Lung CancerPhase 2UNITO-001NCT04940637
UNITO-001- Study in HRR/PDL1 Positive MPM/NSCLC
A Phase 2 study testing niraparib and dostarlimab in people with Lung Cancer and Mesothelioma, run by University of Turin, Italy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Mesothelioma
- What is being tested?
- niraparib and dostarlimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 23 Dec 2020to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Participant must have adequate organ function
- Female participant has a negative urine or serum pregnancy test within 24-72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy and to perform a monthly pregnancy testing from screening through 180 days after the last dose of study treatment, or is of nonchildbearing potential.
- Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment.
- Male participant agrees to use an adequate method of contraception (see Section 4.4 for a list of acceptable birth control methods) starting with the first dose of study treatment through 180 days after the last dose of study treatment. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
- Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
Who cannot join
- Participant with current participation in any interventional clinical trial and/or Participant who received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
- Participant who received major surgery ≤3 weeks prior to initiating protocol therapy and/or has been recovered from any surgical effects.
- Participant who received last treatment ≥12 weeks from initiation of protocol therapy.
- Participant who received radiation therapy within 2 weeks prior to Day 1 of protocol therapy.
- Participant with known hypersensitivity to niraparib and dostarlimab components or excipients.
- Participant who received transfusion (platelets or red blood cells) ≤4 weeks prior to initiating protocol therapy.
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- Participant who received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy.
- Participant with any known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
- Participant with any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Participant with a serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
- Participant with diagnosis, detection, or treatment of another type of malignancy ≤2 years prior to initiating protocol therapy (except basal or squamous cell carcinoma of the skin and cervical cancer that has been definitively treated)
- Participant with known, symptomatic brain or leptomeningeal metastases.
- Patient who experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
- Participant with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (exceeding 10 mg of prednisone or equivalent daily) or any other form of immunosuppressive therapy within 7 days prior to initiating protocol therapy.
- Participant with a known history of human immunodeficiency virus (type 1 or 2 antibodies).
- Participant with a known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
- Participant with an active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Participant with a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment
- Participant has received a live vaccine within 14 days of initiating protocol therapy.
- Participant who received prior treatment with a PARP inhibitor
- Participant who is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and for 180 days after the last dose of study treatment
- Male participant who is expecting to donate sperm or father children while receiving study drug or for 180 days after the last dose of study treatment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOU San Luigi- Department of Oncology
Orbassano, Turin, 10043
Silvia Novello, MD, +390119026978, silvia.novello@unito.it
Silvia Novello, MD
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Cancer, Mesothelioma
- Being tested
- niraparib and dostarlimab
- Medical subject headings
- Lung Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
niraparib and dostarlimabDrug
Also called no other intervention
niraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Niraparib and Dostarlimab | Experimental | niraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks Receives: Drug: niraparib and dostarlimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
the time from the date of the first treatment dose until either disease progression, as assessed by investigator's review according to RECIST v1.1criteria, or modified RECIST for assessment of response in malignant pleural mesothelioma version 1.1 (mRECIST v1.1), or death due to any cause, whichever occurs first.
Measured: 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
Secondary outcomes (4)
Objective response rate
the proportion of participants who have a best overall response of either complete response (CR) or partial responses (PR) as assessed by investigator's review according to RECIST v1.1, or modified RECIST for assessment of response in malignant pleural mesothelioma version 1.1 (mRECIST
Measured: up to 36 months
Disease control rate
the proportion of participants who have complete response (CR), partial responses (PR), or stable disease (SD) as assessed by investigator's review according to RECIST v1.1 or mRECIST v1.1
Measured: up to 36 months
Duration of response
the time from the date a response was first documented until either disease progression or death due to any cause, whichever occurs first.
Measured: up to 36 months
Overall survival
the time from the date of the first dose to death due to any cause
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start23 Dec 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giorgio V Scagliotti, Medicine, Principal investigator, Oncology department-University of Turin- AOU San Luigi Gonzaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940637
- Sponsor's protocol ID
- UNITO-001
- Acronym
- UNITO-001
- Status last verified
- May 2023
- First submitted
- 3 May 2021
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04940637
- Acronym / sponsor ID
- UNITO-001 / UNITO-001
- Conditions
- Lung Cancer, Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib and Dostarlimab | Experimental | Drug: niraparib and dostarlimabniraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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%).
Key exclusion criteria (22 listed)
- Participant with current participation in any interventional clinical trial and/or Participant who received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
- Participant who received major surgery ≤3 weeks prior to initiating protocol therapy and/or has been recovered from any surgical effects.
- Participant who received last treatment ≥12 weeks from initiation of protocol therapy.
- Participant who received radiation therapy within 2 weeks prior to Day 1 of protocol therapy.
- Participant with known hypersensitivity to niraparib and dostarlimab components or excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| niraparib and dostarlimabAlso: no other interventionniraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks | Drug | Niraparib and Dostarlimab |
Primary outcome
PFS
Time frame: 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
the time from the date of the first treatment dose until either disease progression, as assessed by investigator's review according to RECIST v1.1criteria, or modified RECIST for assessment of response in malignant pleural mesothelioma version 1.1 (mRECIST v1.1), or death due to any cause, whichever occurs first.
4 secondary outcomes
Objective response rate
Time frame: up to 36 months
Disease control rate
Time frame: up to 36 months
Duration of response
Time frame: up to 36 months
Overall survival
Time frame: up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio V Scagliotti, Medicine principal investigator
Oncology department-University of Turin- AOU San Luigi Gonzaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing niraparib and dostarlimab in people with Lung Cancer and Mesothelioma, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact giorgio v scagliotti, medicine (+390119026978, giorgio.scagliotti@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.