A phase II trial assessing the efficacy (how well the treatment works), safety and tolerability (side effects of treatment) of the antibody drug durvalumab, administered together with standard chemotherapy and radiotherapy
- Conditions
- Synchronous oligo-metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-003011-22-ES
- Lead Sponsor
- ETOP (European Thoracic Oncology Platform)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 47
- 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 metastass must be available for SBRT)
- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
- Prior chemotherapy, radiotherapy or surgery for NSCLC
- Activating driver mutation: EGRF, ALK, ROS1
- >3 distant metastases
- Brain metastases not amendable for radiosurgery or neurosurgery
- Extracranial metastatic locations such as malignant ascites, pleural or pericardial
effusion, diffuse lymphangitiosis 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Progression-free survival (PFS) at 12 months;Timepoint(s) of evaluation of this end point: after 12 months (±2 weeks) from start of durvalumab treatment.;Main Objective: To evaluate PFS in synchronous oligometastatic NSCLC patients treated with induction immunotherapy, chemotherapy and stereotactic body radiation therapy (SBRT) to all metastases followed by definitive surgery or radiotherapy to the locoregional primary tumour .;<br> Secondary Objective: 1) To evaluate secondary measures of clinical efficacy including distant progression-free survival, overall survival, pattern of disease progression, response to induction therapy, overall response and duration of response.<br> 2) To assess the safety and tolerability of the treatment.<br> 3) To evaluate symptom-specific and global quality of life.<br>
- Secondary Outcome Measures
Name Time Method