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A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

Last updated on April 6, 2018

FOR MORE INFORMATION
Study Location
Southern Cancer Center
Daphne, Alabama, 36526 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Small Cell Lung Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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) for which they had not received chemotherapy for metastatic
disease.

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 in the opinion of the investigator is likely to bleed.

- Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK
translocation positive mutations.

NCT02364999
Pfizer
Completed
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC

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A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Drug: 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.
  • Experimental: Bevacizumab-Pfizer
    Bevacizumab-Pfizer plus paclitaxel and carboplatin
    Interventions:
    • Drug: Bevacizumab-Pfizer
    • Drug: Paclitaxel
    • Drug: Carboplatin
  • Active Comparator: Bevacizumab-EU
    Bevacizumab-EU plus paclitaxel and carboplatin
    Interventions:
    • Drug: Bevacizumab-EU
    • Drug: Paclitaxel
    • Drug: Carboplatin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
719
December 2017
May 2017   (Final data collection date for primary outcome measure)

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.

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Bulgaria,   Chile,   Croatia,   Czechia,   France,   Germany,   Greece,   Hungary,   India,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Philippines,   Poland,   Romania,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Turkey,   Ukraine,   United States
Czech Republic,   Hong Kong,   Slovakia
 
NCT02364999
B7391003
2014-003878-16 ( EudraCT Number )
B7391003 ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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