Trial · NCT02364999
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
NCT02364999, Phase 3, Completed, Pfizer; results first posted 2018-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC. Trials, record NCT02364999. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02364999
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
- NCT number
- NCT02364999
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 719 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- Bevacizumab-Pfizer, Bevacizumab-EU, Paclitaxel, Carboplatin
- First posted
- 2015-02-18
- Last updated
- 2019-02-07
- Other registries' IDs
- eudract:2014-003878-16
- Results first posted
- 2018-06-27
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) by Week 19 | 25 weeks | ORR refers to percentage of participants who achieved complete response (CR) or partial response (PR) by Week 19 of the study in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 which was subsequently confirmed by Week 25. A participant achieved CR if both target and non-target lesions achieved CR, no new lesions; achieved PR if target lesions achieved CR or PR, non-target lesions were assessed as non-CR/non-PD (progressive disease), indeterminate or missing, and no new lesions. For target lesions, CR: complete disappearance of all target lesions except nodal disease (target nodes must decrease to normal size); PR: \>= 30% decrease under baseline of the sum of diameters of all target measurable lesions. For non-target lesions, CR: disappearance of all non-target lesions and normalization of tumor marker levels and all lymph nodes must be normal in size; non-CR/non-PD: persistence of any non-target lesions and/or tumor marker level above the normal limits. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events | 55 weeks | AE was defined as any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of the causal relationship to study treatment. Treatment-emergent AEs (TEAEs) were defined as AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. |
| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 55 weeks | Laboratory evaluation included hematology (hemoglobin, white blood cells, platelets and absolute neutrophil count), blood chemistry (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum or plasma creatinine, sodium, potassium, total calcium, magnesium, blood urea nitrogen or urea, and albumin ), coagulation (international normalized ratio for prothrombin time and activated partial thromboplastin time) and urinalysis (dipstick followed by a quantitative urine protein analysis for results of 2+ or greater). |
| Secondary | Duration of Response (DOR) | 55 weeks | DOR was defined as the time from date of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause in the absence of documented PD. DOR was based on the Brookmeyer and Crowley method. |
| Secondary | Progression Free Survival Rate at 55 Weeks | 55 weeks | This outcome measure refers to the possibility of being progression free at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method. |
| Secondary | Survival Rate at 55 Weeks | 55 weeks | This outcome measure refers to the possibility of being alive at 55 weeks since start of study treatment, estimated from the Kaplan-Meier curve using the product-limit method. |
| Secondary | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5 | |
| Secondary | Number of Participants With Anti-Drug Antibody (ADA) | 55 weeks | ADA assay was performed using a sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) method, which used biotinylated- and ruthenium-labeled PF-06439535 as reagents. Samples with ADA titer greater than or equal to (\>=) 2.29 were considered positive. |
| Secondary | Number of Participants With Neutralizing Antibody (NAb) | 55 weeks | Only samples that were confirmed positive for ADA were further tested for NAb. The NAb analysis was conducted using a single validated quasi-quantitative enzyme-linked immunosorbent assay (ELISA) that utilized PF-06439535 as a reagent. Samples with NAb titer \>=1.70 were considered positive. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) by Week 19 | 25 weeks | The Intent-to-Treat (ITT) population was used for analysis of ORR, and it included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events | 55 weeks | The analysis population included all participants who were randomized and received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | 55 weeks | The analysis population included all participants who were randomized and received at least 1 dose of study treatment, and had laboratory evaluation done. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Response (DOR) | 55 weeks | The analysis population included participants in ITT population (all participants who were randomized to study treatment) who had a confirmed objective response achieved by Week 19. | weeks | MEDIAN |
| SECONDARY | Progression Free Survival Rate at 55 Weeks | 55 weeks | The ITT population was used for analysis, and it included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Survival Rate at 55 Weeks | 55 weeks | The ITT population was used for analysis, and it included all participants who were randomized to study treatment. | percentage of participants | NUMBER |
| SECONDARY | Serum Concentration of Bevacizumab up to 1 Year | Pre-dose from Cycle 1 to Cycle 17, 2.5 hours post-dose in Cycle 1, and 1.5 hours post-dose in Cycle 5 | The analysis population included all participants in the per-protocol population (all participants who were randomized and received study treatment as planned and had no major protocol deviations) who had at least 1 drug concentration measurement after administration of study treatment. | ng/mL | MEAN |
| SECONDARY | Number of Participants With Anti-Drug Antibody (ADA) | 55 weeks | The analysis population included all participants who were randomized and received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Neutralizing Antibody (NAb) | 55 weeks | The analysis population included all participants who had positive ADA results at any time point. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) by Week 19 | PF-06439535 | 45.3 | 95% Confidence Interval 40.01 to 50.57 | percentage of participants | |
| Objective Response Rate (ORR) by Week 19 | Bevacizumab-EU | 44.6 | 95% Confidence Interval 39.40 to 49.89 | percentage of participants | |
| Number of Participants With Treatment-Emergent Adverse Events | PF-06439535 | All-causality AE | 344 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-EU | All-causality AE | 347 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | PF-06439535 | All-causality SAE | 81 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-EU | All-causality SAE | 80 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | PF-06439535 | Bevacizumab-related AE | 190 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-EU | Bevacizumab-related AE | 199 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | PF-06439535 | Bevacizumab-related SAE | 23 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events | Bevacizumab-EU | Bevacizumab-related SAE | 17 | Participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-06439535 | 358 | |
| Overall Study | STARTED | Bevacizumab-EU | 361 | |
| Overall Study | Received Treatment | PF-06439535 | 356 | |
| Overall Study | Received Treatment | Bevacizumab-EU | 358 | |
| Overall Study | COMPLETED | PF-06439535 | 193 | |
| Overall Study | COMPLETED | Bevacizumab-EU | 188 | |
| Overall Study | NOT COMPLETED | PF-06439535 | 165 | |
| Overall Study | NOT COMPLETED | Bevacizumab-EU | 173 |
Source ClinicalTrials.gov
Adverse events435
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Leukopenia | Blood and lymphatic system disorders | PF-06439535 | 26 | 356 | 44 |
| other | Leukopenia | Blood and lymphatic system disorders | Bevacizumab-EU | 30 | 358 | 56 |
| other | Leukopenia | Blood and lymphatic system disorders | Total | 56 | 714 | 100 |
| other | Neutropenia | Blood and lymphatic system disorders | PF-06439535 | 59 | 356 | 130 |
| other | Neutropenia | Blood and lymphatic system disorders | Bevacizumab-EU | 66 | 358 | 144 |
| other | Neutropenia | Blood and lymphatic system disorders | Total | 125 | 714 | 274 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | PF-06439535 | 55 | 356 | 122 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Bevacizumab-EU | 66 | 358 | 125 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Total | 121 | 714 | 247 |
| other | Constipation | Gastrointestinal disorders | PF-06439535 | 39 | 356 | 45 |
1 to 10 of 435Source ClinicalTrials.gov
See all 435 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-06439535 | 144 | 356 |
| Total, all-cause mortality | Bevacizumab-EU | 149 | 358 |
| Total, all-cause mortality | Total | 293 | 714 |
| Total, other adverse events | PF-06439535 | 328 | 356 |
| Total, other adverse events | Bevacizumab-EU | 333 | 358 |
| Total, other adverse events | Total | 661 | 714 |
| Total, serious adverse events | PF-06439535 | 81 | 356 |
| Total, serious adverse events | Bevacizumab-EU | 80 | 358 |
| Total, serious adverse events | Total | 161 | 714 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PF-06439535 vs Bevacizumab-EU: Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02364999
GET https://conductscience.org/api/trials/v1/NCT02364999/results?page=2