In advanced, progressive, well-differentiated nonfunctional GI and lung NET
RADIANT-4 provides robust evidence for the efficacy of AFINITOR in this patient population1
- A prospective, double-blind, randomized, parallel-group, placebo-controlled, multicenter, phase III study of treatment with AFINITOR versus placebo in advanced, progressive, well-differentiated nonfunctional NET of GI or lung origin
- Primary end point: PFS based on central radiology review
- Key secondary end point: OS
- Other secondary end points: ORR, DCR, safety, change in quality of life (FACT-G), and time to WHO PS deterioration
Key inclusion criteria1,2
- Patients with advanced, progressive, well-differentiated nonfunctional GI or lung NET (N=302)
- No active symptoms or history of carcinoid syndrome
- Disease progression within past 6 months
- Prior tumor control therapy was allowed, including:
- One line of chemotherapy
BSC, best supportive care; DCR, disease control rate; FACT-G, Functional Assessment of Cancer Therapy-General; GI, gastrointestinal; NET, neuroendocrine tumor(s); ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PRRT, peptide receptor radionuclide therapy; PS, performance status; RADIANT, RAD001 in Advanced Neuroendocrine Tumors; SSA, somatostatin analogue; WHO, World Health Organization.
- Yao JC, Fazio N, Singh S, et al. Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study. Lancet. 2016;387(10022):968-977.
- AFINITOR [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; May 2016.