Durvalumab for Non-small cell lung cancer (synchronous oligometastatic)

Inclusion criteria

• {"criterion_text":"- Most important inclusion criteria (Cohort 2):\n- Histologically confirmed NSCLC\n- Synchronous oligo-metastatic stage IV disease:\n- maximum of three distant metastases, one of which must be extra-cerebral for SBRT\n- Initial mediastinal staging is recommended (except for lymph nodes <1 cm on CT and PET-negative) preferentially by endobronchial ultrasound (EBUS)\n- Neurosurgical resection of one single CNS metastasis or laparoscopic resection of one adrenal metastasis before study inclusion is allowed (one extra-cerebral metastasis must be available for SBRT)\n- Able to understand and give written informed consent and comply with study procedures\n- Age ≥18 years\n- ECOG Performance Status 0-1\n- Availability of tumour tissue for translational research\n- Adequate haematological, renal and liver function"}

Exclusion criteria

• {"criterion_text":"- Most important exclusion criteria (Cohort 2)\n- Prior chemotherapy, radiotherapy or therapeutic surgery for NSCLC (an exception is the resection of one single CNS or adrenal metastasis, as above)\n- Activating driver mutation: EGFR, ALK, ROS1\n- More than three distant metastases\n- Brain metastases not amenable for radiosurgery or neurosurgery\n- Extra cranial metastatic locations such as malignant ascites, pleural or pericardial effusion, diffuse lymphangiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical exam that is not measurable by reproducible imaging techniques.\n- Primary lung cancer not suitable for radical therapy (pneumonectomy excluded)\n- History of leptomeningeal carcinomatosis\n- Major surgery or significant traumatic injury from which the patient has not recovered at least 28 days before enrolment\n- 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 diarrhoea, 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\n- Active tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection\n- Active autoimmune disease requiring systemic treatment\n- Severe or uncontrolled cardiac disease requiring treatment\n- History of primary immunodeficiency\n- History of allogeneic organ transplant\n- Receipt of live attenuated vaccines within 30 days prior to enrolment\n- Known allergies or hypersensitivity to trial drugs or to any excipient.\n- Sexually active men and women of childbearing potential who are not willing to use a highly effective contraceptive method during the trial and for up to 90 days after last dose of durvalumab monotherapy and up to 180 days after last dose of durvalumab plus tremelimumab combination therapy."}

Primary endpoints

• {"endpoint_text":"- Progression-free survival at 1 year","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pattern of disease progression","definition_or_measurement_approach":""}
• {"endpoint_text":"- Distant progression-free survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Response to induction therapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Duration of response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Toxicity before and after surgery/radiotherapy","definition_or_measurement_approach":""}
• {"endpoint_text":"- Symptom-specific and global quality of life","definition_or_measurement_approach":""}

Netherlands

Earliest CTIS Part Ii Submission Date

23-01-2024

Latest Decision Or Authorization Date

19-09-2024

Processing Time Days

240

Number Of Sites

2

Number Of Participants

4

Spain

Earliest CTIS Part Ii Submission Date

23-01-2024

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

771

Number Of Sites

4

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

23-01-2024

Latest Decision Or Authorization Date

04-03-2026

Processing Time Days

771

Number Of Sites

1

Number Of Participants

4

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":"University Hospital Zuerich","duties_or_roles":"Medical image analysis/ review","organisation_type":"Health care"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"Labelling, QP release, storage and distribution","organisation_type":"Pharmaceutical company"}
• {"country":"Greece","full_name":"Frontier Science Foundation-Hellas","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Centre Hospitalier Universitaire Vaudois","duties_or_roles":"","organisation_type":"Hospital/Clinic/Other health care facility"}