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

Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1)

Time frame · Baseline up to 9 months

Patients with Complete Response (CR), Partial Response (PR), or Stable Disease (SD) at Month 9 were to be considered as "progression-free" based on RECIST v1.1. Patients with missing tumor assessment, or with overall lesion response "unknown" at Month 9 were considered as "non progression-free", unless any of the following assessments at Week 48 or Week 52 indicate CR, PR, or SD, in which case the patient was to be considered as progression-free at Month 9. Patients discontinuing the study for any reason prior to the 9 month assessment were to be considered as "non progression-free".

Summary of Progression-free Survival (PFS) Based on RECIST v1.1

Time frame · Baseline, every 3 months up to 69 months

Time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1

Kaplan-Meier Estimates of Progression-free Survival (PFS)

Time frame · Baseline, every 3 months up to 69 months

Percent (%) event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are time from first study drug administration to objective tumor progression or death from any cause according to RECIST v1.1.

Summary of Time to Response (Months)

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.

Summary of Duration of Response (Months)

Time frame · Every 3 months up to Year 1

Date of first objective tumor response to date of tumor progression or death due to any cause.

12-month Disease Control Rate (DCR) and Objective Response Rate (ORR)

Time frame · Baseline up to Month 12

Objective response rate (ORR) was defined as the percentage of patients showing a best overall response (BOR) of CR or PR during the core study according to RECIST v1.1 criteria. The best overall response is interpreted as the best response recorded from the start of the treatment until disease progression/recurrence, death from any cause or until the patient withdraws consent, whichever is earliest. DCR was was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease during 12 months of treatment according to RECIST v1.1.

Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels

Time frame · Baseline up to Week 52

Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline.

Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set)

Time frame · Baseline up to Month 18

Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

Kaplan-Meier Event-free Probability Estimate Based on CgA Levels

Time frame · Baseline, every 3 months up to Month 18

Kaplan Meier estimates are for Duration of biochemical response (DBR) outcome measure. Events are biochemical progressions i.e. an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause. Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point.

Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment

Time frame · Baseline up Month 24

Time from the first documentation of biochemical response to the first documentation of biochemical progression or to death due to any cause, whichever occurred first. Biochemical progression is defined as an increase of serum CgA levels ≥ 25% compared to baseline.

Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels

Time frame · Baseline, every 3 months up to Month 24

Percent (%) Event-free probability estimate is the estimated probability that a patient will remain event-free up to the specified time point. Percent event-free probability estimates are obtained from the Kaplan-Meier survival estimates. Events are biochemical progressions, i.e., an increase of CgA levels \>= 25% compared to baseline or deaths due to any cause.