KCT0006760
Recruiting
未知
A multicentre two-arm, phase II trial assessing the safety and efficacy of first-line lazertinib and locally ablative radiotherapy in patients with synchronous oligo-metastatic EGFR-mutant non-small cell lung cancer
ConditionsNeoplasms
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Yonsei University Health System, Severance Hospital
- Enrollment
- 68
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically confirmed, treatment naïve EGFR\-mutant NSCLC, with or without T790M resistance mutation.
- •2\.Presence of the sensitising EGFR\-mutation (exon 19 deletion and/or L858R) detected by an accredited laboratory.
- •3\.Synchronous oligometastatic stage IV disease (max 5 lesions)
- •4\.Measurable disease as defined according to RECIST v1\.1
- •5\.All lesions amenable for radical radiotherapy according to local judgment
- •6\.Age \=18 years
- •7\.ECOG performance status 0\-2
- •8\.Life expectancy \=12 months
- •9\.Adequate haematological function:
- •–Haemoglobin ?90 g/L
Exclusion Criteria
- •1\.Prior chemotherapy, immunotherapy, radiotherapy or therapeutical surgery for NSCLC (an exception is the resection of CNS or adrenal metastases)
- •2\.More than 5 distant oligometastases (any second intra\-thoracic lesion will count as a distant metastasis; regional nodal metastases will not count to the 5 oligometastases) and more than 2 intra\-thoracic lesions.
- •3\.Brain metastases not amenable for radiosurgery or neurosurgery
- •4\.Presence of leptomeningeal metastases
- •5\.Symptomatic spinal cord compression
- •6\.Extracranial 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.
- •7\.Currently receiving (or unable to stop use prior to receiving the first dose of lazertinib treatment) medications or herbal supplements known to be potent CYP3A4 inducers that cannot be stopped before enrolment and for the duration of the trial.
- •8\.Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, 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.
- •Patients with a resolved or chronic HBV infection are eligible if they are:
- •Negative for HBsAg and positive for hepatitis B core antibody \[anti\-HBc IgG]
Outcomes
Primary Outcomes
Not specified
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