National Network Genomic Medicine Lung Cancer, Germany

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
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* Other: observational, non-interventional


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observational, non-interventional|observational, non-interventional|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| molecular testing | descriptive data on results, frequency and methods of molecular testing | 1 year | 
| 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 | 
| overall survival | overall survival (in months) | assessed up to 100 months | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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carcinoma, non-small-cell lung* / diagnosis, carcinoma, non-small-cell lung* / genetics, precision medicine, lung neoplasms, neoplasms by site, registry, pathology, molecular