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Nintedanib (BIBF 1120) in Mesothelioma

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. Read our disclaimer for details. Identifier: NCT01907100
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : September 11, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Nintedanib Drug: Pemetrexed Drug: Cisplatin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
Actual Study Start Date : September 19, 2013
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : August 28, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo + pemetrexed/cisplatin
Placebo controlled arm
Drug: Pemetrexed
backbone chemo

Drug: Cisplatin
backbone chemo

Drug: Placebo
Nitedanib matching placebo

Experimental: Nintedanib 200mg + pemetrexed/cisplastin
Experimental arm
Drug: Nintedanib
triple kinase inhibitor; 200mg starting dose

Drug: Cisplatin
backbone chemo

Drug: Pemetrexed
backbone chemo

Primary Outcome Measures :
  1. Progression free survival measured from the time of randomisation to the time of disease progression or death of any cause, whichever occurs earlier [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall survival measured from the time of randomisation to the time of death of any cause [ Time Frame: up to 3 years ]
  2. Objective response according to modified RECIST analysed by objective response rate [ Time Frame: up to 3 years ]
  3. Disease control according to modified RECIST analysed by disease control rate [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

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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:

  • Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)
  • Life expectancy of at least 3 months in the opinion of the investigator
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria

Exclusion criteria:

  • Previous systemic chemotherapy for MPM
  • Prior treatment with nintedanib or any other prior line of therapy
  • Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM
  • Patients with symptomatic neuropathy
  • Radiotherapy (except extremities) within 3 months prior to baseline imaging
  • Active brain metastases (e.g. stable for < 4 weeks)
  • Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
  • Significant cardiovascular diseases
  • Inadequate hematologic, renal, or hepatic function

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): NCT01907100

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Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT01907100     History of Changes
Other Study ID Numbers: 1199.93
2012-005201-48 ( EudraCT Number )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
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Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors