A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/9/2019 |
Start Date: | April 2015 |
End Date: | December 2017 |
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.
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.
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.
We found this trial at
20
sites
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