UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC (NCT04940637) | Clinical Trial Compass
UnknownPhase 2
UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
Italy70 participantsStarted 2020-12-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant must have histological or cytological proven diagnosis of advanced (stage IV) NSCLC without known EGFR-sensitizing mutation or ALK/ROS1 rearrangements and/or histological or cytological proven diagnosis of advanced or metastatic MPM (according to the 8th Edition of the UICC TNM Classification).
* Participant must have experienced disease progression or recurrence during or after at least one systemic therapy for advanced metastatic disease:
* Participant must be able to provide adequate archival tumor tissue specimen for central somatic (s)HRd and PD-L1 status assessment, which may have been collected at any time prior to screening. If no archival FFPE tumor tissue is available, a newly obtained tissue biopsy is required before Cycle 1/Day 1.
* Participant must be able to provide adequate pre-treatment blood samples for central germline (g)HRd assessment.
* Participant must have centrally-confirmed positivity for germline or somatic HRd status and tumor PD-L1 expression (TPS ≥ 1%).
* Participant with NSCLC must have measurable disease by computed tomography (CT) scan as defined by RECIST v1.1: at least 1 tumor lesion ≥10 mm in the longest diameter, or a lymph node ≥15 mm in short axis measurement.
* Participant with MPM must have Evaluable disease or measurable disease as assessed according to the mRECIST v1.1
* Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
* Participant must be ≥ 18 years of age…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PFS
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months