Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Carcinoma, Neuroendocrine

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Everolimus

Pasireotide

Somatostatin

Sirolimus

Temsirolimus

MTOR Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Immunosuppressive Agents

Immunologic Factors

Hormones

Hormone Antagonists

Pasireotide long acting release (LAR) 60 mg will be administered as an intra muscular (i.m.) depot injection once every 28 days starting on Day 1

Everolimus 10 mg taken orally (p.o) once daily starting on Day 1

Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily starting on Day 1

60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1

Pasireotide LAR

10 mg tables administered orally once a day

Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily

Pasireotide LAR and Everolimus Combination

Novartis Pharmaceuticals

This was a multicenter, randomized, phase II study evaluating Everolimus or Pasireotide LAR alone or in combination in adult patients with advanced (unresectable or metastatic) neuroendocrine carcinoma of the lung and thymus

This was a prospective, multicenter, randomized, open-label, 3-arm, phase II study with a single-stage design in each arm. The purpose of this study was 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 was expected that a total of 120 patients with 40 patients in each arm were to be enrolled into this study. Patients were seen weekly for one month and monthly thereafter. Radiological and biochemical response assessments were performed every 3 months.

Patients with disease control (stable disease or better) in the combination arm or monotherapy with pasireotide LAR and everolimus who had not experienced unacceptable toxicity were permitted to continue treatment in the extension phase of the study and were seen every 3 months. Patients could remain in the extension phase as long as they continued to have clinical benefit and had not fulfilled any of the study discontinuation criteria. All patients had a safety follow-up visit 56 days after last treatment dose.

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

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 of the Lung and Thymus - LUNA Trial

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

https://www.clinicalstudydatarequest.com/

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".

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

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.

Time from start of treatment to the first observed objective tumor response (partial response or complete response) observed according to RECIST v1.1.

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

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.

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

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 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.

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.

The percentages are the biochemical response rates i.e. percentage of patients showing normalization i.e. return to within normal ranges, or a decrease of \>= 50% from baseline of 5HIAA concentrations.

Total

18 to <65

≥65 to 84

Age, Customized

Sex: Female, Male

Caucasian

Black

Asian

Race/Ethnicity, Customized

Study Director

Complete response

Partial response

Stable disease

Progression-free (PF) at Month 9

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

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

3 months

6 months

9 months

12 months

15 months

18 months

21 months

24 months

27 months

30 months

33 months

36 months

39 months

42 months

45 months

48 months

51 months

54 months

57 months

60 months

63 months

66 months

69 months

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

25th percentile

Median

75th percentile

Summary of Time to Response (Months)

Summary of Duration of Response (Months)

Objective response (CR+PR)

Disease control rate (CR+PR+SD)

Complete response (CR)

Partial response (PR)

Progressive disease

Unknown

Not assessed

Discontinued before month 12

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

Week 12

Week 24

Week 36

Week 48

Week 52

Full analysis set participants with CgA levels outside normal range at baseline.

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

Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline

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

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

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

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

Full analysis set - participants with 5HIAA levels within normal range at baseline are excluded from the table, therefore 'n' stands for the number of patients with 5-HIAA levels outside normal range at baseline.

Biochemical Response Rate (BRR) for 5HIAA Levels

Core Phase

Extension Phase

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial	NCT01563354	Neuroendocrine ...	Pasireotide LAR Everolimus Pasireotide LAR...	18 Years -	Novartis
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial	NCT01563354	Neuroendocrine ...	Pasireotide LAR Everolimus Pasireotide LAR...	18 Years -	Novartis

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