Clinical trial NCT05934032: National Network Genomic Medicine Lung Cancer, Germany
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Helios Klinikum Emil von Behring
name: Vivantes Hospital Berlin Neukölln
name: University Hospital Carl Gustav Carus
name: Heinrich-Heine University, Duesseldorf
name: University Hospital Erlangen
name: University Hospital, Essen
name: Goethe University
name: University Hospital Freiburg
name: University Hospital Giessen and Marburg
name: University Hospital Halle (Saale)
name: Universitätsklinikum Hamburg-Eppendorf
name: University Hospital Heidelberg
name: Klinikum Hanover-Siloah Hospital
name: University Hospital, Bonn
name: University Hospital Schleswig-Holstein
name: Johannes Gutenberg University Mainz
name: University Hospital Munich (LMU)
name: University Hospital rechts der Isar Munich (TUM)
name: Pius-Hospital Oldenburg
name: University Hospital Regensburg
name: University Hospital Tuebingen
name: Robert Bosch Gesellschaft für Medizinische Forschung mbH
name: University Hospital Ulm
name: Wuerzburg University Hospital
name: University Hospital of Cologne
First posted: 2023-07-06
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: molecular testing
timeFrame: 1 year
measure: treatment patterns
timeFrame: from first diagnosis to death or loss to follow-up, whichever came first, assessed up to 100 months
measure: overall survival
timeFrame: assessed up to 100 months
measure: time to next treatment
timeFrame: 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
measure: progression free survival
timeFrame: from start of treatment to tumour progression, death or loss to follow-up, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
Study officials:
affiliation: University of Cologne
name: Juergen Wolf, Prof. Dr.
role: STUDY_CHAIR
References:
citation: 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.
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.
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.