Niraparib Added to Anti-PD-L1 Antibody Maintenance in SLFN11-positive, Extensive-disease S
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. The primary objective of this trial is to assess the clinical efficacy of the addition of niraparib to anti-PD-L1 monoclonal antibody
| Condition(s) | SCLC,Extensive Stage, SLFN11-positive |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. The primary objective of this trial is 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. |
| Who can participate | Inclusion Criteria: Inclusion 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. Inclusion criteria 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. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | ETOP IBCSG Partners Foundation |
| Locations | Angers, France; Avignon, France; Caen, France; Lyon, France; München, Germany; Meldola, Italy (+12 more sites) |
| Start date | 2023-12-20 |
| NCT ID | NCT05718323 |
| Official listing | https://clinicaltrials.gov/study/NCT05718323 |