National Network Genomic Medicine Lung Cancer, Germany

Carcinoma, Non-Small-Cell Lung Clinical Trial

— nNGM  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05934032
• Other study ID #: NNGM0418
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: July 2023
• Source: University of Cologne
• Contact: Anna Rasokat
• Phone: 004922147896992
• Email: anna.rasokat[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 Germany

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Missing written informed consent

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Non-Small-Cell Lung

Intervention

Other:
• observational, non-interventional
observational, non-interventional

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne

Sponsors (27)

Lead Sponsor

Collaborator

Prof. Dr. Juergen Wolf

Charite University, Berlin, Germany, Goethe University, Heinrich-Heine University, Duesseldorf, Helios Klinikum Emil von Behring, Johannes Gutenberg University Mainz, Klinikum Hanover-Siloah Hospital, Pius-Hospital Oldenburg, Robert Bosch Hospital Stuttgart, Universitätsklinikum Hamburg-Eppendorf, University Hospital Carl Gustav Carus, University Hospital Erlangen, University Hospital Freiburg, University Hospital Giessen and Marburg, University Hospital Halle (Saale), University Hospital Heidelberg, University Hospital Munich (LMU), University Hospital of Cologne, University Hospital rechts der Isar Munich (TUM), University Hospital Regensburg, University Hospital Schleswig-Holstein, University Hospital Tuebingen, University Hospital Ulm, University Hospital, Bonn, University Hospital, Essen, Vivantes Hospital Berlin Neukölln, Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View Citation

Saalfeld 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. — View Citation

Saleh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	molecular testing	descriptive data on results, frequency and methods of molecular testing	1 year
Primary	treatment patterns	descriptive data on systemic treatments (including combination and sequence of treatments)	from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months
Primary	overall survival	overall survival (in months)	assessed up to 100 months
Primary	time to next treatment	time to next treatment (in months)	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
Primary	progression free survival	progression free survival (in months)	from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months

External Links

•   Website of the national Network Genomic Medicine Lung Cancer, Germany