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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab-EU; Drug: Bevacizumab-Pfizer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02364999

2014-003878-16 (EudraCT Number)

B7391003 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 719 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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719 participants in 2 patient groups

Bevacizumab-Pfizer

Experimental group

Description:

Bevacizumab-Pfizer plus paclitaxel and carboplatin

Treatment:

Drug: Bevacizumab-Pfizer

Drug: Carboplatin

Drug: Paclitaxel

Bevacizumab-EU

Active Comparator group

Description:

Bevacizumab-EU plus paclitaxel and carboplatin

Treatment:

Drug: Bevacizumab-EU

Drug: Carboplatin

Drug: Paclitaxel