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 A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer (NCT02259582), a randomized phase 2 study. The primary outcome is To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02259582 |
| Phase | Phase 2 |
| Condition | Nonsquamous Nonsmall Cell Neoplasm of Lung |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 82 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OncoMed Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
The clinical question was whether investigator-assessed response differed between participants receiving carboplatin and pemetrexed with placebo and participants receiving the same chemotherapy with demcizumab. The primary endpoint description specifies a comparison of the placebo/placebo arm with the two demcizumab arms combined. The study also included separate arms for one course and two courses of demcizumab, so the planned combined comparison does not, by itself, describe the response in each demcizumab schedule separately.
The registry describes the population as people with first-line stage IV non-small cell lung cancer, and its condition entry specifies non-squamous disease. The study title and arm descriptions likewise concern non-squamous non-small cell lung cancer. The trial was randomized, double-blind, and phase 2. Its stated purpose was to assess efficacy and safety when demcizumab was added to carboplatin and pemetrexed, compared with placebo alongside those chemotherapy drugs.
Response was assessed by investigators using RECIST v1.1. The endpoint used best overall response, defined in the record as the best unconfirmed response during treatment up to disease progression. Response assessment continued until alternative anti-cancer treatment began or progressive disease developed, whichever happened first; the listed assessment period was up to approximately 26 months.
The practical statistical question is therefore about how the recorded response categories compared across the specified arms, and how precisely those comparisons were estimated. The registry record does not report the response counts, response percentages, effect estimate, confidence interval, or test result. It consequently does not permit a quantitative account of the primary comparison or a conclusion about the size or precision of any difference.
3. Trial Design
This was a randomized, parallel-group phase 2 study with triple masking recorded in the registry. The brief summary describes a 3-arm design with 1:1:1 allocation. Enrollment was 82, and the record is marked completed. The registry title and official title describe a 2-arm study, while the brief summary and arm descriptions identify three treatment arms. This inconsistency in the record is relevant when interpreting the design; the listed arm descriptions distinguish placebo, one course of demcizumab, and two courses of demcizumab.
All arms included pemetrexed and carboplatin for four cycles. The placebo arm then received maintenance pemetrexed and placebo starting at Day 84. The one-course demcizumab arm received one course of demcizumab at 5mg/kg and then maintenance pemetrexed plus placebo starting on Day 84. The third arm received two courses of demcizumab at 5 mg/kg, with maintenance pemetrexed starting on Day 84. The registry gives pemetrexed dosing as 500 mg/m2 and carboplatin dosing as an area under the concentration-time curve of 6 mg/mL x min; it describes administration once every 21 days for the first arm and four cycles for the treatment arms.
The primary outcome was investigator-assessed RECIST v1.1 response rate, with a response defined using best overall response. The registry's primary comparison combined the two demcizumab arms against the placebo/placebo arm. The record does not provide details of the randomization sequence, allocation concealment, or which individuals were included in the triple masking.
Although the design and treatment schedules are described, the record does not report the primary response results. It also does not provide a detailed statistical analysis plan or explain how the combined comparison was to be estimated. The listed safety information is available by arm, but cannot substitute for the missing efficacy results.
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 | Placebo/Placebo Arm (Arm 1) | Demcizumab/Placebo Arm (Arm 2) | Demcizumab/Demcizumab Arm (Arm 3) |
|---|---|---|---|
| STARTED | 25 | 28 | 29 |
| COMPLETED | 9 | 11 | 8 |
| NOT COMPLETED | 16 | 17 | 21 |
Reasons for not completing this period:
| Reason | Placebo/Placebo Arm (Arm 1) | Demcizumab/Placebo Arm (Arm 2) | Demcizumab/Demcizumab Arm (Arm 3) |
|---|---|---|---|
| Physician Decision | 0 | 1 | 0 |
| Death | 0 | 0 | 1 |
| Adverse Event | 1 | 0 | 1 |
| Withdrawal by Subject | 0 | 0 | 1 |
| Disease progression | 14 | 15 | 17 |
| Lack of Subject Adherence to Protocol | 1 | 1 | 1 |
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.
| Characteristic | Unit | Placebo/Placebo Arm (Arm 1) | Demcizumab/Placebo Arm (Arm 2) | Demcizumab/Demcizumab Arm (Arm 3) | Total |
|---|---|---|---|---|---|
| Participants analysed | 25 | 28 | 29 | 82 | |
| Age, Continuous | years | 60 (40 to 77) | 66 (31 to 76) | 61 (39 to 76) | 62 (31 to 77) |
| Sex: Female, Male: Female | Participants | 15 | 15 | 12 | 42 |
| Sex: Female, Male: Male | Participants | 10 | 13 | 17 | 40 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 2 | 1 | 0 | 3 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 23 | 26 | 28 | 77 |
| Race (NIH/OMB): More than one race | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: Belgium | participants | 0 | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 5 | 8 | 7 | 20 |
| Region of Enrollment: Italy | participants | 2 | 2 | 3 | 7 |
| Region of Enrollment: Australia | participants | 14 | 10 | 10 | 34 |
| Region of Enrollment: Spain | participants | 4 | 7 | 8 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as To Compare the Investigator-assessed (RECIST) v1.1 Response Rate in the Treatment Arms., measured over Response assessment data was collected until the subject started alternative anti-cancer treatment or developed progressive disease, whichever occurred first, assessed up to approximately 26 months..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was investigator-assessed response rate under RECIST v1.1. In this context, response rate is a binary summary formed by classifying participants according to whether their recorded best overall response meets the study's response definition. The registry describes best overall response as the best unconfirmed response recorded from treatment start until disease progression, with response categories ordered as complete response, partial response, stable disease, progressive disease, not evaluable, or missing. The listed endpoint unit is participants, and its measure is a count of participants.
Response is used in oncology trials as a way to describe whether measurable disease has met criteria for a recorded response during a specified assessment period. It is not identical to time until progression or overall survival: those outcomes concern different events and require different summaries. The registry's endpoint concerns response assessed by investigators, not an independently assessed response result.
The endpoint's timing also matters. Assessment was to continue until alternative anti-cancer treatment began or progressive disease occurred, whichever came first, with follow-up described as up to approximately 26 months. This means that treatment changes or disease progression could end the response-assessment period.
The record describes the endpoint and comparison but does not report category counts or response rates for any arm. It therefore supplies no numerical estimate of the primary endpoint, and the relative response results cannot be interpreted from the record's endpoint description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a response-rate comparison but does not contain the response counts or arm-specific rates needed to interpret its primary result. It also does not state an effect estimate, confidence interval, or p-value. As a result, there is no reported quantitative basis in this record for describing the direction, magnitude, or precision of the primary comparison. The missing results should not be treated as evidence of either a difference or no difference.
The primary comparison is described as placebo/placebo versus the two demcizumab arms combined. Combining the demcizumab arms would answer a question about the pooled group, not necessarily about either schedule in isolation. The trial separately describes one course and two courses of demcizumab, but arm-specific efficacy outcomes are not reported. Thus, the registry record does not allow a statistical comparison of those schedules or a check of whether the pooled result would represent both arms similarly.
The planned response measure is categorical. A participant's best overall response can fall into categories ranging from complete response to missing or not evaluable. Reducing such information to one response-rate comparison requires a clearly stated rule for which categories count as responses and how non-evaluable or missing observations are handled. The description names the categories and the best-response ordering, but does not report the analysis rule for producing the reported response rate or how missing assessments were treated.
Enrollment was 82. The adverse-event entries list the number at risk and affected for each arm, as well as deaths, but these are safety figures and do not fill the gap in the primary endpoint results. Nor can the enrollment figure alone establish the precision of an efficacy estimate: precision depends on the actual endpoint observations and the analysis used.
The appropriate reading is consequently descriptive and limited. The registry documents the trial question, treatment schedules, endpoint definition, and some safety counts. It does not document the primary response findings or the statistical uncertainty around them. Any broader interpretation of efficacy, including claims about whether demcizumab changed response, would go beyond the results reported in the registry record.
9. Statistical Methods Explained
A randomized trial assigns participants to treatment groups according to an allocation process intended to reduce systematic differences between groups. Randomization supports a fairer comparison of outcomes, but does not guarantee that groups will be identical, especially in a study of this size. The record calls this study randomized and gives a 1:1:1 allocation in its brief summary. It does not report the sequence-generation method or how allocation was concealed before assignment.
What does masking contribute?
Masking is intended to limit the influence of treatment knowledge on care, outcome assessment, or reporting. The registry records triple masking and describes the study as double-blind in its summary and official title. It does not identify which people were masked or explain how masking was maintained. Because the primary endpoint was investigator-assessed, information about masking can matter when considering the possibility of assessment bias; the label alone does not establish how that risk was managed.
What does the response-rate endpoint summarize?
RECIST v1.1 provides criteria for classifying tumor response. This trial's endpoint used the investigator's best overall response, recorded from treatment start until progression. A response-rate analysis ordinarily reduces participant-level category data to a count or proportion meeting a specified response definition. The registry describes the response categories, including complete response, partial response, stable disease, progressive disease, not evaluable, and missing, but does not report the exact rule used to derive the analyzed response rate. It also gives no participant-level or arm-level outcome counts.
A proportion is an estimate based on the participants observed in the relevant group. Its precision depends on the amount of information and the pattern of observed outcomes. A confidence interval expresses uncertainty around an estimate; a narrower interval indicates greater precision under the method used. No response estimate or confidence interval is reported in this registry record, so neither the observed response level nor its precision can be described.
Why is the comparison structure important?
The endpoint description specifies a comparison of the placebo/placebo arm with the two demcizumab arms combined. Pooling treatment arms can make a single comparison possible, but the resulting estimate pertains to the pooled group under the analysis definition. It does not establish that each demcizumab schedule has the same result. Separate arm results and the rationale for combining arms are not reported in the registry record. The title's 2-arm wording also contrasts with the summary and arm descriptions, which describe three arms; this leaves a design-description inconsistency that readers should keep in view.
What can the planning assumptions tell us?
The record describes sample-size illustrations based on a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. For time-to-event outcomes, it specifies total events; for other outcomes, participants per arm. These are planning assumptions for illustrations, not observed results and not the trial's own design justification. They do not constitute observed power. No sample-size justification, target effect, or detailed design calculation for this trial is reported in the registry record.
In general, a planning calculation asks how much information might be needed to detect a prespecified effect under stated assumptions. It is conditional on those assumptions and does not measure the probability that a completed study has found a true effect. When based on an observed effect, such illustrations are especially dependent on the observed estimate; they should not be read as evidence that a treatment effect is established. The registry does not report the primary response effect needed to evaluate such a planning illustration for this outcome.
Why can over-dispersion matter?
For count outcomes, a basic statistical model may assume that variation follows a particular distribution. Over-dispersion means the observed variability is greater than that model expects. If not addressed, uncertainty can be understated and statistical tests can be misleading. This trial's primary endpoint is described as a participant count for a binary response measure, not as a recurrent-event count. The registry does not identify a model or report an over-dispersion assessment, so there is no basis for claiming that such an adjustment was or was not needed. This is a general statistical consideration, not a reported feature of the trial analysis.
More broadly, analysis choices for a binary endpoint may include the way rates are contrasted, the treatment of missing observations, and any adjustment for design factors. These choices affect the interpretation and uncertainty of an estimate. The record does not report the analysis model, covariate adjustments, confidence-interval method, or a detailed testing procedure. Those omissions prevent reconstruction of the primary statistical analysis from the registry description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry record does not report how multiplicity was handled. Multiplicity arises when more than one statistical hypothesis is tested; without a prespecified approach, the chance of at least one false-positive finding across tests can increase. This study has three described treatment arms, and the primary endpoint description specifies a pooled demcizumab comparison against placebo. The record does not say whether separate arm comparisons, secondary endpoints, or other planned tests were part of a broader testing strategy, nor does it report any adjustment or hierarchy.
The record also does not provide a detailed missing-data plan. The endpoint definition includes not-evaluable and missing response categories, but the analysis rule for these categories is not reported. It is therefore unclear from this record how participants without an evaluable response assessment entered the response-rate analysis, whether any imputation was used, or whether sensitivity analyses were conducted. These details matter because the analyzed denominator and assumptions about missing outcomes can affect an estimated response rate.
The record does not describe the analysis population, such as whether the primary analysis included all randomized participants or a defined subset. It also does not report exclusions, deviations from assigned treatment, or a per-protocol analysis. These are not safe to infer from the randomized design or the enrollment figure.
Interim analyses, stopping rules, and the detailed statistical plan are not reported in the registry record. Their absence from the record does not establish that they were absent from the study documentation; it means they cannot be evaluated from the registry entry. The posted primary response results are also not reported, so the statistical consequences of these design and analysis choices cannot be assessed.
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 |
|---|---|---|---|
| Placebo/Placebo Arm (Arm 1) | 6 | 25 | 24.0% |
| Demcizumab/Placebo Arm (Arm 2) | 11 | 28 | 39.3% |
| Demcizumab/Demcizumab Arm (Arm 3) | 15 | 29 | 51.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo/Placebo Arm (Arm 1) | 1 of 25 |
| Demcizumab/Placebo Arm (Arm 2) | 2 of 28 |
| Demcizumab/Demcizumab Arm (Arm 3) | 2 of 29 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo/Placebo Arm (Arm 1) | 25 of 25 |
| Demcizumab/Placebo Arm (Arm 2) | 28 of 28 |
| Demcizumab/Demcizumab Arm (Arm 3) | 29 of 29 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo/Placebo Arm (Arm 1) | Demcizumab/Placebo Arm (Arm 2) | Demcizumab/Demcizumab Arm (Arm 3) |
|---|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 25 | 2 of 28 | 3 of 29 |
| Febrile neutropenia | Blood and lymphatic system disorders | 2 of 25 | 1 of 28 | 1 of 29 |
| Pyrexia | General disorders | 1 of 25 | 0 of 28 | 2 of 29 |
| Abdominal pain | Gastrointestinal disorders | 2 of 25 | 1 of 28 | 0 of 29 |
| Diarrhoea | Gastrointestinal disorders | 0 of 25 | 1 of 28 | 2 of 29 |
| Hypertension | Vascular disorders | 0 of 25 | 1 of 28 | 1 of 29 |
| Non-cardiac chest pain | General disorders | 0 of 25 | 0 of 28 | 2 of 29 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 0 of 25 | 1 of 28 | 1 of 29 |
| Pathological fracture | Musculoskeletal and connective tissue disorders | 1 of 25 | 0 of 28 | 1 of 29 |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 25 | 0 of 28 | 0 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo/Placebo Arm (Arm 1) | Demcizumab/Placebo Arm (Arm 2) | Demcizumab/Demcizumab Arm (Arm 3) |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 18 of 25 | 18 of 28 | 14 of 29 |
| Fatigue | General disorders | 15 of 25 | 16 of 28 | 12 of 29 |
| Constipation | Gastrointestinal disorders | 15 of 25 | 11 of 28 | 11 of 29 |
| Hypertension | Vascular disorders | 4 of 25 | 14 of 28 | 12 of 29 |
| Anaemia | Blood and lymphatic system disorders | 11 of 25 | 11 of 28 | 8 of 29 |
| Vomiting | Gastrointestinal disorders | 9 of 25 | 8 of 28 | 11 of 29 |
| Asthenia | General disorders | 8 of 25 | 10 of 28 | 9 of 29 |
| Diarrhoea | Gastrointestinal disorders | 7 of 25 | 6 of 28 | 13 of 29 |
| Headache | Nervous system disorders | 7 of 25 | 11 of 28 | 7 of 29 |
| Decreased appetite | Metabolism and nutrition disorders | 5 of 25 | 11 of 28 | 9 of 29 |
Serious events with the highest arm-level rate: pneumonia (10.3%), febrile neutropenia (8.0%), abdominal pain (8.0%), pyrexia (6.9%), non-cardiac chest pain (6.9%).
The safety entries are reported by arm as counts of participants at risk and affected, alongside deaths. In the placebo/placebo arm, 6 of 25 participants at risk were affected by a serious adverse event, and 1 death was listed. In the demcizumab/placebo arm, 11 of 28 were affected, with 2 deaths listed. In the demcizumab/demcizumab arm, 15 of 29 were affected, with 2 deaths listed. These are the record's arm-level counts; they are not an efficacy comparison.
The record also lists serious adverse-event terms and percentages, including pneumonia at 10.3%, febrile neutropenia at 8.0%, abdominal pain at 8.0%, pyrexia at 6.9%, non-cardiac chest pain at 6.9%, and diarrhoea at 6.9%. The listed adverse-event information does not establish that an event was caused by a study treatment. The registry entry does not give enough detail to interpret the event-term percentages as comparative risks across arms.
Counts should be read with their at-risk denominators, and descriptive differences should not be treated as proof of a causal safety effect. The record does not report the statistical method for comparing these safety outcomes, confidence intervals, or a causal attribution assessment. Death counts are reported, but the cause of death and its relationship to treatment are not specified in the registry record recorded.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized phase 2 trial was conducted to compare carboplatin and pemetrexed with placebo or truncated courses of demcizumab in first-line stage IV non-squamous non-small cell lung cancer. It describes three treatment arms in the summary and arm details, and it specifies an investigator-assessed RECIST v1.1 response-rate endpoint. It also records selected safety counts by arm.
Those details do not establish what the primary response comparison found. The record does not report response counts, arm-specific rates, an effect estimate, a confidence interval, or a p-value. Without these results, it is not possible to describe the observed direction or size of a response difference, or to judge how precisely one was estimated. The absence of a reported result in this registry entry is not evidence that the groups had identical outcomes.
The endpoint is response, not survival or duration of response. Even if response findings were reported, they would answer a specific question about investigator-assessed best response during the stated assessment period. They would not, on their own, establish every aspect of clinical benefit or characterize outcomes beyond the measure and period studied.
The safety counts are also limited. They are descriptive entries for serious adverse events and deaths, not proof that a treatment caused or prevented those events. The registry record does not include enough information to compare overall safety with statistical precision or assess causal attribution.
Finally, the record does not report details of the primary analysis, handling of missing assessments, analysis population, or multiplicity. These omissions limit the ability to evaluate how the stated comparison was carried out. The most defensible interpretation is that the trial question and some design and safety information are documented, while the primary efficacy result and important analysis details are not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates why a trial design cannot be interpreted separately from its endpoint and analysis. The record describes three treatment schedules but defines the primary comparison by pooling the two demcizumab arms. A pooled estimate would address the combined group, whereas separate schedule estimates would address different questions. Without the results and the analysis rationale, readers cannot judge how the combined comparison relates to each schedule.
It also shows the importance of distinguishing a defined outcome from an available outcome result. The registry specifies a response measure, its assessment framework, and a time window, but does not report the response data or uncertainty. A well-described endpoint is not a substitute for an estimate. Statistical interpretation requires the outcomes observed in each comparison group and a clear account of how they were analyzed.
The difference between response and other clinical outcomes is another statistical point. Best overall response classifies whether a response was recorded under specified criteria; it is not a time-to-event measure. It should not be treated as interchangeable with progression or survival outcomes. The registry's endpoint description makes the measure clear in broad terms, while the absence of results prevents assessment of its actual comparison.
Finally, the record contains a discrepancy in its design wording: its titles say 2-arm, while its summary and arm descriptions specify three arms. This illustrates why registry entries need to be read across their descriptions rather than relying on one label. It also highlights the value of a complete statistical record, including the analysis population, missing-data rules, multiplicity approach, estimates, and measures of uncertainty. Those details allow readers to distinguish a precise result from a tentative one and a planned comparison from a post hoc interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation for statistical interpretation is that no primary response outcomes are reported in the registry record. There are no response counts, rates, effect estimates, confidence intervals, or test results. Consequently, the primary endpoint cannot be quantitatively evaluated from this record.
The study description is internally inconsistent about the number of arms. The titles describe a 2-arm study, whereas the brief summary and arm descriptions identify three arms with different demcizumab schedules. The endpoint description refers to combining the two demcizumab arms against the placebo/placebo arm. The record does not explain the discrepancy in the title or give a rationale for the pooled comparison.
Key analysis details are also not reported: the statistical model or comparison measure, the analysis population, treatment of missing or not-evaluable responses, confidence-interval method, and multiplicity strategy. The registry does not report whether interim analyses, stopping rules, or sensitivity analyses were used. These gaps make it impossible to assess the robustness of a primary estimate even if it were otherwise described.
The endpoint is investigator-assessed, and the record labels masking as triple while also calling the study double-blind in its titles and summary. It does not state which roles were masked or how masking was maintained. It also does not provide details of the response-assessment procedures beyond the RECIST v1.1 definition and assessment period.
The safety data are limited to listed counts and adverse-event terms. The registry record does not report comparative uncertainty, causal attribution, or enough detail to interpret all event percentages across arms. These limitations do not establish that the trial itself lacked methods or data; they describe what is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer — NCT02259582.
- Registry record last updated 2020-09-09; status last verified 2020-09.
- Results first posted 2018-08-20.
- 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
NCT02259582 is a completed randomized phase 2 study in first-line stage IV non-squamous non-small cell lung cancer. Its brief summary describes three arms: carboplatin and pemetrexed with placebo, with one course of demcizumab, or with two courses of demcizumab. The study titles describe a 2-arm design, in contrast to the three arms in the summary and arm descriptions.
The primary endpoint was investigator-assessed RECIST v1.1 response rate based on best overall response. The stated comparison was placebo/placebo against the two demcizumab arms combined, with response assessment continuing until alternative anti-cancer treatment or progressive disease, up to approximately 26 months.
The record reports enrollment of 82 and selected safety counts by arm. It does not report the primary response results, statistical uncertainty, detailed analysis methods, missing-data rules, or multiplicity approach. The efficacy findings and their precision therefore cannot be interpreted from the registry record.