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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

ETOP IBCSG Partners Foundation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

31 May 2024 → ongoing

Decision date (initial)

2024-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

GlaxoSmithKline Research & Development Limited

External identifiers

EU CT number

2022-502092-33-00

ClinicalTrials.gov

NCT05718323

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

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.

Conditions and MedDRA coding

Extensive-disease small cell lung cancer and high SLFN11-expression

Study design 5 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)

Secondary endpoints 1

1. • Progression-free survival (PFS) • Overall survival (OS) • Disease control rate (DCR) by investigator assessment (according to RECIST v1.1) • Adverse events according to CTCAE v5.0

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

ETOP IBCSG Partners Foundation

Sponsor organisation

ETOP IBCSG Partners Foundation

Address

Effingerstrasse 33

City

Bern

Postcode

3008

Country

Switzerland

Scientific contact point

Organisation

ETOP IBCSG Partners Foundation

Contact name

ETOP IBCSG Partners Regulatory Office

Public contact point

Organisation

ETOP IBCSG Partners Foundation

Contact name

ETOP IBCSG Partners Regulatory Office

Third parties 3

Locations

5 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications