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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02364999
Registration number
NCT02364999
Ethics application status
Date submitted
10/02/2015
Date registered
18/02/2015
Titles & IDs
Public title
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
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Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF- 06439535 PLUS PACLITAXEL-CARBOPLATIN AND BEVACIZUMAB PLUS PACLITAXEL -CARBOPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED NON-SQUAMOUS NON-SMALL CELL LUNG CANCER.
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Secondary ID [1]
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0
2014-003878-16
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Secondary ID [2]
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B7391003
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer
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0
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Condition category
Condition code
Cancer
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0
0
0
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Lung - Mesothelioma
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Cancer
0
0
0
0
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Lung - Non small cell
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Cancer
0
0
0
0
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab-Pfizer
Treatment: Drugs - Bevacizumab-EU
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Experimental: Bevacizumab-Pfizer - Bevacizumab-Pfizer plus paclitaxel and carboplatin
Active comparator: Bevacizumab-EU - Bevacizumab-EU plus paclitaxel and carboplatin
Treatment: Drugs: Bevacizumab-Pfizer
Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.
Treatment: Drugs: Bevacizumab-EU
bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.
Treatment: Drugs: Paclitaxel
Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
Treatment: Drugs: Carboplatin
carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR) by Week 19
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Assessment method [1]
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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.
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Timepoint [1]
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25 weeks
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Secondary outcome [1]
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Number of Participants With Treatment-Emergent Adverse Events
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Assessment method [1]
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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.
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Timepoint [1]
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55 weeks
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Secondary outcome [2]
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Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
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Assessment method [2]
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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).
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Timepoint [2]
0
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55 weeks
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Secondary outcome [3]
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Duration of Response (DOR)
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Assessment method [3]
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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.
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Timepoint [3]
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55 weeks
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Secondary outcome [4]
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Progression Free Survival Rate at 55 Weeks
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Assessment method [4]
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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.
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Timepoint [4]
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55 weeks
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Secondary outcome [5]
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Survival Rate at 55 Weeks
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Assessment method [5]
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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.
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Timepoint [5]
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55 weeks
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Secondary outcome [6]
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Serum Concentration of Bevacizumab up to 1 Year
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Assessment method [6]
0
0
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Timepoint [6]
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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
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Secondary outcome [7]
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Number of Participants With Anti-Drug Antibody (ADA)
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Assessment method [7]
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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.
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Timepoint [7]
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0
55 weeks
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Secondary outcome [8]
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Number of Participants With Neutralizing Antibody (NAb)
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Assessment method [8]
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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.
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Timepoint [8]
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55 weeks
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Eligibility
Key inclusion criteria
* Male and female patients age at least 18 years of age, or age of consent in the region.
* Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised International System for Staging Lung Cancer criteria of 2010) or recurrent non-small cell lung cancer (NSCLC).
* Histologically or cytologically confirmed diagnosis of predominately non-squamous NSCLC.
* Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin based on local standard of care, for the treatment of advanced or metastatic non-squamous NSCLC.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and mixed adenosquamous carcinomas of predominantly squamous nature.
* Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation that is likely to bleed.
* Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK translocation positive mutations.
* Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if surgical resection for primary disease was performed.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2017
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Sample size
Target
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Accrual to date
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Final
719
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Epic Pharmacy - Lismore
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Recruitment hospital [2]
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The Tweed Hospital - Tweed Heads
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Recruitment hospital [3]
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Cardiac Services, John Flynn Private Hospital - - Tugun
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Recruitment hospital [4]
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South Coast Radiology, John Flynn Private Hospital - Tugun
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Recruitment hospital [5]
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Austin Health - Olivia Newton - John Cancer & Wellness Centre - Heidelberg
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Recruitment hospital [6]
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Western Health, Sunshine Hospital - St Albans
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Recruitment postcode(s) [1]
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2480 - Lismore
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Recruitment postcode(s) [2]
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2485 - Tweed Heads
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Recruitment postcode(s) [3]
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4224 - Tugun
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3021 - St Albans
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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0
0
United States of America
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State/province [2]
0
0
California
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0
0
United States of America
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0
Connecticut
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0
0
United States of America
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0
0
Georgia
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0
0
United States of America
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0
0
Illinois
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0
0
United States of America
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0
0
Maryland
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0
0
United States of America
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0
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New Jersey
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0
0
United States of America
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Texas
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0
0
Brazil
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Bahia
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0
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Brazil
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Ceara
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Brazil
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Minas Gerais
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Brazil
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Parana
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Brazil
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RIO Grande DO SUL
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Brazil
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Santa Catarina
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Brazil
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SAO Paulo
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Bulgaria
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State/province [18]
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Shumen
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Chile
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State/province [19]
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Region DE LA Araucania
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Chile
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Region Metropolitana
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Chile
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Región DE LA Araucanía
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Chile
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V Region
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Croatia
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Zagreb
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Czechia
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State/province [24]
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Nova Ves pod Plesi
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Czechia
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Novy Jicin
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Czechia
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Pelhrimov
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Pribram
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France
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Mont De Marsan Cedex
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France
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Montbeliard
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France
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Nantes Cedex
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France
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Toulon Cedex 9
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Germany
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Bayreuth
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Germany
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Berlin
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Germany
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Braunschweig
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Germany
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Coswig
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Germany
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Dresden
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Germany
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Esslingen a.N.
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Germany
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Frankfurt am Main
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Germany
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Gauting
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Germany
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Groebenzell
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Germany
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Halle (Saale)
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Homburg/Saar
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Germany
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Karlsruhe
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Germany
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Koblenz
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Germany
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Leer
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Germany
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Leipzig
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Germany
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Moers
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Germany
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Neumuenster
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Greece
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Crete
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Athens
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Greece
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Patras
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Thessaloniki
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Budapest
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Deszk
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Hungary
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Farkasgyepu
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Hungary
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Gyor
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Hungary
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Matrahaza
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Hungary
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Szolnok
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Hungary
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Torokbalint
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Hungary
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Zalaegerszeg
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Maharashtra
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India
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Rajasthan
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Italy
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BG
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Italy
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BS
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Italy
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CT
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Italy
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FC
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Italy
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LU
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Italy
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RM
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Italy
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SO
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Italy
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VR
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Japan
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Aomori
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Ishikawa
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Japan
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Kanagawa
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MIE
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Japan
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Miyagi
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Kochi
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Japan
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Oita
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Japan
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Okayama
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Korea, Republic of
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Chungcheongbuk-do
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Gangdong-gu
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Gyeonggi-do
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Seoul
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Malaysia
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Negeri Sembilan
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Penang
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Arnhem
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Netherlands
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Ede
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Netherlands
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Helmond
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Cebu
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Philippines
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Davao DEL SUR
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Poland
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Elblag
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Lodz
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Rzeszow
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Szczecin-Zdunowo
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Constanta
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Timisoara
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Vinnytsia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Pfizer
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Summary
Brief summary
This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
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Trial website
https://clinicaltrials.gov/study/NCT02364999
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Trial related presentations / publications
Li CSW, Sweeney K, Cronenberger C. Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin(R)) in patients with advanced non-squamous non-small cell lung cancer. Cancer Chemother Pharmacol. 2020 Mar;85(3):487-499. doi: 10.1007/s00280-019-03946-8. Epub 2019 Nov 26. Reinmuth N, Bryl M, Bondarenko I, Syrigos K, Vladimirov V, Zereu M, Bair AH, Hilton F, Liau K, Kasahara K. PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin(R)), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study. BioDrugs. 2019 Oct;33(5):555-570. doi: 10.1007/s40259-019-00363-4.
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Public notes
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Contacts
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/99/NCT02364999/SAP_000.pdf
Study protocol
https://cdn.clinicaltrials.gov/large-docs/99/NCT02364999/Prot_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02364999