A phase I/II randomised study of Tarceva® (erlotonib), used concurrently with thoracic radiation in patients with advanced non-small cell lung cancer

ISRCTN	ISRCTN92263269
DOI	https://doi.org/10.1186/ISRCTN92263269
Secondary identifying numbers	MAST1006

Submission date: 13/10/2008
Registration date: 16/01/2009
Last edited: 13/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Stephen Mangar
Scientific

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

Study information

Study design	Phase I: Interventional open-label single-centre trial Phase II: Open-label randomised controlled multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
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 acronym	TACTICAL
Study objectives	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(s)	West Midlands Research Ethics Committee, approval pending as of 13/10/2008, ref: 08/H1208/41
Health condition(s) or problem(s) studied	Non-small cell lung cancer (NSCLC)
Intervention	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	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Erlotonib (Tarceva®)
Primary outcome measure	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 study start date	01/01/2009
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	80 Years
Sex	Both
Target number of participants	Phase I: 18; Phase II: 80 (total: 98)
Key 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
Key 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
Date of first enrolment	01/01/2009
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Hammersmith Hospital

London
W12 0HS
United Kingdom

Sponsor information

Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

c/o Dr Rodney Gale
Hammersmith House
Hammersmith Hospital
Du Cane Road
London
W12 0HS
England
United Kingdom

Phone	+44 (0)20 8383 3329
Email	rodney.gale@imperial.nhs.uk
Website	http://www.imperial.nhs.uk
"ROR"	https://ror.org/056ffv270

Funders

Funder type

Industry

Roche Products Limited (UK) (ref: MO21781)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

13/10/2017: No publications found, verifying study status with principal investigator.