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 nonsmall cell lung cancer
- Conditions
- nonsmall cell lung cancer and lung cancer10027476
- Registration Number
- NL-OMON52875
- Lead Sponsor
- ETOP IBCSG Partners Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 12
- Histological confirmed NSCLC
- Synchronous oligo-metastatic stage IV disease:
- Max. 3 distant metastases, one of which must be extra-cerebral for SBRT
- Neurosurgical resection of one single CNS metastasis or laparoscopic
resection of one
adrenal metastasis before study inclusion is allowed (one extra-cerebral
metastase must be
available for SBRT)
- Initial mediastinal staging is recommended (except for lymph nodes < 1cm
on CT and PET-
negative) preferentially by endobronchial ultrasound
- Able to understand and give written informed consent and comply with study
procedures
- Age >=18 years
- ECOG 0-1
- Availability of tumour tissue for translational research
- Adequate haematological, renal and liver function
- Prior chemotherapy, radiotherapy or surgery for NSCLC (an exception is the
resection of
one single CNS or adrenal metastasis)
- Activating driver mutation: EGRF, ALK, ROS1
- More than 3 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
- Active tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus
(HIV)
infection
- 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.
- Sexually active men and women of childbearing potential who are not willing
to use an effective
contraceptive method during the trial and for up to 90 days after last dose
of durvalumab monotherapy or 180 days after the last dose of durvalumab en
tremelimumab combination therapy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br><br /><br>Progression-free survival at 12 months</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints:<br /><br><br /><br>- Overall survival<br /><br>- Pattern of disease progression<br /><br>- Distant progression-free survival<br /><br>- Response to induction therapy<br /><br>- Overall response<br /><br>- Duration of response<br /><br>- Toxicity before and after surgery/radiotherapy<br /><br>- Symptom-specific and global quality of life</p><br>