Phase 2
N=124
3-arm Trial to Evaluate Pasireotide LAR/Everolimus Alone/in Combination in Patients With Lung/Thymus NET - LUNA Trial
Neuroendocrine Carcinoma of the Lung and Thymus
Bottom Line
View on ClinicalTrials.gov: NCT01563354 ↗Enrolled (actual)
124
Serious AEs
42.7%
Results posted
Apr 2021
Primary outcome: Primary: Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) — 0; 0; 0; 2.4 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pasireotide LAR (Drug); Everolimus (Drug); Pasireotide LAR and Everolimus Combination (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Progression-free at 9 Months Based on Response Evaluation Criteria In Solid Tumors v1.1 (RECIST v1.1) |
0; 0; 0; 2.4; 2.4; 2.4 | — |
| SECONDARY Summary of Progression-free Survival (PFS) Based on RECIST v1.1 |
8.51; 12.48; 16.53 | — |
| SECONDARY Kaplan-Meier Estimates of Progression-free Survival (PFS) |
83.6; 91.2; 88.6; 68.2; 63.5; 85.5 | — |
| SECONDARY Summary of Time to Response (Months) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Summary of Duration of Response (Months) |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY 12-month Disease Control Rate (DCR) and Objective Response Rate (ORR) |
2.4; 2.4; 4.9; 80.5; 73.8; 78.0 | — |
| SECONDARY Biochemical Response Rate (BRR) for Chromogranin A (CgA) Levels |
20.6; 7.4; 17.1; 8.8; 7.4; 20.0 | — |
| SECONDARY Duration of Biochemical Response (DBR), by Treatment (Full Analysis Set) |
14.75; 2.00; 8.38 | — |
| SECONDARY Kaplan-Meier Event-free Probability Estimate Based on CgA Levels |
75.0; 37.5; 77.8; 56.3; NA; 77.8 | — |
| SECONDARY Summary of Biochemical Progression-free Survival Based on CgA Levels by Treatment |
2.89; 2.86; 5.62 | — |
| SECONDARY Kaplan-Meier Event-free Probability Estimate for Biochemical Progression-free Survival Based on CgA Levels |
43.1; 35.4; 77.1; 29.5; 17.7; 44.5 | — |
| SECONDARY Biochemical Response Rate (BRR) for 5HIAA Levels |
20.0; 11.1; 10.0; 5.0; 11.1; 20.0 | — |
Summary
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01563354). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.