Afatinib Monotherapy in Patients With ERBB-deregulated Metastatic Urothelial Tract Carcinoma After Failure of Platinum Based Chemotherapy (LUX-Bladder 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02780687
Recruitment Status : Recruiting
First Posted : May 23, 2016
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

The purpose of this trial is to assess the anti-tumour activity and safety of afatinib monotherapy in patients with urothelial tract carcinoma carrying ERBB2 or ERBB3 mutations or ERBB2 amplifications (Cohort A), and EGFR amplification positive tumours (Cohort B), progressing despite previous platinum based chemotherapy, and thereby to improve their prognosis.

The antitumour activity of afatinib monotherapy in these patients will be assessed by progression free survival rate at 6 months (PFS6). This will be the primary endpoint of the trial. A key secondary endpoint will also be defined, the objective response rate (ORR).

Condition or disease Intervention/treatment Phase
Urologic Neoplasms Drug: Afatinib Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LUX-Bladder 1: Phase II Open Label Single Arm Exploratory Trial of Oral Afatinib Monotherapy Following Platinum Failure for Patients With Advanced/Metastatic Urothelial Tract Carcinoma With Genetic Alterations in ERBB Receptors.
Actual Study Start Date : June 9, 2016
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Afatinib Drug: Afatinib

Primary Outcome Measures :
  1. Progression Free Survival at 6 months in Cohort A (defined as the proportion of patients who does not show disease progression by the 24-week tumour assessment). [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) in Cohort A, defined as number of complete response (CR) or partial response (PR) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1. [ Time Frame: From Baseline to disease progression (up to 2 years) ]
  2. Progression free survival (PFS) in Cohort A, defined as the time from first drug administration to the date of disease progression, or date of death whichever is earlier [ Time Frame: Starting with first drug administration and until up to 2 years for each patient ]
  3. Overall Survival (OS) in Cohort A, defined as the time from first drug administration to the date of death [ Time Frame: From first drug administration to date of death (up to 5 years) ]
  4. Disease Control Rate (DCR) in Cohort A, defined as complete response (CR), partial response (PR), stable disease (SD) or Non-CR/Non-Progressive Disease (NN) according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 [ Time Frame: From first drug administration to disease progression (up to 2 years) ]
  5. Duration of objective response (DOR) in Cohort A, according to Response Evaluation Criteria In Solid Tumours (RECIST) 1.1 [ Time Frame: From first drug administration to disease progression (up to 2 years) ]
  6. Tumour shrinkage in Cohort A, measured as the maximum percentage decrease from baseline sum of target lesion diameters after treatment until disease progression [ Time Frame: From first drug administration to disease progression (up to 2 years) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Recurrent or metastatic urothelial cancer
  • Patients must have failed prior platinum based treatment (adjuvant or 1st line)
  • Archival tissue sample available for biomarker testing at pre-screening and tissue banking.
  • Patients should complete a pre-screening biomarker analysis and should fulfill the following: for Cohort A tumour should show a ERBB2 (epidermal growth factor family receptor 2) or ERBB3 mutation, or ERBB2 gene amplification; for Cohort B tumour should show EGFR (Epidermal Growth Factor Receptor) amplification.
  • Further inclusion criteria apply

Exclusion criteria:

  • Prior use of EGFR, ERBB2 or ERBB3 targeted treatment
  • Chemotherapy within 4 weeks prior to the start of study treatment. Biological therapy or investigational agents within 4 weeks prior to the start of study treatment or prior to passing 5 half-lives, i.e. systemic clearance, whatever comes first
  • Known brain metastases or signs hereof, uncontrolled spinal cord compression or leptomeningeal carcinomatosis
  • Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02780687

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

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A.O. San Camillo Forlanini Recruiting
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Hospital Germans Trias i Pujol Recruiting
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Hospital Santa Creu i Sant Pau Recruiting
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Hospital Clínic de Barcelona Recruiting
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Hospital Vall d'Hebron Recruiting
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Hospital Universitario de Elche Recruiting
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Hospital Universitari de Girona Doctor Josep Trueta Recruiting
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Hospital Duran i Reynals Recruiting
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Hospital Universitario Lucus Augusti Recruiting
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Hospital Ramón y Cajal Recruiting
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Hospital Clínico San Carlos Recruiting
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Hospital Universitario 12 de Octubre Recruiting
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Hospital La Paz Recruiting
Madrid, Spain, 28046
CIO Clara Campal Recruiting
Madrid, Spain, 28050
Hospital Son Espases Recruiting
Palma de Mallorca, Spain, 07010
CS Parc Taulí Recruiting
Sabadell, Spain, 08208
Hospital Virgen Macarena Recruiting
Sevilla, Spain, 41009
Hospital Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT02780687     History of Changes
Other Study ID Numbers: 1200.261
2015-005427-10 ( EudraCT Number )
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site