Trial · NCT01563354
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
NCT01563354, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2021-04-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial. Trials, record NCT01563354. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01563354
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
- NCT number
- NCT01563354
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 124 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Neuroendocrine Carcinoma of the Lung and Thymus
- Interventions
- Pasireotide LAR, Everolimus, Pasireotide LAR and Everolimus Combination
- First posted
- 2012-03-27
- Last updated
- 2021-04-02
- Other registries' IDs
- eudract:2011-002872-17
- Results first posted
- 2021-04-02
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | 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 | Summary of Progression-free Survival (PFS) Based on RECIST v1.1 | 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 |
| Secondary | Kaplan-Meier Estimates of Progression-free Survival (PFS) | 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. |
| Secondary | Summary of Time to Response (Months) | 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. |
| Secondary | Summary of Duration of Response (Months) | Every 3 months up to Year 1 | Date of first objective tumor response to date of tumor progression or death due to any cause. |
| Secondary | 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) | 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. |
| Secondary | Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels | Baseline up to Week 52 | Percentage of patients showing normalization or a decrease of ≥ 30% of serum CgA concentrations compared to baseline. |
| Secondary | Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) | 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. |
| Secondary | Kaplan-Meier Event-free Probability Estimate Based on CgA Levels | 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. |
| Secondary | Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Baseline up to 9 months | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Summary of Progression-free Survival (PFS) Based on RECIST v1.1 | Baseline, every 3 months up to 69 months | Full analysis set | months | MEDIAN |
| SECONDARY | Kaplan-Meier Estimates of Progression-free Survival (PFS) | Baseline, every 3 months up to 69 months | Full analysis set | event free probability estimates | NUMBER |
| SECONDARY | Summary of Time to Response (Months) | Every 3 months up to Year 1 | Full analysis set | months | NUMBER |
| SECONDARY | Summary of Duration of Response (Months) | Every 3 months up to Year 1 | Full analysis set | months | NUMBER |
| SECONDARY | 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) | Baseline up to Month 12 | Full analysis set | percentage of participants | NUMBER |
| SECONDARY | Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels | Baseline up to Week 52 | Full analysis set participants with CgA levels outside normal range at baseline. | percentage of participants | NUMBER |
| SECONDARY | Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) | Baseline up to Month 18 | Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline | months | MEDIAN |
| SECONDARY | Kaplan-Meier Event-free Probability Estimate Based on CgA Levels | Baseline, every 3 months up to Month 18 | Full analysis set - participants who have experienced biochemical response during the study and had CgA levels outside normal range at baseline | event free probability estimates | NUMBER |
| SECONDARY | Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment | Baseline up Month 24 | Full analysis set | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group207
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR | Complete response | 0 | 95% Confidence Interval 0.0 to 8.6 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Everolimus | Complete response | 0 | 95% Confidence Interval 0.0 to 8.4 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR and Everolimus Combination | Complete response | 0 | 95% Confidence Interval 0.0 to 8.6 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR | Partial response | 2.4 | 95% Confidence Interval 0.1 to 12.9 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Everolimus | Partial response | 2.4 | 95% Confidence Interval 0.1 to 12.6 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR and Everolimus Combination | Partial response | 2.4 | 95% Confidence Interval 0.1 to 12.9 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR | Stable disease | 34.1 | 95% Confidence Interval 20.1 to 50.6 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Everolimus | Stable disease | 31.0 | 95% Confidence Interval 17.6 to 47.1 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR and Everolimus Combination | Stable disease | 48.8 | 95% Confidence Interval 32.9 to 64.9 | percentage of participants |
| Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) | Pasireotide LAR | Progression-free (PF) at Month 9 | 39.0 | 95% Confidence Interval 24.2 to 55.5 | percentage of participants |
1 to 10 of 207Source ClinicalTrials.gov
See all 207 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core Phase | STARTED | Pasireotide LAR | 41 | |
| Core Phase | STARTED | Everolimus | 42 | |
| Core Phase | STARTED | Pasireotide LAR and Everolimus Combination | 41 | |
| Core Phase | Entered Extension Phase | Pasireotide LAR | 12 | |
| Core Phase | Entered Extension Phase | Everolimus | 14 | |
| Core Phase | Entered Extension Phase | Pasireotide LAR and Everolimus Combination | 15 | |
| Core Phase | COMPLETED | Pasireotide LAR | 12 | |
| Core Phase | COMPLETED | Everolimus | 14 | |
| Core Phase | COMPLETED | Pasireotide LAR and Everolimus Combination | 15 | |
| Core Phase | NOT COMPLETED | Pasireotide LAR | 29 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events516
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide LAR | 9 | 41 | |
| other | Anaemia | Blood and lymphatic system disorders | Everolimus | 14 | 42 | |
| other | Anaemia | Blood and lymphatic system disorders | Pasireotide LAR and Everolimus Combination | 10 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pasireotide LAR | 0 | 41 | |
| other | Leukopenia | Blood and lymphatic system disorders | Everolimus | 3 | 42 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pasireotide LAR and Everolimus Combination | 3 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pasireotide LAR | 0 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Everolimus | 9 | 42 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pasireotide LAR and Everolimus Combination | 7 | 41 | |
| other | Palpitations | Cardiac disorders | Pasireotide LAR | 4 | 41 |
1 to 10 of 516Source ClinicalTrials.gov
See all 516 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pasireotide LAR | 2 | 41 |
| Total, all-cause mortality | Everolimus | 7 | 42 |
| Total, all-cause mortality | Pasireotide LAR and Everolimus Combination | 3 | 41 |
| Total, other adverse events | Pasireotide LAR | 40 | 41 |
| Total, other adverse events | Everolimus | 42 | 42 |
| Total, other adverse events | Pasireotide LAR and Everolimus Combination | 40 | 41 |
| Total, serious adverse events | Pasireotide LAR | 17 | 41 |
| Total, serious adverse events | Everolimus | 20 | 42 |
| Total, serious adverse events | Pasireotide LAR and Everolimus Combination | 16 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29074099 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01563354
GET https://conductscience.org/api/trials/v1/NCT01563354/results?page=2