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 |
| Protocol serial number | MAST1006 |
| Sponsor | Imperial College Healthcare NHS Trust (UK) |
| Funder | Roche Products Limited (UK) (ref: MO21781) |
- 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
Scientific
Department of Radiotherapy
Hammersmith Hospital
Du Cane Road
London
W12 0HS
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Phase I: Interventional open-label single-centre trial Phase II: Open-label randomised controlled multi-centre trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Erlotonib (Tarceva®) |
| Primary outcome measure(s) |
Phase I: Evaluation of early safety and efficacy of erlotinib by determining the maximum tolerated dose in combination with external beam radiotherapy |
| Key secondary outcome measure(s) |
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. |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Hammersmith Hospital
London
W12 0HS
United Kingdom
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/10/2017: No publications found, verifying study status with principal investigator.
