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

This study has been terminated.
(Poor recruitment)
Hoffmann-La Roche
Information provided by (Responsible Party):
Gedske Daugaard, Rigshospitalet, Denmark Identifier:
First received: March 23, 2007
Last updated: December 10, 2014
Last verified: December 2014

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 Intervention Phase
Non Small Cell Lung Cancer Drug: erlotinib Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Gedske Daugaard, Rigshospitalet, Denmark:

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

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

Enrollment: 24
Study Start Date: March 2007
Study Completion Date: August 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1 medicine
erlotinib daily
Drug: erlotinib
150mg daily
Other Name: tarceva


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Gedske Daugaard, Professor, Rigshospitalet, Denmark Identifier: NCT00452075     History of Changes
Other Study ID Numbers: ML 20539
Study First Received: March 23, 2007
Last Updated: December 10, 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 processed this record on August 18, 2017