This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours (NCT02683941), a randomized phase 3 study. The primary outcome is Median Progression-Free Survival (PFS) Time in Subjects Randomised to Lanreotide in the Double-Blind Phase or Open-Label Treatment Phase, Assessed by Central Review.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02683941 |
| Phase | Phase 3 |
| Condition | Neuroendocrine Tumors in Lung |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 77 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ipsen |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with well-differentiated, metastatic and/or unresectable, typical or atypical lung neuroendocrine tumours. The registry describes an ITT population of all randomized subjects, analysed as randomized regardless of treatment received.
Intervention
Lanreotide Autogel/Depot 120 mg plus best supportive care (BSC). The planned schedule was every 28 days until disease progression, death, or unacceptable toxicity.
Comparator
Placebo plus BSC during the double-blind phase. The placebo description says subjects could enter the open-label phase for lanreotide treatment.
Primary question
The study aimed to describe progression-free survival (PFS) among subjects randomized to lanreotide, assessed by central review using RECIST v1.1. The registry record does not report the median PFS estimate or its 95% confidence interval, so the size and precision of the primary result cannot be assessed from this record.
The study was designed for well-differentiated lung neuroendocrine tumours that were metastatic and/or unresectable, with typical or atypical histology. The clinical question is therefore specific to this recorded population and treatment context; it should not be generalized to other tumour types or populations based on this trial record alone.
The stated primary objective was to describe antitumour efficacy in terms of PFS. The record describes assessment during the double-blind phase or the open-label treatment phase for subjects randomized to lanreotide. It does not report a comparative primary estimate between the randomized groups. The secondary outcomes listed include PFS assessed by local review, objective response rate, time to treatment failure, chromogranin A measures, and quality-of-life outcomes. Their presence in the registry does not establish what those results were; those results are not reported in the registry record.
3. Trial Design
This was a Phase 3, prospective, randomized, double-blind, multicenter, parallel-group study. It compared lanreotide plus BSC with placebo plus BSC in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary neuroendocrine tumours. The registry reports enrollment of 77. It gives the study status as terminated and lists a start date of 2017-03-06 and primary completion date of 2020-02-28.
The study included a double-blind phase and an open-label phase. The double-blind phase comprised screening, baseline, and treatment. The open-label phase comprised treatment and follow-up. In the double-blind phase, the lanreotide and placebo descriptions specify 120 mg every 28 days until disease progression, death, or unacceptable toxicity. The placebo description says a participant could enter the open-label phase to receive lanreotide. The summary describes an open-label treatment phase and an open-label follow-up phase in the safety records.
The registry summary says recruitment was stopped prematurely. It attributes the decision to slow and difficult recruitment in the context of guideline updates that recommended somatostatin analogues in first line for locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond observation. The summary says subjects still being treated in the double-blind phase were to transition to open-label treatment. The available summary ends mid-sentence, so any further details about the transition are not reported in the registry record.
Random allocation and double masking are recorded, but the randomization procedure, allocation concealment details, and masking procedures are not reported in the registry record. The planned sample-size justification and any interim analyses are not reported in the registry record. The record describes the primary population as ITT and says subjects were analysed as randomized regardless of treatment received, but the full account of the primary analysis population is truncated.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: This study consisted of two phases: the double-blind phase, and the open-label phase. 77 subjects were randomised to receive study treatment until disease progression, unacceptable toxicity, withdrawal for any reason, or up to 18 months after the last subject was randomised. Subjects were randomised 2:1 to either lanreotide autogel/depot 120 milligrams (mg) plus best supportive care (BSC) every 28 days (Q4 weeks) or placebo plus BSC Q4 weeks.
Double-blind Phase
| Stage | Lanreotide | Placebo |
|---|---|---|
| STARTED | 51 | 26 |
| COMPLETED | 41 | 21 |
| NOT COMPLETED | 10 | 5 |
Reasons for not completing this period:
| Reason | Lanreotide | Placebo |
|---|---|---|
| Adverse Event | 0 | 1 |
| Withdrawal by Subject | 4 | 2 |
| Lost to Follow-up | 1 | 0 |
| Disease Progression | 5 | 2 |
Open-label Treatment Phase
| Stage | Lanreotide | Placebo |
|---|---|---|
| STARTED | 21 | 19 |
| COMPLETED | 1 | 6 |
| NOT COMPLETED | 20 | 13 |
Reasons for not completing this period:
| Reason | Lanreotide | Placebo |
|---|---|---|
| Withdrawal by Subject | 0 | 2 |
| Disease Progression | 1 | 2 |
| Study Termination by the Sponsor | 18 | 9 |
| Other | 1 | 0 |
Open-label Follow-up Phase
| Stage | Lanreotide | Placebo |
|---|---|---|
| STARTED | 18 | 8 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 18 | 8 |
Reasons for not completing this period:
| Reason | Lanreotide | Placebo |
|---|---|---|
| Withdrawal by Subject | 3 | 3 |
| Lost to Follow-up | 1 | 0 |
| Study Termination by the Sponsor | 6 | 4 |
| Other | 8 | 1 |
Analysis population for the primary outcome, as defined in the registry: The ITT population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received. One subject randomised to lanreotide should have been censored in the PFS analysis treatment for discontinuation for toxicity or other reasons, however the baseline central radiological assessment was performed prior to the randomisation date, therefore the subject was excluded from the analysis.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The intention to treat (ITT) population included all randomised subjects. Subjects were analysed as randomised, regardless of the treatment received.
| Characteristic | Unit | Lanreotide | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 51 | 26 | 77 | |
| Age, Continuous | years | 66.4 (SD 11.94) | 65.8 (SD 13.89) | 66.2 (SD 12.54) |
| Sex: Female, Male: Female | Participants | 23 | 12 | 35 |
| Sex: Female, Male: Male | Participants | 28 | 14 | 42 |
| Race/Ethnicity, Customized: Ethnicity – Hispanic or Latino | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Ethnicity – Not Hispanic or Latino | Participants | 9 | 4 | 13 |
| Race/Ethnicity, Customized: Ethnicity – Missing | Participants | 42 | 22 | 64 |
| Race/Ethnicity, Customized: Race – American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 3 | 0 | 3 |
| Race/Ethnicity, Customized: Race – Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – Black or African American | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: Race – White | Participants | 35 | 19 | 54 |
| Race/Ethnicity, Customized: Race – More than one race | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: Race – Missing | Participants | 12 | 7 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Median Progression-Free Survival (PFS) Time in Subjects Randomised to Lanreotide in the Double-Blind Phase or Open-Label Treatment Phase, Assessed by Central Review, measured over Up to a maximum of 33 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint is median PFS time, measured in months. The registry defines PFS as the time from randomization to disease progression or death from any cause. Tumour progression was assessed by central review using RECIST v1.1 criteria every 12 weeks. The timeframe is up to a maximum of 33 months.
PFS is a time-to-event outcome: each subject’s follow-up contributes information about when progression or death occurs, or about the period during which the subject is known not to have experienced either event. The median is the time by which the estimated event-free proportion has reached the halfway point. It gives a time-based summary without requiring every subject to experience an event, although its precision depends on the observed follow-up and events.
Central review applies a common assessment process across participants, which can reduce variation associated with local interpretation of imaging. The registry says PFS times were estimated with the Kaplan-Meier product-limit method. A 95% confidence interval is listed as the dispersion measure, but the primary median and interval are not reported in the registry record. Consequently, the endpoint definition and planned assessment are available, but the primary estimate’s magnitude and precision are not.
The primary title refers to subjects randomized to lanreotide in the double-blind phase or open-label treatment phase. The description also states that PFS was assessed during either phase. The record’s account of how these phases were combined for the primary endpoint is not fully available, and details beyond the stated description are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies PFS as the primary outcome and gives its definition, assessment approach, timeframe, and estimation method. However, it does not report the primary median PFS or its 95% confidence interval. Without those values, the result’s direction, magnitude, and precision cannot be described. No conclusion about the comparative effect of lanreotide and placebo can be drawn from the primary endpoint information in this record.
The record lists secondary outcomes, including PFS assessed by local review, objective response rate, time to treatment failure, chromogranin A changes, and quality-of-life measures. It does not report their estimates in the available information. These outcomes therefore cannot be used to fill the gap in the primary result or to characterize treatment effects.
The enrollment figure is 77, while the adverse-event records give phase-specific groups at risk of 51 for double-blind lanreotide and 26 for double-blind placebo. The open-label treatment and follow-up safety records give groups at risk of 40 and 26, respectively. These are phase-specific safety figures; they should not be treated as a single set of randomized comparison groups. The registry record does not explain the relationship between these phase-specific counts and the full enrollment in enough detail to reconstruct participant flow.
The record is marked terminated and describes premature stopping of recruitment because of slow and difficult recruitment in the setting of guideline updates. Early recruitment stopping can affect how much information accumulates, but the record does not report a formal assessment of its effect on the primary estimate. It also does not report the planned sample-size justification or any interim analysis details. Those omissions prevent assessment of whether the study reached its planned information target or whether any formal stopping boundary was used.
The PFS description notes that one subject randomized to lanreotide should have been censored because of discontinuation for toxicity or other reasons. The available description is cut off before completing its explanation. The precise handling of this issue is not reported in the registry record. This is relevant because censoring assumptions affect time-to-event estimates, but the record does not provide enough information to determine its influence.
These limitations concern what can be interpreted from the registry record, not evidence that the study had a particular result. The safest statistical reading is that the endpoint and design are described, while the principal numerical efficacy result is absent. The safety counts can be read as recorded phase-specific counts, with the caveat that adverse-event context and exposure details are incomplete.
9. Statistical Methods Explained
The primary outcome is a time-to-event measure. For each participant, the time origin is randomization, and the event is the first recorded disease progression or death from any cause. The registry specifies central review using RECIST v1.1 every 12 weeks. These criteria provide a structured approach to classifying tumour response and progression. The record does not provide the actual assessment results or the primary median estimate.
How does Kaplan-Meier estimation work?
In general, the Kaplan-Meier product-limit method estimates the probability of remaining free of the event over time. It updates that estimate at observed event times, using the participants still under observation just before each event. A participant whose follow-up ends without a recorded event can be censored: their observed time contributes information up to the point follow-up ends, but the method does not treat them as having experienced the event then. This method can accommodate participants with different follow-up durations, provided the assumptions behind censoring are reasonable.
The registry identifies Kaplan-Meier estimation and a 95% confidence interval as the primary summary approach. A confidence interval expresses uncertainty around an estimate under the analysis method; it is not a guarantee that the true value lies within the interval. Because neither the median nor its interval is reported, the precision of the primary estimate cannot be evaluated. The stated maximum timeframe is up to 33 months, but this does not by itself establish how long any individual participant was followed.
What does the median represent?
For a time-to-event distribution, the median is the time at which the estimated probability of remaining event-free reaches 50%. It is a compact summary of the estimated distribution, not a description of every participant’s experience. If the estimated event-free curve does not reach that point within the available follow-up, a median may not be estimable; whether that occurred in this study is not reported in the registry record.
The primary endpoint title refers to the lanreotide group in the double-blind phase or open-label treatment phase, while the description says PFS was assessed during either phase. The listed ITT definition says all randomized subjects were included and analysed as randomized, regardless of treatment received. However, the available population description is truncated, and full details of the analysis population and phase handling are not reported in the registry record.
Why does censoring matter?
Censoring is common in time-to-event analyses when observation ends before the event is observed. In general, Kaplan-Meier estimates rely on the idea that censored participants have event prospects comparable to those who remain under observation, conditional on the analysis. If reasons for leaving follow-up are related to a participant’s event risk, the estimate may be affected. The record specifically notes that one subject randomized to lanreotide should have been censored after discontinuation for toxicity or other reasons, but the available description ends before explaining the issue. The exact applied handling and its consequences are not reported in the registry record.
The assessment schedule of every 12 weeks also means the recorded timing of progression depends on when assessments are performed. In general, assessments at scheduled intervals can locate progression within an interval rather than at the exact biological onset. Central review can support consistent classification, but it does not remove the inherent timing limits of scheduled assessments.
What can be inferred from the safety counts?
The adverse-event information is reported separately for the double-blind lanreotide, double-blind placebo, open-label treatment, and open-label follow-up phases. In general, safety counts describe events observed among the participants considered at risk in each phase. The phases differ in treatment and context, so their counts are not interchangeable with a randomized efficacy comparison. The registry does not report exposure-adjusted event rates or a complete account of how participants moved between phases.
Over-dispersion is a general issue when event counts vary more than a simple statistical model expects; accounting for it can affect uncertainty estimates. The registry information available for this analysis does not specify a count model or provide a basis for assessing over-dispersion. Likewise, no sponsor-reported hazard ratio is included in the registry entries, so a hazard-ratio interpretation is not possible. The primary endpoint description instead specifies a median and confidence interval, neither of which is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes alongside the primary PFS outcome. These include central- and local-review PFS, objective response rate, time to treatment failure, chromogranin A measures, and quality-of-life measures. When multiple outcomes are examined, the chance of at least one apparently notable result can increase if each is interpreted without accounting for the number of analyses. Statistical approaches to multiplicity can include prespecified testing hierarchies or adjusted significance thresholds. Whether any such approach was planned or used is not reported in the registry record.
The record states that the primary PFS distribution was estimated using Kaplan-Meier, with median and 95% confidence interval. It does not report a significance test, a hazard ratio, a comparative estimate, or a multiplicity procedure. The number and arrangement of planned hypothesis tests, if any, are not reported in the registry record. Accordingly, the secondary outcome list should be treated as an inventory of outcomes, not as evidence of positive or negative findings.
The ITT population is described as all randomized subjects, analysed according to randomized assignment regardless of treatment received. The description is truncated after referring to a censoring issue for one subject randomized to lanreotide. The full missing-data approach, including how other incomplete outcome observations were handled, is not reported in the registry record. The record also does not report the extent or pattern of missing endpoint data.
In general, ITT analysis aims to preserve the randomized comparison by retaining participants in their assigned groups. Time-to-event analysis can use partial follow-up through censoring, but this depends on how censoring is defined and whether its assumptions are plausible. The available record does not provide enough detail to assess these issues fully for this study.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Double-Blind Phase: Lanreotide | 10 | 51 | 19.6% |
| Double-Blind Phase: Placebo | 7 | 26 | 26.9% |
| Open-Label Treatment Phase | 1 | 40 | 2.5% |
| Open-Label Follow-Up Phase | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Double-Blind Phase: Lanreotide | 2 of 51 |
| Double-Blind Phase: Placebo | 0 of 26 |
| Open-Label Treatment Phase | 0 of 40 |
| Open-Label Follow-Up Phase | 7 of 26 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Double-Blind Phase: Lanreotide | 48 of 51 |
| Double-Blind Phase: Placebo | 25 of 26 |
| Open-Label Treatment Phase | 26 of 40 |
| Open-Label Follow-Up Phase | 0 of 26 |
Most frequent serious adverse event terms
| Event term | Organ system | Double-Blind Phase: Lanreotide | Double-Blind Phase: Placebo | Open-Label Treatment Phase | Open-Label Follow-Up Phase |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 1 of 51 | 2 of 26 | 0 of 40 | 0 of 26 |
| Atrial fibrillation | Cardiac disorders | 1 of 51 | 0 of 26 | 0 of 40 | 0 of 26 |
| Atrioventricular block complete | Cardiac disorders | 1 of 51 | 0 of 26 | 0 of 40 | 0 of 26 |
| Myocardial infarction | Cardiac disorders | 1 of 51 | 0 of 26 | 0 of 40 | 0 of 26 |
| Abdominal pain | Gastrointestinal disorders | 1 of 51 | 0 of 26 | 0 of 40 | 0 of 26 |
| Diarrhoea | Gastrointestinal disorders | 0 of 51 | 1 of 26 | 0 of 40 | 0 of 26 |
| Gastritis | Gastrointestinal disorders | 0 of 51 | 1 of 26 | 0 of 40 | 0 of 26 |
| Inguinal hernia | Gastrointestinal disorders | 0 of 51 | 1 of 26 | 0 of 40 | 0 of 26 |
| Pancreatitis acute | Gastrointestinal disorders | 1 of 51 | 0 of 26 | 0 of 40 | 0 of 26 |
| Subileus | Gastrointestinal disorders | 0 of 51 | 1 of 26 | 0 of 40 | 0 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Double-Blind Phase: Lanreotide | Double-Blind Phase: Placebo | Open-Label Treatment Phase | Open-Label Follow-Up Phase |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 32 of 51 | 8 of 26 | 9 of 40 | 0 of 26 |
| Fatigue | General disorders | 13 of 51 | 10 of 26 | 1 of 40 | 0 of 26 |
| Abdominal pain | Gastrointestinal disorders | 10 of 51 | 5 of 26 | 4 of 40 | 0 of 26 |
| Asthenia | General disorders | 11 of 51 | 5 of 26 | 2 of 40 | 0 of 26 |
| Decreased appetite | Metabolism and nutrition disorders | 6 of 51 | 6 of 26 | 3 of 40 | 0 of 26 |
| Constipation | Gastrointestinal disorders | 8 of 51 | 4 of 26 | 1 of 40 | 0 of 26 |
| Nausea | Gastrointestinal disorders | 6 of 51 | 4 of 26 | 3 of 40 | 0 of 26 |
| Dizziness | Nervous system disorders | 8 of 51 | 2 of 26 | 2 of 40 | 0 of 26 |
| Headache | Nervous system disorders | 4 of 51 | 4 of 26 | 4 of 40 | 0 of 26 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 6 of 51 | 4 of 26 | 2 of 40 | 0 of 26 |
Serious events with the highest arm-level rate: pneumonia (7.7%), diarrhoea (3.8%), gastritis (3.8%), inguinal hernia (3.8%), subileus (3.8%).
The registry reports serious adverse-event counts by study phase. In the double-blind phase, the lanreotide group had 10 serious adverse events among 51 at risk, and the placebo group had 7 among 26 at risk. In the open-label treatment phase, 1 serious adverse event was reported among 40 at risk. In the open-label follow-up phase, none was reported among 26 at risk. Deaths recorded by phase were 2, 0, 0, and 7, respectively.
These are phase-specific figures, not a single randomized comparison across all phases. The open-label phases differ from the double-blind phase in treatment context, and the registry does not provide exposure-adjusted rates or enough participant-flow detail to reconcile phase counts with the full study enrollment. The counts alone do not establish whether an event was caused by study treatment.
The record lists pneumonia at 7.7% as the most frequent serious adverse-event term, followed by diarrhoea, gastritis, inguinal hernia, subileus, and asthenia, each at 3.8%. The denominators and event-counting details for these percentages are not reported in the registry record. They should therefore be read as listed terms and percentages, not as comparable risks across treatment groups. Safety interpretation also requires consideration of duration of exposure and participant characteristics, details that are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that SPINET was a randomized, double-blind, parallel-group Phase 3 study of lanreotide plus BSC versus placebo plus BSC in a defined lung neuroendocrine tumour population. It describes PFS as the primary endpoint, assessed through central review using RECIST v1.1 and estimated with Kaplan-Meier methods. It also provides phase-specific adverse-event counts and describes why recruitment was stopped prematurely.
Those details do not establish the primary outcome result. The median PFS and its 95% confidence interval are not reported in the registry record, and no comparative hazard ratio or other primary treatment-effect estimate is available in the registry record for this analysis. It is therefore not possible to state the magnitude, direction, or precision of the comparative effect from this record. The secondary outcome results are also not reported in the registry record.
The safety data indicate that serious events and deaths were recorded across the study phases, with counts differing by phase. They cannot, on their own, establish a causal relationship with treatment or support direct comparisons across phases. The percentages listed for serious adverse-event terms lack the denominator information needed for fuller interpretation.
In general, a randomized design can support a more credible comparison than an uncontrolled design, but interpretation still depends on the analysis, follow-up, missing data, and reporting of results. Here, the registry’s description of the ITT approach is incomplete, and the note about one subject’s censoring is truncated. This record therefore supports an account of the study’s design and stated methods, but not a conclusion about efficacy or a complete assessment of safety.
13. Why This Trial Matters Statistically
This trial is statistically notable for its combination of a randomized double-blind phase and subsequent open-label treatment and follow-up phases. The design can help distinguish outcomes observed under the initial masked comparison from those recorded after open-label treatment begins. However, results from later phases do not retain the same randomized comparison context, and phase-specific safety figures should not be read as if all phases were arms of one randomized contrast.
The primary outcome is time-to-event PFS, a measure that uses information from participants with different follow-up durations and allows for censoring. Its interpretation depends on event definitions, assessment timing, and censoring rules. The registry states a central-review schedule and Kaplan-Meier method, and it flags a possible censoring issue for one subject. The available description does not fully explain how that issue was handled.
The study’s premature recruitment stop is also important when considering the amount of information available. The registry attributes the decision to slow and difficult recruitment in the context of guideline updates. It does not report a sample-size justification, a formal evaluation of the consequences of stopping, or interim-analysis details. Those omissions limit assessment of the statistical implications of the stop.
Most importantly, the primary numerical estimate is not reported in the registry record. A clearly specified design and endpoint do not substitute for the effect estimate and its uncertainty. Readers can understand what the study intended to measure, but cannot evaluate the primary result’s magnitude or precision from the record.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint’s numerical result is absent: the registry record does not report the median PFS or its 95% confidence interval. It also does not report a comparative hazard ratio or other comparative primary estimate. This prevents assessment of the magnitude and precision of the principal efficacy outcome.
The available description of the primary population is truncated. It states that the ITT population included all randomized subjects and that subjects were analysed as randomized, regardless of treatment received, but then cuts off during a note about one subject randomized to lanreotide who should have been censored. The actual censoring handling and full explanation are not reported in the registry record.
The registry reports premature recruitment stopping and a transition of subjects still treated in the double-blind phase to open-label treatment. The summary ends mid-sentence, and details of the transition and its impact on endpoint follow-up are not reported in the registry record. Participant flow across phases, the extent of missing outcome information, and exposure duration by group are also not reported in the registry record.
Multiplicity procedures, interim analyses, the planned sample-size justification, and the statistical plan beyond the stated endpoint method are not reported in the registry record. Secondary outcomes are named without corresponding numerical estimates in the registry entries. Safety percentages for serious adverse-event terms are listed without their denominators, and no exposure-adjusted safety rates are given. These gaps limit interpretation of both efficacy and safety and mean that the registry description cannot support a full independent reconstruction of the study results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours — NCT02683941.
- Registry record last updated 2022-07-06; status last verified 2022-06.
- Results first posted 2021-10-29.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02683941 is a Phase 3, prospective, randomized, double-blind, multicenter, parallel-group study of lanreotide Autogel/Depot 120 mg plus BSC versus placebo plus BSC for well-differentiated, metastatic and/or unresectable, typical or atypical lung neuroendocrine tumours. The registry reports enrollment of 77 and lists the study as terminated. The stated dates are 2017-03-06 for study start and 2020-02-28 for primary completion.
The primary outcome is median PFS assessed by central review using RECIST v1.1, with Kaplan-Meier estimation and a 95% confidence interval. The primary numerical result is not reported in the registry record. The record describes premature recruitment stopping in the context of slow and difficult recruitment following guideline updates, and reports safety counts separately across the double-blind and open-label phases.