LaMB - maintenance lapatinib versus placebo after first-line chemotherapy in patients with locally advanced or metastatic bladder cancer
| ISRCTN | ISRCTN35418671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35418671 |
| ClinicalTrials.gov (NCT) | NCT00949455 |
| Clinical Trials Information System (CTIS) | 2007-001826-28 |
| Protocol serial number | 5660 |
| Sponsor | Queen Mary, University of London (UK) |
| Funder | GlaxoSmithKline (UK) |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 04/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Charlotte Rofe
Scientific
Scientific
ECMC, Barts and the London School of Medicine and Dentistry
Old Anatomy Building
Charterhouse Square
London
EC1M 6BQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised multicentre double-blinded trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A phase II/III, randomised, two-arm comparison of maintenance lapatinib versus placebo after first-line chemotherapy in patients with HER1 and/or HER2 overexpressing locally advanced or metastatic bladder cancer |
| Study acronym | LaMB |
| Study objectives | Metastatic bladder cancer is treated with platinum analogue based chemotherapy. In this study patients will initially be treated with standard chemotherapy for locally advanced and metastatic bladder cancer. Those patients who have either a response to treatment (Response Evaluation Criteria in Solid Tumours [RECIST] criteria) or stabilisation of disease will go onto the study. Only those patients who are HER1 and/or HER2 positive will be eligible, as previous studies have shown that these individuals are most likely to respond to treatment with lapatinib. Patients will be randomised to receive maintenance therapy with either lapatinib or placebo. Therapy will continue until disease progression, excessive toxicity or patient request, at which point the treatment will be stopped and patients will be treated according to the doctor's discretion. |
| Ethics approval(s) | South East Research Ethics Committee, 28/11/2007, ref: 07/H1102/73 |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Bladder Cancer; Disease: Bladder (advanced) |
| Intervention | 1. Lapatinib 2. Placebo Dosage given = 1500 mg (6 x 250 mg tablets) per day. Patients will receive treatment until progression of disease. Follow up is continued at doctor's discretion until death. |
| Intervention type | Drug |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Lapatinib |
| Primary outcome measure(s) |
Compare progression-free survival (PFS) in patients with HER1 and/or HER2 over expressing stage IV b, measured after the last follow up of the last patient. |
| Key secondary outcome measure(s) |
Measured after the last follow up of the last patient: |
| Completion date | 01/06/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 204 |
| Total final enrolment | 232 |
| Key inclusion criteria | 1. Histologically confirmed metastatic or locally advanced stage IV transitional cell carcinoma of the urothelium 2. Able to commence study drug 3 - 8 weeks after completion of 1st line chemotherapy for metastatic bladder cancer 3. HER1 and/or HER 2 positive, confirmed by central lab 4. Objective response or stable disease following 4 - 8 cycles of first-line chemotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3 6. Left ventricular ejection fraction (LVEF) within normal range as measured by ECHO or MUGA 7. Written informed consent 8. Aged over 18 years, either sex |
| Key exclusion criteria | 1. Progression with first-line chemotherapy for metastatic disease 2. Previous anti-HER1 or HER2 therapy 3. More than one line of chemotherapy for metastatic or locally advanced disease 4. Significant cardiac disease 5. Patients receiving less than 4 or more than 8 cycles of chemotherapy before randomisation 6. Major surgery or curative radiotherapy after chemotherapy (palliative radiotherapy is allowed) |
| Date of first enrolment | 31/10/2008 |
| Date of final enrolment | 01/06/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
ECMC, Barts and the London School of Medicine and Dentistry
London
EC1M 6BQ
United Kingdom
EC1M 6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No | |
| Results article | results | 01/01/2017 | Yes | No | |
| Basic results | 20/05/2019 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 04/04/2022 | No | Yes |
Editorial Notes
04/04/2022: Plain English results added.
20/05/2019: The following changes were made to the trial record:
1. Added clinicaltrialsregister.eu link to basic results (scientific).
2. The total final enrollment was added.
08/03/2019: Publication references added.
14/03/2017: No publications found in PubMed, verifying study status with principal investigator
