Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Malignant Mesothelioma

Lurbinectedin 3.2 mg/m2 i.v. every 3 weeks (one cycle) until progression, unacceptable toxicity or patient's withdrawal.

Lurbinectedin

Yannis Metaxas, MD

Roger von Moos, Prof

Miklos Pless, MD

Federica Grosso, MD

Aim of this study is to provide the "proof of concept" of efficacy and tolerability of lurbinectedin monotherapy in progressive malignant mesotheliomas.

Malignant mesothelioma arises from the mesothelial cells of the pleural, peritoneal or pericardial lining and is often associated with asbestos exposition. There is no cure for most malignant mesotheliomas and the scope of all three major oncological therapeutic procedures (surgery, radiotherapy and chemotherapy) is to reduce/eliminate symptoms as well as to prolong progression free survival (PFS) and/or overall survival (OS). While progressive patients are still in good health able to undertake a second-line treatment, there is no standard treatment for progressive disease.

Lurbinectedin is a novel compound structurally related to trabectedin and with similar mode of action. Pre-clinical data showed a better safety profile than trabectedin. Lurbinectedin has been already tested in different Phase I-II trials showing promising activity in ovarian, pancreatic, breast, small and non-small cell lung cancer as well as in other tumor types, with objective responses averaging 30%, disease stabilization up to 75% and having manageable toxicity. Although lurbinectedin has not been widely tested in mesotheliomas, some mesothelioma patients have been already treated with lurbinectedin where again promising activity has been observed.

Prospective 2-stage single-arm open-label multicenter phase II trial.

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.

Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma. A Multicenter, Single-arm Phase II Trial

PFS at 12 weeks is defined as absence of progression or death due to any cause during 12 weeks (±2 weeks) after registration.

Patients with no tumor assessment at 12 weeks (±2 weeks) will be considered:

* Progressed at 12 weeks, if they have no following tumor assessment within the trial (patient died, refused, started a new treatment or was lost to follow-up) or if they progress at the following tumor assessment after 12 weeks (±2 weeks).
* Progression-free at 12 weeks, if they do not progress at the following tumor assessment after 12 weeks (±2 weeks).

PFS is defined as time from registration to one of the following events, whichever occurs first:

* Relapse or progression according to the modified RECIST criteria for malignant pleural mesothelioma
* Death due to any cause Patients not experiencing an event will be censored at the date of last evaluable tumor assessment before starting a subsequent treatment, if any.

OR is defined as complete response (CR) or partial response (PR) achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.

Patients without any tumor assessment during trial treatment will be regarded as having a non-evaluable response (NE) and shall be considered as failures for this endpoint.

DC is defined as CR, PR or stable disease (SD) for at least 12 weeks achieved by the patient during trial treatment. Tumor response will be evaluated according to the modified RECIST criteria for malignant pleural mesothelioma.

OS is defined as time from registration until death due to any cause. Patients alive or lost to follow-up will be censored at the last date they were known to be alive.

TTF is defined as time from registration until treatment discontinuation due to any reason (unacceptable toxicity, patient refusal, progression, death or any other event that determines the termination of the trial treatment).

Patients not experiencing an event will be censored at the date of their last available assessment or visit.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research
Lurbinectedin Monotherapy in Patients With Progressive Malignant Pleural Mesothelioma.	NCT03213301	Malignant Pleur...	Lurbinectedin	18 Years -	Swiss Group for Clinical Cancer Research

Spots Global Cancer Trial Database for progressive malignant pleural mesothelioma