Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer (TOPICAL)

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: NCT00275132
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : December 3, 2014
Cancer Research UK
Roche Pharma AG
Information provided by (Responsible Party):
University College, London

Brief Summary:

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: erlotinib hydrochloride Drug: Matched placebo Phase 3

Detailed Description:



  • Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.


  • Compare progression-free survival and response rate.
  • Compare toxicity.
  • Compare the quality of life.
  • Compare cost-effectiveness.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral erlotinib once daily for up to 24 months.
  • Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy
Study Start Date : April 2005
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Erlotinib
Tarceva (OSI-774, erlotinib) PO 150mg daily
Drug: erlotinib hydrochloride
Tarceva (OSI-774, erlotinib) PO 150 mg daily
Other Names:
  • OSI-774
  • Tarceva
Placebo Comparator: Matched placebo
Matched placebo PO daily
Drug: Matched placebo
Matched placebo PO daily

Primary Outcome Measures :
  1. Overall survival [ Time Frame: between date of randomisation and date of death from any cause ]

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death. ]
  2. Adverse events/Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment ]
  3. Quality of life [ Time Frame: between randomisation and 8 weeks. ]
    QL will be measured using the patient-completed EORTC-QLQ C30 and lung cancer module (LC 14). The primary QL outcome measures will be changes in overall QL and the five most commonly reported lung cancer symptoms (fatigue, breathlessness, cough, emotional functioning and pain).

  4. Cost-effectiveness [ Time Frame: from date of randomisation to death ]
    Effectiveness will be estimated in terms of quality-adjusted life years. Mean survival will be calculated on the basis of observed mortality (i.e. a within-trial estimate) and by extrapolating the survival curves if some patients remain alive at the end of the trial.

Information from the National Library of Medicine

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


  • Histologically or cytologically confirmed non-small cell lung cancer

    • Advanced disease (stage IIIB or IV)
    • Diagnosis within 62 days prior to randomization
  • Not suitable for first-line chemotherapy, as defined by the following criteria*:

    • ECOG performance status 2-3
    • ECOG performance status 0-1 AND creatinine clearance < 60 mL/min
  • NOTE: *These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
  • No symptomatic brain metastases


  • Estimated life expectancy of at least 8 weeks
  • Able to take oral medication
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No severe uncontrolled infection
  • No unstable angina
  • No myocardial infarction within the past month
  • No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
  • No acute renal failure
  • Bilirubin < 2 times upper limit of normal (ULN)
  • Transaminases < 2 times ULN (5 times ULN if liver metastases are present)
  • Creatinine < 5 times ULN
  • No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
  • No other prior or current malignant disease likely to interfere with study treatment or comparisons


  • No prior chemotherapy
  • No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
  • No prior palliative radiotherapy

    • Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
  • No concurrent cyclooxygenase-2 inhibitors

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): NCT00275132

United Kingdom
London Lung Cancer Group
London, England, United Kingdom, NW1 2ND
Sponsors and Collaborators
University College, London
Cancer Research UK
Roche Pharma AG
Study Chair: Siow M Lee, MD, PhD, FRCP University College London Hospitals

Responsible Party: University College, London Identifier: NCT00275132     History of Changes
Other Study ID Numbers: CDR0000457755
ISRCTN ( Registry Identifier: 77383050 )
Cancer Research UK (CTAAC) ( Other Grant/Funding Number: C1438/A4147 )
Roche AG Pharma ( Other Grant/Funding Number: MO17591 )
UCL Trial Sponsor reference ( Other Identifier: UCL/05/173 )
EudraCT number ( Other Identifier: 2004-000729-31 )
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2011

Keywords provided by University College, London:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

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