Clinical trial • Phase II • Oncology|Respiratory

NIRAPARIB for Pleural mesothelioma|Non-small cell lung cancer

Phase II trial of NIRAPARIB for Pleural mesothelioma|Non-small cell lung cancer. open-label. 48 participants.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Pleural mesothelioma|Non-small cell lung cancer
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody

Key dates

Initial CTIS Submission Date
15-11-2024
First CTIS Authorization Date
09-12-2024

Trial design

open-label Phase II trial across 19 sites in Italy.

Open Label
Yes
Biomarker Stratified
True, PD-L1 expression (>=1%) and germline or somatic HRR gene mutations
Target Sample Size
48
Trial Duration For Participant
730

Eligibility

Recruits 48 Vulnerable population not selected. Participants are adults (age over 18 and under 75) and informed consent from the participant is required. Subject information and informed consent forms for adults are provided (multiple versions). No paediatric consent or assent procedures described..

Pregnancy Exclusion
Pregnancy / breastfeeding
Vulnerable Population
Vulnerable population not selected. Participants are adults (age over 18 and under 75) and informed consent from the participant is required. Subject information and informed consent forms for adults are provided (multiple versions). No paediatric consent or assent procedures described.

Inclusion criteria

  • {"criterion_text":"-Diagnosis (cyto or histological) of Mesothelioma or non-small cell lung cancer EGFR / ALK / ROS1 in advanced wild type\n- Disease progression to at least one previous systemic therapy line\n- Presence of germline and / or somatic mutations in DNA shelter genes and PD-L1 expression = 1%\n- Informed consent\n- Age over 18 and under 75\n- Disease measurable according to RECIST criteria\n- Consent to biological material analysis (tissue biopsy)\n- Performance status 0-1\n- Adequate organ functions"}

Exclusion criteria

  • {"criterion_text":"- Participation in other clinical studies\n- Presence of EGFR gene sensitizing mutations or ALK / ROS1 rearrangements\n- Immunodeficiency diagnosis\n- History of tuberculous infection\n- Known hypersensitivity to Niraparib or Dostarlimab, or excipients\n- Previous diagnosis of myelodysplastic syndrome or acute myeloid leukemia\n- Other known malignancy requiring active treatment\n- Diagnosis of autoimmune diseases Current or past non-infectious pneumonia treated with steroids or evidence of interstitial lung disease\n- Symptomatic cerebral or leptomeningeal metastases\n- Known medical conditions that may in some way preclude participation in the study because they confuse the results of the study itself or interfere with the participation of the subject, at the discretion of the researchers involved\n- Psychiatric comorbidities that preclude participation in the study / informed consent\n- Pregnancy / breastfeeding\n- Previous therapy with PARP inhibitors (poly-adenosine diphosphate-ribose)\n- Previous therapy with anti PD-1 or PD-L1 agents\n- HIV infection\n- Hepatitis B infection\n- Vaccinations within 30 days from the start of the experimental treatment"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-To evaluate the progression free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-To evaluate the objective response rate (ORR)\n- To evaluate the duration of response (DOR)\n- To evaluate the disease control rate (DCR)\n- To evaluate the overall survival (OS)\n- To evaluate the safety and tolerability of the combination of Niraparib and dostarlimab","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
48
Recruitment Window Months
82
Consent Approach
Informed consent is required from participants (adults >18). Subject information and informed consent forms for adults are provided (multiple versions present in the documents). A prescreening consent form is available. Documents include versions in Italian and English (e.g. 'informedconsent patientrecruitmentprocedure en' and Italian 'Modulo consenso adulti'). No assent or paediatric consent described.

Geography

Total Number Of Sites
19
Total Number Of Participants
48

Italy

Earliest CTIS Part Ii Submission Date
15-11-2024
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
530
Number Of Sites
19
Number Of Participants
48

Sites

Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
Oncology
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Ente Ecclesiastico Ospedale Generale Regionale Miulli
Department Name
Oncology
Principal Investigator Name
Antonella Cristofano
Principal Investigator Email
a.cristofano@miulli.it
Contact Person Name
Antonella Cristofano
Contact Person Email
a.cristofano@miulli.it
Site Name
IRCCS Istituti Fisioterapici Ospitalieri- Istituto Nazionale tumori Regina Elena
Department Name
Oncology
Principal Investigator Name
Federico Cappuzzo
Principal Investigator Email
federico.cappuzzo@ifo.gov.it
Contact Person Name
Federico Cappuzzo
Contact Person Email
federico.cappuzzo@ifo.gov.it
Site Name
Istituto Oncologico Veneto
Department Name
Oncology
Principal Investigator Name
Giulia Pasello
Principal Investigator Email
giulia.pasello@iov.veneto.it
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@iov.veneto.it
Site Name
Centro Di Riferimento Oncologico Di Aviano
Department Name
Oncology
Principal Investigator Name
Brigida Stanzione
Principal Investigator Email
brigida.stanzione@cro.it
Contact Person Name
Brigida Stanzione
Contact Person Email
brigida.stanzione@cro.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
oncology
Principal Investigator Name
Diego Cortinovis
Principal Investigator Email
diegoluigi.cortinovis@irccs-sangerardo.it
Contact Person Name
Diego Cortinovis
Site Name
A.O.U. Policlinico "G. Rodolicp-San Marco"
Department Name
Oncology
Principal Investigator Name
Hector Soto Parra
Principal Investigator Email
hsotoparra@yahoo.it
Contact Person Name
Hector Soto Parra
Contact Person Email
hsotoparra@yahoo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Oncology
Principal Investigator Name
Angelo Delmonte
Principal Investigator Email
angelo.delmonte@irst.emr.it
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Careggi University Hospital
Department Name
radiotherapy
Principal Investigator Name
Vieri Scotti
Principal Investigator Email
vieri.scotti@unifi.it
Contact Person Name
Vieri Scotti
Contact Person Email
vieri.scotti@unifi.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncology
Principal Investigator Name
Domenico Galetta
Principal Investigator Email
galetta@oncologico.bari.it
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
Oncology
Principal Investigator Name
Mariacarmela Santarpia
Principal Investigator Email
mariacarmela.santarpia@polime.it
Contact Person Name
Mariacarmela Santarpia
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
Oncology
Principal Investigator Name
Carlo Genova
Principal Investigator Email
carlo.genova@hsanmartino.it
Contact Person Name
Carlo Genova
Contact Person Email
carlo.genova@hsanmartino.it
Site Name
AUSL di Reggio Emilia IRCCS, Arcispedale Santa Maria Nuova di Reggio Emilia
Department Name
Oncology
Principal Investigator Name
Giulia Alberti
Principal Investigator Email
Giulia.Alberti@ausl.re.it
Contact Person Name
Giulia Alberti
Contact Person Email
Giulia.Alberti@ausl.re.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Department Name
Oncology
Principal Investigator Name
Rita Chiari
Principal Investigator Email
rita.chiari@ospedalimarchenord.it
Contact Person Name
Rita Chiari
Site Name
Istituto Nazionale Dei Tumori
Department Name
Oncology
Principal Investigator Name
Alessandro Morabito
Principal Investigator Email
a.morabito@istitutotumori.na.it
Contact Person Name
Alessandro Morabito
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Oncology
Principal Investigator Name
Francesco Grossi
Principal Investigator Email
francesco.grossi@asst-settelaghi.it
Contact Person Name
Francesco Grossi
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Oncology
Principal Investigator Name
Giampiero Romano
Principal Investigator Email
giampieroromano@tiscali.it
Contact Person Name
Giampiero Romano
Contact Person Email
giampieroromano@tiscali.it
Site Name
Azienda USL Toscana Centro
Department Name
Oncology
Principal Investigator Name
Giulia Meoni
Principal Investigator Email
giulia.meoni@uslcentro.toscana.it
Contact Person Name
Giulia Meoni
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
Oncology
Principal Investigator Name
Francesco Agustoni
Principal Investigator Email
F.Agustoni@smatteo.pv.it
Contact Person Name
Francesco Agustoni
Contact Person Email
F.Agustoni@smatteo.pv.it

Sponsor

Primary sponsor

Full Name
Universita' Degli Studi Di Torino
Organisation Type
Educational Institution
Country Of Registered Address
Italy

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"Other - packaging. secondary labelling and QP release","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
NIRAPARIB
Active Substance
NIRAPARIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
-
Maximum Dose
300 mg
Investigational Product Name
JEMPERLI 500 mg concentrate for solution for infusion
Active Substance
DOSTARLIMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
EU/1/21/1538/001
Maximum Dose
1000 mg
Combination Treatment
Yes

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