Carcinoma, Non-Small-Cell LungnNGMNCT05934032
National Network Genomic Medicine Lung Cancer, Germany
An observational study of Carcinoma, Non-Small-Cell Lung, run by Prof. Dr. Juergen Wolf at 1 site in Germany.
Trial summary
Registry of the national Network Genomic Medicine Lung Cancer (nNGM), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (NSCLC) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- observational, non-interventional
- How many people
- 30,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Dec 2030
- How long will I take part?
- 10 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: Participants with histologically confirmed NSCLC are enrolled by 23 certified cancer centres and more than 400 network partners (hospitals and oncological practices) across Germany.
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed, locally advanced or metastatic NSCLC (Union for International Cancer Control [UICC] stage IIIb/IV; non-resectable NSCLC)
- From 07/2023: histologically confirmed NSCLC stage Ib, II, III (UICC)
Who cannot join
- Missing written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne
Anna Rasokat, anna.rasokat@uk-koeln.de
About this study
Official title: Registry of the National Network Genomic Medicine Lung Cancer (nNGM), Linking Data on Molecular Diagnostics, Clinical Characteristics, Treatment Patterns and Outcomes of Subjects With Non-Small Cell Lung Cancer in Germany
Registry of the national Network Genomic Medicine Lung Cancer (nNGM), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (NSCLC) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in Germany
Read the detailed description
Within the national Network Genomic Medicine Lung Cancer (nNGM), comprehensive molecular diagnostics and treatment recommendations are provided by 23 certified cancer centres according to standardized procedures for patients with non-resectable NSCLC. More than 400 network partners across Germany (including hospitals and oncological practices) report data on subsequent treatment and outcomes to the nNGM registry. Clinical outcomes are continuously evaluated through analysis of data collected in a decentralized registry. The nNGM registry records the patient journey and course of the disease from first histologically confirmed diagnosis to death or loss to follow-up and comprises detailed data on demographic and clinical characteristics, molecular diagnostics (including comprehensive biomarker testing results), treatments (targeted therapy, immunotherapy, chemotherapy, radiotherapy, best supportive care) and outcomes (overall survival, response, disease progression, time to next treatment). Patients have been actively involved throughout all stages of the design and running of the network and its registry.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- observational, non-interventional
- Keywords
- carcinoma, non-small-cell lung* / diagnosis, carcinoma, non-small-cell lung* / genetics, precision medicine, lung neoplasms, neoplasms by site, registry, pathology, molecular
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Disease, Lung Neoplasms, Neoplasms by Site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational, non-interventionalOther
observational, non-interventional
What is being measured
The primary outcome is the main question the study is designed to answer.
molecular testing
descriptive data on results, frequency and methods of molecular testing
Measured: 1 year
treatment patterns
descriptive data on systemic treatments (including combination and sequence of treatments)
Measured: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months
overall survival
overall survival (in months)
Measured: assessed up to 100 months
time to next treatment
time to next treatment (in months)
Measured: from start of treatment to the start of the next therapy, death or loss to follow-up, whichever came first, assessed up to 100 months
progression free survival
progression free survival (in months)
Measured: from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Apr 2018
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 30,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Juergen Wolf
- Sponsor type
- University, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Helios Klinikum Emil von Behring, Vivantes Hospital Berlin Neukölln, University Hospital Carl Gustav Carus, Heinrich-Heine University, Duesseldorf, University Hospital Erlangen, University Hospital, Essen, Goethe University, University Hospital Freiburg, University Hospital Giessen and Marburg, University Hospital Halle (Saale), Universitätsklinikum Hamburg-Eppendorf, University Hospital Heidelberg, Klinikum Hanover-Siloah Hospital, University Hospital, Bonn, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz, University Hospital Munich, University Hospital rechts der Isar Munich (TUM), Pius-Hospital Oldenburg, University Hospital Regensburg, University Hospital Tuebingen, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), University Hospital Ulm, Wuerzburg University Hospital, University Hospital of Cologne
- Responsible party
- Sponsor-investigator, Prof. Dr. Juergen Wolf, University of Cologne
- Investigators
- Juergen Wolf, Prof. Dr., Study chair, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934032
- Sponsor's protocol ID
- NNGM0418
- Acronym
- nNGM
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Janning M, Suptitz J, Albers-Leischner C, Delpy P, Tufman A, Velthaus-Rusik JL, Reck M, Jung A, Kauffmann-Guerrero D, Bonzheim I, Brandlein S, Hummel HD, Wiesweg M, Schildhaus HU, Stratmann JA, Sebastian M, Alt J, Buth J, Esposito I, Berger J, Togel L, Saalfeld FC, Wermke M, Merkelbach-Bruse S, Hillmer AM, Klauschen F, Bokemeyer C, Buettner R, Wolf J, Loges S; National Network Genomic Medicine Lung Cancer (nNGM). Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM). Ann Oncol. 2022 Jun;33(6):602-615. doi: 10.1016/j.annonc.2022.02.225. Epub 2022 Mar 6.
PubMed 35263633Saleh MM, Scheffler M, Merkelbach-Bruse S, Scheel AH, Ulmer B, Wolf J, Buettner R. Comprehensive Analysis of TP53 and KEAP1 Mutations and Their Impact on Survival in Localized- and Advanced-Stage NSCLC. J Thorac Oncol. 2022 Jan;17(1):76-88. doi: 10.1016/j.jtho.2021.08.764. Epub 2021 Sep 30.
PubMed 34601169Saalfeld FC, Wenzel C, Christopoulos P, Merkelbach-Bruse S, Reissig TM, Lassmann S, Thiel S, Stratmann JA, Marienfeld R, Berger J, Desuki A, Velthaus JL, Kauffmann-Guerrero D, Stenzinger A, Michels S, Herold T, Kramer M, Herold S, Tufman A, Loges S, Alt J, Joosten M, Schmidtke-Schrezenmeier G, Sebastian M, Stephan-Falkenau S, Waller CF, Wiesweg M, Wolf J, Thomas M, Aust DE, Wermke M; National Network Genomic Medicine Lung Cancer (nNGM). Efficacy of Immune Checkpoint Inhibitors Alone or in Combination With Chemotherapy in NSCLC Harboring ERBB2 Mutations. J Thorac Oncol. 2021 Nov;16(11):1952-1958. doi: 10.1016/j.jtho.2021.06.025. Epub 2021 Jul 8.
PubMed 34245914Bischoff P, Reck M, Overbeck T, Christopoulos P, Rittmeyer A, Luders H, Kollmeier J, Kulhavy J, Kemper M, Reinmuth N, Roper J, Janning M, Sommer L, Aguinarte L, Koch M, Wiesweg M, Wesseler C, Waller CF, Kauffmann-Guerrero D, Stenzinger A, Stephan-Falkenau S, Trautmann M, Lassmann S, Tiemann M, Klauschen F, Sebastian M, Griesinger F, Wolf J, Loges S, Frost N; National Network Genomic Medicine Lung Cancer (nNGM) Collaborator Group. Outcome of First-Line Treatment With Pembrolizumab According to KRAS/TP53 Mutational Status for Nonsquamous Programmed Death-Ligand 1-High (>/=50%) NSCLC in the German National Network Genomic Medicine Lung Cancer. J Thorac Oncol. 2024 May;19(5):803-817. doi: 10.1016/j.jtho.2023.12.015. Epub 2023 Dec 13.
PubMed 38096950
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry of the National Network Genomic Medicine Lung Cancer (nNGM), Linking Data on Molecular Diagnostics, Clinical Characteristics, Treatment Patterns and Outcomes of Subjects With Non-Small Cell Lung Cancer in Germany
- ClinicalTrials.gov ID
- NCT05934032
- Acronym / sponsor ID
- nNGM / NNGM0418
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- carcinoma, non-small-cell lung* / diagnosis, carcinoma, non-small-cell lung* / genetics, precision medicine, lung neoplasms, neoplasms by site, registry, pathology, molecular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Prof. Dr. Juergen WolfUniversity, hospital or other
- Collaborators
- Charite University, Berlin, Germany, Helios Klinikum Emil von Behring, Vivantes Hospital Berlin Neukölln, University Hospital Carl Gustav Carus, Heinrich-Heine University, Duesseldorf, University Hospital Erlangen, University Hospital, Essen, Goethe University, University Hospital Freiburg, University Hospital Giessen and Marburg, University Hospital Halle (Saale), Universitätsklinikum Hamburg-Eppendorf, University Hospital Heidelberg, Klinikum Hanover-Siloah Hospital, University Hospital, Bonn, University Hospital Schleswig-Holstein, Johannes Gutenberg University Mainz, University Hospital Munich, University Hospital rechts der Isar Munich (TUM), Pius-Hospital Oldenburg, University Hospital Regensburg, University Hospital Tuebingen, Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF), University Hospital Ulm, Wuerzburg University Hospital, University Hospital of Cologne
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Jul 2023 (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.
Registry of the national Network Genomic Medicine Lung Cancer (nNGM), linking data on molecular diagnostics, clinical characteristics, treatment patterns and outcomes of subjects with non-small cell lung cancer (NSCLC) from 23 specialized cancer centres and more than 400 general hospitals and oncological practices in Germany
Detailed description
Within the national Network Genomic Medicine Lung Cancer (nNGM), comprehensive molecular diagnostics and treatment recommendations are provided by 23 certified cancer centres according to standardized procedures for patients with non-resectable NSCLC. More than 400 network partners across Germany (including hospitals and oncological practices) report data on subsequent treatment and outcomes to the nNGM registry. Clinical outcomes are continuously evaluated through analysis of data collected in a decentralized registry. The nNGM registry records the patient journey and course of the disease from first histologically confirmed diagnosis to death or loss to follow-up and comprises detailed data on demographic and clinical characteristics, molecular diagnostics (including comprehensive biomarker testing results), treatments (targeted therapy, immunotherapy, chemotherapy, radiotherapy, best supportive care) and outcomes (overall survival, response, disease progression, time to next treatment). Patients have been actively involved throughout all stages of the design and running of the network and its registry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with histologically confirmed NSCLC are enrolled by 23 certified cancer centres and more than 400 network partners (hospitals and oncological practices) across Germany.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Histologically confirmed, locally advanced or metastatic NSCLC (Union for International Cancer Control [UICC] stage IIIb/IV; non-resectable NSCLC)
- From 07/2023: histologically confirmed NSCLC stage Ib, II, III (UICC)
Key exclusion criteria (1 listed)
- Missing written informed consent
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 |
|---|---|---|
| observational, non-interventionalobservational, non-interventional | Other | – |
Primary outcome
molecular testing
Time frame: 1 year
descriptive data on results, frequency and methods of molecular testing
treatment patterns
Time frame: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months
descriptive data on systemic treatments (including combination and sequence of treatments)
overall survival
Time frame: assessed up to 100 months
overall survival (in months)
time to next treatment
Time frame: from start of treatment to the start of the next therapy, death or loss to follow-up, whichever came first, assessed up to 100 months
time to next treatment (in months)
progression free survival
Time frame: from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months
progression free survival (in months)
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 6 Jul 2023.
- Background: PubMed 35263633Janning M, Suptitz J, Albers-Leischner C, Delpy P, Tufman A, Velthaus-Rusik JL, Reck M, Jung A, Kauffmann-Guerrero D, Bonzheim I, Brandlein S, Hummel HD, Wiesweg M, Schildhaus HU, Stratmann JA, Sebastian M, Alt J, Buth J, Esposito I, Berger J, Togel L, Saalfeld FC, Wermke M, Merkelbach-Bruse S, Hillmer AM, Klauschen F, Bokemeyer C, Buettner R, Wolf J, Loges S; National Network Genomic Medicine Lung Cancer (nNGM). Treatment outcome of atypical EGFR mutations in the German National Network Genomic Medicine Lung Cancer (nNGM). Ann Oncol. 2022 Jun;33(6):602-615. doi: 10.1016/j.annonc.2022.02.225. Epub 2022 Mar 6.
- Background: PubMed 34601169Saleh MM, Scheffler M, Merkelbach-Bruse S, Scheel AH, Ulmer B, Wolf J, Buettner R. Comprehensive Analysis of TP53 and KEAP1 Mutations and Their Impact on Survival in Localized- and Advanced-Stage NSCLC. J Thorac Oncol. 2022 Jan;17(1):76-88. doi: 10.1016/j.jtho.2021.08.764. Epub 2021 Sep 30.
- Background: PubMed 34245914Saalfeld FC, Wenzel C, Christopoulos P, Merkelbach-Bruse S, Reissig TM, Lassmann S, Thiel S, Stratmann JA, Marienfeld R, Berger J, Desuki A, Velthaus JL, Kauffmann-Guerrero D, Stenzinger A, Michels S, Herold T, Kramer M, Herold S, Tufman A, Loges S, Alt J, Joosten M, Schmidtke-Schrezenmeier G, Sebastian M, Stephan-Falkenau S, Waller CF, Wiesweg M, Wolf J, Thomas M, Aust DE, Wermke M; National Network Genomic Medicine Lung Cancer (nNGM). Efficacy of Immune Checkpoint Inhibitors Alone or in Combination With Chemotherapy in NSCLC Harboring ERBB2 Mutations. J Thorac Oncol. 2021 Nov;16(11):1952-1958. doi: 10.1016/j.jtho.2021.06.025. Epub 2021 Jul 8.
- Derived from this study: PubMed 38096950Bischoff P, Reck M, Overbeck T, Christopoulos P, Rittmeyer A, Luders H, Kollmeier J, Kulhavy J, Kemper M, Reinmuth N, Roper J, Janning M, Sommer L, Aguinarte L, Koch M, Wiesweg M, Wesseler C, Waller CF, Kauffmann-Guerrero D, Stenzinger A, Stephan-Falkenau S, Trautmann M, Lassmann S, Tiemann M, Klauschen F, Sebastian M, Griesinger F, Wolf J, Loges S, Frost N; National Network Genomic Medicine Lung Cancer (nNGM) Collaborator Group. Outcome of First-Line Treatment With Pembrolizumab According to KRAS/TP53 Mutational Status for Nonsquamous Programmed Death-Ligand 1-High (>/=50%) NSCLC in the German National Network Genomic Medicine Lung Cancer. J Thorac Oncol. 2024 May;19(5):803-817. doi: 10.1016/j.jtho.2023.12.015. Epub 2023 Dec 13.
- Website of the national Network Genomic Medicine Lung Cancer, GermanyLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Carcinoma, Non-Small-Cell Lung
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
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.
Juergen Wolf, Prof. Dr. study chair
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Prof. Dr. Juergen Wolf at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Contact Anna Rasokat (004922147896992, anna.rasokat@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
molecular testing (time frame: 1 year). The study lists 5 primary outcomes in all. 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 NCT05934032, which also lists 4 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 6 Jul 2023.