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In advanced, progressive, well-differentiated nonfunctional GI and lung NET

RADIANT-4 provides robust evidence for the efficacy of AFINITOR in this patient population1

RADIANT-4 trial design

Crossover from the placebo arm to the AFINITOR arm after progression was not allowed during the masked period of the study.

 

Trial overview1,2

  • 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:
    • SSAs
    • Interferons
    • One line of chemotherapy
    • PRRT
*BSC included all care that was provided to patients and deemed necessary by the treating physician, such as but not restricted to antidiarrheals and analgesics. BSC excluded use of antitumor therapies such as SSAs, interferon, tumor ablative procedures, and radiation and/or concurrent chemotherapy. Radiation or surgery intended for palliation was allowed. Optimal care of the patient was based on the treating physician’s best medical judgment.1
Abbreviations:
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.
References:
  1. 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.
  2. AFINITOR [summary of product characteristics]. Basel, Switzerland: Novartis Pharma AG; May 2016.