A Study of PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer (APM4074g)

May 16, 2017 updated by: Genentech, Inc.

A Randomized, Double-Blind, Phase II Trial of Paclitaxel + Carboplatin + Bevacizumab With or Without PRO95780 in Patients With Previously Untreated, Advanced-Stage Non-Small Cell Lung Cancer

This is a randomized, double-blind, Phase II, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of PRO95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated Stage IIIB, Stage IV, or recurrent non-small cell lung cancer (NSCLC). Approximately 120 patients will be randomized to one of two treatment arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ability to understand and willingness to sign a written informed consent
  • Histologically or cytologically confirmed NSCLC
  • Advanced NSCLC
  • Measurable disease
  • ECOG performance status of 0 or 1
  • Age ≥ 18 years
  • Use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men

Exclusion Criteria:

  • Squamous cell histology
  • Prior malignancy other than NSCLC (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization
  • Untreated or unstable CNS metastases
  • Myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization
  • Uncontrolled hypertension
  • History of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization
  • Major surgical procedure within 28 days prior to randomization
  • Serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization
  • Persistent history of gross hemoptysis relating to the patient's NSCLC
  • Known HIV infection
  • Known to be positive for hepatitis C or hepatitis B surface antigen
  • Chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function
  • Use of anticoagulation therapy
  • Participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization
  • Pregnancy (e.g., positive HCG test) or breast feeding
  • Known sensitivity to any of the products to be administered during the study
  • Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 2
Drug: placebo
Intravenous repeating dose
Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose
EXPERIMENTAL: 1
Drug: bevacizumab
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: PRO95780
Intravenous repeating dose
Drug: carboplatin
Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: Length of study
Length of study
Changes in vital signs, physical findings, and clinical laboratory results during and following PRO95780 administration
Time Frame: Length of study
Length of study
Progression-free survival, as determined by independent review facility
Time Frame: Length of study
Length of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 24 months
24 months
Objective response and duration of response, as determined by independent review facility
Time Frame: Length of study
Length of study
Progression-free survival, objective response, and duration of objective response, as determined by the investigator
Time Frame: Length of study
Length of study
Pharmacokinetic parameters
Time Frame: Length of study
Length of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2007

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

May 30, 2007

First Submitted That Met QC Criteria

May 30, 2007

First Posted (ESTIMATE)

May 31, 2007

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APM4074g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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