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Completed

NCT Number: NCT01563354

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

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

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Key information

Conditions

Neuroendocrine Carcinoma of the Lung and Thymus Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological confirmed advanced well differentiated typical and atypical carcinoid tumors of the lung or thymus
  • Patients of all treatment lines including naive patients could have been enrolled
  • At least one measurable lesion of disease on CT scan or MRI
  • Radiological documentation of disease progression within 12 months prior to randomization
  • Adequate liver, renal and bone marrow function
  • WHO Performance Status 0-2

Exclusion criteria

  • Poorly differentiated neuroendocrine carcinoma
  • Non-neuroendocrine thymoma
  • Patients with severe functional disease who required symptomatic treatment with somatostatin analogs
  • Prior therapy with mTOR inhibitors
  • History of liver disease
  • Baseline QTcF> 470 msec
  • Uncontrolled diabetes mellitus despite adequate therapy

Treatment and study plan

pasireotide LAR

Drug

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

Other names: SOM230

Everolimus

Drug

10 mg tables administered orally once a day

Other names: RAD001

Pasireotide LAR and Everolimus Combination

Drug

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

Other names: SOM230 + RAD001

Primary outcomes

  1. 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".

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Biochemical Response Rate (BRR) for 5HIAA Levels

    Time frame: Baseline up Week 52

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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 of the Lung and Thymus - LUNA Trial

Acronym: LUNA

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Mar 27, 2012
Registry last updated
Apr 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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