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New treatment option for SCLC,Extensive Stage
Official title Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease SCLC
ClinicalTrials.gov ID: NCT05718323
What this study is testing
What is Niraparib?
Niraparib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for sclc,extensive stage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- RAISE is an international, multicentre, single-arm phase II trial. The trial treatment consists of the addition of niraparib, 200 mg orally once daily to anti-PD-L1 antibody maintenance.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- for SLFN11-expression testing
- Written IC part 1: for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the...
- Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification).
- Availability of FFPE tumour tissue for screening. for trial participation
- Written IC part 2: for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention.
You likely can't join if
- Symptomatic brain metastases
- Any clinically active cancer, other than SCLC Exception: malignancies with negligible risk of metastases or death (e.g. 5-year OS rate of \>90%)...
- History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis...
- Any lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or equivalent dose of other steroid).
- Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator...
- Inadequately controlled hypertension, defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg. The patient must be...
See the full eligibility criteria
- for SLFN11-expression testing
- Written IC part 1: for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory.
- Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification).
- Availability of FFPE tumour tissue for screening. for trial participation
- Written IC part 2: for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention.
- High SLFN11-expression on FFPE tumour material: SLFN11-expression is determined at the central screening laboratory in Basel. Overexpression is defined as detectable protein expression by IHC in ≥20% of tumour cells.
- Patients must have received standard first-line chemo-immunotherapy, consisting of 4 cycles of platinum-etoposide chemotherapy in combination with an anti-PD-L1 antibody (atezolizumab or durvalumab). Patients who...
- ED-SCLC must not have progressed during or after standard chemo-immunotherapy (as per RECIST v1.1).
- Patients must be candidates for ongoing maintenance treatment with immune-checkpoint inhibition.
- Adequate haematological function:
- Adequate renal function:
- Adequate liver function:
- ECOG PS 0-2
- Age ≥18 years
- Women of childbearing potential, including women who had their last menstruation in the last 2 years, must have a negative urinary or serum pregnancy test within 4 weeks before enrolment and within 3 days before...
- Symptomatic brain metastases
- Any clinically active cancer, other than SCLC Exception: malignancies with negligible risk of metastases or death (e.g. 5-year OS rate of \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma...
- History of idiopathic pulmonary fibrosis, organising pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed...
- Any lung disease requiring systemic steroids in doses of \>10 mg prednisolone (or equivalent dose of other steroid).
- Any serious concomitant systemic disorders (for example active infection, unstable cardiovascular disease) which in the opinion of the investigator would compromise the patient's ability to complete the trial or...
- Inadequately controlled hypertension, defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \>95 mmHg. The patient must be considered stable and hypertension medically controlled.
- History of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML).
- Prior Reversible Encephalopathy Syndrome (PRES)
- Severe renal or hepatic impairment.
- Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
- Treated with live vaccine within 30 days before enrolment.
- Hypersensitivity to niraparib or any of its excipients (e.g., tartrazine).
- Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and within the required timelines after last dose of niraparib treatment.
- Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Avignon, France
- Caen, France
- Lyon, France
- München, Germany
- Meldola, Italy
- Milan, Italy
- Perugia, Italy
- A Coruña, Spain
- Jaén, Spain
- Madrid, Spain
- Baden, Switzerland
- Basel, Switzerland
- Bern, Switzerland
- Sankt Gallen, Switzerland
- Sion, Switzerland
- Solothurn, Switzerland
- Winterthur, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Avignon, France; Caen, France; Lyon, France; München, Germany; Meldola, Italy and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.