UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC — UNITO-001  

Lung Cancer Clinical Trial

Official title: A Phase II, Open-Label, Single Arm, Prospective, Multicenter Study of Niraparib Plus Dostarlimab in Patients With Advanced NSCLC and/or MPM, and Positive for PD-L1 Expression and Germline or Somatic Mutations in the HRR Genes

Status Recruiting

Clinical Trial Summary

This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma (MPM), and positive for PD-L1 expression (TPS ≥ 1%) and germline or somatic mutations in the DNA homologous recombination repair (HRR) genes.

Clinical Trial Description

This is a single arm, prospective, interventional, multicenter phase 2 study of the combination of niraparib and dostarlimab in patients with advanced non-small cell lung cancer (NSCLC) and/or malignant pleural mesothelioma (MPM), and positive for PD-L1 expression (TPS ≥ 1%) and germline or somatic mutations in the DNA homologous recombination repair (HRR) genes.

Approximately 70 eligible patients with previously treated advanced disease, not amenable for curative treatment will be included in this study and will be grouped as follows:

• Homologous recombination deficiency (HRd)-positive and PD-L1-positive advanced NSCLC referred to as Cohort A (n= 35)

• HRd-positive and PD-L1-positive advanced MPM referred to as Cohort B (n= 35)

HRd-positive and PD-L1-positive are defined as follows:

• HRd-positive: Tumors that harbor known or suspected deleterious germline or somatic mutations in the HRR genes, based on the HRd Assay.

• PD-L1-positive: Tumors with PD-L1 expression on at least 1% of tumor cells based on immunohistochemistry (IHC) analysis. ;

Related Conditions & MeSH terms

• Lung Cancer
• Mesothelioma

• NCT number: NCT04940637
• Study type: Interventional
• Source: University of Turin, Italy
• Contact: giorgio v scagliotti, medicine
• Phone: +390119026978
• Email: giorgio.scagliotti@unito.it
• Status: Recruiting
• Phase: Phase 2
• Start date: December 23, 2020
• Completion date: June 30, 2025