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

January 10, 2006
January 11, 2006
December 3, 2014
April 2005
April 2009   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: between date of randomisation and date of death from any cause ]
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Complete list of historical versions of study NCT00275132 on Archive Site
  • Progression free survival [ Time Frame: from the date of randomisation to the date of first clinical evidence of progressive disease, or death. ]
  • Adverse events/Toxicity [ Time Frame: during and for 28 days following Tarceva/placebo treatment ]
  • 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).
  • 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.
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Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy

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.



  • 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.

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Lung Cancer
  • Drug: erlotinib hydrochloride
    Tarceva (OSI-774, erlotinib) PO 150 mg daily
    Other Names:
    • OSI-774
    • Tarceva
  • Drug: Matched placebo
    Matched placebo PO daily
  • Experimental: Erlotinib
    Tarceva (OSI-774, erlotinib) PO 150mg daily
    Intervention: Drug: erlotinib hydrochloride
  • Placebo Comparator: Matched placebo
    Matched placebo PO daily
    Intervention: Drug: Matched placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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April 2009
April 2009   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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 )
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University College, London
University College, London
  • Cancer Research UK
  • Roche Pharma AG
Study Chair: Siow M Lee, MD, PhD, FRCP University College London Hospitals
University College, London
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP