Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer (NCT00979212), a randomized phase 2 study. The primary outcome is Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab..

2. Clinical Question

This question focuses on a finding assessed at surgery after induction treatment, rather than on survival or symptoms. The registry describes the primary outcome timeframe as from randomization to protocol surgery, approximately 12 weeks; the nodal assessment was made at surgery 4-6 weeks after chemoradiation. The comparison therefore concerns the proportion meeting a specific surgical and pathological outcome in each randomized group. It does not, by itself, establish how the treatments compare on every other outcome collected in the trial.

3. Trial Design

The registry describes a randomized phase II study with a parallel-group design and no masking. One group received induction chemotherapy with paclitaxel and carboplatin plus radiation therapy. The other received the same induction treatment with panitumumab added. The intended treatment sequence in both groups included surgery if operable, followed by consolidation chemotherapy with paclitaxel and carboplatin.

The registry lists enrollment of 71 participants and identifies the study status as completed. The recorded start is 2011-02, and primary completion is 2015-12. The primary outcome population is described as all eligible patients who started study treatment. Outcome counts posted for that endpoint are 22 in the chemoradiotherapy group and 39 in the group with panitumumab. These endpoint counts should not be mistaken for the registry’s overall enrollment figure; the reason for the difference is not reported in the registry record.

The primary outcome was assessed from randomization to protocol surgery, approximately 12 weeks. The protocol description places the nodal assessment at surgery 4-6 weeks after chemoradiation. Participants who could not undergo surgery were classified as not having mediastinal nodal clearance. Other posted outcomes include overall survival, patterns of first failure, adverse events, surgical morbidity, FDG-PET/CT prediction, and response rate.

Details such as the method used to generate the random allocation sequence, allocation concealment, the trial’s original sample-size justification, planned interim analyses, and the statistical analysis plan are not reported in the registry record. Randomization is reported, but further procedural details should not be inferred from that description.

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 eligible patients who started study treatment

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 eligible patients receiving protocol treatment

6. Primary Endpoint

The registry lists the primary outcome as Mediastinal Nodal Clearance After Completion of Induction Chemoradiotherapy With or Without Panitumumab., measured over From date of randomization to time of protocol surgery, approximately 12 weeks..

The primary endpoint is the percentage of participants whose mediastinal nodes, involved at study registration, were clear of disease after induction chemoradiotherapy with or without panitumumab. The assessment was made at protocol surgery, described as occurring 4-6 weeks after chemoradiation. The broader outcome timeframe is from randomization to surgery, approximately 12 weeks.

This endpoint records a specific finding at surgery. It is not a general measure of tumor response, survival, or all disease in the body. The registry’s operational rule is important: when surgery could not be performed, the participant was counted as not having mediastinal nodal clearance. Thus the posted percentage reflects both the nodal-clearance definition and that rule for participants without surgery.

A binary percentage is useful for describing how often a defined event occurred in each group. The registry reports percentages and 95% confidence intervals for both groups. In the chemoradiotherapy group, clearance was recorded for 68.2% (95% CI 45.1% to 86.1%); in the group also receiving panitumumab, it was recorded for 48.7% (95% CI 32.4% to 65.2%). Those intervals describe uncertainty around each group’s percentage. The endpoint does not, on its own, describe the size or direction of effects on the trial’s other outcomes.

7. Results Posted in the Registry

• Induction CT+RT+Panitumumab: 48.7% (19/39) versus 68.2% (15/22) on control; risk difference -19.5 percentage points (95% CI -44.5 to 5.5), risk ratio 0.71 (0.46–1.10); unadjusted two-proportion z-test p = 0.142.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Overall Survival

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Induction CT+RT+Panitumumab: 89.7% (35/39) versus 95.5% (21/22) on control; risk difference -5.7 percentage points (95% CI -18.6 to 7.2), risk ratio 0.94 (0.82–1.08); unadjusted two-proportion z-test p = 0.435.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Induction CT+RT+Panitumumab and the control. The interval gives the range of effects that remain compatible with the data.

Surgical Morbidities in Patients With Resectable Disease at Reassessment

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Induction CT+RT+Panitumumab: 20.0% (6/30) versus 42.1% (8/19) on control; risk difference -22.1 percentage points (95% CI -48.5 to 4.3), risk ratio 0.48 (0.20–1.16); unadjusted two-proportion z-test p = 0.095.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Induction CT+RT+Panitumumab and the control. The interval gives the range of effects that remain compatible with the data.

Response Rate

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Induction CT+RT+Panitumumab: 61.5% (24/39) versus 77.3% (17/22) on control; risk difference -15.7 percentage points (95% CI -39.0 to 7.5), risk ratio 0.80 (0.57–1.11); unadjusted two-proportion z-test p = 0.209.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Induction CT+RT+Panitumumab and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes broaden the description beyond mediastinal nodal clearance. They cover overall survival, response, surgical morbidity, adverse events, patterns of first failure, and the predictive role of FDG-PET/CT data. The posted results span different types of outcomes and assessment windows, so they should not be treated as multiple interchangeable measurements of the primary endpoint.

At a broad level, the secondary results do not turn the uncertain primary comparison into a clear, uniform pattern across outcomes. Each secondary estimate has its own uncertainty and analysis population. For example, survival follow-up and postoperative morbidity address different events in different contexts from nodal clearance after induction treatment. A direction that appears similar across some estimates would not establish consistency or a shared treatment effect without considering each endpoint’s precision and methods.

Unadjusted secondary comparisons carry less weight when many outcomes are assessed. General statistical explanation: as the number of statistical comparisons grows, the chance of finding at least one apparently notable result by chance can increase. Multiplicity methods can address this issue, but whether the trial used such methods is not reported in the registry record. The presence of several outcomes is not itself evidence that a particular finding is false; it is a reason to interpret isolated secondary results cautiously.

The registry reports no sponsor analyses for the posted secondary outcomes in the registry record for this record. The simple recalculations are therefore not substitutes for a stated, prespecified analysis plan. The outcome definitions, populations, follow-up, and statistical methods should be considered separately, and secondary findings should be understood as supportive descriptions rather than as an independent confirmation of the primary result.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Overall Survival
• Patterns of First Failure
• Percentage of Patients With Grade 3 or Higher Acute and Late Adverse Events
• Surgical Morbidities in Patients With Resectable Disease at Reassessment
• Ability of FDG-PET/CT Scan Data to Predict Outcome
• Response Rate

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary: each participant is classified as having or not having mediastinal nodal clearance under the registry’s definition. A group percentage describes the proportion classified as having clearance. The registry reports the percentage in each group and a 95% confidence interval. General statistical explanation: a confidence interval expresses the uncertainty associated with an estimate under the method used to construct it. A wide interval indicates that the observed data do not pin down the underlying percentage precisely.

The comparison can also be expressed as a difference between the two group percentages. A difference of zero represents no separation in the estimated percentages. The recalculated confidence interval for the primary comparison spans zero, so the data do not distinguish a nonzero difference clearly under that unadjusted calculation. The recalculated p-value is 0.142. A p-value measures how unusual data at least as inconsistent with a specified null hypothesis would be if that null hypothesis and the test assumptions held. It is not the probability that the null hypothesis is true, nor does it measure the clinical importance of an observed difference.

The registry’s own primary analysis is listed as a Fisher Exact test and reports p = 0.96. A Fisher Exact test is a method for testing association in a two-by-two table of counts. The registry does not post an effect estimate or confidence interval for that analysis. The recalculation uses posted summary statistics and is unadjusted; it is not a substitute for a complete analysis based on participant-level data or for the sponsor’s reported analysis. The registry does not explain the difference between the reported p-value and the recalculated one.

General statistical explanation: counts and percentages answer related but distinct descriptive questions. Counts show how many participants had an outcome, while percentages put those counts in the context of the number assessed in each group. Here, the primary outcome counts are 15 of 22 and 19 of 39, corresponding to the posted percentages. The different group sizes contribute to the uncertainty in the estimates; small outcome groups can yield broad confidence intervals.

The registry lists several secondary outcomes, including overall survival, response rate, surgical morbidity, and adverse events. Each is defined and assessed in its own way. A percentage outcome at a fixed assessment is not interchangeable with a time-to-event outcome. General statistical explanation: time-to-event analyses account for the timing of events and may also account for participants whose event time is not observed during follow-up. The registry does not provide enough detail in the posted record to describe the specific analysis methods for every secondary outcome.

The simple unadjusted calculations are descriptive comparisons of the posted summaries. They do not adjust for baseline characteristics, account for unreported participant-level details, or replace prespecified modeling. Whether such adjustments or models were planned is not reported in the registry record. Likewise, the record does not state whether the sponsor’s test was prespecified or whether other analyses were conducted but not posted.

General statistical explanation: over-dispersion is a concern when variability in data is greater than a model assumes; using a model that underestimates variability can make uncertainty look too small. It is not a reported feature or analysis issue established for this binary endpoint. More broadly, a statistical method must match the outcome structure and the assumptions of the data. The available registry information does not support claims about assumptions beyond the analysis labels and estimates that are posted.

Randomization is intended to make treatment groups comparable on average, but it does not guarantee balance in a trial of this size. The registry does not report detailed baseline comparisons in the registry record for this analysis. It also does not report the randomization sequence method, allocation concealment, or a detailed missing-data plan. The endpoint does specify one outcome rule for inability to undergo surgery: those participants are classified as not having clearance. That rule is part of the endpoint definition, not a general account of how other missing outcomes were handled.

11. Confidence Intervals and Precision

The primary group estimates have broad 95% confidence intervals. For chemoradiotherapy alone, the clearance estimate is 68.2%, with a 95% confidence interval from 45.1% to 86.1%. For chemoradiotherapy with panitumumab, the estimate is 48.7%, with a 95% confidence interval from 32.4% to 65.2%. The ranges indicate substantial uncertainty about the underlying percentages in each group.

General statistical explanation: a confidence interval is not a range that contains a fixed percentage of individual participant outcomes. It is an interval generated by a statistical procedure to express uncertainty about a population quantity. Its width depends on factors including the amount of information in the data and the variability of the outcome. In this trial, the primary outcome groups contain 22 and 39 participants, and the confidence intervals are correspondingly important context for reading the point estimates.

The recalculated confidence interval for the difference between groups spans no difference. This means the data are compatible with no separation as well as with differences in either direction. It does not prove the groups are equivalent, and it does not show that all possible differences are equally plausible. The sponsor’s reported analysis does not include a confidence interval in the registry record, so its precision cannot be assessed from that result alone.

Confidence intervals should be read alongside the endpoint definition and the analysis population. The primary endpoint counts participants who could not undergo surgery as not having nodal clearance. The estimate therefore reflects this particular classification rule. It should not be generalized to a different endpoint definition without a separate analysis.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effect, not the trial’s original design calculation. For these binary outcomes, the figures are participants per arm. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect.

The 80% power column describes the number of participants per arm that a new, hypothetical study would require under those assumptions to have an 80% chance of detecting the specified effect, if that effect and the assumptions held. The 90% power column gives the corresponding planning target for a 90% chance. These are design quantities for a future study, not summaries of how likely the completed trial was to detect an effect.

The rows that plan for 100%, 75%, or 50% of the observed effect represent different assumed effect sizes. Smaller effects require more participants to detect, so the planning figures increase as the assumed fraction decreases. This relationship is a general feature of statistical planning: weaker separation between groups takes more information to distinguish from chance variation.

These figures are not observed power. Observed power is not a useful way to reinterpret the results after the fact; the confidence intervals and estimates describe the uncertainty in the observed data more directly. The registry does not report the trial’s own original sample-size assumptions or justification, so the planning illustrations should not be mistaken for the study’s prespecified target or for evidence about why enrollment took the value recorded.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.682; treatment proportion p₁ = 0.487; average p̄ = 0.584.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6969 = 1.3660.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6832 = 0.5750.
4. n = (1.3660 + 0.5750)² / (-0.1946)² = 99.4, rounded up to 100 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.681818181818182                          # control proportion
p1 <- 0.487179487179487                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(979212)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 100 (80% power), 133 (90% power)
 75% of observed effect: n per arm = 175 (80% power), 233 (90% power)
 50% of observed effect: n per arm = 384 (80% power), 514 (90% power)
power.prop.test: 99.4 
Simulated power at n = 100 per arm: 0.807 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s sponsor-reported primary analysis is a Fisher Exact test with p = 0.96. The simple unadjusted recalculation from the posted summary statistics gives p = 0.142. These are markedly different inferential results. The sponsor’s reported analysis does not include an effect estimate or confidence interval in the registry record, so the result cannot be compared with the recalculation on those measures using the posted information.

The recalculation is an unadjusted analysis of the summary counts and should be read as a separate statistical check, not as a replacement for the sponsor’s analysis. The registry does not explain the difference, and the record does not contain enough information to identify its cause. No explanation should be inferred from the difference alone. Readers should retain both results in view and note that the reported sponsor p-value does not agree with the simple recalculation.

The registry does not report whether the sponsor’s analysis was prespecified, what additional analytical decisions were made, or whether the p-value reflects any adjustment. Such details are not reported in the registry record. The arm percentages and their confidence intervals remain useful descriptive information, while the disagreement between p-values is a limitation in interpreting the inferential evidence.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists seven outcome measures and posts six secondary outcomes. The primary endpoint is one of several outcomes considered, but a multiplicity strategy for controlling the overall chance of false-positive findings is not reported in the registry record. Whether secondary endpoints were ordered hierarchically, adjusted for multiple comparisons, or treated as exploratory is also not reported.

This omission matters when interpreting several unadjusted results together. General statistical explanation: when many hypotheses are tested, the chance of at least one result appearing notable by chance can rise. A prespecified adjustment or testing hierarchy can help control that risk. Without a reported plan, secondary p-values or apparent patterns should not be treated as if they were independently confirmatory. The registry record does not provide a basis for reconstructing an unreported plan.

The primary endpoint population is stated as all eligible patients who started study treatment. The endpoint definition classifies a participant who could not undergo surgery as not having nodal clearance. This supplies a specific rule for the primary outcome in that circumstance. Broader missing-data procedures, reasons for missing assessments, sensitivity analyses, and analysis populations for the secondary outcomes are not reported in the registry record.

The registry reports overall enrollment of 71, while the posted primary outcome counts are 22 and 39. The reason those figures differ is not reported in the registry record. The record also does not give sufficient information to describe the allocation sequence method, concealment, or detailed participant flow. These gaps limit assessment of how the analysis population was formed and how incomplete data may affect interpretation.

Interim analyses, stopping boundaries, and the original statistical analysis plan are not reported in the registry record. Their absence from the posted details should not be taken to mean that a particular procedure was or was not used.

16. Safety Results

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

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: lung infection (13.2%), diarrhea (9.1%), thromboembolic event (9.1%), sepsis (7.9%), pneumonitis (7.9%).

The registry reports serious adverse events for 8 of 22 participants in the chemoradiotherapy group and 20 of 38 in the group receiving panitumumab with chemoradiotherapy. It also reports other adverse events for 22 of 22 and 37 of 38 participants, respectively. These are counts of participants with events in the posted safety groups; they do not by themselves describe the number of events per participant, timing, duration, or severity distribution beyond the serious-event classification.

The listed serious-event terms include lung infection, diarrhea, thromboembolic event, sepsis, pneumonitis, and atrial fibrillation, each with a posted percentage. Those percentages describe the registry’s listed terms, not a complete account of all safety outcomes. The record’s group sizes differ between the safety results and the primary endpoint results; the reason is not reported in the registry record.

Safety comparisons should be read descriptively in light of the group sizes and the available detail. The registry entries do not provide an inferential comparison for these adverse-event counts, nor do they specify exposure-adjusted rates or comprehensive event-level information. These results are not a basis for medical advice or for concluding that one regimen is safer overall.

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

The primary result describes the proportion of participants recorded as having mediastinal nodal clearance after induction chemoradiotherapy, under a definition that counts inability to undergo surgery as no clearance. The posted percentage was 68.2% in the group receiving chemoradiotherapy and 48.7% in the group receiving panitumumab as well. The confidence intervals are broad, and the unadjusted recalculation does not clearly distinguish the groups.

This does not establish that the treatments are equivalent. Nor does it establish that adding panitumumab caused a particular difference. The registry provides a randomized comparison, but the posted primary group counts are limited, the estimates are imprecise, and the sponsor-reported p-value differs from the simple unadjusted recalculation. Those features constrain how firmly the comparison can be interpreted.

The endpoint is a surgical assessment of nodal status. It is not the same as overall survival, response rate, quality of life, or all adverse effects. Results on one of those outcomes should not be substituted for the primary endpoint, and a primary-endpoint result cannot answer every question about treatment outcomes.

The findings apply to the trial’s recorded population and definitions. The registry describes potentially operable stage IIIA, N2+ non-small cell lung cancer and reports that participants unable to undergo surgery were counted as not having clearance. It does not provide all the details needed to determine how the posted results would apply to populations or treatment settings beyond this study.

In short, the posted data show different observed clearance percentages but leave substantial uncertainty about the comparison. They do not, by themselves, prove benefit, lack of benefit, equivalence, or a safety conclusion. They are statistical findings from a completed phase II trial and should be interpreted alongside the registry’s limitations and the results for other outcomes.

18. Why This Trial Matters Statistically

This trial is statistically interesting because it compares an added treatment against a shared chemoradiotherapy backbone using a defined outcome assessed at surgery. The endpoint rule for participants unable to undergo surgery makes the outcome definition consequential: the posted percentage combines the surgical assessment with a stated classification for those without surgery.

The trial also illustrates why point estimates should be read together with uncertainty. The two group percentages differ descriptively, but their confidence intervals are broad and the recalculated comparison is inconclusive. A point estimate alone can make a small study appear more decisive than its data warrant. The interval estimates give a more informative account of how much uncertainty remains.

A further statistical issue is the contrast between the sponsor-reported Fisher Exact p-value and the unadjusted recalculated p-value. The registry does not explain the discrepancy. Reporting both makes clear that a single p-value is not a complete account of a result and that transparent methods and estimates matter when readers assess evidence.

Finally, the multiple secondary outcomes raise questions about multiplicity, missing data, and analysis populations. The registry record does not report a multiplicity plan or comprehensive missing-data procedures. Those omissions do not invalidate the posted findings, but they limit what can be concluded from isolated secondary patterns. The case underscores the value of clear outcome definitions, confidence intervals, and transparent reporting of analysis decisions.

19. 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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The registry record gives limited detail about the statistical design and conduct. The original sample-size justification, analysis plan, allocation sequence generation, allocation concealment, and any interim analyses are not reported. It is therefore not possible to assess from the posted record whether the trial’s design was intended to provide a particular level of precision for the primary comparison.

The primary endpoint has broad confidence intervals and is based on 22 participants in one group and 39 in the other. The registry’s overall enrollment is 71, but the reason the primary endpoint counts differ from that enrollment is not reported in the registry record. Participant flow and reasons for non-inclusion in the posted endpoint counts are not specified in the registry record for this analysis.

The primary outcome has a specific rule for participants who could not have surgery, but wider missing-data handling is not reported. The record also does not explain the difference between the sponsor’s Fisher Exact p-value and the unadjusted recalculated p-value. The sponsor analysis has no posted effect estimate or confidence interval, which limits comparison of the two inferential summaries.

The trial includes several secondary outcomes, but a multiplicity plan is not reported. Methods and analysis populations for the secondary outcomes are not fully described in the registry record. Finally, the posted outcomes are limited to the endpoints and timeframes recorded; they do not provide a complete account of every potential treatment effect or harm.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer — NCT00979212.
• Registry record last updated 2022-06-15; status last verified 2022-05.
• Results first posted 2016-08-16.
• 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.

23. Record Summary

NCT00979212 is a completed randomized phase II, parallel-group study with no masking. It enrolled 71 participants with potentially operable stage IIIA, N2+ non-small cell lung cancer. The comparison was induction chemotherapy with paclitaxel and carboplatin plus radiation therapy, with or without panitumumab; both treatment sequences included surgery if operable and consolidation chemotherapy.

The primary outcome was mediastinal nodal clearance at protocol surgery, with participants unable to undergo surgery classified as not having clearance. Posted rates were 68.2% and 48.7%, with broad 95% confidence intervals. The unadjusted recalculation gives p = 0.142, while the registry reports a Fisher Exact p-value of 0.96; the reason for the difference is not reported.

Secondary results address survival, response, surgery-related morbidity, and other outcomes. The registry does not report the original sample-size justification, multiplicity plan, or comprehensive missing-data and analysis details.