| 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.
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| Not Provided |
| |
| 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.
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| 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 |
