A Study of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Genentech, Inc.
Study ID
NCT00855894
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Pertuzumab — DRUG
    After a single administration of a loading dose of 840 mg IV, patients received a maintenance dose of 420 mg IV every 3 weeks (q3w).
  • Erlotinib — DRUG
    Patients received 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.

Study Details

This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response rate.

Key Dates

First listed
Mar 5, 2009
Start date
Mar 31, 2009
Status verified
May 2013
Primary completion
Mar 31, 2012
Completion
Mar 31, 2012

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pertuzumab + erlotinib
    Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.

Primary Outcome Measure

Percentage of Patients With a 2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET) Response at Day 56 in All Patients and in Epidermal Growth Factor Receptor (EGFR) Mutant and Wild-type Subgroups [ Time Frame: Baseline to Day 56 ]

Locations (4)

FacilityCityStateZIPSite coordinators
-Los AngelesCalifornia90033-
-Rancho MirageCalifornia92270-
-OmahaNebraska68114-
-SeattleWashington98195-

Find similar trials in Los Angeles, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease

Related Studies