EUCTR2018-003011-22-ES
Active, not recruiting
Phase 1
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 - CHESS
ETOP (European Thoracic Oncology Platform)0 sites47 target enrollmentJuly 5, 2019
ConditionsSynchronous 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]
DrugsIMFINZI
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Synchronous oligo-metastatic Non-Small Cell Lung Cancer (NSCLC)
- Sponsor
- ETOP (European Thoracic Oncology Platform)
- Enrollment
- 47
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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
Exclusion Criteria
- •\- 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
Outcomes
Primary Outcomes
Not specified
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