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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
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
Timepoint [1] 0 0
25 weeks
Secondary outcome [1] 0 0
Number of Participants With Treatment-Emergent Adverse Events
Timepoint [1] 0 0
55 weeks
Secondary outcome [2] 0 0
Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality)
Timepoint [2] 0 0
55 weeks
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
55 weeks
Secondary outcome [4] 0 0
Progression Free Survival Rate at 55 Weeks
Timepoint [4] 0 0
55 weeks
Secondary outcome [5] 0 0
Survival Rate at 55 Weeks
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)
Timepoint [7] 0 0
55 weeks
Secondary outcome [8] 0 0
Number of Participants With Neutralizing Antibody (NAb)
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
Sex
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
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2017
Sample size
Target
Accrual to date
Final
719
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
Country [1] 0 0
United States of America
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Alabama
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Maryland
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New Jersey
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Texas
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Bahia
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Parana
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RIO Grande DO SUL
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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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Sao Paulo
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Bulgaria
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Shumen
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Chile
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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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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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Czechia
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Pribram
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Montbeliard
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Dresden
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Gauting
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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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BG
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BS
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CT
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FC
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LU
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RM
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SO
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Jud Cluj
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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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
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Turkey
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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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KYIV Region
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Ukraine
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Chernivtsi
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Ukraine
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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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Sumy
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Uzhhorod
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Ukraine
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT02364999