BridgeMD
A clinical study to test the effect of niraparib and immunotherapy, for patients with small cell lung cancer (SCLC) that is positive for SLFN11.
EU CTIS ID: 2022-502092-33-00
What this study is testing
To assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody maintenance treatment in patients with SLFN11-positive ED-SCLC which has not progressed following standard first-line chemo-immunotherapy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria for SLFN11-expression testing • Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification). • Availability of FFPE tumour tissue for central testing of SLFN11. • Written IC for SLFN11-screening must be signed and dated by the patient and the investigator prior to sending any tumour material to the central laboratory. Most important inclusion criteria for trial participation (See Section 7.2 for the complete list): • 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 started the immunotherapy at chemotherapy cycle 2, are eligible. • Patients must not have progressed on the standard chemo-immunotherapy (as per RECIST v1.1) • Patients must be candidates for maintenance treatment with immune-checkpoint inhibition. • Adequate haematological, renal and liver function • ECOG PS 0-2 • Age ≥18 years • Written IC 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
- Most important exclusion criteria (See Section 7.3 for the complete list): • Symptomatic brain metastases • Any clinically active cancer, other than SCLC • Consolidating thoracic radiotherapy • 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 tomography (CT) scan. • 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 interfere with the evaluation of the efficacy and safety of the protocol treatment. • Inadequately controlled hypertension, defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg. • 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. • Treatment with live vaccine within 30 days before enrolment. • 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
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. 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 EU CTIS; the study team decides eligibility.