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InOncology.com

LUME-Meso clinical trial

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Nintedanib Plus Pemetrexed/Cisplatin vs Placebo Plus Pemetrexed/Cisplatin in First-Line Malignant Pleural Mesothelioma

An international, double-blind, randomised, multicentre, placebo-controlled, Phase II/III study of nintedanib* plus pemetrexed/cisplatin vs placebo plus pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma (MPM).

 

Trial CT.gov-Identifier: NCT01907100

Patients

Phase III:

Patients with unresectable MPM (≥18 years old)

Histologically confirmed epithelioid MPM

Measurable disease according to modified Response Evaluation Criteria In Solid Tumours

No prior first-line therapies for MPM

Life expectancy ≥3 months

Eastern Cooperative Oncology Group performance score of 0–1

 

N=450

Randomisation 1:1

Nintedanib 200 mg + Standard chemotherapy with pemetrexed 500 mg/m² and cisplatin 75 mg/m² Oral twice daily (Days 2–21 of every 3-week cycle) + Intravenous (IV; Day 1)
Placebo 200 mg + Standard chemotherapy with pemetrexed 500 mg/m² and cisplatin 75 mg/m² Oral twice daily (Days 2–21 of every 3-week cycle) + Intravenous (IV; Day 1)

Endpoints

Primary outcome measure:

  • Progression-free survival (PFS)

 

Key secondary outcome measure:

  • Overall survival (OS)

 

Secondary outcome measures:

  • Objective response rate
  • Disease control rate
  • Health-related quality of life

Trial Status

The LUME-Meso trial, initiated as a Phase II trial in September 2013, was extended in April 2016 to include a confirmatory Phase III part. This is a global study being conducted across six regions and is currently recruiting participants. The Phase II results have been reported.

 

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References

1

Clinicaltrials.gov. https://clinicaltrials.gov/ct2/show/NCT01907100 (Accessed: July 2017).

2

Scagliotti GV, et al. Clin Lung Cancer 2017;[Epub ahead of print]. https://doi.org/10.1016/j.cllc.2017.03.010. Accessed: July 2017.

3

Grosso F, et al. J Thorac Oncol 2017;12(1 Suppl):S329–S330.

4

Nowak AK, et al. J Clin Oncol 2017;35(Suppl; Abstract 8506).

5

Grosso F, et al. J Clin Oncol 2017. In press.

* Nintedanib is being investigated in malignant pleural mesothelioma (MPM) and is not approved for this use. The efficacy and safety of nintedanib in MPM have not been established.