Phase III study of selpercatinib vs chemotherapy plus /- pembrolizumab in untreated RET positive non-small-cell lung cancer

Selpercatinib, a novel, highly selective and potent, inhibitor of RET, demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival.

Automated summary

Selpercatinib, a highly selective RET inhibitor, demonstrated clinically meaningful antitumor activity with manageable toxicity in RET fusion-positive non-small-cell lung cancer patients. The ongoing Phase III trial, LIBRETTO-431, is evaluating selpercatinib versus chemotherapy in treatment-naive patients with RET fusion-positive nonsquamous non-small-cell lung cancer, with progression-free survival as the primary endpoint.