Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Stephen Mangar


Contact details

Department of Radiotherapy
Hammersmith Hospital
Du Cane Road
W12 0HS
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Tarceva® (erlotonib), used concurrently with thoracic radiation in patients with advanced non-small cell lung cancer: a phase I/II open-label randomised controlled trial



Study hypothesis

To explore the use of concurrent radiotherapy and an oral tablet called erlotinib (an epidermal growth factor inhibitor) for the treatment of advanced non-small cell lung cancer and assess whether combination therapy improves response and overall survival compared to radiotherapy alone.

Ethics approval

West Midlands Research Ethics Committee, approval pending as of 13/10/2008 (ref: 08/H1208/41)

Study design

Phase I: Interventional open-label single-centre; Phase II: Open-label randomised controlled multi-centre

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Non-small cell lung cancer (NSCLC)


Phase I: All 18 patients will receive erlotonib 150 mg orally (po) once daily. This will be combined with radiotherapy consisting of an initial radiation dose of 30 Gy/10 factions (3 Gy, 5 days per week, 2 weeks) for the first 6 patients, with a view to dose escalation to 36 Gy/12 fractions with two further groups of 6 patients depending on observed dose limiting toxicity levels.

Phase II: Radiotherapy will be administered to all patients at the optimal dose determined in Phase 1 - either 30 Gy/10 fractions or 36 Gy/12 fractions. Half of patients will also receive erlotinib 150 mg po, once daily. Erlotinib and follow-up will continue after the radiotherapy until disease progression or the development of grade 3 or 4 toxicity despite dose reduction.

Follow-up: Each subject is followed for 12 weeks including pre-treatment and treatment visits, then monthly for 6 months if there is no progression and then annually until progression.

Intervention type



Not Specified

Drug names

Erlotonib (Tarceva®)

Primary outcome measures

Phase I: Evaluation of early safety and efficacy of erlotinib by determining the maximum tolerated dose in combination with external beam radiotherapy.

Phase II: Evaluation of disease control rate at 6 months.

Secondary outcome measures

1. Objective response rate, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) at baseline, 6 weeks after radiotherapy treatment (Visit 9, Week 9) and 6 months.
2. Duration of response
3. Time to progression
4. Time to distant failure
5. Overall survival
6. Safety

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

Patients (both males and females) with non-small cell lung cancer (NSCLC) with:
1. Histologically or cytologically confirmed non-small cell lung cancer
2. Unresectable stage III or metastatic disease suitable for fractionated palliative radiotherapy
3. One dimensionally measurable disease
4. No prior radiotherapy for this cancer
5. Forced expiratory volume in 1 second (FEV1) >1
6. Performance status less or equal to 2
7. Adequate haematologic function
8. Serum creatinine concentration >1.5 x upper limit or normal (ULN) and /or EDTA clearance >60 ml/min
9. Bilirubin level <1.5 x ULN
10. Age 18-80 years
11. Females of child bearing potential must agree to comply with effective contraceptive measures

Participant type


Age group




Target number of participants

Phase I: 18; Phase II: 80 (total: 98)

Participant exclusion criteria

Patients with non-small cell lung cancer must not meet any of the following:
1. Previous radiotherapy for non-small cell lung cancer
2. Concurrent treatment with other experimental drugs
3. Past or current history of other neoplasms, except a) curatively treated non-melanoma skin cancer or b) adequately treated in-situ cancer of the cervix or c) other cancer curatively treated and with no evidence of disease for at least 5 years
4. Significant cardiac disease, clinical congestive cardiac failure, cardiac arrhythmia, uncontrolled hypertension or recent history of myocardial infarction/ischaemia
5. Serious intercurrent medical or psychiatric illness, including serious active infection
6. Pregnant or nursing women

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Department of Radiotherapy
W12 0HS
United Kingdom

Sponsor information


Imperial College Healthcare NHS Trust (UK)

Sponsor details

c/o Dr Rodney Gale
Hammersmith House
Hammersmith Hospital
Du Cane Road
W12 0HS
United Kingdom
+44 (0)20 8383 3329

Sponsor type




Funder type


Funder name

Roche Products Limited (UK) (ref: MO21781)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes