Clinical Trials /

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

NCT02364999

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 3

Trial Eligibility

Document

A Comparative Study Of PF-06439535 Plus <span class="go-doc-concept go-doc-intervention">Paclitaxel</span>-<span class="go-doc-concept go-doc-intervention">Carboplatin</span> And <span class="go-doc-concept go-doc-intervention">Bevacizumab</span> Plus <span class="go-doc-concept go-doc-intervention">Paclitaxel</span>-<span class="go-doc-concept go-doc-intervention">Carboplatin</span> Patients With Advanced Non-Squamous NSCLC

Title

  • Brief Title: A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
  • Official Title: 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.
  • Clinical Trial IDs

    NCT ID: NCT02364999

    ORG ID: B7391003

    NCI ID: 2014-003878-16

    Trial Conditions

    Non-small Cell Lung Cancer (NSCLC)

    Trial Interventions

    Drug Synonyms Arms
    Bevacizumab-Pfizer Bevacizumab-Pfizer
    Bevacizumab-EU Bevacizumab-EU
    Paclitaxel Bevacizumab-Pfizer, Bevacizumab-EU
    Carboplatin Bevacizumab-Pfizer, Bevacizumab-EU

    Trial Purpose

    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 and
    bevacizumab-EU plus paclitaxel and carboplatin by comparing the best confirmed objective
    response rate (ORR) by Week 19 in first-line treatment for patients with advanced
    (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Bevacizumab-Pfizer Experimental Bevacizumab-Pfizer plus paclitaxel and carboplatin Bevacizumab-Pfizer, Paclitaxel, Carboplatin
    Bevacizumab-EU Active Comparator Bevacizumab-EU plus paclitaxel and carboplatin Bevacizumab-EU, Paclitaxel, Carboplatin

    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) 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:

    - 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.

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

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Best confirmed objective Response Rate (ORR)

    Secondary Outcome Measures

    Duration of response (DOR)

    Peak and trough

    Incidence of anti-drug (bevacizumab) antibodies (ADA), including neutralizing antibodies (NAb)

    Progression-free survival

    Survival Rate

    Peak and trough

    Trial Keywords