Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Im ersten Teil der Studie erhalten alle Patienten standardmässige Chemotherapie (4-6 Zyklen) plus Strahlentherapie für ihre Metastasen. Zusätzlich erhalten die Patienten Immuntherapie (Durvalumab plus Tremelimumab).
Drei Monate nach Beginn der Studienbehandlung wird ein FDG/PET/CT-Scan durchgeführt. Alle Patienten, bei denen die Lungenkrebserkrankung stabil geblieben ist oder ihre Grösse reduziert hat, erhalten entweder eine chirurgische Versorgung oder Strahlentherapie zur Behandlung ihrer Lungenkrebserkrankung. Die Behandlung mit Durvalumab wird für einen Zeitraum von maximal einem Jahr oder bis zum Wiederauftreten der Erkrankung fortgesetzt. Die Behandlung mit Tremelimumab besteht aus 4 Zyklen.
Patienten, bei denen die Lungenkrebserkrankung zum Zeitpunkt des FDG/PET/CT-Scans nicht stabil geblieben ist oder sich ausgeweitet hat, stellen die gesamte Studienbehandlung ein und treten in die Nachbeobachtungsphase der Studie über.
Nach Ende des Behandlungszeitraumes werden alle Patienten für etwa 2,5 Jahre nachbeobachtet, abhängig vom jeweiligen Eintrittszeitpunkt des Patienten in die Studie.
Malattie studiate(Fonte di dati: BASEC)
nicht-kleinzelligem Lungenkrebs
Health conditions
(Fonte di dati: WHO)
Non-small Cell Lung Cancer;Stage IV;Oligometastasis
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
• Chemotherapie, bestehend aus 4-6 Zyklen Carboplatin in Standard-Dosierung plus intravenös verabreichtes Paclitaxel 175 mg/m2 alle 3 Wochen, plus
• Strahlentherapie (SBRT) der Metastasen, plus
• Intravenös injiziertes Durvalumab 1500 mg alle 3 Wochen für 4-6 Zyklen (wird während der Chemotherapie am selben Tag verabreicht).
• Intravenös injiziertes Tremelimumab 75 mg alle 3 Wochen für 4 Zyklen
Die Immuntherapie mit Durvalumab wird nach Abschluss der Chemotherapie und bei stabilen Krankheitszustand im 4-Wochen Intervall fortgeführt bis zu maximal einem Jahr oder bis zum Wiederauftreten der Krebserkrankung.
Interventions
(Fonte di dati: WHO)
Drug: Durvalumab;Drug: Carboplatin;Drug: Paclitaxel;Radiation: Stereotactic body radiation therapy (SBRT);Procedure: Surgical resection - definitive local treatment.;Radiation: Radical radiotherapy - definitive local treatment.;Drug: Tremelimumab
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: BASEC)
- Histologisch bestätigter nicht-kleinzelliger Lungenkrebs (Non Small Cell Lung Carcinoma, NSCLC)
- Messbarer Krankheitsgrad nach RECIST v1.1 Kriterien
- Synchrone oligo-metastatische Erkrankung im Stadium IV
Criteri di esclusione
(Fonte di dati: BASEC)
- Vorherige Chemotherapie, Strahlentherapie oder therapeutische Operation für nicht-kleinzelligen Lungenkrebs (NSCLC)
- Aktivierung von Driver-Mutationen, wie z.B. EGFR, ALK, ROS1
- Mehr als drei Fernmetastasen
Inclusion/Exclusion Criteria
(Fonte di dati: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Histologically confirmed non-small cell lung cancer
- Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases,
one of which must be extra-cerebral for stereotactic body radiotherapy (SBRT);
Initial mediastinal staging is recommended (except for lymph nodes <1 cm on CT and
PET-negative) preferentially by endobronchial ultrasound (EBUS); Neurosurgical
resection of one single central nervous system (CNS) metastasis or laparoscopic
resection of one adrenal metastasis before study inclusion is allowed (one
extra-cerebral metastasis must be available for SBRT)
- Able to understand and give written informed consent and comply with study
procedures
- Age =18 years
- ECOG Performance Status 0-1
- Availability of tumour tissue for translational research
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Prior chemotherapy, radiotherapy or therapeutic surgery for NSCLC (an exception is
the resection of one single CNS or adrenal metastasis, as above)
- Activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), proto-oncogene receptor tyrosine kinase (ROS1)
- More than three distant metastases
- Brain metastases not amendable for radiosurgery or neurosurgery
- Extracranial metastatic locations such as malignant ascites, pleural or pericardial
effusion, diffuse lymphangiomatosis of skin or lung, diffuse bone marrow metastasis,
abdominal masses/abdominal organomegaly, identified by physical exam that is not
measurable by reproducible imaging techniques.
- Primary lung cancer not suitable for radical therapy (pneumonectomy excluded)
- History of leptomeningeal carcinomatosis
- Major surgery or significant traumatic injury from which the patient has not
recovered at least 28 days before enrolment
- Any uncontrolled intercurrent illness, including but not limited to: ongoing or
active infection, symptomatic congestive heart failure, uncontrolled hypertension,
unstable angina pectoris, cardiac arrhythmia, interstitial lung disease or serious
chronic gastrointestinal conditions associated with diarrhea, which in the
investigator's opinion makes it undesirable for the patient to participate in the
trial or which would jeopardise compliance with the protocol
- Known active hepatitis infection, positive hepatitis C virus (HCV) antibody,
hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc) at
screening.
- Known positivity for human immunodeficiency virus (positive HIV 1/2 antibodies) or
active tuberculosis infection (clinical evaluation that includes clinical history,
physical examination and radiographic findings, and TB testing in line with local
practice)
- Active autoimmune disease requiring systemic treatment
- Severe or uncontrolled cardiac disease requiring treatment
- History of active primary immunodeficiency
- History of allogeneic organ transplant
- Receipt of live attenuated vaccines within 30 days prior to enrolment
- Known allergies or hypersensitivity to trial drugs or to any excipient.
- Women who are pregnant or in the period of lactation.
- Sexually active men and women of childbearing potential who are not willing to use a
highly effective contraceptive method during the trial and up to 90 days after last
dose of durvalumab monotherapy or 180 days after the last dose of durvalumab and
tremelimumab combination therapy
-
Altre informazioni sulla sperimentazione
Stato di reclutamento
Recruiting
Titolo scientifico
(Fonte di dati: WHO)
A Multicentre Single Arm Phase II Trial Assessing the Efficacy of Immunotherapy, Chemotherapy and Stereotactic Radiotherapy to Metastases Followed by Definitive Surgery or Radiotherapy to the Primary Tumour, in Patients with Synchronous Oligo-metastatic Non-small Cell Lung Cancer
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)
Progression-free survival at 12 months
Punti finali secondari
(Fonte di dati: WHO)
Overall survival;Pattern of disease progression;Response to induction therapy;Distant progression-free survival;Overall response;Duration of response;Symptom-specific and global quality of life: The Lung Cancer Symptom Scale;Toxicity before and after surgery/radiotherapy
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)
Berna, Ginevra, Losanna, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Italy, Netherlands, Spain, Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Barbara Ruepp
+41 31 511 94 16
etop-regulatory@etop.ibcsg.org
Contatto per informazioni generali
(Fonte di dati: WHO)
Matthias Guckenberger, MD-PhD;Isabelle Schmitt-Opitz, MD;Barbara Ruepp, PharmD
University Hospital, Z?rich
+41315119400
barbara.ruepp@etop.ibcsg.org
Contatto per informazioni scientifiche
(Fonte di dati: WHO)
Matthias Guckenberger, MD-PhD;Isabelle Schmitt-Opitz, MD;Barbara Ruepp, PharmD
University Hospital, Z?rich
+41315119400
barbara.ruepp@etop.ibcsg.org
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
05.09.2019
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2019-01234
Secondary ID (Fonte di dati: WHO)
2018-003011-22
ESR-17-13224
ETOP 14-18
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