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SNCTP000003022 | NCT03620669 | BASEC2018-01254

Studie SAKK 19/17 - Durvalumab bei Patienten mit PD-L1-positivem fortgeschrittenem nicht-kleinzelligem Bronchialkarzinom (NSCLC) und ungenügendem Allgemeinzustand - Eine multizentrische einarmige Phase II Studie.

Base di dati: BASEC (Importata da 01.07.2022) , WHO (Importata da 19.05.2022)
Cambiato: 19 mag 2022, 14:11
Categoria di malattie: Cancro del polmone

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Mit dieser Studie wird bei Patienten mit einem PD-L1 positiven fortgeschrittenen NSCLC und einem ungenügenden Allgemeinzustand untersucht, wie die Immuntherapie mit Durvalumab wirkt und wie verträglich diese ist. Zudem soll mit zusätzlichen Untersuchungen des Tumormaterials sowie des Bluts die Wirkung der Immuntherapie besser verstanden und herausgefunden werden, weshalb die Therapie bei einigen Patienten besser wirkt als bei anderen. Durvalumab ist ein sogenannter anti-PD-L1 Antikörper, der sich auf das Immunsystem auswirkt. Der Antikörper erkennt PD-L1, ein Eiweiss, welches sich bei einigen Patienten auf der Oberfläche der Tumorzellen befindet. Der Tumor nutzt PD-L1 dazu, gewisse Immunzellen (T-Zellen) in ihrer Aufgabe der Tumorvernichtung zu behindern. Durvalumab blockiert durch das Binden an PD-L1 dessen Wirkung und kann dadurch Ihrem Immunsystem helfen, in der Tumorabwehr eine aktive Rolle zu spielen. Diese Studie wird an mehreren Spitälern in der Schweiz durchgeführt. Es werden 48 Patienten in die Studie eingeschlossen. Alle Studienteilnehmer werden die gleiche Behandlung erhalten (Studienmedikament Durvalumab). Die Studie dauert etwa 7.5 Jahre. Durvalumab ist als Medikament in der Schweiz noch nicht zugelassen.

Malattie studiate(Fonte di dati: BASEC)

PD-L1-positives fortgeschrittenes nicht-kleinzelliges Bronchialkarzinom (NSCLC) und ungenügender Allgemeinzustand

Health conditions (Fonte di dati: WHO)

NSCLC Stage IV;NSCLC Stage IIIB

Malattia rara (Fonte di dati: BASEC)

No

Interventi esaminati (p. es. medicamento, terapia, campagna) (Fonte di dati: BASEC)

Um an der Behandlung im Rahmen der Studie teilnehmen zu können, müssen die Patienten gewisse Einschlusskriterien erfüllen. Diese werden vorgängig abgeklärt. Sobald ein Patient die Einschlusskriterien erfüllt und sich für die Studienteilnahme entscheidet, wird dieser jeweils am ersten Tag eines 4-wöchentlichen Zyklus das Studienmedikament Durvalumab erhalten. Die Dauer der Behandlung ist solange vorgesehen, wie das Medikament beim Patienten wirkt und von diesem vertragen wird.
Im Rahmen der Studie sind alle 2-4 Wochen klinische Kontrollen und Blutuntersuchungen vorgesehen. Eine radiologische Kontrolle mittels Computertomographie wird alle 8 Wochen durchgeführt. Dabei wird die Wirksamkeit der Behandlung überprüft.

Interventions (Fonte di dati: WHO)

Drug: Durvalumab

Criteri per la partecipazione alla sperimentazione (Fonte di dati: BASEC)

Es können alle Personen teilnehmen, die an einem fortgeschrittenen PD-L1 positiven NSCLC leiden, einen sog. Performance Status 2 haben und mindestens 18 Jahre alt sind. Die Niere und die Leber müssen zudem ausreichend gut funktionieren.

Criteri di esclusione (Fonte di dati: BASEC)

Nicht teilnehmen hingegen dürfen Personen, die Autoimmunerkrankungen oder chronische Infektionen haben und eine Dauertherapie mit Kortison (Steroide) benötigen. Patienten, die im fortgeschrittenen Stadium schon vorbehandelt wurden oder an einer anderen bösartigen Tumorerkrankung leiden, müssen ebenfalls von dieser Studie ausgeschlossen werden.

Inclusion/Exclusion Criteria (Fonte di dati: WHO)


Inclusion Criteria:

- Written informed consent according to Swiss law and ICH/GCP regulations before
registration and prior to any trial specific procedures

- Histologically confirmed NSCLC, advanced or recurrent disease (stage IIIB to IV).
Cytology could be accepted if histology is not possible

- PD-L1 expression of = 25% of the tumor cells by local testing (Ventana SP142 excluded)

- No sensitizing EGFR mutation (L858R or exon 19 deletions), ALK fusion oncogene or
rearrangements of the ROS1 gene detected in patients with a non-squamous cell NSCLC

- Patient unsuitable for platinum-containing combination chemotherapy according to
investigator or due to patient preference

- WHO PS of 2. Confirmation of PS2 by a second medical doctor is mandatory.

- Age = 18 years

- Baseline QoL forms and GA questionnaires have been completed

- Bone marrow function: hemoglobin = 90 g/L, neutrophil count = 1.5 x 109/L, platelet
count = 100 x 109/L

- Hepatic function: bilirubin = 1.5 x ULN (except for patients with Gilbert's disease =
3.0 x ULN); patients without liver metastases: AST and ALT = 2.5 x ULN, patients with
documented liver metastases: AST and ALT = 5 x ULN

- Renal function: estimated glomerular filtration rate (eGFR)> 30 mL/min/1.73m²
(according to CKD-EPI formula)

- Measurable or evaluable disease (by RECIST v1.1)

- Patients with asymptomatic untreated CNS metastases are eligible, provided they meet
the following:

- = 5 CNS lesions with a maximum diameter of one lesion of 10 mm

- Only supratentorial metastases allowed (i.e., no metastases to midbrain, pons,
cerebellum, medulla, or spinal cord)

- No evidence of progression at registration compared to the latest brain imaging

- No ongoing requirement for corticosteroids as therapy for CNS disease

- Patients with symptomatic treated CNS metastases are eligible, provided they meet the
following:

- No ongoing requirement for corticosteroids as therapy for CNS disease;
anticonvulsants at a stable dose allowed

- No stereotactic radiation or whole-brain radiation within 7 days prior to
registration

- No evidence of progression at registration, after completion of CNS-directed
therapy

- Tumor tissue available for central PD-L1 assessment and translational research
(preferably histology but cytology could be allowed if histology is not possible). In
case of scarce tumor material, a rebiopsy, if clinically possible, is encouraged

- Women with child-bearing potential are using effective contraception, are not pregnant
or lactating and agree not to become pregnant during trial treatment and during the 3
months thereafter. A negative pregnancy test before inclusion into the trial is
required for all women with child-bearing potential

- Men agree not to father a child during trial treatment and during 3 months thereafter

- Body weight > 30kg.

- Life expectancy > 3 months.

Exclusion criteria:

Any potential patient who meets any of the following criteria has to be excluded from
entering the trial.

- History of hematologic or primary solid tumor malignancy, unless in remission for at
least 3 years before registration with the exception of pT1-2 prostate cancer Gleason
score <6, adequately treated cervical carcinoma in situ or localized non-melanoma skin
cancer

- Prior adjuvant systemic anti-cancer treatment within 6 months before registration

- Prior systemic treatment for metastatic NSCLC

- Prior treatment with a PD-1 or PD-L1 inhibitor

- Current or prior use of immunosuppressive medication within 28 days before the first
dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or
systemic corticosteroids at physiological doses (i.e. which must not exceed 10 mg/day
of prednisone or an equivalent corticosteroid)

- Concomitant drugs contraindicated for use with durvalumab such as corticosteroids,
methotrexate, azathioprine and tumor necrosis factor (TNF)-a blockers

- Concurrent treatment with other experimental drugs or other anticancer therapy,
treatment in a clinical trial within 28 days prior to registration

- Major surgical procedure within 14 days prior to registration

- Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with
the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome,
or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid
arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this
criterion:

- Patients with vitiligo or alopecia

- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement

- Any chronic skin condition that does not require systemic therapy

- Patients without active disease in the last 5 years may be included but only
after consultation with the coordinating investigator

- Patients with celiac disease controlled by diet alone

- Uncontrolled diabetes mellitus

- Known history of human immunodeficiency virus (HIV) or active chronic Hepatitis C or
Hepatitis B Virus infection or any uncontrolled active systemic infection requiring
intravenous (iv) antimicrobial treatment

- Known history of tuberculosis

- Known history of primary immunodeficiency

- Known history of allogeneic organ transplant

- Receipt of live attenuated vaccine within 28 days prior to registration

- Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or
IV; unstable angina pectoris, history of myocardial infarction within the last six
months, serious arrhythmias requiring medication (with exception of atrial
fibrillation or paroxysmal supraventricular tachycardia), significant QT-prolongation,
uncontrolled hypertension

- Any other serious underlying medical, psychiatric, psychological, familial or
geographical condition, which in the judgment of the investigator may interfere with
the planned staging, treatment and follow-up, affect patient compliance or place the
patient at high risk from treatment-related complications.

- Patients with dyspnea grade = 3 according to the modified Medical Research Council
(mMRC) dyspnea scale.

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/show/NCT03620669

Altri dati sulla sperimentazione dalla banca dati dell’OMS (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03620669
Altre informazioni sulla sperimentazione

Data di registrazione della sperimentazione

3 lug 2018

Inserimento del primo partecipante

4 dic 2018

Stato di reclutamento

Recruiting

Titolo scientifico (Fonte di dati: WHO)

First Line Durvalumab in Patients With PD-L1 Positive, Advanced NSCLC With Performance Status 2 Unsuitable for Combination Chemotherapy. A Multicenter, Single-arm Phase II Trial

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Fase (Fonte di dati: WHO)

Phase 2

Punti finali primari (Fonte di dati: WHO)

Overall survival (OS) at 6 months

Punti finali secondari (Fonte di dati: WHO)

Objective response (OR) according to RECIST 1.1;Objective response according to iRECIST (iOR);Duration of response (DoR) according to RECIST 1.1;Duration of response according to iRECIST (iDoR);Progression-free survival (PFS) according to RECIST 1.1;Progression-free survival according to iRECIST (iPFS);Overall survival (OS);Adverse events (AEs);Quality of life (QoL): Core 30 (QLQ-C30);Geriatric assessment (GA) - Screening instrument (G8);Geriatric assessment (GA) - Assessment with IADL;Geriatric assessment (GA)

Contatto per informazioni (Fonte di dati: WHO)

Please refer to primary and secondary sponsors

Risultati della sperimentazione (Fonte di dati: WHO)

Sintesi dei risultati

ancora nessuna informazione disponibile

Collegamento ai risultati nel registro primario

ancora nessuna informazione disponibile

Informazioni sulla disponibilità dei dati dei singoli partecipanti

ancora nessuna informazione disponibile

Siti di esecuzione della sperimentazione

Siti di esecuzione in Svizzera (Fonte di dati: BASEC)

Aarau, Baden, Basilea, Bellinzona, Berna, Brugg, Chur, Friburgo, Ginevra, Ilanz, Locarno, Samedan, San Gallo, Thun, Thusis, Winterthur

Paesi di esecuzione (Fonte di dati: WHO)

Switzerland

Contatto per maggiori informazioni sulla sperimentazione

Dati della persona di contatto in Svizzera (Fonte di dati: BASEC)

SAKK, Dr. Martina Schneider
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Michael Mark, MD;Sabrina Chiquet
Kantonsspital Graubünden
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Michael Mark, MD;Sabrina Chiquet
Kantonsspital Graubünden
+41 31 389 91 91
trials@sakk.ch

Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)

Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)

Kantonale Ethikkommission Zürich

Data di autorizzazione da parte della commissione d’etica

17.10.2018

Altri numeri di identificazione delle sperimentazioni

Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID) (Fonte di dati: BASEC)

2018-01254

Secondary ID (Fonte di dati: WHO)

SAKK 19/17
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