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 Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer (NCT03713944), a na phase 2 study. The primary outcome is Progression Free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03713944 |
| Phase | Phase 2 |
| Condition | NSCLC Stage IV, NSCLC, Recurrent |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Nasser Hanna |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned chemotherapy- and immunotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer. The registry also lists recurrent non-small cell lung cancer as a condition. Enrollment was 30. Eligibility details beyond the description of the intended population are not reported in the registry record.
Intervention
Participants were assigned to a regimen of carboplatin, pemetrexed, atezolizumab and bevacizumab. Treatment was planned every 3 weeks for up to 4 cycles. Patients without progressive disease after those cycles could continue maintenance pemetrexed, atezolizumab and bevacizumab until progression or intolerable toxicity.
Comparator
There was no separate comparator group. The design is identified as single-group, and allocation is listed as not applicable. Consequently, the study does not provide a randomized, concurrent control comparison for estimating how outcomes differ from another treatment.
Primary question
The primary endpoint was progression-free survival: the time from treatment initiation until disease progression or death. The study asked how long participants remained alive without progression while receiving the regimen. The registry record does not report the median progression-free survival or its confidence interval, so the endpoint result cannot be described from the record.
This is a phase II study, so its design centers on describing outcomes in a defined treatment group rather than making a randomized treatment comparison. The primary endpoint uses time-to-event information: each participant contributes follow-up until progression or death, or until follow-up ends without either event. The registry describes progression using RECIST criteria and defines the endpoint timeframe as from C1D1 until progression or death, up to a maximum of 20 Months.
The clinical question is therefore narrower than whether the regimen is better than another option. Without a comparator group, outcomes cannot separate the regimen's effects from other influences on disease course, patient characteristics or care. The registry record also does not report the endpoint estimate, so it cannot establish the observed duration of progression-free survival in this study.
3. Trial Design
The registry describes a multicenter, single-arm phase II study. Its status is terminated. Enrollment was 30. The record lists Nasser Hanna as sponsor and gives the study start as 2018-11-15 and primary completion as 2021-12-16. The reason for termination is not reported in the registry record.
All eligible participants were to receive carboplatin, pemetrexed, atezolizumab and bevacizumab. The regimen was scheduled every 3 weeks for up to 4 cycles. Patients with non-progressive disease after those cycles could continue maintenance pemetrexed, atezolizumab and bevacizumab until disease progression or intolerable toxicities. This describes the planned treatment pathway; the registry record does not report how many participants completed each treatment stage or received maintenance.
The study has no masking and no allocation to a control arm. In a single-group design, the outcome distribution describes the enrolled participants under the study regimen, but it cannot by itself estimate a treatment contrast against a concurrent control. Differences from outcomes in another population or study could reflect patient selection, follow-up, disease characteristics or other aspects of care as well as treatment.
The registry record identifies progression-free survival as the primary outcome and lists overall response rate, disease control rate, overall survival and adverse events among secondary outcomes. It also lists five outcome measures but no analysis entries. Numerical results for the primary endpoint and the listed secondary outcomes are not reported in the registry record. The protocol's sample-size justification, any interim analysis plan and the detailed statistical analysis plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Study Treatment
| Stage | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|
| STARTED | 30 |
| COMPLETED | 0 |
| NOT COMPLETED | 30 |
Reasons for not completing this period:
| Reason | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|
| Patient non-compliance | 1 |
| Alternative Cancer Therapy | 3 |
| Disease Progression | 18 |
| AE/Side Effects/Complications | 2 |
| Death | 2 |
| Withdrawal by Subject | 1 |
| Subject decided to come off study due to hip replacement | 1 |
| Symptomatic Deterioration | 2 |
Follow up
| Stage | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|
| STARTED | 30 |
| COMPLETED | 14 |
| NOT COMPLETED | 16 |
Reasons for not completing this period:
| Reason | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|
| Withdrawal by Subject | 2 |
| Death | 11 |
| Study Terminated | 3 |
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 | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|---|
| Participants analysed | 30 | |
| Age, Continuous | years | 64 (38 to 83) |
| Sex/Gender, Customized: Gender – Female | Participants | 20 |
| Sex/Gender, Customized: Gender – Male | Participants | 10 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 2 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 28 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: RACE – Asian | Participants | 3 |
| Race/Ethnicity, Customized: RACE – Black or African American | Participants | 5 |
| Race/Ethnicity, Customized: RACE – Multiple (White and Asian) | Participants | 1 |
| Race/Ethnicity, Customized: RACE – Unknown | Participants | 1 |
| Race/Ethnicity, Customized: RACE – White | Participants | 20 |
| Disease Status at Study Entry: Recurrent Disease | Participants | 3 |
| Disease Status at Study Entry: Stage IV | Participants | 27 |
| PD-L1 Expression Category(Dako 22C3): <1 % | Participants | 8 |
| PD-L1 Expression Category(Dako 22C3): 1-49 % | Participants | 15 |
| PD-L1 Expression Category(Dako 22C3): >=50 % | Participants | 7 |
| Primary Histology: Adenocarcinoma | Participants | 26 |
| Primary Histology: NSCLC, NOS | Participants | 4 |
| Smoking Status: Former (not actively smoking) | Participants | 22 |
| Smoking Status: Never (Less than 100 cigarettes in a lifetime) | Participants | 8 |
| Received chemotherapy previously: No | Participants | 24 |
| Received chemotherapy previously: Yes | Participants | 6 |
| Baseline ECOG: 0 | Participants | 10 |
| Baseline ECOG: 1 | Participants | 20 |
| EGFR Mutation testing done: No | Participants | 2 |
| EGFR Mutation testing done: Yes | Participants | 28 |
| ALK Mutation testing done: No | Participants | 4 |
| ALK Mutation testing done: Yes | Participants | 26 |
| ROS-1 Rearrangement testing done: No | Participants | 7 |
| ROS-1 Rearrangement testing done: Yes | Participants | 23 |
| HER-2 Mutation testing done: No | Participants | 23 |
| HER-2 Mutation testing done: Yes | Participants | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Progression Free Survival, measured over From C1D1 until progression or death up to maximum of 20 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 treatment initiation until disease progression or death. It combines two clinically relevant ways follow-up can end: documented worsening of disease and death from any cause. The registry defines progression using RECIST criteria, referring to changes in target lesions, non-target lesions or the appearance of new lesions. The described timeframe is from C1D1 until progression or death up to maximum of 20 Months.
Time-to-event endpoints are useful when the timing of an event matters and participants may have different lengths of follow-up. A median summarizes the time by which half of the event-time distribution has been reached, when the data allow that quantity to be estimated. A confidence interval conveys uncertainty around an estimate; a wider interval generally indicates less precision. These are general statistical explanations, not reported study results.
The registry identifies the primary endpoint as a median with a 95% confidence interval, but the median and interval values are not reported in the registry record. The record also does not report the number of progression or death events, the censoring details, or the method used to calculate the interval. Therefore, the endpoint definition is available, but its numerical estimate and precision cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supports a description of study design and intended treatment, but not an account of the primary efficacy result. It identifies a phase II, single-group study with enrollment of 30 and progression-free survival as the primary endpoint. The median progression-free survival and its 95% confidence interval are not reported in the registry record. No conclusion about the observed duration or precision of progression-free survival can therefore be drawn from these entries.
Because the study has no concurrent control group, any outcome observed within the treated group would be descriptive. A single-group result cannot directly show how outcomes would have differed under another regimen or under no study treatment. Even if an outcome estimate were available, it would not isolate the treatment contribution from participant characteristics, disease course, follow-up patterns or other care. This is a design limitation, not a claim about the treatment's effect.
The status is terminated, but the reason for termination is not reported in the registry record. Termination alone does not indicate whether the study stopped for safety, recruitment, operational, efficacy or other reasons. Those explanations should not be inferred. The record also does not report the number treated, follow-up completeness, or whether every enrolled participant contributed to the primary analysis.
The adverse-event entries describe counts in the treatment group. They list 12 participants affected by serious adverse events, 30 affected by other adverse events, and 11 deaths. These figures should be read as reported safety summaries, not as evidence that the regimen caused each event or death. The record does not supply attribution, timing, exposure duration, event-level detail or a comparator that could support a causal contrast.
Interpretation is also constrained by the absence of analysis entries and numerical efficacy results. The record lists secondary outcomes, but does not report their estimates. It does not provide a stated analysis population, missing-data approach, or detailed statistical plan. Thus, the design and outcome definitions can be described, while treatment effects, statistical uncertainty and the reasons for study termination remain unestablished by the registry record.
9. Statistical Methods Explained
Progression-free survival is a time-to-event endpoint. For each participant, the relevant time starts at treatment initiation and ends at the first qualifying event, progression or death. The registry definition counts death from any cause and describes progression according to RECIST criteria. A time-to-event analysis can use information from participants with different follow-up durations, including those whose event has not been observed by the end of follow-up. Such participants are generally censored at their last known event-free time, but the censoring rules used in this study are not reported in the registry record.
What does the median describe?
A median time-to-event estimate is a summary of the event-time distribution. It is the point at which the estimated proportion remaining event-free reaches the halfway point, if the observed follow-up supports estimating that point. It is not the average time for every participant, and it does not describe what will happen to any particular person. The registry lists a median as the primary summary, but its value is not reported in the registry record.
What does a confidence interval add?
A confidence interval expresses statistical uncertainty around an estimate under the assumptions of the analysis method. It is not a range containing a fixed proportion of individual participants' event times. Its width reflects the information available and the method used. The registry identifies a 95% confidence interval for the primary endpoint, but does not report its bounds or the method used to calculate it. Without those values, the precision of the primary estimate cannot be evaluated.
How should the single-group design be understood?
In a single-group study, the analysis describes outcomes among participants who received the study regimen. There is no randomized comparison to balance prognostic factors across treatment groups. A difference between this group's outcomes and an external benchmark would not automatically represent a treatment effect, because populations, outcome assessment and follow-up could differ. The registry lists allocation as not applicable and the model as single-group; it does not report a concurrent control arm.
The record's planning assumptions describe a normal-approximation illustration with two-sided significance level 0.05 and equal allocation between two arms, with an effect defined as a stated fraction of the observed effect. That planning framework does not match the listed single-group design as a direct observed comparison. A planning illustration is not an observed result or observed power. The registry does not report the illustration's resulting sample-size values, the protocol's own sample-size justification, or a rationale explaining its relation to the trial design.
What do the analysis entries show?
The record lists no analysis entries. It does not report a hazard ratio or a statistical comparison for progression-free survival. It also does not report a test statistic, p-value, model specification, or covariate adjustment. These omissions prevent evaluation of inferential results, but do not establish that no analysis was conducted outside the registry record. The analysis plan is not reported in the registry record.
Why do event definitions and follow-up matter?
Time-to-event estimates depend on clear event definitions, consistent assessment and adequate follow-up. The registry describes progression criteria and sets a maximum timeframe of 20 Months, but does not report assessment schedules, independent review, censoring rules, follow-up distribution or the number of observed events. These details help assess whether participants were observed comparably and how much information supports an estimate. Their absence from the registry record means those aspects cannot be evaluated.
More generally, a median and confidence interval provide complementary information: the median locates the estimated event-time summary, while the interval conveys its uncertainty. Neither alone establishes a causal treatment effect in a single-group study. The values needed to assess the primary endpoint's magnitude and precision are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists progression-free survival as the primary outcome and names overall response rate, disease control rate, overall survival and adverse events among secondary outcomes. When a study evaluates several outcomes, multiplicity can arise if many statistical tests are used to support claims. Repeated testing can increase the chance of at least one apparently notable result by chance. This is a general statistical issue; the registry record does not report a multiplicity adjustment, testing hierarchy or strategy for interpreting the secondary outcomes.
There are no analysis entries listed, and numerical results for the primary and secondary outcomes are not reported in the registry record. It is therefore not possible to determine which outcomes were analyzed, whether analyses were prespecified, or how any statistical uncertainty was handled. The detailed statistical plan is not reported in the registry record.
Missing-data handling is also not described. For a time-to-event endpoint, follow-up that ends before a recorded progression or death may be handled through censoring, but the rules for censoring and the completeness of follow-up are not reported in the registry record. The record does not describe reasons for missing assessments, withdrawals, or how such cases entered the primary analysis.
The analysis population is not reported in the registry record. It is not stated whether the primary analysis included all enrolled participants, only participants who began treatment, or another defined group. The record also does not describe deviations from assigned treatment or how they were handled. These gaps limit interpretation of both the endpoint and the safety summaries; they should not be filled by assuming a conventional analysis approach.
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 |
|---|---|---|---|
| Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab | 12 | 30 | 40.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab | 11 of 30 |
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 |
|---|---|
| Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab | 30 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|---|
| BACK PAIN | Musculoskeletal and connective tissue disorders | 2 of 30 |
| THROMBOEMBOLIC EVENT | Vascular disorders | 2 of 30 |
| ANEMIA | Blood and lymphatic system disorders | 1 of 30 |
| COLONIC PERFORATION | Gastrointestinal disorders | 1 of 30 |
| CONFUSION | Psychiatric disorders | 1 of 30 |
| DEATH NOS | General disorders | 1 of 30 |
| ESOPHAGEAL STENOSIS | Gastrointestinal disorders | 1 of 30 |
| FALL | Injury, poisoning and procedural complications | 1 of 30 |
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | 1 of 30 |
| GASTROINTESTINAL DISORDERS - OTHER, SPECIFY | Gastrointestinal disorders | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab |
|---|---|---|
| FATIGUE | General disorders | 27 of 30 |
| HYPERTENSION | Vascular disorders | 24 of 30 |
| CONSTIPATION | Gastrointestinal disorders | 21 of 30 |
| NAUSEA | Gastrointestinal disorders | 21 of 30 |
| ANEMIA | Blood and lymphatic system disorders | 18 of 30 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 18 of 30 |
| DYSPNEA | Respiratory, thoracic and mediastinal disorders | 17 of 30 |
| INSOMNIA | Psychiatric disorders | 16 of 30 |
| HYPERLIPIDEMIA | Metabolism and nutrition disorders | 15 of 30 |
| VOMITING | Gastrointestinal disorders | 13 of 30 |
Serious events with the highest arm-level rate: back pain (6.7%), thromboembolic event (6.7%), anemia (3.3%), colonic perforation (3.3%), confusion (3.3%).
The registry reports serious adverse events for the single treatment group. It lists 30 participants at risk for serious events and 12 affected. For other adverse events, it lists 30 at risk and 30 affected. The record lists 11 deaths. These are separate registry summaries and should not be added together: the entries do not establish that the categories are mutually exclusive or describe overlap among events and participants.
The serious-event terms with the largest listed percentages are back pain and thromboembolic event, each at 6.7%. Anemia, colonic perforation, confusion and death NOS are each listed at 3.3%. These figures are registry summaries; the record does not give detailed event narratives, timing, duration, severity grading beyond the serious-event designation, or the number of events per affected participant.
Counts and listed percentages do not establish causation. The record does not report whether events were judged related to treatment, whether deaths were treatment-related, or the timing of events relative to exposure. With no comparator group, the safety entries cannot estimate a comparative risk. They describe what the registry reports for this group, with important attribution and context details not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a phase II, single-group study of carboplatin, pemetrexed, atezolizumab and bevacizumab in chemotherapy- and immunotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer. It establishes that progression-free survival was the primary endpoint and records an enrollment of 30. It also describes the planned initial and maintenance treatment pathway and provides limited adverse-event summaries.
The record does not report a median progression-free survival or its 95% confidence interval. It therefore does not establish the observed primary endpoint result or its precision. Numerical results for the listed secondary outcomes are also not reported in the registry record. The status is terminated, but the reason is not reported and cannot be inferred from status alone.
Even if outcome estimates were available, the single-group design would not provide a randomized comparison with another treatment. Outcomes in the enrolled group could reflect the treatment, characteristics of the participants, disease course, supportive care or other influences. The design cannot separate these explanations through a concurrent control contrast.
The safety counts should likewise be treated as descriptive registry entries, not as proof that the regimen caused the reported events or deaths. The record does not include event attribution or a comparison group. It does not report the analysis population, missing-data procedures, detailed statistical analysis plan or follow-up completeness.
Accordingly, the registry record supports statements about the intended study design, endpoint definition and recorded safety summaries. It does not support a quantified claim about progression-free survival, a comparative treatment effect, or a causal interpretation of adverse events. These distinctions are important when reading a study whose record contains design information but not reported efficacy estimates.
13. Why This Trial Matters Statistically
This study illustrates the difference between an outcome definition and an outcome result. The registry specifies progression-free survival as the primary endpoint and describes how progression is defined, but does not report the estimate or its confidence interval. A clearly named endpoint is not enough to assess the result: readers also need the observed estimate, its uncertainty and information about follow-up and analysis.
The single-group design also highlights the boundary between describing outcomes and estimating comparative effects. A treatment group's observed experience can be informative descriptively, but without a concurrent control it cannot directly show how outcomes compare under another treatment. This matters when interpreting phase II studies and when considering whether an observed pattern represents a treatment effect.
The record's terminated status and safety counts call for context rather than speculation. The reason for termination and event attribution are not reported in the registry record. Neither status nor event counts alone explains why the study ended or whether treatment caused a reported event.
Finally, the record illustrates why analysis details matter. The population included in the primary analysis, handling of missing follow-up, multiplicity strategy and statistical plan are not reported. These choices affect how estimates are calculated and interpreted. Their absence means the design can be described, but the statistical strength and clinical meaning of efficacy findings cannot be judged from the registry record.
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 most direct limitation is that the registry record does not report the primary endpoint estimate or its confidence interval. It also does not report numerical results for the listed secondary outcomes. Without these results, the study's observed efficacy outcomes cannot be described or assessed for precision.
The study is single-group and has no concurrent randomized comparator. This limits causal interpretation: outcomes cannot be contrasted within the study against another treatment group. The record also does not report a sample-size justification, and the listed planning assumptions describe equal allocation between two arms despite the single-group design. The relationship between that planning illustration and the actual study design is not explained in the registry record.
The reason for termination is not reported. The record does not say how many participants completed treatment, received maintenance therapy, or remained under follow-up. It does not give the number of primary endpoint events, assessment schedule, censoring rules or follow-up completeness.
Analysis details are limited. The record does not report an analysis population, missing-data method, multiplicity approach, statistical model, or detailed analysis plan. Safety interpretation is also constrained because event attribution, timing and detailed event descriptions are not reported. These limitations concern the information available in the registry record; they do not establish what may have been analyzed or documented elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer — NCT03713944.
- Registry record last updated 2023-03-01; status last verified 2023-02.
- Results first posted 2023-03-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a multicenter, single-arm phase II study of carboplatin, pemetrexed, atezolizumab and bevacizumab for chemotherapy- and immunotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer. Enrollment was 30. The study status is terminated; the reason is not reported in the registry record.
Progression-free survival was the primary endpoint, defined as time from treatment initiation to progression or death. Its median and 95% confidence interval are not reported in the registry record. Secondary outcomes include overall response rate, disease control rate, overall survival and adverse events, without numerical outcome results listed.
The safety entries list 12 participants affected by serious adverse events, 30 affected by other adverse events and 11 deaths. The record does not report event attribution or a comparative control group. Analysis populations, missing-data procedures and the detailed statistical plan are not reported in the registry record.