NCT02139904: VIM

Vinorelbine in Mesothelioma

Completed Phase 2 Last updated 12 October 2021

What this trial tests

Phase 2 trial testing Vinorelbine in Mesothelioma in 154 participants. Completed in 17 March 2021.

Timeline

1 March 2016

Primary endpoint
17 March 2021

17 March 2021

Quick facts

Lead sponsor	Wales Cancer Trials Unit
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	154
Start date	1 March 2016
Primary completion	17 March 2021
Estimated completion	17 March 2021
Sites	1 location across United Kingdom

Drugs / interventions tested

• Vinorelbine (vinorelbine) — full drug profile →
• Active Symptom Control

Conditions studied

• Mesothelioma — all drugs for Mesothelioma →

Sponsor

Wales Cancer Trials Unit — full company profile →

Who can join

18 and older, any sex, with Mesothelioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is for patients with malignant mesothelioma of the lung lining (called pleura) who have had previous chemotherapy with a platinum-based regimen whose disease has progressed. Malignant pleural mesothelioma (MPM) is an aggressive, frequently drug resistant, and incurable disease that is increasing in incidence in the UK and worldwide. All patients with MPM will relapse following first line chemotherapy and at present, there is no standard treatment available for patients in the second line setting. The vinca alkaloid chemotherapy drug vinorelbine has shown promising activity in a single arm UK trial. However to date, there has been no randomised evaluation of vinorelbine in mesothelioma in the second line setting. In addition, there have been no trials which have looked at underlying molecular changes in mesothelioma which may predict vinorelbine efficacy; This might allow vinorelbine to be used in patients only where there is a chance of benefit. Studies suggest that vinorelbine requires a gene called BRCA1 (shown to be absent in 38% of mesothelioma cases) in order to induce cell death in mesothelioma. The VIM trial aims to establish whether vinorelbine in patients with MPM helps them live longer and whether the BRCA1 gene is helpful in selecting patients most likely to benefit from treatment.

Patients will be randomised (1:2) to receive either active symptom control (ASC) (which is all supportive care deemed necessary for pain management excluding disease modifying treatment) or ASC with vinorelbine. Patients will continue vinorelbine treatment until evidence of disease progression (or unacceptable toxicity to the drug or patient withdrawal). If vinorelbine activity is demonstrated, we will use the results from this trial to inform the design of a future phase III trial.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current chemotherapy strategies in malignant pleural mesothelioma.
   de Gooijer CJ, Baas P, Burgers JA. · · 2018 · cited 31× · PMID 30450296 · DOI 10.21037/tlcr.2018.04.10
2. CONFIRM: a double-blind, placebo-controlled phase III clinical trial investigating the effect of nivolumab in patients with relapsed mesothelioma: study protocol for a randomised controlled trial.
   Fennell DA, Kirkpatrick E, Cozens K, Nye M, et al · · 2018 · cited 31× · PMID 29669604 · DOI 10.1186/s13063-018-2602-y
3. Active symptom control with or without oral vinorelbine in patients with relapsed malignant pleural mesothelioma (VIM): A randomised, phase 2 trial.
   Fennell DA, Porter C, Lester J, Danson S, et al · · 2022 · cited 20× · PMID 35706488 · DOI 10.1016/j.eclinm.2022.101432
4. Salvage Therapy for Relapsed Malignant Pleural Mesothelioma: A Systematic Review and Network Meta-Analysis.
   Tsai YC, Chen HL, Lee TH, Chang HM, et al · · 2021 · cited 14× · PMID 35008346 · DOI 10.3390/cancers14010182
5. BAP1 loss induces mitotic defects in mesothelioma cells through BRCA1-dependent and independent mechanisms.
   Singh A, Busacca S, Gaba A, Sheaff M, et al · · 2023 · cited 11× · PMID 36550359 · DOI 10.1038/s41388-022-02577-3
6. Fibrosis in Mesothelioma: Potential Role of Lysyl Oxidases.
   Perryman L, Gray SG. · · 2022 · cited 9× · PMID 35205728 · DOI 10.3390/cancers14040981
7. Analysis of new treatments proposed for malignant pleural mesothelioma raises concerns about the conduction of clinical trials in oncology.
   Meirson T, Nardone V, Pentimalli F, Markel G, et al · · 2022 · cited 5× · PMID 36514092 · DOI 10.1186/s12967-022-03744-6
8. Unveiling the research directions for pyrrolidine-based small molecules as versatile antidiabetic and anticancer agents.
   Kumar S, Kohal R, Mondal D, Kumari S, et al · · 2025 · cited 1× · PMID 40351281 · DOI 10.1080/17568919.2025.2501923