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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02364999




Registration number
NCT02364999
Ethics application status
Date submitted
10/02/2015
Date registered
18/02/2015
Date last updated
7/02/2019

Titles & IDs
Public title
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
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.
Secondary ID [1] 0 0
2014-003878-16
Secondary ID [2] 0 0
B7391003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR) by Week 19 - 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.
Timepoint [1] 0 0
25 weeks
Secondary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events - 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.
Timepoint [1] 0 0
55 weeks
Secondary outcome [2] 0 0
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) - 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).
Timepoint [2] 0 0
55 weeks
Secondary outcome [3] 0 0
Duration of Response (DOR) - 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.
Timepoint [3] 0 0
55 weeks
Secondary outcome [4] 0 0
Progression Free Survival Rate at 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.
Timepoint [4] 0 0
55 weeks
Secondary outcome [5] 0 0
Survival Rate at 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.
Timepoint [5] 0 0
55 weeks
Secondary outcome [6] 0 0
Serum Concentration of Bevacizumab up to 1 Year
Timepoint [6] 0 0
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 outcome [7] 0 0
Number of Participants With Anti-Drug Antibody (ADA) - 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.
Timepoint [7] 0 0
55 weeks
Secondary outcome [8] 0 0
Number of Participants With Neutralizing Antibody (NAb) - 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.
Timepoint [8] 0 0
55 weeks

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Epic Pharmacy - Lismore
Recruitment hospital [2] 0 0
The Tweed Hospital - Tweed Heads
Recruitment hospital [3] 0 0
Cardiac Services, John Flynn Private Hospital - - Tugun
Recruitment hospital [4] 0 0
South Coast Radiology, John Flynn Private Hospital - Tugun
Recruitment hospital [5] 0 0
Austin Health - Olivia Newton - John Cancer & Wellness Centre - Heidelberg
Recruitment hospital [6] 0 0
Western Health, Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 0 0
2480 - Lismore
Recruitment postcode(s) [2] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [3] 0 0
4224 - Tugun
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
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United States of America
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Alabama
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California
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Connecticut
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Georgia
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Illinois
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Maryland
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Shumen
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Chile
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Chile
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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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Nova Ves pod Plesi
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Leer
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Chungcheongbuk-do
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Gangdong-gu
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Negeri Sembilan
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Arnhem
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Helmond
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Wodzislaw-Slaski
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Romania
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Dolj
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Cluj-Napoca
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Constanta
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Craiova
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Jud Cluj
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Romania
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Timisoara
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Russian Federation
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Moscow Region
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Russian Federation
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Ryshkovskiy Village Council
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Russian Federation
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Russian Federation
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Udmurt Republic
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Russian Federation
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Russian Federation
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Arkhangelsk
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Russian Federation
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Ryazan
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Saint Petersburg
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Sochi
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Gauteng
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South Africa
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Kwa-zulu Natal
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South Africa
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Western CAPE
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Valencia
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Taiwan
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Changhua
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Thailand
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Bangkok
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Thailand
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Chiang RAI
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Thailand
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Phitsanulok
Country [146] 0 0
Turkey
State/province [146] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Ukraine
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Ukraine
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Chernivtsi
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Dnipropetrovsk
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Kharkiv
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Kryvyi Rih
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Lviv
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Poltava
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Sumy
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Uzhhorod
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Vinnytsia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT02364999
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications