016/714
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 865 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian Cancer Society, Northern Health Authority, St. Olavs Hospital, Copenhagen University Hospital, Rigshospitalet, Odense University Hospital, Oslo University Hospital, University of Tromso
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC patients | – | Other: Will look for immune infiltrationResected NSCLC patients with curative intent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pasients coming for resection of primary NSCLC with a curative intent
Key inclusion criteria (4 listed)
- resectable NSCLC
- Age 18 and above
- no other malignancy last 5 years
- informed consent
Key exclusion criteria (5 listed)
- multiple tumor foci
- preoperative chemo- or radiotherapy
- non-NSCLC histology
- no tissue available for study
- metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Will look for immune infiltration | Other | NSCLC patients |
Primary outcome
Overall survival
Time frame: 5 year follow-up
Overall survival in the 1) overall population and in the 2) squamous cell carcinoma and 3) adenocarcinoma subgroups.
2 secondary outcomes
TTR
Time frame: 5 year follow-up
Disease-specific survival
Time frame: 5 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Background: PubMed 26578726Donnem 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.
- Results publication: PubMed 37100205Rakaee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lill-Tove R Busund, MD, PhD principal investigator
University Hospital of North Norway
Sigve Andersen, MD,PhD principal investigator
University Hospital of North Norway
Tom Dønnem, MD,PhD principal investigator
University Hospital of North Norway
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by University Hospital of North Norway at 5 sites in 2 countries.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway, Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Overall survival (time frame: 5 year follow-up). 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 NCT03299478, which also lists 2 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 11 Jun 2024.