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 Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations (NCT04323436), a randomized phase 2 study. The primary outcome is Randomized Part: Progression-Free Survival (PFS) by BIRC as Per RECIST 1.1.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04323436 |
| Phase | Phase 2 |
| Condition | Carcinoma, Non-Small-Cell Lung |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 31 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
People with locally advanced or metastatic non-small-cell lung cancer carrying MET exon 14 skipping mutations. The study was described as first-line treatment; the randomized-part outcome population was defined as assigned participants who received at least one dose of study treatment.
Intervention
Capmatinib in combination with spartalizumab. The run-in part also evaluated this combination.
Comparator
Capmatinib in combination with placebo in the planned randomized part. The study was placebo-controlled and double-blind.
Primary question
Whether progression-free survival, assessed by a blinded independent review committee using RECIST 1.1, differed between the combination and capmatinib-plus-placebo groups in the randomized part.
The clinical question is defined by the planned comparison, not by a result. The registry record states that the randomized part was not initiated and that data were not collected for its primary outcome. Consequently, the posted record cannot establish whether the planned groups differed in progression-free survival.
The record describes a run-in part involving capmatinib with spartalizumab, and lists a capmatinib-only group in the safety information. Those run-in data do not constitute the intended randomized comparison. Without the randomized part, treatment allocation cannot support a direct estimate of the difference between the planned groups.
3. Trial Design
This was a phase II, randomized, parallel-group, placebo-controlled study with quadruple masking. It was designed to evaluate capmatinib with spartalizumab against capmatinib with placebo as first-line treatment for locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations. Novartis Pharmaceuticals is listed as the sponsor.
The study record describes a run-in part and a randomized part. The run-in included capmatinib with spartalizumab; the randomized part was planned to compare that combination with capmatinib and placebo. However, the registry states that the randomized part was not initiated and that its data were not collected. The planned design therefore should not be mistaken for a completed randomized comparison.
Enrollment is recorded as 31. The study began on 2020-08-19, and the primary completion date is recorded as 2022-12-14. The status is terminated. The reason for termination is not reported in the registry record, nor is a protocol-level explanation of how the enrolled participants were allocated across study parts.
The primary endpoint was planned for assessment up to 6 years. The registry lists 34 outcome measures and no analyses. Several run-in outcomes are listed, including dose reductions and interruptions, dose intensity, disease control rate, progression-free survival by investigator assessment, and capmatinib pharmacokinetic measures. Numerical findings for these outcomes are not reported in the registry record.
Although the study was designed as randomized and masked, those design features apply to the planned randomized part. They do not turn the run-in safety observations into randomized evidence. The distinction matters when interpreting both efficacy and safety: the registry record does not provide the randomized-part comparison described in the study design.
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: The screening period began once patients had signed the study informed consent. Screening evaluations were performed within 28 days prior to the first dose of study treatment. After screening, the treatment period started on Cycle 1 Day 1. The study enrollment was halted during the Run-in part per sponsor's decision. Following the study enrollment halt, spartalizumab treatment was discontinued and Part 2 was not initiated.
Overall Study
| Stage | Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Placebo |
|---|---|---|---|
| STARTED | 31 | 0 | 0 |
| Treated With Capmatinib + Spartalizumab | 28 | 0 | 0 |
| Treated With Capmatinib Only | 3 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 |
| NOT COMPLETED | 31 | 0 | 0 |
Reasons for not completing this period:
| Reason | Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Placebo |
|---|---|---|---|
| Adverse Event | 7 | 0 | 0 |
| Transfer to another clinical study or to other alternative treatment option | 8 | 0 | 0 |
| Death | 1 | 0 | 0 |
| Physician Decision | 2 | 0 | 0 |
| Progressive disease | 10 | 0 | 0 |
| Subject decision | 3 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All patients to whom study treatment had been assigned and who received at least one dose of study treatment (i.e. at least one dose of any component of the study treatment that is capmatinib or spartalizumab) in the single arm run-in part. Patients were analyzed according to the treatment they were assigned to.
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: All patients to whom study treatment had been assigned and who received at least one dose of study treatment (i.e. at least one dose of any component of the study treatment that is capmatinib or spartalizumab). The randomized part of the study was not initiated.
| Characteristic | Unit | Run-in Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Spartalizumab 400 mg Q4W | Randomized Part: Capmatinib 400 mg BID + Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 31 | 0 | 0 | 31 | |
| Age, Continuous | years | 71.6 (SD 9.50) | — | — | 71.6 (SD 9.50) |
| Sex: Female, Male: Female | Participants | 16 | 0 | 0 | 16 |
| Sex: Female, Male: Male | Participants | 15 | 0 | 0 | 15 |
| Race/Ethnicity, Customized: White | Participants | 23 | 0 | 0 | 23 |
| Race/Ethnicity, Customized: Black or African American | Participants | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: Asian | Participants | 6 | 0 | 0 | 6 |
| Race/Ethnicity, Customized: Unknown | Participants | 1 | 0 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Randomized Part: Progression-Free Survival (PFS) by BIRC as Per RECIST 1.1, measured over Up to 6 years.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The planned primary endpoint was progression-free survival assessed by a blinded independent review committee under RECIST 1.1. It was defined as the time from the start of treatment to the first documented disease progression or death from any cause, with tumor response evaluated by the committee.
In general, a time-to-event endpoint records how long it takes for a specified event to occur. Progression-free survival combines progression and death into the event definition, so either can end a participant’s time without a recorded event. This makes the endpoint useful for describing the duration until disease progression or death within a defined study population. It does not, by itself, describe every aspect of treatment experience or establish an effect on outcomes that were not measured by this endpoint.
Independent review is intended to assess tumor response using stated criteria separately from the treating investigator’s assessment. That can make endpoint ascertainment more consistent, although the registry record does not describe the committee’s procedures in detail.
The planned assessment window was up to 6 years. Crucially, the randomized part was not initiated and the registry says its primary-outcome data were not collected. No randomized-part progression-free survival estimate, event count, confidence interval, or treatment comparison is reported in the registry record. The endpoint definition therefore describes what the study intended to measure, not an observed randomized result.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry records a planned randomized efficacy comparison but no data from that comparison. Its primary outcome was progression-free survival by blinded independent review under RECIST 1.1. The record explicitly states that the randomized part was not initiated and that data were not collected. There is therefore no randomized-part estimate to interpret as evidence for or against a difference between capmatinib with spartalizumab and capmatinib with placebo.
Enrollment is recorded as 31, but that total does not supply an efficacy result. The record does not state how many participants contributed to each study part or provide a randomized population for the primary endpoint. It would be misleading to treat the enrollment total as if it were the size of a completed randomized comparison, or to infer outcomes from the planned study design.
The record includes safety information for run-in groups. These observations describe participants under the listed run-in treatment conditions, not a randomized contrast between the intended treatment groups. The group labels include combination treatment before and after discontinuing spartalizumab, as well as capmatinib alone. The data should be read according to those labels; they do not establish a comparative safety effect. In particular, the run-in group counts are not a substitute for a prespecified, randomized comparison.
The study status is terminated, but the reason is not reported in the registry record. Termination alone does not establish why the study stopped, whether stopping was related to efficacy, safety, recruitment, or another consideration, or what conclusions the sponsor drew. Those explanations should not be inferred from status alone.
The registry lists 34 outcome measures and no analyses. It includes run-in outcomes such as disease control rate, investigator-assessed progression-free survival, dose intensity, dose modifications, and pharmacokinetic measures, but numerical results for those outcomes are not reported in the registry record. Without estimates and their uncertainty, the listed outcomes cannot support claims about the magnitude or precision of effects.
In general, a confidence interval communicates the range of effect estimates compatible with the data under the analysis assumptions. No interval for the randomized primary endpoint is reported, so its precision cannot be assessed. The sound statistical interpretation is limited: the intended randomized question remains unanswered by the posted registry data. This is not evidence that the two regimens had equal outcomes, and it is not evidence that they differed.
9. Statistical Methods Explained
The study design and the available results answer different questions. A randomized, parallel-group design specifies how a comparative study is intended to assign participants and compare outcomes. Here, the registry describes randomization, placebo control, quadruple masking, and a parallel model. But it also states that the randomized part was not initiated. The design features describe the plan; they do not demonstrate that a randomized comparison was conducted.
What does progression-free survival measure?
Progression-free survival is a time-to-event outcome. In this study, the event was the first documented progression or death from any cause, and time began at treatment start. Participants without a recorded event by the end of observation would ordinarily contribute follow-up up to that point; the detailed censoring rules are not reported in the registry record. In general, time-to-event methods are used because participants may have different lengths of follow-up and not all will experience the event during observation.
A time-to-event analysis commonly describes event timing while accounting for participants whose event time is not observed during the available follow-up. The precise statistical model, test, censoring rules, and handling of potential departures from model assumptions are not reported in the registry record. No hazard ratio, median progression-free survival, event count, or confidence interval for the randomized primary endpoint is reported.
Why use an independent review?
The endpoint was to be assessed by a blinded independent review committee using RECIST 1.1. In general, prespecified response criteria help define what counts as progression, and independent review can provide an assessment separate from the treating investigator. Blinding can reduce the risk that knowledge of treatment assignment influences outcome assessment. The registry record does not report details of the committee’s operating procedures or whether any review was completed for the randomized comparison.
What can the run-in information establish?
The run-in part and randomized part have different inferential roles. Run-in observations can describe what was recorded among participants receiving the listed treatment conditions. Without randomized allocation to the intended comparison, they cannot isolate a treatment contrast from other differences between participants, timing, or study circumstances. In general, randomization supports a comparison by making assigned groups comparable in expectation, while masking can limit some forms of bias. Those protections cannot be assumed for a comparison that the registry says was never initiated.
The safety groups are labelled as capmatinib with spartalizumab before discontinuing spartalizumab, capmatinib with spartalizumab after discontinuing it, and capmatinib alone. The record gives affected and at-risk counts for serious events, other events, and deaths. These figures are descriptive for the listed groups. The record does not explain the relationship between the groups or provide a randomized safety analysis, so they should not be combined into a causal comparison.
How should uncertainty and planning be understood?
In general, an estimate is more informative when accompanied by a measure of uncertainty, such as a confidence interval. A confidence interval expresses the precision of an estimate under the analysis method; it is not a guarantee that the true value lies within the interval. Because no randomized primary-endpoint estimate or interval is reported, neither the direction nor precision of a randomized treatment contrast can be assessed.
Sample-size planning is also distinct from observed evidence. In general, a planning calculation uses assumptions about the effect to detect, variability or event rates, significance level, allocation, and desired power. Such calculations describe design scenarios; they do not establish that a study had a particular probability of detecting an effect after the fact. The sample-size justification and the trial’s own planning assumptions are not reported in the registry record. Numerical planning results are not reported in the registry record either.
Finally, no analysis plan describing multiplicity control, missing-data handling, analysis populations, interim analyses, or the primary statistical model is reported in the registry record. These omissions limit assessment of how a completed analysis would have been conducted, independently of the more fundamental limitation that the randomized part did not proceed.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 34 outcome measures, including the planned primary endpoint and several run-in measures. When a study evaluates multiple outcomes, time points, or analyses, multiplicity can increase the chance of finding an apparently notable result by chance if the analyses are treated as independent opportunities for a finding. In general, a statistical plan may designate a primary endpoint and specify how other comparisons are handled. The registry record does not report a multiplicity strategy, a hierarchy of secondary outcomes, or an analysis plan for controlling the interpretation of multiple results.
The record states that the randomized part was not initiated and that data were not collected for its primary outcome. Thus, missing primary efficacy results are not simply a matter of unreported follow-up within a completed randomized cohort: the planned randomized comparison did not generate data according to the record. The reason for that status is not reported.
Specific methods for handling missing observations, incomplete follow-up, censoring, or deviations from assigned treatment are not reported in the registry record. The record also does not describe an intention-to-treat or other analysis population for a completed randomized comparison. It defines the intended primary population as assigned patients who received at least one dose in the randomized part, but that part was not initiated. No randomized analysis population can therefore be evaluated from the posted information.
These gaps prevent review of how a randomized estimate would have been produced or how robust it would be to missing data and analysis choices. They do not justify filling in unreported procedures by assuming standard practice.
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 |
|---|---|---|---|
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab) | 11 | 28 | 39.3% |
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab) | 8 | 28 | 28.6% |
| Run-in Part: Capmatinib 400mg BID Only | 1 | 3 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab) | 4 of 28 |
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab) | 0 of 28 |
| Run-in Part: Capmatinib 400mg BID Only | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab) | 25 of 28 |
| Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab) | 18 of 28 |
| Run-in Part: Capmatinib 400mg BID Only | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab) | Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab) | Run-in Part: Capmatinib 400mg BID Only |
|---|---|---|---|---|
| General physical health deterioration | General disorders | 1 of 28 | 0 of 28 | 1 of 3 |
| Pneumonia | Infections and infestations | 1 of 28 | 0 of 28 | 1 of 3 |
| Respiratory tract infection | Infections and infestations | 1 of 28 | 0 of 28 | 1 of 3 |
| Alanine aminotransferase increased | Investigations | 1 of 28 | 1 of 28 | 0 of 3 |
| Pancreatitis | Gastrointestinal disorders | 0 of 28 | 1 of 28 | 0 of 3 |
| Medical device site haemorrhage | General disorders | 0 of 28 | 1 of 28 | 0 of 3 |
| Oedema | General disorders | 0 of 28 | 1 of 28 | 0 of 3 |
| Oedema peripheral | General disorders | 0 of 28 | 0 of 28 | 1 of 3 |
| Pyrexia | General disorders | 0 of 28 | 0 of 28 | 1 of 3 |
| Drug-induced liver injury | Hepatobiliary disorders | 1 of 28 | 0 of 28 | 0 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (Prior Discontinuing Spartalizumab) | Run-in Part: Capmatinib 400mg BID + Spartalizumab 400mg Q4W (After Discontinuing Spartalizumab) | Run-in Part: Capmatinib 400mg BID Only |
|---|---|---|---|---|
| Oedema peripheral | General disorders | 11 of 28 | 15 of 28 | 3 of 3 |
| Blood creatinine increased | Investigations | 10 of 28 | 11 of 28 | 2 of 3 |
| Aspartate aminotransferase increased | Investigations | 9 of 28 | 6 of 28 | 1 of 3 |
| Alanine aminotransferase increased | Investigations | 8 of 28 | 6 of 28 | 1 of 3 |
| Nausea | Gastrointestinal disorders | 9 of 28 | 2 of 28 | 1 of 3 |
| Constipation | Gastrointestinal disorders | 8 of 28 | 1 of 28 | 2 of 3 |
| Lipase increased | Investigations | 3 of 28 | 5 of 28 | 1 of 3 |
| Hypoalbuminaemia | Metabolism and nutrition disorders | 1 of 28 | 5 of 28 | 2 of 3 |
| Fatigue | General disorders | 3 of 28 | 3 of 28 | 1 of 3 |
| Amylase increased | Investigations | 3 of 28 | 4 of 28 | 0 of 3 |
Serious events with the highest arm-level rate: general physical health deterioration (33.3%), oedema peripheral (33.3%), pyrexia (33.3%), pneumonia (33.3%), respiratory tract infection (33.3%).
The serious adverse event figures are presented for run-in groups, not for the planned randomized comparison. The listed groups are capmatinib with spartalizumab before discontinuing spartalizumab, the same combination after discontinuing spartalizumab, and capmatinib alone. For each group, the registry gives the number at risk and the number affected by serious events, other events, and deaths.
The serious-event counts are 11 of 28, 8 of 28, and 1 of 3 across the listed groups. The counts for other events are 25 of 28, 18 of 28, and 3 of 3. Deaths are recorded as 4, 0, and 0. These are descriptive counts within the stated groups. The registry does not provide a randomized comparison or an analysis that adjusts for differences between these groups.
The listed serious-event terms each have a reported percentage of 33.3%: general physical health deterioration, peripheral oedema, pyrexia, pneumonia, respiratory tract infection, and streptococcal infection. The registry record does not clarify the denominator or further detail the relationship among these terms, so the percentages should be interpreted as presented rather than treated as comparative risks.
In general, adverse-event counts depend on the population observed, duration of observation, and event definitions. Those details are not fully. The figures describe recorded events; they do not by themselves establish that a treatment caused an event or compare the safety of the randomized regimens.
12. What the Result Does, and Does Not, Mean
The record establishes that a phase II study was planned to compare capmatinib with spartalizumab against capmatinib with placebo for locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations. It also establishes that the primary endpoint was intended to be progression-free survival assessed by blinded independent review using RECIST 1.1.
What the record does not establish is the result of that randomized comparison. The randomized part was not initiated, and its primary-outcome data were not collected. There is no reported randomized estimate, uncertainty interval, or treatment-group comparison for progression-free survival. The record therefore does not show whether the planned groups had similar or different outcomes.
The enrollment total of 31 and the run-in safety observations do not fill that gap. The safety information is grouped by run-in treatment conditions, including a group after spartalizumab discontinuation and a capmatinib-only group. It is not a randomized comparison of the intended regimens. The record also does not report numerical results for the listed run-in efficacy outcomes.
The terminated status indicates the study did not continue as planned, but it does not explain why. The reason for termination, any decision process, and any conclusions drawn by the sponsor are not reported in the registry record. No explanation should be inferred from the status alone.
In general, a missing randomized result is not evidence of no effect, just as the planned hypothesis is not evidence of an effect. The appropriate conclusion is narrower: the registry record describes the intended question and some run-in safety observations, but it does not provide data to answer the primary randomized efficacy question or quantify its precision.
13. Why This Trial Matters Statistically
This study illustrates why a registered design and a reported result must be distinguished. Randomization, placebo control, masking, and a parallel-group structure describe protections built into the planned comparison. The registry also states that the randomized part was not initiated. As a result, the planned methods cannot be treated as evidence that an efficacy comparison was completed.
It also illustrates the importance of keeping distinct study parts separate. Run-in safety observations can be useful descriptions of events recorded under specified treatment conditions, but they do not answer the same question as a randomized comparison. Combining groups with different labels or interpreting them as randomized arms would obscure the design and could invite unsupported conclusions.
The endpoint definition is another important part of interpretation. Progression-free survival was defined from treatment start to progression or death, with tumor response assessed by an independent review committee under RECIST 1.1. That definition makes the intended outcome clear, but a clear endpoint cannot replace the missing endpoint data. Without estimates and measures of uncertainty, neither the magnitude nor precision of the intended contrast can be evaluated.
Finally, the record’s omissions matter for reproducibility. The analysis plan, multiplicity approach, missing-data procedures, and reason for termination are not reported. Their absence does not prove that no such plans or reasons existed outside the registry record; it means they cannot be assessed from this record. Careful statistical reading separates documented details from plausible explanations and avoids turning a planned trial into a result that was never reported.
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 main limitation is explicit: the randomized part was not initiated and its primary-outcome data were not collected. The planned randomized question therefore has no reported efficacy result. This prevents estimation of the treatment contrast, assessment of its uncertainty, or evaluation of the primary endpoint as planned.
Enrollment is recorded as 31, but the registry does not report how participants were distributed across the run-in groups or provide a randomized analysis population. The run-in safety group sizes differ, including a capmatinib-only group of 3, so these descriptive observations should not be read as evidence from balanced randomized arms. The record does not report follow-up duration for the safety groups or detailed event-ascertainment procedures.
The study is listed as terminated, but the reason for termination is not reported in the registry record. The available information also does not describe the study’s sample-size justification, its own statistical analysis plan, multiplicity procedures, missing-data methods, interim analyses, or the model intended for the primary endpoint. Numerical findings for the listed run-in efficacy and pharmacokinetic outcomes are not reported in the registry record.
These limitations constrain what can be concluded from the registry. They do not establish why the study ended, whether unreported analyses exist elsewhere, or what the outcomes would have been if the randomized part had proceeded.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Capmatinib and Spartalizumab/Placebo in Advanced NSCLC Patients With MET Exon 14 Skipping Mutations — NCT04323436.
- Registry record last updated 2024-10-09; status last verified 2024-10.
- Results first posted 2024-02-06.
- 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
The registry describes a phase II randomized, double-blind, placebo-controlled, parallel-group study sponsored by Novartis Pharmaceuticals. It planned to compare capmatinib with spartalizumab against capmatinib with placebo as first-line treatment for locally advanced or metastatic non-small-cell lung cancer with MET exon 14 skipping mutations.
Enrollment is recorded as 31. The study began on 2020-08-19, has a primary completion date of 2022-12-14, and is listed as terminated. Its planned primary endpoint was progression-free survival assessed by a blinded independent review committee under RECIST 1.1, up to 6 years. The randomized part was not initiated, and primary-outcome data were not collected. The reason for termination is not reported in the registry record.
The registry includes descriptive run-in safety information, but no randomized primary efficacy result or analysis is reported.