patients with advanced non-small cell lung cancer and malignant pleural mesothelioma, positive for PD-L1 expression and germ or somatic mutations in DNA damage repair genes MedDRA version: 20.0 Level: PT Classification code 10062042 Term: Lung neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10045155 Term: Tumor of pleura System Organ Class: 10029104 - Neoplasms benign, malignant and
Conditions
Interventions
Trade Name: ZEJULA
Product Name: niraparib
Product Code: [MK-4827]
Pharmaceutical Form: Capsule, hard
CAS Number: 1038915-60-4
Current Sponsor code: MK-4827
Concentration unit: mg milligram(s)
Concent
Sponsors
DIPARTIMENTO DI ONCOLOGIA-UNIVERSITA' DEGLI STUDI DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Diagnosis (cyto or histological) of Mesothelioma or non-small cell lung cancer EGFR / ALK / ROS1 in advanced wild type - Disease progression to at least one previous systemic therapy line - Presence of germline and / or somatic mutations in DNA shelter genes and PD-L1 expression = 1% - Informed consent - Age over 18 and under 75 - Disease measurable according to RECIST criteria - Consent to biological material analysis (tissue biopsy) - Performance status 0-1 - Adequate organ functions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: - Participation in other clinical studies - Presence of EGFR gene sensitizing mutations or ALK / ROS1 rearrangements - Immunodeficiency diagnosis - History of tuberculous infection - Known hypersensitivity to Niraparib or Dostarlimab, or excipients - Previous diagnosis of myelodysplastic syndrome or acute myeloid leukemia - Other known malignancy requiring active treatment - Diagnosis of autoimmune diseases Current or past non-infectious pneumonia treated with steroids or evidence of interstitial lung disease - Symptomatic cerebral or leptomeningeal metastases - 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 - Psychiatric comorbidities that preclude participation in the study / informed consent - Pregnancy / breastfeeding - Previous therapy with PARP inhibitors (poly-adenosine diphosphate-ribose) - Previous therapy with anti PD-1 or PD-L1 agents - HIV infection - Hepatitis B infection - Vaccinations within 30 days from the start of the experimental treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the progression free survival (PFS);Secondary Objective: To evaluate the objective response rate (ORR) To evaluate the duration of response (DOR) To evaluate the disease control rate (DCR) To evaluate the overall survival (OS) To evaluate the safety and tolerability of the combination of Niraparib and dostarlimab;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: the time from the date of the first treatment dose until either disease progression | — |
Countries
Italy
Contacts
Public ContactDATA CENTER
AOU SAN LUIGI-DIPARTIMETNO DI ONCOLOGIA
Outcome results
None listed