Clinical trial • Phase II • Oncology|Respiratory

NIRAPARIB TOSILATE MONOHYDRATE for Small cell lung cancer (extensive stage)

Phase II trial of NIRAPARIB TOSILATE MONOHYDRATE for Small cell lung cancer (extensive stage). open-label, none/not specified-controlled. 35 participants.

Overview

Trial Therapeutic Area
Oncology|Respiratory
Trial Disease
Small cell lung cancer (extensive stage)
Trial Stage
Phase II
Drug Modality
Small molecule|Monoclonal antibody
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
16-10-2023
First CTIS Authorization Date
15-02-2024

Trial design

open-label, none/not specified-controlled Phase II trial across 13 sites in Romania, Germany, France and others.

Open Label
Yes
Comparator
None/Not specified
Biomarker Stratified
True, SLFN11 expression (selected for high SLFN11-expression defined as IHC in ≥20% of tumour cells)
Target Sample Size
35

Eligibility

Recruits 35 No vulnerable population selected. Minimum age is ≥18 years. Written informed consent must be signed and dated by the patient and the investigator prior to SLFN11 screening and prior to any trial-related intervention; no assent procedures for minors are described because minors are excluded..

Vulnerable Population
No vulnerable population selected. Minimum age is ≥18 years. Written informed consent must be signed and dated by the patient and the investigator prior to SLFN11 screening and prior to any trial-related intervention; no assent procedures for minors are described because minors are excluded.

Inclusion criteria

  • {"criterion_text":"- Histologically or cytologically confirmed ED-SCLC (stage IV according to the 8th TNM classification)."}
  • {"criterion_text":"- Availability of FFPE tumour tissue for central testing of SLFN11."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Patients must not have progressed on the standard chemo-immunotherapy (as per RECIST v1.1)"}
  • {"criterion_text":"- Patients must be candidates for maintenance treatment with immune-checkpoint inhibition."}
  • {"criterion_text":"- Adequate haematological, renal and liver function"}
  • {"criterion_text":"- ECOG PS 0-2"}
  • {"criterion_text":"- Age ≥18 years"}
  • {"criterion_text":"- Written IC for trial participation must be signed and dated by the patient and the investigator prior to any trial-related intervention"}

Exclusion criteria

  • {"criterion_text":"- Symptomatic brain metastases"}
  • {"criterion_text":"- Any clinically active cancer, other than SCLC"}
  • {"criterion_text":"- Consolidating thoracic radiotherapy"}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Any lung disease requiring systemic steroids in doses of >10 mg prednisolone (or equivalent dose of other steroid)."}
  • {"criterion_text":"- 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."}
  • {"criterion_text":"- Inadequately controlled hypertension, defined as systolic blood pressure >150 mmHg and/or diastolic blood pressure >95 mmHg."}
  • {"criterion_text":"- History of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)."}
  • {"criterion_text":"- Prior Reversible Encephalopathy Syndrome (PRES)."}
  • {"criterion_text":"- Severe renal or hepatic impairment."}
  • {"criterion_text":"- Any clinically significant gastrointestinal (GI) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels."}
  • {"criterion_text":"- Treatment with live vaccine within 30 days before enrolment."}
  • {"criterion_text":"- Judgment by the investigator that the patient is unlikely to comply with trial procedures, restrictions and requirements."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS) rate at 3 months by investigator assessment (according to RECIST v1.1)","definition_or_measurement_approach":"PFS rate at 3 months assessed by investigator according to RECIST v1.1"}

Secondary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Disease control rate (DCR) by investigator assessment (according to RECIST v1.1)","definition_or_measurement_approach":"Assessed by investigator according to RECIST v1.1"}
  • {"endpoint_text":"- Adverse events according to CTCAE v5.0","definition_or_measurement_approach":"Safety assessed by recording adverse events graded per CTCAE v5.0"}

Recruitment

Planned Sample Size
35
Recruitment Window Months
24
Consent Approach
Written informed consent is required from each patient; the protocol requires the written IC for SLFN11 screening to be signed and dated by the patient and the investigator prior to sending tumour material to the central laboratory, and a written IC for trial participation to be signed and dated by the patient and the investigator prior to any trial-related intervention. Age eligibility is ≥18 years (no assent). Subject information and ICF documents are provided in multiple languages (documents available for DE, FR, IT, ES, EN in the CTIS document list).

Geography

Total Number Of Sites
13
Total Number Of Participants
35

Romania

Earliest CTIS Part Ii Submission Date
31-10-2023
Latest Decision Or Authorization Date
20-02-2024
Processing Time Days
112
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Medisprof S.R.L.
Department Name
Medical oncology
Contact Person Name
Adrian Udrea
Contact Person Email
adrianudrea@medisprof.ro

Germany

Earliest CTIS Part Ii Submission Date
13-08-2025
Latest Decision Or Authorization Date
28-01-2026
Processing Time Days
168
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
LMU Klinikum Muenchen AöR
Department Name
Pneumologie – Med V
Contact Person Name
Diego Kauffmann-Guerrero

France

Earliest CTIS Part Ii Submission Date
24-01-2024
Latest Decision Or Authorization Date
02-02-2026
Processing Time Days
740
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Centre Hospitalier Regional D'Angers
Department Name
Medical oncology
Contact Person Name
Youssef Oulkohuir
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Medical oncology
Contact Person Name
Simon Deshayes
Contact Person Email
deshayes-si@chu-caen.fr
Site Name
Centre Leon Berard
Department Name
Medical oncology
Contact Person Name
Maurice Pérol
Site Name
Centre Hospitalier D Avignon
Department Name
Medical oncology
Contact Person Name
Nicolas Cloarec
Contact Person Email
cloarec.nicolas@ch-avignon.fr

Italy

Earliest CTIS Part Ii Submission Date
20-12-2023
Latest Decision Or Authorization Date
06-02-2026
Processing Time Days
779
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
European Institute Of Oncology S.r.l.
Department Name
Medical oncology
Contact Person Name
Antonio Passaro
Contact Person Email
Antonio.Passaro@ieo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L.
Department Name
Medical oncology
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Medical oncology
Contact Person Name
Giulio Metro
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
Medical oncology
Contact Person Name
Adolfo Favaretto

Spain

Earliest CTIS Part Ii Submission Date
23-11-2023
Latest Decision Or Authorization Date
09-03-2026
Processing Time Days
837
Number Of Sites
3
Number Of Participants
10

Sites

Site Name
Hospital Universitario De Jaen
Department Name
Medical oncology
Contact Person Name
Jose Antonio López López
Contact Person Email
Jall92hs@gmail.com
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Medical oncology
Contact Person Name
Mariano Provencio
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
SERVICIO ONCOLOGÍA
Contact Person Name
Rosario Garcia Campelo

Sponsor

Primary sponsor

Full Name
ETOP IBCSG Partners Foundation
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Switzerland

Third parties

  • {"country":"Switzerland","full_name":"Centre Hospitalier Universitaire Vaudois","duties_or_roles":"code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Switzerland","full_name":"Institut für medizinische Genetik und Pathologie, Universitätsspital Basel","duties_or_roles":"code 4","organisation_type":"Health care"}
  • {"country":"Greece","full_name":"Frontier Science Foundation-Hellas","duties_or_roles":"code 10; code 11","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
NIRAPARIB (sponsor product code GSK3985771 / tablet)
Active Substance
NIRAPARIB TOSILATE MONOHYDRATE
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Orphan Designation
Yes
Starting Dose
200 mg orally once daily (300 mg if body weight ≥77 kg and platelets ≥150 g/L)
Dose Levels
200 mg; 300 mg (if body weight ≥77 kg and platelets ≥150 g/L)
Frequency
once daily
Maximum Dose
300 mg
Dose Escalation Increase
200 mg; 300 mg
Investigational Product Name
IMFINZI (durvalumab) 50 mg/mL concentrate for solution for infusion
Active Substance
DURVALUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
intravenous infusion
Authorisation Status
Marketing authorisation number EU/1/18/1322/001 and EU/1/18/1322/002 (products listed in CTIS record)
Investigational Product Name
Tecentriq (atezolizumab) concentrate for solution for infusion
Active Substance
ATEZOLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
intravenous infusion
Authorisation Status
Marketing authorisation number EU/1/17/1220/001 and EU/1/17/1220/002 (products listed in CTIS record)
Combination Treatment
Yes

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