A clinical study to test the effect of niraparib and immunotherapy, for patients with small cell lung cancer (SCLC) that is positive for SLFN11.

Phase 1

Recruiting

• Conditions: Extensive-disease small cell lung cancer and high SLFN11-expression; MedDRA version: 21.1Level: PTClassification code: 10041067Term: Small cell lung cancer Class: 100000004864; MedDRA version: 21.1Level: PTClassification code: 10041068Term: Small cell lung cancer extensive stage Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code: 10025044Term: Lung cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2022-502092-33-00
• Lead Sponsor: ETOP IBCSG Partners Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified