Phase 3
Completed N=719
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
Source: ClinicalTrials.gov NCT02364999 ↗Enrolled (actual)
719
Serious AEs
22.6%
Results posted
Jun 2018
Primary outcomePrimary: Objective Response Rate (ORR) by Week 19 — 45.3; 44.6 percentage of participants
◆ Published Evidence
Established
56citations · ~8 / year
PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin<sup>®</sup>), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.
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.
Linked Publications (2)
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PF-06439535 (a Bevacizumab Biosimilar) Compared with Reference Bevacizumab (Avastin<sup>®</sup>), Both Plus Paclitaxel and Carboplatin, as First-Line Treatment for Advanced Non-Squamous Non-Small-Cell Lung Cancer: A Randomized, Double-Blind Study.
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Population pharmacokinetic modeling of PF-06439535 (a bevacizumab biosimilar) and reference bevacizumab (Avastin<sup>®</sup>) in patients with advanced non-squamous non-small cell lung cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) by Week 19 |
45.3; 44.6 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events |
344; 347; 81; 80; 190; 199 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) |
303; 304 | — |
| SECONDARY Duration of Response (DOR) |
36.3; 28.7 | 0.1077 |
| SECONDARY Progression Free Survival Rate at 55 Weeks |
32.3; 30.5 | 0.4492 |
| SECONDARY Survival Rate at 55 Weeks |
65.8; 64.1 | 0.4726 |
| SECONDARY Serum Concentration of Bevacizumab up to 1 Year |
68.08; 116.4; 280000; 302200; 54350; 58930 | — |
| SECONDARY Number of Participants With Anti-Drug Antibody (ADA) |
1; 3; 5; 5 | — |
| SECONDARY Number of Participants With Neutralizing Antibody (NAb) |
1; 0; 0; 3 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02364999) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.