Status:
UNKNOWN
Alflutinib Versus Alflutinib Plus Chemotherapy for NSCLC
Lead Sponsor:
The First Affiliated Hospital of Henan University of Science and Technology
Conditions:
NSCLC
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Aim: the aim of this study is to investigated whether the combination of alflutinib with cytotoxic chemotherapy might hold additive efficacy, as well as tolerability .
Detailed Description
alflutinib is a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) that is active in the central nervous system (CNS) and which potently and selectively inhibits ...
Eligibility Criteria
Inclusion
- histologically or cytologically diagnosed non-squamous NSCLC of stage IIIB or IV (based on the 7th edition of the TNM classification) or recurrent;
- an EGFR mutation, including an exon-19 deletion (Ex19del), L858R, or other (L861Q, G719A, G719C, or G719S), as well as the T790M mutation of EGFR as detected in a tissue or liquid biopsy sample obtained after disease progression during first-line EGFR-TKI (gefitinib, erlotinib, or afatinib) treatment;
- WHO performance status of 0 or 1;
- no prior neoadjuvant or adjuvant chemotherapy in the 12 months preceding study enrollment;
- adequate bone marrow reserve and organ function.
Exclusion
- treatment with an EGFR-TKI within 7 days of the first dose of the study treatment;
- symptomatic CNS metastases;
- evidence of interstitial pneumonia, pulmonary fibrosis, or radiation pneumonitis requiring steroid treatment as revealed by a computed tomography (CT) scan.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05209256
Start Date
March 1 2022
End Date
January 1 2025
Last Update
January 26 2022
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