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A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy

Phase 3
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

A Randomised, Placebo-Controlled Trial of Erlotinib in Patients With Advanced NSCLC Unsuitable for Chemotherapy



- 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.

Inclusion Criteria


- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

between date of randomisation and date of death from any cause

Safety Issue:


Principal Investigator

Siow M Lee, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

April 2005

Completion Date:

March 2012

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms