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SNCTP000003439 | NCT03965468 | BASEC2019-01234

Eine Forschungsstudie, die die Wirksamkeit, Sicherheit und Verträglichkeit von Immuntherapie bei der gleichzeitigen Verabreichung mit Standard-Chemotherapie und Strahlentherapie bei Patienten mit nicht-kleinzelligem Lungenkrebs untersucht.

Data source: BASEC (Imported from 02.01.2025), WHO (Imported from 19.12.2024)
Changed: Dec 18, 2024, 11:50 AM
Disease category: Lung Cancer

Brief description of trial (Data source: 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.

Health conditions investigated(Data source: BASEC)

nicht-kleinzelligem Lungenkrebs

Health conditions (Data source: WHO)

Non-small Cell Lung Cancer;Stage IV;Oligometastasis

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: 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 (Data source: 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

Criteria for participation in trial (Data source: 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

Exclusion criteria (Data source: 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 (Data source: 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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT03965468

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03965468
Further information on trial

Recruitment status

Recruiting

Academic title (Data source: 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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

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

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Progression-free survival at 12 months

Secundary end point (Data source: 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

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Bern, Geneva, Lausanne, Zurich

Countries (Data source: WHO)

Italy, Netherlands, Spain, Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Barbara Ruepp
+41 31 511 94 16
etop-regulatory@etop.ibcsg.org

Contact for general information (Data source: WHO)

Matthias Guckenberger, MD-PhD;Isabelle Schmitt-Opitz, MD;Barbara Ruepp, PharmD
University Hospital, Z?rich
+41315119400
barbara.ruepp@etop.ibcsg.org

Contact for scientific information (Data source: WHO)

Matthias Guckenberger, MD-PhD;Isabelle Schmitt-Opitz, MD;Barbara Ruepp, PharmD
University Hospital, Z?rich
+41315119400
barbara.ruepp@etop.ibcsg.org

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Kantonale Ethikkommission Zürich

Date of authorisation by the ethics committee

05.09.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2019-01234

Secondary ID (Data source: WHO)

2018-003011-22
ESR-17-13224
ETOP 14-18
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