Erlotinib as First-line Treatment of Advanced Non-small Cell Lung Cancer (NSCLC) for Patients Unfit for Chemotherapy

Sponsor
Rigshospitalet, Denmark
Study ID
NCT00452075
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

A phase II study of Tarceva (Erlotinib) and predictive markers as first-line treatment of advanced non-small cell lung cancer for patients unfit for chemotherapy (NSCLC) Clinical Phase II Stage IIIB or IV non-small cell lung cancer (NSCLC) Primary end point: Disease control rate (= CR+PR and SD at 8 weeks /patients). Secondary end point: Safety (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected TarcevaTM related AEs) .Correlation of EGFR expression rate (HER1) and FISH potentially predictive for response. An open-label, non randomized, multicenter, clinical trial of TarcevaTM as single agent The sample size is 29 patients in 2 stages and based on Simon´s optimal 2 stage design. Stage 1 will accrue 10 patients, if less than 1 response is observed the study will stop; if more than 1 response is observed the accrual will continue up till 29 patients. A total of 29 patients would be entered and the treatment will be declared to have sufficient activity to deserve further attention if at least 5 patients obtain disease control.

Key Dates

First listed
Mar 26, 2007
Start date
Mar 31, 2007
Status verified
Dec 2014
Primary completion
Feb 28, 2010
Completion
Aug 31, 2010

Study Design

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

Arms

  • Experimental: arm 1 medicine
    erlotinib daily

Primary Outcome Measure

Disease control rate [ Time Frame: 2010 ]

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