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 Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer (NCT01822496), a randomized phase 2 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01822496 |
| Phase | Phase 2 |
| Condition | Stage III Non-Small Cell Lung Cancer AJCC v7, Stage IIIA Non-Small Cell Lung Cancer AJCC v7, Stage IIIB Non-Small Cell Lung Cancer AJCC v7 |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 59 |
| Arms in the primary outcome | 4 |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
Eligible patients with stage III non-small cell lung cancer, including stage IIIA and IIIB disease under AJCC v7. The registry record reports an enrollment of 59 participants.
Intervention
For the EGFR-labeled group, the experimental strategy was induction erlotinib for 12 weeks, followed by chemotherapy and radiation therapy. For the ALK-labeled group, it was induction crizotinib for 12 weeks, followed by chemotherapy and radiation therapy. Patients without a partial or complete response after 6 weeks of induction therapy were to start chemoradiation immediately.
Comparator
Within each labeled group, the comparator was chemotherapy and radiation therapy without erlotinib or crizotinib. Chemotherapy could be cisplatin/etoposide or paclitaxel/carboplatin.
Primary question
The primary endpoint was progression-free survival, measured from randomization until progression, death, or last known follow-up. The study’s clinical question was how outcomes with the individualized strategies compared with chemoradiation without the corresponding induction drug. Because the study terminated early and no statistical testing was done, the posted results describe arm-specific outcomes but do not establish a statistically tested treatment contrast.
3. Trial Design
This was a randomized, open-label, parallel-group phase II study sponsored by the National Cancer Institute. The registry record lists an enrollment of 59 and identifies stage III non-small cell lung cancer, including stage IIIA and IIIB disease under AJCC v7. The study started on 2013-11-04, had a primary completion date of 2018-06-04, and is listed as terminated. The reason for termination is not reported in the registry record.
The treatment strategies were individualized according to the EGFR and ALK labels used for the arms. In each labeled group, participants were assigned to an induction-drug strategy or to chemoradiation without that drug. The induction strategies used erlotinib or crizotinib for 12 weeks before chemotherapy and radiation therapy. Participants who had no partial or complete response after 6 weeks of induction were to begin chemoradiation immediately. Chemotherapy could use cisplatin and etoposide or paclitaxel and carboplatin.
Randomization describes how treatment assignment was intended to reduce systematic differences between groups. Open-label means masking was not used; participants and study personnel were not blinded to assigned treatment. The registry record does not report the randomization method, allocation ratio, stratification factors, or details of concealment of treatment assignment. It also does not report the intended sample-size justification or a planned analysis schedule.
The posted progression-free survival results are presented separately for four arms. The number of participants listed for those arm-specific results is 14 for EGFR: Erlotinib, 21 for EGFR: No Erlotinib, 9 for ALK: Crizotinib, and 7 for ALK: No Crizotinib. These arm-level values do not, by themselves, explain why the study terminated or how participants without an endpoint value were handled.
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
| Stage | EGFR: Erlotinib | EGFR: No Erlotinib | ALK: Crizotinib | ALK: No Crizotinib |
|---|---|---|---|---|
| STARTED | 16 | 23 | 9 | 11 |
| Eligible | 14 | 21 | 9 | 7 |
| Eligible With Disease Assessment | 10 | 15 | 6 | 4 |
| Eligible and Started Study Treatment | 14 | 20 | 9 | 7 |
| COMPLETED | 14 | 21 | 9 | 7 |
| NOT COMPLETED | 2 | 2 | 0 | 4 |
Reasons for not completing this period:
| Reason | EGFR: Erlotinib | EGFR: No Erlotinib | ALK: Crizotinib | ALK: No Crizotinib |
|---|---|---|---|---|
| Protocol Violation | 2 | 2 | 0 | 1 |
| Withdrawal by Subject | 0 | 0 | 0 | 3 |
Analysis population for the primary outcome, as defined in the registry: Eligible patients
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: Eligible patients
| Characteristic | Unit | EGFR: Erlotinib | EGFR: No Erlotinib | ALK: Crizotinib | ALK: No Crizotinib | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 14 | 21 | 9 | 7 | 51 | |
| Age, Customized: Age (years) – ≤ 49 | Participants | 2 | 3 | 3 | 0 | 8 |
| Age, Customized: Age (years) – 50 - 59 | Participants | 4 | 5 | 4 | 2 | 15 |
| Age, Customized: Age (years) – 60 -69 | Participants | 4 | 9 | 2 | 1 | 16 |
| Age, Customized: Age (years) – ≥ 70 | Participants | 4 | 4 | 0 | 4 | 12 |
| Sex: Female, Male: Female | Participants | 4 | 6 | 4 | 5 | 19 |
| Sex: Female, Male: Male | Participants | 10 | 15 | 5 | 2 | 32 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 2 | 0 | 0 | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 13 | 19 | 9 | 6 | 47 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 3 | 1 | 1 | 7 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 1 | 1 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 12 | 15 | 7 | 5 | 39 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 0 | 0 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over From randomization to study termination. Maximum follow-up was 39.0 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from randomization until the first documented progression or death. For participants without a recorded progression or death by their last known follow-up, the time is censored at that last follow-up. The registry defines progression using RECIST v1.1: a 20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions at any location.
This endpoint combines information about disease progression and death while accounting for the timing of events. A median progression-free survival is the time by which half of the relevant population has had an event, under the endpoint’s time-to-event definition. It is not an estimate of an individual participant’s outcome, nor does a median alone describe the full distribution of event times.
The registry reports the timeframe as randomization to study termination, with maximum follow-up of 39.0 months. It also states that no statistical testing was done due to early study termination. Thus, the endpoint results are descriptive arm-specific estimates, not a formally tested comparison between treatment strategies.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The median progression-free survival was 21.1 months for EGFR: Erlotinib, with a reported 95% confidence interval from 8.5 months; an upper confidence limit is not reported in the registry record. For EGFR: No Erlotinib, the median was 9.2 months, with a 95% confidence interval from 8.7 months; the upper limit is not reported in the registry record. These are separate arm estimates. The registry record reports no statistical test comparing them, so the observed separation between the medians should not be treated as evidence of a statistically established treatment effect.
For ALK: Crizotinib, median progression-free survival was 14.7 months, with a 95% confidence interval from 6.4 to 19.5 months. A median and confidence interval are not reported for ALK: No Crizotinib. The registry’s note on missing or non-estimable values indicates that a two-arm comparison was not available for this median time endpoint. Without an estimate for that arm, a direct comparison of the ALK-labeled strategies cannot be interpreted from the posted progression-free survival results.
Confidence intervals convey uncertainty around an estimate. Wider intervals indicate less precision, while an interval whose limit is not reported cannot be fully assessed from the registry entry. The intervals reported for these arms should not be read as tests of a difference between arms: overlap or non-overlap is not a substitute for a prespecified comparative analysis. No hazard ratios are posted for the primary endpoint, and no primary-endpoint p-value is reported.
The study was terminated, and the registry explicitly says that statistical testing was not done because of early termination. The reason for termination, the planned enrollment target, and the sponsor’s statistical analysis plan are not reported in the registry record. The estimates therefore provide descriptive information about participants with available endpoint data, with limited precision and no inferential comparison. They do not establish that one strategy produced longer or shorter progression-free survival than its comparator.
The response endpoint supplies a separate secondary result, but it does not replace the primary time-to-event endpoint. Its unadjusted comparison is also uncertain, and the record does not report a multiplicity adjustment. Secondary findings should therefore be treated as exploratory context rather than confirmation of a treatment difference. The posted data support careful description of the observed arm outcomes, not a causal conclusion about the benefit or harm of adding either induction drug.
9. Statistical Methods Explained
What does a median time-to-event estimate describe?
Progression-free survival is a time-to-event outcome. Each participant contributes time from randomization until progression or death, or until the last known follow-up when neither event has been recorded. The latter observation is censored: it tells the analysis that the participant remained without a recorded event through the known follow-up time, but it does not establish what happened afterward. The registry describes the median for each arm rather than a hazard ratio or a formal comparative test.
In general, a median time-to-event estimate locates the point in the estimated event-time distribution at which half of the population has experienced the event. It does not reveal the shape of that distribution, the timing of every event, or the experience of any particular participant. A median can be estimated even when some follow-up is censored, subject to the method’s assumptions and the amount of information available. The statistical method used to estimate these medians is not reported in the registry record.
How should confidence intervals be read?
A confidence interval expresses uncertainty around an estimate under a statistical procedure. It does not guarantee that the true value lies within the reported limits, and it is not a range of individual participant outcomes. The registry gives 95% confidence intervals for the primary medians. For two arms, it reports a lower limit but no upper limit; an upper limit is not reported in the registry record. For the ALK: Crizotinib arm, both limits are reported. For ALK: No Crizotinib, the median and limits are not available.
These are arm-specific intervals. Their presence does not amount to a test of the difference between arms. A comparative analysis would need to estimate the contrast using an appropriate method and report its uncertainty. The registry says no statistical testing was done for progression-free survival due to early study termination. Comparative hazard ratios, their confidence intervals, and a primary-endpoint p-value are not reported in the registry record.
What does the response comparison add?
The posted complete or partial response comparison is a binary outcome, meaning that each assessed participant is classified as having or not having a response under the study’s outcome definition. In the EGFR-labeled comparison, the reported response percentages are 50.0% for EGFR: Erlotinib and 26.7% for EGFR: No Erlotinib. The unadjusted risk difference is -0.233, with a 95% confidence interval from -0.616 to 0.149, and an unadjusted p-value of 0.234. The interval includes values on either side of no difference, so these data do not provide a precise estimate of the direction or size of the contrast. The posted analysis is unadjusted; it should not be mistaken for an adjusted or definitive treatment-effect analysis.
The sample-size illustrations associated with this response contrast are planning examples, not observed power and not the trial’s design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The examples calculate participants per arm for detecting 100% of the observed effect, 75% of the observed effect, or 50% of the observed effect. For 80% power, the corresponding planning figures are 67, 124, and 284 participants per arm; for 90% power, they are 90, 165, and 379 participants per arm. These figures describe hypothetical planning under the stated assumptions, not a retrospective claim about the probability that this trial would detect an effect.
Why does early termination matter for interpretation?
Early termination can leave fewer observations and less follow-up information than would be available in a completed study, which can make estimates less precise or leave some quantities not estimable. The registry states that no testing was done for the primary endpoint because of early termination. The reason for termination and whether any interim analyses occurred are not reported in the registry record. It would therefore be inappropriate to infer why the study stopped or whether its results were examined at an interim point.
For general interpretation, a p-value measures how compatible data are with a specified statistical model and null hypothesis; it does not measure the probability that a treatment works, nor does it quantify clinical importance. A confidence interval is usually more informative about the range of estimates compatible with the data, but it too depends on the analysis assumptions. In this record, the response p-value is explicitly unadjusted, and no primary progression-free survival test was performed. The record does not report a prespecified hierarchy or multiplicity strategy.
The record gives eligible patients as the primary population label and supplies arm-level counts, but further analysis-population definitions are not reported. The handling of missing outcome information beyond censoring at last known follow-up is not described. These gaps limit the ability to assess how the analyses correspond to the randomized population and how incomplete observations may have affected the estimates.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies eligible patients as the primary population for progression-free survival and describes censoring at last known follow-up. The results report arm-specific counts, but the detailed rules for inclusion in each analysis are not reported in the registry record. An intention-to-treat definition, per-protocol population, or other analysis-population specification is not reported. The response results use different arm counts from the progression-free survival results; the reason for those differences and the handling of participants without response assessments are not reported in the registry record.
For progression-free survival, censoring is described when a participant has no recorded progression or death by last known follow-up. The registry does not report the number or reasons for censored observations, missing assessments, withdrawals, or loss to follow-up. It also does not report sensitivity analyses assessing the impact of incomplete follow-up. These omissions make it difficult to assess whether missing information could have affected the arm-specific time-to-event estimates.
Multiplicity concerns arise because the study lists several secondary outcomes and includes distinct treatment comparisons. In general, multiple analyses create more opportunities for chance findings than a single planned test. The registry does not report a multiplicity adjustment, a formal testing hierarchy, or which secondary comparisons were prespecified. The response p-value is unadjusted. It should therefore not be interpreted as if it controlled the overall chance of a false-positive result across the study’s outcome and comparison set.
Primary-endpoint testing was not done due to early termination. Interim analyses, stopping rules, and the reason for termination are not reported in the registry record. The planned sample-size justification and complete statistical analysis plan are also not reported. These missing details prevent assessment of whether the posted analyses follow a prespecified plan or how termination affected the intended inferential framework. No assumptions about the protocol or the conduct of unreported analyses can be made from the available record.
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 |
|---|---|---|---|
| EGFR: Erlotinib | 1 | 14 | 7.1% |
| EGFR: No Erlotinib | 7 | 20 | 35.0% |
| ALK: Crizotinib | 4 | 9 | 44.4% |
| ALK: No Crizotinib | 2 | 7 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| EGFR: Erlotinib | 1 of 14 |
| EGFR: No Erlotinib | 3 of 20 |
| ALK: Crizotinib | 2 of 9 |
| ALK: No Crizotinib | 1 of 7 |
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 |
|---|---|
| EGFR: Erlotinib | 14 of 14 |
| EGFR: No Erlotinib | 20 of 20 |
| ALK: Crizotinib | 8 of 9 |
| ALK: No Crizotinib | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | EGFR: Erlotinib | EGFR: No Erlotinib | ALK: Crizotinib | ALK: No Crizotinib |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | 0 of 14 | 2 of 20 | 1 of 9 | 0 of 7 |
| Lung infection | Infections and infestations | 0 of 14 | 2 of 20 | 0 of 9 | 1 of 7 |
| Fatigue | General disorders | 0 of 14 | 1 of 20 | 0 of 9 | 1 of 7 |
| Fever | General disorders | 0 of 14 | 1 of 20 | 1 of 9 | 0 of 7 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 0 of 14 | 1 of 20 | 1 of 9 | 0 of 7 |
| Atrial fibrillation | Cardiac disorders | 0 of 14 | 0 of 20 | 0 of 9 | 1 of 7 |
| Diarrhea | Gastrointestinal disorders | 0 of 14 | 0 of 20 | 1 of 9 | 0 of 7 |
| Esophageal fistula | Gastrointestinal disorders | 1 of 14 | 0 of 20 | 0 of 9 | 0 of 7 |
| Esophageal stenosis | Gastrointestinal disorders | 0 of 14 | 1 of 20 | 0 of 9 | 0 of 7 |
| Esophagitis | Gastrointestinal disorders | 0 of 14 | 0 of 20 | 1 of 9 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | EGFR: Erlotinib | EGFR: No Erlotinib | ALK: Crizotinib | ALK: No Crizotinib |
|---|---|---|---|---|---|
| Fatigue | General disorders | 13 of 14 | 14 of 20 | 6 of 9 | 7 of 7 |
| Nausea | Gastrointestinal disorders | 10 of 14 | 16 of 20 | 6 of 9 | 4 of 7 |
| Cough | Respiratory, thoracic and mediastinal disorders | 12 of 14 | 12 of 20 | 4 of 9 | 6 of 7 |
| Esophagitis | Gastrointestinal disorders | 10 of 14 | 12 of 20 | 4 of 9 | 3 of 7 |
| Anemia | Blood and lymphatic system disorders | 8 of 14 | 10 of 20 | 4 of 9 | 6 of 7 |
| Diarrhea | Gastrointestinal disorders | 8 of 14 | 10 of 20 | 5 of 9 | 2 of 7 |
| Constipation | Gastrointestinal disorders | 6 of 14 | 11 of 20 | 2 of 9 | 5 of 7 |
| Lymphocyte count decreased | Investigations | 8 of 14 | 10 of 20 | 2 of 9 | 4 of 7 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 7 of 14 | 9 of 20 | 3 of 9 | 4 of 7 |
| Platelet count decreased | Investigations | 5 of 14 | 9 of 20 | 2 of 9 | 5 of 7 |
Serious events with the highest arm-level rate: atrial fibrillation (14.3%), fatigue (14.3%), lung infection (14.3%), aspiration (14.3%), cough (14.3%).
The adverse-event record reports serious adverse events for each arm as counts of participants at risk and participants affected. The affected counts are 1 of 14 for EGFR: Erlotinib, 7 of 20 for EGFR: No Erlotinib, 4 of 9 for ALK: Crizotinib, and 2 of 7 for ALK: No Crizotinib. These counts describe the posted safety data; they do not establish that an event was caused by the assigned treatment. The record also reports deaths by arm, but does not state in these figures whether the deaths were treatment-related.
Other adverse events are listed separately, with affected counts of 14 of 14, 20 of 20, 8 of 9, and 7 of 7 across the same arms. The registry lists atrial fibrillation, fatigue, lung infection, aspiration, cough, and dyspnea among the top serious-event terms, each at 14.3%. The denominator and arm-specific distribution for those term percentages are not reported in the registry record.
Safety counts need to be interpreted in light of the number of participants represented in each arm and the study’s early termination. The record does not provide a comparative statistical test for these figures or sufficient detail to attribute events to a particular drug or treatment component. Counts alone are descriptive and do not support a claim that one strategy is safer than another.
12. What the Result Does, and Does Not, Mean
The primary results describe median progression-free survival in the arms for which an estimate is reported. They show the observed medians and available confidence limits in this study population, with incomplete interval limits for two arms and no median estimate for ALK: No Crizotinib. The record states that primary-endpoint statistical testing was not done because the study terminated early. Accordingly, these values are not a statistically tested comparison and do not establish that adding erlotinib or crizotinib changed progression-free survival.
The response outcome offers a secondary, unadjusted comparison in the EGFR-labeled groups. Its estimate is uncertain, and the confidence interval includes values on both sides of no difference. The other listed secondary outcomes do not have detailed comparative results reported in the registry record, apart from the posted adverse-event information. Taken together, these data provide a limited descriptive account rather than a complete set of confirmatory results.
In general, an observed difference between arm estimates can arise from treatment effects, chance, differences in the participants represented, or limitations in measurement and follow-up. Randomization is intended to support fair comparisons, but it cannot guarantee precise estimates, particularly when the amount of information is limited. Confidence intervals and the absence of a formal primary test matter when judging how precisely these results distinguish among possible effects.
The study record does not report why termination occurred, the planned enrollment target, the original statistical plan, or the handling of all missing outcome data. Without those details, the posted outcomes cannot answer whether termination altered the analysis or whether unreported considerations affected the study’s conclusions. The findings should be understood as the results reported for this trial, not as proof for or against either treatment strategy and not as a basis for individual medical decisions.
13. Why This Trial Matters Statistically
This trial is statistically notable because it used a randomized parallel design to study individualized strategies, while reporting several arm-specific outcomes without a primary comparative test. That distinction matters: randomization can make a treatment comparison more interpretable, but the design alone does not supply the precision or inferential evidence that a completed, adequately analyzed comparison would require. The record reports medians and confidence intervals for some arms, but not all.
The registry explicitly links the absence of statistical testing to early termination. That makes transparent reporting especially important. Readers need to distinguish descriptive estimates from tested contrasts, and to notice where intervals have missing limits or estimates are not available. The reported progression-free survival results permit some description of arm outcomes, but not a conclusive ranking of strategies.
The secondary response analysis illustrates another statistical issue: an unadjusted result from one outcome has to be considered in the setting of several listed outcomes and comparisons. Without a reported multiplicity plan, secondary findings are exploratory. The planning illustrations also require careful interpretation: they express hypothetical participants-per-arm requirements under stated assumptions and are not observed power or evidence about the study’s original design.
Finally, the registry record shows why missingness and analysis populations matter. The available endpoint counts vary by outcome, while detailed reasons and analysis rules are not reported. For clinical researchers, the central lesson is to read the estimand, available observations, uncertainty, and analysis status together. A numerical estimate is not self-interpreting; the surrounding design and reporting determine what it can support.
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 early termination is a central limitation because the registry states that no statistical testing was done for the primary endpoint. The reason for termination and the planned enrollment target are not reported in the registry record. Consequently, it is not possible to determine from the posted record how termination related to recruitment, study conduct, or the intended precision of the estimates.
The arm-specific progression-free survival results are incomplete. No median is reported for ALK: No Crizotinib, and upper confidence limits are not reported for EGFR: Erlotinib or EGFR: No Erlotinib. A comparative hazard ratio or other primary-endpoint contrast is also not reported. These gaps constrain both the precision assessment and the ability to compare strategies.
The registry reports enrollment of 59, while arm-level counts differ across the posted progression-free survival and response results. The reasons for those differing analysis counts, the rules for handling missing assessments, and any sensitivity analyses are not reported. The registry does not describe the randomization method, allocation ratio, stratification factors, or detailed analysis populations. Those omissions limit assessment of how the results relate to the randomized groups.
Several secondary outcomes are listed, but detailed comparative results for most are not reported in the registry record. A multiplicity plan and complete statistical analysis plan are also not reported, and the response comparison is unadjusted. These limits mean that secondary findings cannot be treated as confirmatory evidence. The record identifies the study as open-label and terminated, but further conclusions about conduct, adherence, or the cause of termination would be speculative.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Erlotinib Hydrochloride or Crizotinib and Chemoradiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer — NCT01822496.
- Registry record last updated 2019-08-05; status last verified 2019-06.
- Results first posted 2019-08-05.
- 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
NCT01822496 is a randomized, open-label phase II parallel study of individualized combined-modality therapy for stage III non-small cell lung cancer. The study compared induction erlotinib or crizotinib followed by chemoradiation with chemoradiation without the corresponding induction drug. Enrollment was 59; the record lists the study as terminated.
The primary endpoint was progression-free survival from randomization to progression, death, or last known follow-up. Arm-specific medians are reported for three arms, while a median is not reported for ALK: No Crizotinib. The registry states that no statistical testing was done for this endpoint because of early termination. A secondary complete or partial response comparison is posted for the EGFR-labeled arms, with an unadjusted p-value of 0.234. The record also contains descriptive adverse-event counts. The reason for termination, a complete statistical analysis plan, and detailed comparative results for most listed secondary outcomes are not reported in the registry record.