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
EudraCT/CTIS number	2007-001826-28
ClinicalTrials.gov number	NCT00949455
Secondary identifying numbers	5660

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

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-lapatinib-for-people-with-bladder-cancer-that-has-spread

Contact information

Ms Charlotte Rofe
Scientific

ECMC, Barts and the London School of Medicine and Dentistry
Old Anatomy Building
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Study information

Study design	Randomised multicentre double-blinded 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 below to request a patient 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
Pharmaceutical study type(s)
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Lapatinib
Primary outcome measure	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.
Secondary outcome measures	Measured after the last follow up of the last patient: 1. To compare overall survival (OS) between the two groups 2. Evaluate the safety and tolerability
Overall study start date	31/10/2008
Completion date	01/06/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 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

England
United Kingdom

Study participating centre

ECMC, Barts and the London School of Medicine and Dentistry

London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary, University of London (UK)
University/education

5 Walden Street
Whitechapel
London
E1 2EF
England
United Kingdom

Website	http://www.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Industry

GlaxoSmithKline (UK)
Government organisation / For-profit companies (industry)

Alternative name(s): GlaxoSmithKline plc., GSK plc., GSK
Location: United Kingdom

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	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
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