A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) (NCT05577715), a randomized phase 2 study. The primary outcome is Objective Response Rate as Per Investigator.

2. Clinical Question

The question is whether investigator-assessed tumor response was observed among participants treated with MORAb-202 after progression on prior therapies, alongside a description of adverse events. The registry defines objective response using complete response or partial response as best overall response. It also lists disease control rate, duration of response, and progression-free survival as secondary outcomes, all assessed by the investigator.

The record does not provide an objective-response count, percentage, or confidence interval, and it lists no analyses. Therefore, the clinical question can be described from the registered endpoint and study aim, but the posted record does not show the primary result or permit interpretation of the observed response rate. The registry's randomized allocation label does not resolve the absence of a listed comparator group or comparative results.

3. Trial Design

This is a Phase 2 study of MORAb-202 in participants with previously treated metastatic NSCLC adenocarcinoma. The official title describes it as open-label and randomized. The registry metadata also identifies masking as none. The study aim was to characterize safety and tolerability and assess objective response.

The record lists enrollment of 31 and identifies the primary-outcome population as all randomized participants. Its status is terminated. The recorded start date is 2022-11-14, and the primary completion date is 2024-08-12. The reason for termination is not reported in the registry record, so the status alone does not explain why the study ended.

There is an important design-record inconsistency: allocation is identified as randomized, while the model is identified as single group. The arm descriptions list MORAb-202 without a description of another group, and the safety results give one MORAb-202 25mg/m^2 group. The registry record does not report a comparator or explain this mismatch. As a result, the available information supports describing the intended randomized, open-label study and the listed MORAb-202 group, but not a treatment contrast.

The primary endpoint is investigator-assessed objective response rate. The listed secondary outcomes are adverse events and serious adverse events, adverse events of special interest and deaths, grade 3/4 laboratory abnormalities in SI units, disease control rate, duration of response, and progression-free survival. The record identifies six outcome measures overall, but does not provide results for these outcomes beyond the safety counts and terms described in the record.

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.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All Randomized Participants

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.

6. Primary Endpoint

The registry lists the primary outcome as Objective Response Rate as Per Investigator, measured over From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months).

The primary endpoint is objective response rate (ORR) as assessed by the investigator. It is defined as the percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR), using RECIST v1.1. CR requires disappearance of target lesions, with pathological lymph nodes reduced to a short axis < 10 mm. PR requires at least a 30% decrease in the sum of target-lesion diameters from baseline.

The endpoint is used to summarize the proportion of participants meeting a prespecified tumor-response definition. It differs from a time-to-event measure: it classifies whether a participant's best recorded response meets the CR or PR criteria rather than describing how long a response or disease-control state lasts. The registry names disease control rate, duration of response, and progression-free survival as separate secondary outcomes.

The record gives a timeframe from randomization until objectively documented progression or death, whichever occurs first, up to approximately 12 months. It specifies a 95% confidence interval and the Clopper-Pearson method. However, no ORR numerator, denominator for the endpoint result, percentage, or interval is reported in the registry record. The endpoint definition can therefore be explained, but the observed response rate and its precision cannot be assessed from the posted results.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a binary response classification summarized as a percentage. Each participant's best overall response is classified under RECIST v1.1, and CR or PR qualifies as an objective response. In general, a binary endpoint records whether a defined event or state occurred; the percentage expresses the share of the analysis population meeting that definition. The registry names all randomized participants as the primary-outcome population.

How is objective response defined?

The response categories use changes in target lesions. CR is defined as disappearance of all target lesions, with pathological lymph nodes reduced in short axis to < 10 mm. PR is defined as at least a 30% decrease in the sum of target-lesion diameters, using the baseline sum as reference. The registry also describes progressive disease as at least a 20% increase from the smallest sum during the study, with an absolute increase of at least 5 mm. These criteria explain how response status is defined; they do not give the number of participants who met each category.

Investigator assessment means that the endpoint is attributed to the investigator's assessment under the stated criteria. The study is open-label and has no masking recorded. In general, knowledge of treatment assignment can be relevant when outcomes involve assessment, but the registry record does not report whether any additional review process was used. Such a process should not be assumed.

What does the confidence interval method indicate?

The registry specifies a 95% confidence interval calculated using the Clopper-Pearson method. In general, a confidence interval represents uncertainty around an estimated quantity under a statistical method and its assumptions. The Clopper-Pearson approach is an exact binomial interval used for proportions. The registry's choice of method is stated, but the interval limits and the underlying response count are not reported. Its numerical precision therefore cannot be evaluated from the record.

The endpoint timeframe is described as running from randomization to objectively documented progression or death, whichever occurs first, up to approximately 12 months. That wording appears in the endpoint record alongside an ORR definition based on best overall response. The record does not explain how participants without an evaluable response, participants who discontinue, or participants with incomplete follow-up were handled for the endpoint. It would be inappropriate to infer those rules.

Can the study's treatment effect be estimated from the registry?

No primary ORR estimate or analysis is listed. The registry records a randomized allocation label but also a single-group model and only one named MORAb-202 safety group. It does not report a comparator group or between-group results. In general, a comparative effect requires outcome information for the groups being compared and a defined analysis. Those elements are not available in the posted record, so no treatment contrast can be reconstructed.

The record gives no statistical analysis plan, hypothesis-testing procedure, adjustment strategy, or interim-analysis information. These are not reported in the registry record. The absence of those details should not be filled by assuming standard practice. In particular, no p-value or adjustment method can be inferred from the endpoint description or the stated confidence-interval method.

How should the safety summaries be understood?

The registry presents counts of participants at risk and affected for serious and other adverse events, plus deaths, for the MORAb-202 group. In general, an at-risk denominator provides context for a count, while an affected count describes participants meeting the recorded event category. These are descriptive summaries. The record does not provide exposure-adjusted rates, timing, a comparator, or an account of overlap among categories. It also does not establish that reported events were caused by MORAb-202.

Over-dispersion is a general concern when variation in count data exceeds what a simple probability model expects; it can affect uncertainty estimates if a model assumes less variability than the data contain. The posted primary endpoint is a participant-level binary percentage rather than a reported count-model analysis, and no model-based analysis is listed. Thus, over-dispersion is not a reported feature of this study's primary analysis, and no specific adjustment for it can be attributed to the investigators.

The registry's sample-size assumptions describe a planning illustration based on an observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. Those are stated as illustration assumptions, not as the trial's own design. No sample-size illustration outputs are included in the record details, and no trial-specific sample-size justification is reported. Such planning calculations, in general, are not observed power and do not substitute for endpoint results.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("MORAb-202 25mg/m^2")
n      <- c(31)
events <- c(3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  MORAb-202 25mg/m^2  31  3  9.7  2.0  25.8  3.3  24.9  3.5  25.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record does not report a multiplicity strategy. It identifies ORR as the primary outcome and lists secondary outcomes covering safety, disease control rate, duration of response, and progression-free survival. It does not state whether hypotheses were tested, whether any testing hierarchy was prespecified, or whether results were adjusted for multiple comparisons. No adjustment procedure should therefore be inferred. In general, multiplicity matters when several outcomes or comparisons are assessed because the chance of at least one chance finding can increase across multiple tests; the record does not say how this issue was addressed.

Missing-data handling is not reported in the registry record. The endpoint timeframe and the population label are given, but there is no account of how unevaluable participants, incomplete assessments, withdrawal, or loss to follow-up were treated. The record does not describe imputation, censoring, sensitivity analyses, or a rule for assigning response status when data are incomplete. These details are important to interpreting a percentage endpoint, but they cannot be reconstructed from the registered definition alone.

The primary-outcome population is identified as all randomized participants. This population label does not establish how many had evaluable endpoint data or how missing observations were handled. The record lists no analyses and provides no primary result. Accordingly, neither an analysis-population flow nor the impact of missing data can be assessed. These absences limit interpretation but do not show which analytic choices were made in any unreported analysis.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: hip fracture (3.2%), rib fracture (3.2%), blood creatinine increased (3.2%), neoplasm progression (3.2%), cerebrovascular accident (3.2%).

For the MORAb-202 25mg/m^2 group, the registry lists 31 participants at risk for serious adverse events and 7 affected. For other adverse events, it lists 31 at risk and 29 affected. The number of deaths is listed as 7. These are separate registry summaries; the record does not clarify whether the same participants appear in more than one category, or whether deaths were related to treatment.

The serious adverse-event terms listed are hip fracture, rib fracture, blood creatinine increased, neoplasm progression, cerebrovascular accident, and syncope. Each term is reported as 3.2%. The record does not provide further event-level timing, severity details beyond the serious-event classification, or a comparator for these terms. The listed percentages should be interpreted as registry entries rather than as comparative risks.

In general, adverse-event counts describe events recorded during a study and do not by themselves establish causation. A treatment-related interpretation would require relevant context and assessment not given in these summaries. The registry record does not report exposure-adjusted rates or explain whether events could recur within a participant.

13. What the Result Does, and Does Not, Mean

The record does show how the investigators intended to define the primary outcome: objective response based on best overall response of CR or PR under RECIST v1.1. It also documents the study's stated aim to characterize safety and tolerability, and provides a limited adverse-event summary for the MORAb-202 group. These registry entries describe the planned question and the safety information entered in the registry.

The record does not show the observed ORR. There is no response numerator, percentage, or confidence interval, and no primary analysis is listed. Without those results, it is not possible to describe the frequency of objective response or its precision from the posted record. Nor does the record provide a comparator outcome that would allow a comparative estimate.

The safety counts should not be read as proof of benefit or harm caused by MORAb-202. The record gives counts and selected event terms, but does not establish causal attribution, provide comparative safety data, or clarify overlap among categories. The reported deaths are not identified as treatment-related in the available information.

The randomized and single-group design labels do not align, and the record does not explain the inconsistency. The status is terminated, but the reason is not reported in the registry record. Neither fact can be used to infer why results are absent or what analyses may have been performed outside the registry.

In general, a trial result is most informative when the endpoint definition, analysis population, estimate, uncertainty, and relevant comparison are all available. Here, the definition is described, but the key primary estimate and its uncertainty are not. The registry record therefore supports a description of the study and its limitations, not a conclusion about the clinical effect of MORAb-202.

14. Why This Trial Matters Statistically

This record is statistically notable because the registered study design information is internally difficult to reconcile. It describes an open-label randomized Phase 2 study, yet the model is recorded as single group and the arm and safety information identifies only MORAb-202. Without clarification or comparator results, the intended inferential contrast is uncertain.

The primary endpoint is defined in detail, including RECIST v1.1 response criteria and the Clopper-Pearson confidence-interval method. But a well-specified outcome definition is not itself an outcome result. No response estimate, confidence interval, or analysis is listed. This distinction matters: readers can understand what was to be measured without being able to assess what the study observed.

The safety record also illustrates the limits of descriptive counts. Counts and percentages identify recorded events, but without comparative data, exposure context, or causal assessment they do not quantify a treatment-related excess. The record's safety summaries are useful as registry information, while remaining insufficient for a comparative safety inference.

Finally, the registry identifies an all-randomized primary population but does not report missing-data rules, analysis details, or a reason for termination. These omissions leave uncertainty about how the planned question was addressed. In general, transparent reporting of the analysis population, endpoint results, uncertainty, and study status context supports statistical interpretation. Those are the central gaps readers should keep in mind for this record.

15. 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 most important limitation is the absence of a reported primary endpoint estimate. Although ORR is defined and a confidence-interval method is named, the registry record gives no response count, percentage, or interval. The record also lists no analyses. The primary result's magnitude and precision therefore cannot be assessed.

Design details are inconsistent: the allocation is recorded as randomized, while the model is recorded as single group. The arm information and safety summary identify MORAb-202 but do not describe a comparator or give comparative results. The record does not explain the discrepancy, so the intended comparison cannot be established from these entries.

The reason for the terminated status is not reported in the registry record. The record also does not report a sample-size justification, statistical analysis plan, multiplicity handling, missing-data rules, or interim analyses. No assumption about these matters can fill the gap.

Safety interpretation is limited to the listed participant counts and serious-event terms. The record does not provide comparative safety results, event timing, exposure-adjusted rates, or information about overlap between categories. It does not establish that deaths or adverse events were caused by treatment.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) — NCT05577715.
• Registry record last updated 2025-09-04; status last verified 2025-09.
• Results first posted 2025-09-04.
• 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.

19. Record Summary

NCT05577715 is a Phase 2, open-label study of MORAb-202 in previously treated metastatic NSCLC adenocarcinoma. The registry records randomized allocation, a single-group model, enrollment of 31, and terminated status. The recorded start date is 2022-11-14, with primary completion on 2024-08-12.

The primary outcome is investigator-assessed ORR, defined as the percentage with CR or PR by RECIST v1.1, with a 95% confidence interval specified using the Clopper-Pearson method. The record does not report an ORR estimate or analysis. Safety information lists one MORAb-202 25mg/m^2 group, counts for serious and other adverse events and deaths, and selected serious-event terms.

The reason for termination, comparator results, missing-data handling, multiplicity strategy, and statistical analysis plan are not reported in the registry record. The mismatch between randomized allocation and single-group model is unexplained.