3
Indication details
- Control Arm
- Single arm
- FDA Therapeutic Indication
- Unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease
- Tumour Type
-
Endocrine Tumours
- Tumour Sub-type
- Neuroendocrine Tumour - Lung and thymic carcinoids
- Tumour Stage
- Unresectable or metastatic
- Trial Name
- LUNA
- NCT Number
- NCT01563354
- Trial Phase
- Phase II
Approval details
- FDA Approval
- FDA approval February 2016
- EMA Approval
- EMA (CHMP) April 2016 EC decision July 2016
- Comment
- EMA and FDA approval were based only on the RADIANT-4 phase III trial. The single arm phase II LUNA trial was not the basis for registration, however, the ESMO-MCBS scoring is provided since scores can be generated for positive studies considered to be important or relevant for the ESMO Guidelines Committee.
Primary Outcome(s)
- Primary Outcome(s)
- PFS
- Evaluated Outcome
- PFS
- Form(s)
- Form 3
Outcome Data
- PFS Gain
- 12.5 months
Adjustments
- QoL Comment
-
QoL was not a prespecified endpoint
Score (after adjustments)
- Preliminary non-curative score
-
3
- Non-curative score
-
3
Scorecard details
- ESMO-MCBS version
- ESMO-MCBS v1.1
- Scorecard ID
- 186
- Scorecard version
- 1
- Issue date
- 14.07.2020
- Last update
- 14.09.2023
Legend
Information about symbols, abbrevations and color codes
Red = negative
Green = positive
Grey = neutral
?
Grey + ? = neutral with pending data
- DFS
- Disease-Free Survival
- DoR
- Duration of Response
- EFS
- Event-Free Survival
- HR
- Hazard Ratio
- NEB
- No evaluable benefit
- NI
- Non-inferiority Study
- ORR
- Overall Response Rate
- OS
- Overall Surival
- pCR
- Pathological Complete Response/Remission
- PFS
- Progression-Free Survival
- QoL
- Quality of Life
- RFS
- Relapse-Free Survival
- RR
- Response Rate
QoL adjustments
Other adjustments*
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
QoL adjustments
Red = negative / deterioration
Green = positive / improvement
Other adjustments*
Red = negative / deterioration
Green = positive / improvement
Serious and disabling adverse effects
Red = negative / deterioration
Green = positive / improvement
* Other adjustments include:
- Long-term plateau in the survival curve
- Long-term plateau in the PFS curve
- Early stopping or crossover
- Only improved PFS mature data shows no OS advantage and no improved Qol.