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New combo therapy aims to extend remission in aggressive lung cancer

NCT ID NCT05718323

Disease control Sponsor: ETOP IBCSG Partners Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial tests whether adding the drug niraparib to standard maintenance therapy can help people with a specific type of advanced small cell lung cancer (SLFN11-positive) stay cancer-free longer. About 44 participants will receive niraparib pills plus an anti-PD-L1 antibody after initial chemo-immunotherapy. The main goal is to see how many patients have no cancer growth after 3 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 44 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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. * 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 treatment start. Exclusion Criteria: * 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 skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or stage I uterine cancer. Hormonal therapy for non-metastatic prostate or ductal carcinoma in situ is allowed. Consolidating thoracic radiotherapy. Palliative radiotherapy to the brain or to bones is allowed. * 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. 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.

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SCLC,extensive stage SLFN11-positive

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bürgerspital Solothurn

    RECRUITING

    Solothurn, Switzerland

  • CHU - Angers

    RECRUITING

    Angers, France

  • Caen - CHU

    RECRUITING

    Caen, France

  • Centre Hospitalier d'Avignon

    RECRUITING

    Avignon, France

  • Centre Hospitalier du Valais Romand

    RECRUITING

    Sion, Switzerland

  • Complejo Hospitalario Universitario a Coruña

    NOT_YET_RECRUITING

    A Coruña, Spain

  • Complejo Hospitalario de Jaén

    RECRUITING

    Jaén, Spain

  • Hospital Universitario Puerta de Hierro

    RECRUITING

    Madrid, Spain

  • Inselspital Bern

    RECRUITING

    Bern, Switzerland

  • Instituto Europeo di Oncologia (IEO)

    NOT_YET_RECRUITING

    Milan, Italy

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

    RECRUITING

    Meldola, Italy

  • Kantonsspital Baden

    RECRUITING

    Baden, Switzerland

  • Kantonsspital St. Gallen

    RECRUITING

    Sankt Gallen, Switzerland

  • Kantonsspital Winterthur

    RECRUITING

    Winterthur, Switzerland

  • LMU Klinikum / Thoracic Oncology center Münich

    RECRUITING

    München, Germany

  • Lyon - Centre Léon Bérard

    NOT_YET_RECRUITING

    Lyon, France

  • Santa Maria della Misericordia Hospital

    RECRUITING

    Perugia, Italy

  • University Hospital Basel

    RECRUITING

    Basel, Switzerland

More trials for these conditions

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