Lung CancerNCT04654364
Lung Cancer Registry
An observational study of Lung Cancer and NSCLC Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 3 sites in Austria.
Trial summary
Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC Stage IV, NSCLC, Stage III
- How many people
- 290 participants
- Where
- 3 sitesAustria
- Study dates
- 18 Aug 2020to 6 May 2026
- How long will I take part?
- 5 Years
- 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: The registry will be made available for all disciplines and physicians caring for cancer patients with locally advanced or metastatic lung cancer in Austria. In a first step patients with diagnosis after 01.01.2019 will be included. In a second step the registry will be expanded to include patients with diagnosis before 01.01.2019.
Who may be able to join
- stage III A-C and IV A-B NSCLC
- limited disease (LD) and extensive disease (ED) SCLC)
- patients ≥ 18 years
Who cannot join
- Due to the non-interventional design of the registry there are no specific exclusion criteria.
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
Innsbruck, Tyrol, 6020
Kepler Universitätsklinikum GmbH, Med. Campus III, Klinik für Lungenheilkunde / Pneumologie
Linz, Upper Austria, 4021
Universitätsklinik für Innere Medizin III, PMU Salzburg
Salzburg, State of Salzburg, 5020
About this study
Official title: AGMT Lung Cancer Registry
Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.
This malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.
Despite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.
Read the detailed description
This registry is designed as multicenter observational cohort of patients with lung cancer. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.
A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.
Data will be collected from all sites willing to participate.
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
General characteristics
To describe the general characteristics of advanced or metastatic stage patients in Austria (Stage III A-C and IV A-B NSCLC, limited disease (LD) and extensive disease (ED) SCLC)
Measured: 10 years
Molecular testing
To describe molecular testing in patients with advanced or metastatic lung cancer
- number of patients with molecular testing
- methods for molecular testing
- number of patients with PD-L1 testing
- PD-L1 % range per disease stage
- PD-L1 test antibody used
- number of genes tested
- number of patients with at least one mutation identified
- number of patients with at least one druggable target identified
Measured: 10 years
Characterize subgroups
To describe and characterize subgroups
- Number of patients with NSCLC
- Number of patients that receive immune-checkpoint inhibitors
- Number of patients with targetable/druggable mutations
Measured: 10 years
Treatment duration
To describe duration of treatment
Measured: 10 years
Treatment frequency
To describe frequency of treatment
Measured: 10 years
Degree of treatment response
To describe degree of treatment response in %
Measured: 10 years
Treatment sequence
To describe sequence of use of various treatments
Measured: 10 years
Outcome OS
To describe patient outcome by means of overall survival (OS) in %
Measured: 10 years
Outcome PFS
To describe patient outcome by means of progression free survival (PFS) in %
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start18 Aug 2020
- Primary completion6 May 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Other
- Enrolment
- 290 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Pfizer, Merck Sharp & Dohme LLC, Janssen, LP, Bristol-Myers Squibb, Amgen
- Responsible party
- Sponsor
- Investigators
- Richard Greil, MD, Study chair, AGMT gemeinnützige GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654364
- Sponsor's protocol ID
- AGMT_LungCA-Reg
- Status last verified
- Oct 2026
- First submitted
- 26 Nov 2020
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analyzed during the current study are not publicly available but are available from AGMT (Austrian Group Medical Tumor Therapy) upon reasonable request. Requests for access to these data should be directed to AGMT via office@agmt.at.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGMT Lung Cancer Registry
- ClinicalTrials.gov ID
- NCT04654364
- Acronym / sponsor ID
- AGMT_LungCA-Reg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- AstraZeneca, Pfizer, Merck Sharp & Dohme LLC, Janssen, LP, Bristol-Myers Squibb, Amgen
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- 6 May 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 4 Dec 2020 (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.
Lung cancer is the second most common cancer in Austria with 2.868 men and 2.009 women diagnosed in 2016. Reflecting the high mortality of this disease, 2.415 men and 1.534 women died from lung cancer. Therefore, lung cancer is the most common reason for cancer associated death in men and second most common reason in women.
This malignant disease can be divided into two main groups: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). NSCLC is a paradigm for personalized medicine, with an increasing number of targetable gene alterations. Despite this growing diversity of molecular subtypes, in most patients no targetable mutation can be detected. For these patients check-point inhibitors with or without chemotherapy is the mainstay of the initial tumor therapy. Until recently, little progress has been made in the treatment of SCLC in last decades. Recently, an overall survival benefit by the addition of an immune-checkpoint inhibitor to first-line chemotherapy for advanced SCLC has been reported.
Despite the progress in the treatment of NSCLC, the performance of predictive biomarkers is weak. Therefore, the development of more precise prediction models is of great importance for the progress of personalized treatment strategies.
Detailed description
This registry is designed as multicenter observational cohort of patients with lung cancer. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.
A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.
Data will be collected from all sites willing to participate.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry will be made available for all disciplines and physicians caring for cancer patients with locally advanced or metastatic lung cancer in Austria. In a first step patients with diagnosis after 01.01.2019 will be included. In a second step the registry will be expanded to include patients with diagnosis before 01.01.2019.
Key inclusion criteria (3 listed)
- stage III A-C and IV A-B NSCLC
- limited disease (LD) and extensive disease (ED) SCLC)
- patients ≥ 18 years
Key exclusion criteria (1 listed)
- Due to the non-interventional design of the registry there are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General characteristics
Time frame: 10 years
To describe the general characteristics of advanced or metastatic stage patients in Austria (Stage III A-C and IV A-B NSCLC, limited disease (LD) and extensive disease (ED) SCLC)
Molecular testing
Time frame: 10 years
To describe molecular testing in patients with advanced or metastatic lung cancer * number of patients with molecular testing * methods for molecular testing * number of patients with PD-L1 testing * PD-L1 % range per disease stage * PD-L1 test antibody used * number of genes tested * number of patients with at least one mutation identified * number of patients with at least one druggable target identified
Characterize subgroups
Time frame: 10 years
To describe and characterize subgroups * Number of patients with NSCLC * Number of patients that receive immune-checkpoint inhibitors * Number of patients with targetable/druggable mutations
Treatment duration
Time frame: 10 years
To describe duration of treatment
Treatment frequency
Time frame: 10 years
To describe frequency of treatment
Degree of treatment response
Time frame: 10 years
To describe degree of treatment response in %
Treatment sequence
Time frame: 10 years
To describe sequence of use of various treatments
Outcome OS
Time frame: 10 years
To describe patient outcome by means of overall survival (OS) in %
Outcome PFS
Time frame: 10 years
To describe patient outcome by means of progression free survival (PFS) in %
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. The datasets generated and/or analyzed during the current study are not publicly available but are available from AGMT (Austrian Group Medical Tumor Therapy) upon reasonable request. Requests for access to these data should be directed to AGMT via office@agmt.at.
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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.
Richard Greil, MD study chair
AGMT gemeinnützige GmbH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and NSCLC Stage IV, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 3 sites in Austria.
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 16 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 3 sites in Austria. 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?
General characteristics (time frame: 10 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2026.