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SNCTP000003711 | NCT03540420 | BASEC2019-02067

ACHILES Verbessert die Immuntherapie das Überleben von Patienten mit kleinzelligem Lungenkarzinom im Stadium Limited Disease, die eine Chemo- und Strahlentherapie erhalten haben?

Base di dati: BASEC (Importata da 28.03.2024), WHO (Importata da 20.03.2024)
Cambiato: 19 gen 2024, 01:00
Categoria di malattie: Cancro del polmone

Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)

Mit der Studie soll untersucht werden, ob das Überleben von Patienten mit kleinzelligem Lungenkarzinom ohne Metastasen, d.h. im limitierten Stadium («limited disease»), durch eine Immuntherapie mit Atezolizumab im Anschluss an die kombinierte Radio-Chemotherapie verbessert werden kann. Einige Patienten sind nach der aktuellen Standardbehandlung (kombinierte Radio-Chemotherapie) geheilt, bei vielen kehrt die Krankheit jedoch zurück. Die Studie untersucht, ob das Rückfallrisiko durch eine zusätzliche Immuntherapie mit Atezolizumab reduziert werden kann. Mehrere Studien haben bereits gezeigt, dass eine Immuntherapie (u.a. mit Atezolizumab) bei metastasiertem kleinzelligem Lungenkarzinom wirksam ist. Atezolizumab wirkt, indem es das Immunsystem bei der Abwehr der Krebserkrankung unterstützt. Atezolizumab kann das Immunsystem aber auch dazu bringen, körpereigenen Organe und Gewebe anzugreifen und deren Funktion zu beeinträchtigen, was Nebenwirkungen hervorrufen kann.

Malattie studiate(Fonte di dati: BASEC)

Kleinzelliges Lungenkarzinom im Stadium Limited Disease

Health conditions (Fonte di dati: WHO)

Small-cell Lung Cancer

Malattia rara (Fonte di dati: BASEC)

No

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

Alle Teilnehmer erhalten die Standardbehandlung bestehend aus vier Zyklen Chemotherapie mit einem Platin-Derivat und Etoposid zusätzlich zur Strahlentherapie. Patienten, die auf diese Behandlung gut ansprechen, wird eine vorsorgliche Schädelbestrahlung angeboten, um Metastasen vorzubeugen. Patienten, die für die Studienbehandlung in Frage kommen, werden nach dem Zufallsprinzip entweder der Interventionsgruppe, d.h. Behandlung mit Atezolizumab, oder der Kontrollgruppe, d.h. keine aktive Therapie und regelmässige Kontrolle, zugewiesen. Patienten im Kontrollarm werden nach den lokal und national geltenden Richtlinien beobachtet.
Die individuelle Behandlung dauert insgesamt etwa 1 Jahr und 3 Monate. Im Rahmen dieser Studie werden die Studienteilnehmer insgesamt über einen Zeitraum von 5 Jahren nach Studienbeginn beobachtet.

Interventions (Fonte di dati: WHO)

Drug: Atezolizumab

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

Es können alle Personen teilnehmen, die an einem kleinzelligen Lungenkarzinom im limitierten Stadium («limited disease») leiden und bei denen eine kombinierte Radio-Chemotherapie geplant ist. Ausserdem müssen Sie mindestens 18 Jahre alt sein.

Criteri di esclusione (Fonte di dati: BASEC)

Nicht teilnehmen hingegen dürfen Patienten, die bereits eine andere Immuntherapie hatten oder mit anderen experimentellen Medikamenten oder im Rahmen einer anderen Forschungsstudie behandelt werden.

Inclusion/Exclusion Criteria (Fonte di dati: WHO)

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Histologically or cytologically confirmed small-cell lung cancer

- Previous radiotherapy to the thorax is allowed as long as the patient can receive TRT
of 45 Gy.

- Stage I-III according to TNM v8 ineligible for surgery provided all lesions can be
included in a tolerable radiotherapy field ("limited disease")

- ECOG performance status 0-2

- Measureable disease according to the RECIST 1.1

- Adequate organ function defined as: (a) Serum alanine transaminase (ALT) = 2.5 x upper
limit of normal (ULN); (b) Total serum bilirubin = 1.5 x ULN; (c)Absolute neutrophil
count (ANC) = 1.5 x 10 superscr 9/L; (d) Platelets = 100 x 10 superscr 9/L ; (e)
Creatinine < 100 ?mol/L and calculated creatinine-clearance > 50 ml/min. If calculated
creatinine-clearance is < 50 ml/min, an EDTA clearance should be performed

- No malignant cells in pericardial or pleural fluid (at least 1 sample should be
obtained if pleural fluid is present) If there is so little fluid that it cannot
easily be collected, the patient is considered eligible.

- Pulmonary function: FEV1 > 1 l or > 30 % of predicted value and DLCO > 30 % of
predicted value

- Female patients of childbearing potential (Postmenarcheal, not postmenopausal (>12
continuous months of amenorrhea with no identified cause other than menopause), and no
surgical sterilization) should use highly effective contraception and take active
measures to avoid pregnancy while undergoing atezolizumab treatment and for at least 5
months after the last dose. Birth control methods considered to be highly effective
are listed in Appendix D of the protocol

- Written informed consent

Exclusion Criteria:

- previous systemic therapy for SCLC or immune checkpoint blockade therapy

- 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 study, or would interfere with the evaluation of the
efficacy and safety of the study treatment

- lung disease requiring systemic steroids in doses of >10 mg prednisolone (or
equivalent dose of other steroid)

- previous allogeneic or organ transplant

- active or history of autoimmune disease or immune deficiency, including, but not
limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid
antibody syndrome, Wegener granulomatosis, Sj?gren syndrome, Guillain-Barr? syndrome,
or multiple sclerosis

- history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis
obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of
active pneumonitis on screening chest computed tomography (CT) scan

- live vaccine administered in the last 30 days

- active infection requiring IV antibiotics

- active viral hepatitis or HIV-positive

- conditions - medical, social, psychological - which could prevent adequate information
and follow-up

- clinically active cancer other than SCLC with the exception of malignancies with a
negligible risk of metastases or death (e.g. 5-years OS rate of >90%), such as
adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma,
localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
Hormonal therapy for non-metastatic prostate or breast cancer is allowed.

- pregnant or lactating women

Altri dati sulla sperimentazione nel registro primario dell’OMS

https://clinicaltrials.gov/ct2/show/NCT03540420

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

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03540420
Altre informazioni sulla sperimentazione

Stato di reclutamento

Active, not recruiting

Titolo scientifico (Fonte di dati: WHO)

A Randomized Phase II Study Comparing Atezolizumab After Concurrent Chemo-radiotherapy With Chemo-radiotherapy Alone in Limited Disease Small-cell Lung Cancer

Tipo di sperimentazione (Fonte di dati: WHO)

Interventional

Disegno della sperimentazione (Fonte di dati: WHO)

Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Fase (Fonte di dati: WHO)

Phase 2

Punti finali primari (Fonte di dati: WHO)

2 year survival

Punti finali secondari (Fonte di dati: WHO)

Progression free survival;Best response rate during study treatment period;Number of treatment-related adverse events as assessed by CTCAE v5.0;Patient-reported Health related quality of life on the EORTC QLQ-C30 and LC13 questionnaires.

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)

Basilea, Berna, Chur, Locarno, Lugano, Mendrisio, Meyriez, Payerne, Riaz, San Gallo, Tafers, Thun, Winterthur

Paesi di esecuzione (Fonte di dati: WHO)

Denmark, Lithuania, Netherlands, Norway, Sweden, Switzerland

Contatto per maggiori informazioni sulla sperimentazione

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

SAKK, Zuzanna Maniecka
+41 31 389 91 91
trials@sakk.ch

Contatto per informazioni generali (Fonte di dati: WHO)

Torstein B R?, MD, PhD
Norwegian University of Science and Technology

Contatto per informazioni scientifiche (Fonte di dati: WHO)

Torstein B R?, MD, PhD
Norwegian University of Science and Technology

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)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Data di autorizzazione da parte della commissione d’etica

23.01.2020

Altri numeri di identificazione delle sperimentazioni

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

2019-02067

Secondary ID (Fonte di dati: WHO)

2017-004572-62
2017-11-03BHG
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