EUCTR2018-003011-22-NL
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 non-small cell lung cancer - CHESS
ConditionsSynchronous oligo-metastatic Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 21.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Synchronous oligo-metastatic Non-Small Cell Lung Cancer (NSCLC)
- Sponsor
- ETOP IBCSG Partners Foundation
- Enrollment
- 96
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Histological confirmed NSCLC
- •\- Measurable disease as assessed by RECIST v1\.1
- •\- Synchronous oligo\-metastatic stage IV disease:
- •\- max 3 distant metastases, one of which must be extra\-cerebral for SBRT
- •\- Initial mediastinal staging is recommended (except for lymph nodes \<1cm on CT and PET\-negative) preferably by endobronchial ultrasound (EBUS)
- •\- 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
- •\- Body weight \>30kg
Exclusion Criteria
- •\- Prior chemotherapy, radiotherapy or therapeutical surgery for NSCLC (an exception is the resection of one single CNS or adrenal metastasis)
- •\- Activating driver mutation: EGFR, 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 lymphangiomatosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical examination 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 unresolved toxicities (grade \=2\) from previous anticancer therapy other than for NSCLC, with the exception of alopecia or vitiligo, and the laboratory values defined in the inclusion criteria:
- •\- Patients with grade \=2 neutropathy will be evaluated on a case\-by\-case basis after consultation with the ETOP Medical Affairs team.
Outcomes
Primary Outcomes
Not specified
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