Status:
UNKNOWN
The Study of Exosome EML4-ALK Fusion in NSCLC Clinical Diagnosis and Dynamic Monitoring
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Untreated Advanced NSCLC Patients
FISH Identified ALK Fusion Positive or Negative
Eligibility:
All Genders
18+ years
Brief Summary
The application of ALK inhibitors in the first-line cancer treatment can significantly increase the PFS and ORR of patients those with EML4-ALK fusion. The contemporary clinical ALK fusion detection a...
Eligibility Criteria
Inclusion
- All eligible patients must have histologically or cytologically confirmed stage IIIB-IV unresectable NSCLC positive or negative for EML4-ALK4 fusion as defined by FISH. Patients must have an ECOG PS of 0- 1 and have at least 1 measurable lesions (RECIST 1.1 standard). For eligible patients, prior ALK inhibitor therapy or previous systemic anticancer therapy is not allowed or has been completed over 12 months. Patients with brain metastasis are eligible only in a stable central nervous system condition and treatment outcome, cannot receive glucocorticoids and drugs prohibited in the exclusion criteria ≤14 days before the first dose of study drug.
Exclusion
- Eligible patients must not have received any major surgery ≤28 days before the first dose of study drug and must not have received any minor surgery or radiotherapy ≤14 days before the first dose of study drug. Any acute toxic reaction must have recovered to ≤ Grade 1 (except for hair loss). Patients with carcinomatous meningitis, leptomeningeal disease or spinal cord compression must be excluded.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04499794
Start Date
August 1 2020
End Date
March 31 2025
Last Update
August 5 2020
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021