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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00452075
Recruitment Status : Terminated (Poor recruitment)
First Posted : March 26, 2007
Last Update Posted : December 11, 2014
Hoffmann-La Roche
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: erlotinib Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib and Predictive Markers as First-line Treatment of Advanced Non-small Cell Lung Cancer for Patients Unfit for Chemotherapy
Study Start Date : March 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: arm 1 medicine
erlotinib daily
Drug: erlotinib
150mg daily
Other Name: tarceva

Primary Outcome Measures :
  1. Disease control rate [ Time Frame: 2010 ]

Secondary Outcome Measures :
  1. To investigate the tolerability and safety of erlotinib in patients, who can not receive chemotherapy, by registration of side-effects. [ Time Frame: 2010 ]
  2. Correlation of EGFR expression rate and FISH potentially predictive for response [ Time Frame: 2010 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) NSCLC.
  • Chemo-naïve patients.
  • Patients who are in the investigator's opinion not medically suitable for chemotherapy.
  • Measurable disease according to the RECIST criteria.
  • ECOG performance status of 0 - 3.
  • Life expectancy of at least 12 weeks.
  • Patients must be able to take oral medication.
  • Serum calcium within normal ranges
  • ≥ 4 weeks since prior surgery or radiation therapy
  • For all females of childbearing potential a negative pregnancy test must be obtained within 48 hours before starting therapy and must use effective contraception
  • 18 years of age or older
  • Written (signed) Informed Consent to participate in the study

Exclusion Criteria:

  • Prior systemic antitumor therapy
  • Any unstable systemic disease which according to the investigator contraindicates the use of the study drug render the subject at high risk from treatment complications (including active infection, unstable angina, myocardial infarction within the previous month, inflammatory bowel disease, hepatic disease with serum bilirubin ≥ 2 upper limit of normal (ULN) or AST and/or ALT ≥ 2 x ULN (or ≥ 5 x ULN if clearly attributable to liver metastasis), renal disease with acute renal failure or serum creatinine ≥ 5 x ULN.
  • Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
  • Nursing mothers or pregnant woman.
  • Hypersensitivity to Tarceva or co-formulants.
  • Patients with brain metastasis or spinal cord compression that has not yet been definitively treated with surgery and/or radiation.
  • Patients with brain metastasis or spinal cord compression that not are in a stable condition despite treatment with steroids.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00452075

Department of Oncology, Rigshospitalet
Copenhagen, Denmark, 2100
Department of Oncology, Odense University Hospital
Odense, Denmark, 5000
Department of Oncology, Århus University Hospital
Århus, Denmark, 8000
Sponsors and Collaborators
Rigshospitalet, Denmark
Hoffmann-La Roche
Principal Investigator: Pappot Helle, MD, DMSC Department of Oncology, Rigshospitalet, Denmark

Responsible Party: Gedske Daugaard, Professor, Rigshospitalet, Denmark Identifier: NCT00452075     History of Changes
Other Study ID Numbers: ML 20539
First Posted: March 26, 2007    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by Gedske Daugaard, Rigshospitalet, Denmark:
EGFR expression

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action