Phase II, Open-label, Single-arm, Multicenter Study to Assess the Activity and Safety of Alectinib as Neoadjuvant Treatment in Surgically Resectable Stage III ALK-positive NSCLC: ALNEO Trial

Patients with potentially resectable stage III ALK+ NSCLC (any T with N2, T4N0-1) will be registered to receive oral alectinib 600 mg twice daily for 2 cycles of 4 weeks each (8 weeks totally) during the neoadjuvant phase. After definitive surgery, patients will enter in the adjuvant setting, during which they will receive alectinib 600 mg twice daily for 24 cycles (96 weeks). The primary endpoint is MPR, defined as ≤10% residual viable tumor cells histologically detected in the resected primary tumor and all resected lymph nodes after surgery. Secondary endpoints include pathological complete response, objective response, event-free survival, disease-free survival, overall survival, adverse events. Our case report supports the feasibility of alectinib as neoadjuvant treatment. ALNEO study will further explore the activity and safety of this novel treatment strategy. READ ARTICLE

Clinical Lung Cancer DOI:10.1016/j.cllc.2021.02.014

Authors: Alessandro Leonetti, Roberta Minari, Luca Boni, Letizia Gnetti, Michela Verzè, LuigiVentura LucaMusini, Michele Tognetto and Marcello Tiseo

Real-World OutcomesKirk SmithFebruary 24, 2021ALK-TKI, Neoadjuvant Alectinib, Adjuvant Alectinib, Major pathological response, Trial design

Biomarkers in Lung Cancer

Key Points: Biomarkers can be used for risk assessment, detection, diagnosis, and prognosis and to personalize treatment in lung cancer. Clinically useful biomarkers for selection of high-risk patients for lung cancer screening and to differentiate early lung cancer from benign pulmonary nodules are needed. Biomarkers for nodule management and determination of high-risk groups for lung cancer screening are at all phases of development, from discovery to clinical utility studies. Current trends in lung cancer biomarker development include the integration of clinical and radiologic features with molecular biomarkers, the application of artificial intelligence to molecular and imaging biomarker development, the use highly sensitive technologies such as next-generation sequencing for molecular exploration, and a commitment to high-quality clinical validation and utility studies. READ ARTICLE

Clinics in Chest Medicine. DOI: 10.1016/j.ccm.2019.10.004

Authors: Catherine R. Sears, Peter J. Mazzone

Review PaperKirk SmithMarch 1, 2020Lung cancer screening, Lung nodules, Next-generation sequencing, Radiomics, Clinical utility, Trial design