In advanced, progressive pNET
RADIANT-3 has a robust clinical trial design
RADIANT-3: The largest (N=410) phase 3 trial in the treatment of advanced, progressive pNET1
†Yes or no.
‡BSC could include SSA therapy.
§Crossover to AFINITOR was allowed upon disease progression.
- This was a prospective, double-blind, randomized, parallel-group, placebo-controlled, international, multicenter Phase III study of treatment with AFINITOR versus placebo in advanced, progressive pNET
- The primary end point was PFS‖
- After the primary end point was achieved, the study was unblinded and patients were enrolled in the open-label period to assess the secondary end point of OS1
- Other secondary end points: safety, objective response rate (complete response or partial response), and response duration
Key eligibility criteria1
- Advanced (unresectable or metastatic) pNET
- Radiologic disease progression ≤12 months prior to randomization
- Measurable disease per RECIST
- Prior antitumor therapy allowed
- WHO performance status ≤2
BSC, best supportive care; OS, overall survival; PFS, progression-free survival; pNET, pancreatic neuroendocrine tumor(s); RADIANT, RAD001 in Advanced Neuroendocrine Tumors; RECIST, Response Evaluation Criteria In Solid Tumors; SSA, somatostatin analogue; WHO, World Health Organization.
- Yao JC, Shah MH, Ito T, et al; for the RAD001 in Advanced Neuroendocrine Tumors, Third Trial (RADIANT-3) Study Group. Everolimus for advanced pancreatic neuroendocrine tumors. N Engl J Med. 2011;364(6):514-523.