A randomised, placebo-controlled trial of Tarceva (OSI-774, erlotinib) in patients with advanced non-small cell lung cancer unsuitable for chemotherapy

Phase 3

Completed

• Conditions: Cancer; on-small cell lung cancer (NSCLC); Metastatic neoplasm of the lungs

• Registration Number: ISRCTN77383050
• Lead Sponsor: niversity College London (UK)

Brief Summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23078958 2015 cost-effectiveness results in: http://www.ncbi.nlm.nih.gov/pubmed/26137881

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-02-25
• Study Completion: 2008-01-31
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 664

Inclusion Criteria

1. Diagnosis within 62 days prior to randomisation (this criteria was added on the 12th June 2007)
2. Histologically or cytologically confirmed NSCLC
3. Advanced disease NSCLC (stage IIIb or IV)
4. Chemotherapy-naive patients
5. Patients considered unsuitable for chemotherapy, for example:*
5.1. Eastern Cooperative Oncology Group (ECOG) performance status two or three
5.2. ECOG performance status zero or one with a calculated creatinine clearance less than or equal to 60 ml/min (Cockroft formula)
6. Aged 18 years or over
7. Estimated life expectancy of at least 8 weeks
8. Able to take oral medication
9. Using effective contraception if of reproductive potential (women of child bearing potential must have a negative pregnancy test performed by a healthcare professional prior to randomisation)
10. Willing and able to give informed consent
11. Willing to participate in the biological study

* examples given do not imply that all such patients are unsuitable for chemotherapy - patients should be considered individually

Exclusion Criteria

1. Previous treatment with any biological anti-cancer therapy (e.g. Iressa, thalidomide, cetuximab)
2. Prior chemotherapy
3. Prior palliative radiotherapy (except to bone metastases, within the last 2 weeks)
4. Pregnant or lactating women
5. Evidence of other significant laboratory finding or concurrent uncontrolled medical illness which in the opinion of the investigator would interfere with protocol treatment or results comparison or render the subject at high risk from treatment complications. Examples include:
5.1. Severe uncontrolled infection
5.2. Cardiovascular: unstable angina, myocardial infarction within 1 month
5.3. Gastro-intestinal: uncontrolled inflammatory bowel disease (e.g. Crohn's or ulcerative colitis)
5.4. Hepatic:
5.4.1. Serum bilirubin more than or equal to 2 x Upper Limit of Normal (ULN)
5.4.2. Serum transaminases more than or equal to 2 x ULN in the absence of liver metastases, or more than or equal to 5 x ULN with liver metastases
5.5. Renal:
5.5.1. Acute renal failure
5.5.2. Serum creatinine more than or equal to 5 x ULN
6. Other previous or current malignant disease likely to interfere with protocol treatment or comparisons
7. Symptomatic brain metastases
8. Current treatment with Cox II inhibitor

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effect on survival of Tarceva compared to placebo in patients with advanced NSCLC not suitable for chemotherapy.

Secondary Outcome Measures

Name	Time	Method
1. Progression free survival<br>2. Toxicity<br>3. Response rate<br>4. Quality of life<br>5. Cost-effectiveness