Phase 2
Completed 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
Source: ClinicalTrials.gov NCT01563354 ↗
Enrolled (actual)
124
Serious AEs
42.7%
Results posted
Apr 2021
Primary outcomePrimary: 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
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
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 | — |
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. Informational only — not medical advice.