| Abstract: |
Selpercatinib, a first-in-class, highly selective and potent central nervous system-active RET kinase inhibitor demonstrated clinically meaningful activity with manageable toxicity in pretreated and treatment-naive advanced/metastatic RET fusion-positive non-small-cell lung cancer (NSCLC). LIBRETTO-432 is a global, randomized, double-blind, phase III trial evaluating selpercatinib versus placebo in stage IB-IIIA, RET fusion-positive NSCLC, previously treated with definitive surgery or radiation; participants must have undergone available anti-cancer therapy (including chemotherapy or durvalumab) or not be suitable for it, per investigator's discretion. The primary end point is investigator-assessed event-free survival (EFS) in the primary analysis population (stage II-IIIA RET fusion-positive NSCLC). Key secondary end points include EFS in the overall population, overall survival, and time to distant disease recurrence in the central nervous system. Selpercatinib is approved in multiple countries for the treatment of advanced or metastatic RET-altered lung cancers. Selpercatinib has shown promising efficacy and safety results in patients with advanced/metastatic RET fusion-positive NSCLC. This is a summary of the LIBRETTO-432 study which compares selpercatinib with placebo in patients with earlier stages (stage IB-IIIA) of RET fusion-positive NSCLC, who have already undergone surgery or radiotherapy and applicable adjuvant chemotherapy. This study is active and currently recruiting new participants. This trial will evaluate how long people live without evidence of cancer recurrence, both during and after treatment. Side effects will also be evaluated in this study. Clinical Trial Registration: NCT04819100 (ClinicalTrials.gov). |
| Keywords: |
genetics; pyridines; adjuvant therapy; chemotherapy, adjuvant; cancer staging; neoplasm staging; neoplasm recurrence, local; protein kinase inhibitor; carcinoma, non-small-cell lung; lung neoplasms; randomized controlled trials as topic; pathology; protein kinase inhibitors; lung tumor; clinical trials, phase iii as topic; pyrazole derivative; tumor recurrence; pyrazoles; adjuvant chemotherapy; targeted therapy; protein ret; ret protein, human; proto-oncogene proteins c-ret; non-small-cell lung cancer; pyridine derivative; non small cell lung cancer; randomized controlled trial (topic); phase 3 clinical trial (topic); stage ib; early stage; humans; human; phase iii trial; stage ii; ret rearrangement; stage iiia; selpercatinib; ret fusion-positive; ret kinase inhibitor
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