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

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: Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: placebo; Drug: bevacizumab; Drug: paclitaxel; Drug: PRO95780; Drug: carboplatin

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 2

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.

Study record dates

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: Cancer; NSCLC; Avastin; APM4074g
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Carboplatin; Paclitaxel; Bevacizumab
• Other Study ID Numbers: APM4074g