Abstract
The detection of molecular alterations is crucial for the individualized treatment of advanced non-small cell lung cancer (NSCLC). Missing targetable alterations may have a major impact on patient’s progression free and overall survival. Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations. In the retrospective study detection rate of epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared to other standard biopsy techniques. This prospective, randomized, multicenter, single blinded study evaluates the accuracy of molecular genetic characterization of NSCLC for different cell sampling techniques. Key inclusion criteria are suspected lung cancer or the suspected relapse of known NSCLC that is bronchoscopically visible. Patients will be randomized, either to have a CB or a bronchoscopic forceps biopsy (FB). If indicated, a transbronchial needle aspiration (TBNA) of suspect lymph nodes will be performed. Blood liquid biopsy will be taken before tissue biopsy. The primary endpoint is the detection rate of molecular genetic alterations in NSCLC, using CB and FB. Secondary endpoints are differences in the combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy. This trial plans to recruit 540 patients, with 178 evaluable patients per study cohort. A histopathological and molecular genetic evaluation will be performed by the affiliated pathology departments of the national network for genomic medicine in lung cancer (nNGM), Germany. We will compare the diagnostic value of solid tumor tissue, lymph node cells and liquid biopsy for the molecular genetic characterization of NSCLC. This reflects a real world clinical setting, with potential direct impact on both treatment and survival.
Highlights
Lung cancer is one of the most common cancers, with 230,000 new diagnoses per annum in the United States and 410,000 in Europe, with a prevalence of approximately 1.8 million patients worldwide [1,2,3,4]
The secondary objectives assess differences in the detection of molecular genetic alterations in Non-small cell lung cancer (NSCLC) between liquid biopsy, solid tumor tissue biopsy obtained by bronchoscopic techniques, cytological material obtained by TBNA, and to compare combined methods
The local investigators pre-screen any potential participant with pulmonary lesions which were suspicious of lung cancer, or known NSCLC with suspected relapse or progression, in accordance with the inclusion and exclusion criteria; after giving informed consent, patients are eligible for study entry
Summary
Lung cancer is one of the most common cancers, with 230,000 new diagnoses per annum in the United States and 410,000 in Europe, with a prevalence of approximately 1.8 million patients worldwide [1,2,3,4]. Precise and correct characterization of the molecular genetic profile in patients with non-curable advanced stage III and IV NSCLC is crucial for ensuring optimal treatment; missing any targetable alteration may result in suboptimal therapy and could even impair patients’ overall outcome. The detection of a single tumor cell type does not necessarily reflect the tumor, with its inherent heterogeneity, since NSCLC tumor heterogeneity has been known and characterized in various studies for a long time [23,24,25,26,27,28,29,30,31,32,33,34].
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