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

Sponsor
Genentech, Inc.
Study ID
NCT00480831
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — DRUG
    Intravenous repeating dose
  • carboplatin — DRUG
    Intravenous repeating dose
  • paclitaxel — DRUG
    Intravenous repeating dose
  • placebo — DRUG
    Intravenous repeating dose
  • PRO95780 — DRUG
    Intravenous repeating dose

Study Details

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.

Key Dates

First listed
May 31, 2007
Start date
Jun 30, 2007
Status verified
May 2017
Primary completion
Aug 31, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
128 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Placebo Comparator: 2

Primary Outcome Measure

Adverse events [ Time Frame: Length of study ]

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