NCT00480831

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jun 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2007

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

3.2 years

First QC Date

May 30, 2007

Last Update Submit

May 16, 2017

Conditions

Non-Small Cell Lung Cancer

Keywords

NSCLCCancerAvastinAPM4074g

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Objective response and duration of response, as determined by independent review facility

    Length of study

  • Overall survival

    24 months

  • Progression-free survival, objective response, and duration of objective response, as determined by the investigator

    Length of study

  • Pharmacokinetic parameters

    Length of study

Study Arms (2)

1

EXPERIMENTAL
Drug: bevacizumabDrug: carboplatinDrug: paclitaxelDrug: PRO95780

2

PLACEBO COMPARATOR
Drug: bevacizumabDrug: carboplatinDrug: paclitaxelDrug: placebo

Interventions

bevacizumabDRUG

Intravenous repeating dose

12
carboplatinDRUG

Intravenous repeating dose

12
paclitaxelDRUG

Intravenous repeating dose

12
placeboDRUG

Intravenous repeating dose

2
PRO95780DRUG

Intravenous repeating dose

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasms

Interventions

BevacizumabCarboplatinPaclitaxeldrozitumab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCoordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Gordon Bray, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2007

First Posted

May 31, 2007

Study Start

June 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

May 18, 2017

Record last verified: 2017-05