Molecular Landscape Analysis and Clinical Implications for NSCLC Patients With Rare Mutations

Study Overview
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Brief Summary
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Lung cancer is the most common primary cancer of the lung and is responsible for the ever increasing number of cancer-related deaths worldwide. Especially in China, the burden of lung cancer has been rising rapidly due to its large and growing population. Histologically, approximately 85% of lung cancers are non-small-cell lung cancer (NSCLC). Molecular targeted therapy has been shown to dramatically improve the quality of life and survival outcomes of NSCLC patients. One of the most important targeted drugs in NSCLC has been the epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs), while there exists some other rare targetable mutation in NSCLC. Emerging evidence underlines that, rather than a single point mutation, some rare mutations present with a wide array of mutations, essentially in NSCLC. Different rare mutations with NSCLC have divergent clinical and therapeutic implications with a particular distinction. Therefore, there is an unmet need for more effective therapies for NSCLC with rare mutations. In summary, identification of genetic alterations in NSCLC with rare mutations is increasingly essential to perform molecular diagnostics and individualized treatments. This project aims to create a registry of patients with NSCLC with rare mutations to further the characterization of molecular alterations and develop (novel) treatments based on the detection.

Official Title
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Molecular Landscape Analysis and Clinical and Therapeutic Implications for NSCLC Patients With Rare Mutations

Conditions
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NSCLC, NSCLC Stage IV, NSCLC, Recurrent

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically proven diagnosis of NSCLC with rare mutations including EGFR rare mutations, ALK fusion, ROS1 fusion, BRAF V600E, cMET exon 14 skipping, KRAS G12C, RET fusion, NTRK fusion, etc. 18 years of age or older Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records | 20 years | 
| Disease control rate (DCR) | Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records | 20 years | 
| Progression-free survival (PFS) | Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records | 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | Collect detailed clinical information on patients with NSCLC with rare mutations via the electronic medical records | 20 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, rare mutations, molecular landscape, next-generation sequencing (NGS), targeted therapy, immunotherapy, chemotherapy