Clinical Trial: 3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Multicenter 3-arm Trial to Evaluate the Efficacy and Safety of Pasireotide LAR or Everolimus Alone or in Combination in Patients With Well Differentiated Neuroendocrine Carcinoma

Brief Summary: This is a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study is to test the effectiveness and safety of Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma (typical and atypical) of the lung and thymus. It is expected that a total of 120 patients with 40 patients in each arm will be enrolled into this study. Patients with disease control (SD or better) in the combination arm or monotherapy with pasireotide LAR and everolimus and who are not experiencing unacceptable toxicity are permitted to continue treatment after the 12 month treatment period in the extension phase of the study. Primary Endpoint is defined as the proportion of patients who are progression-free at 9 months according to RECIST V 1.1

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Proportion of patients progression-free at 9 months [ Time Frame: 9 months ]

Original Primary Outcome: Proportion of patients progression-free at 12 months [ Time Frame: 12 months ]

Current Secondary Outcome:

• Progression-free survival [ Time Frame: Every 3 months up to Year 1 ]
  Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1
• Disease control rate [ Time Frame: Every 3 months up to Year 1 ]
  Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1
• Time to response [ Time Frame: Every 3 months up to Year 1 ]
  Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1
• Duration of response [ Time Frame: Every 3 months up to Year 1 ]
  Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
• Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ]
  Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA compared to baseline.
• Rate and severity of adverse events [ Time Frame: Week 2, 3, 4 and 7; every month up to 56 days after end of study treatment ]

Original Secondary Outcome:

• Progression-free survival [ Time Frame: Every 3 months up to Year 1 ]
  Time from first study drug administration to objective tumor progression or death from any cause
• Disease control rate [ Time Frame: Every 3 months up to Year 1 ]
  Proportion of patients showing a best overall response of complete response, partial response or stable disease during 12 months of treatment
• Time to response [ Time Frame: Every 3 months up to Year 1 ]
  Time from start of treatment to the first observed objective tumor response (partial response or complete response)
• Duration of response [ Time Frame: Every 3 months up to Year 1 ]
  Time from onset of the first objective tumor response (partial response or complete response) to objective tumor progression or death from any cause
• Time to progression [ Time Frame: Every 3 months up to Year 1 ]
  Time from date of start of treatment to date of event defined as the first documented progression or death due to underling disease.
• Biochemical response rate [ Time Frame: Every 3 months up to Year 1 ]
  Percentage of patients showing normalization or a decrease > or = 50% of serum CgA, urinary 5HIAA
• Rate and severity of adverse events [ Time Frame: Week 2, 3 and 4; every month up to Year 3 ]

Information By: Novartis

Dates:
Date Received: March 20, 2012
Date Started: August 16, 2013
Date Completion: November 30, 2017
Last Updated: March 6, 2017
Last Verified: March 2017