This study aimed to evaluate the efficacy and safety of third-generation EGFR-TKI plus anlotinib as maintenance after chemotherapy plus immunotherapy in advanced NSCLC with small cell transformation after EGFR-TKI resistance.
This prospective interventional clinical study aims to evaluate the efficacy and safety of third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4-6 cycles of chemotherapy and immunotherapy in patients with advanced NSCLC who developed small cell transformation after EGFR-TKI resistance.Approximately 30 non-small cell lung cancer patients who developed small cell transformation after EGFR-TKI resistance were enrolled and treated with 4-6 cycles of chemotherapy plus immunotherapy followed by maintenance therapy with third-generation EGFR-TKI combined with anlotinib.The study is expected to commence recruitment in mainland China in about November 2024. It is expected that the trial will end in December 2026.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
third-generation EGFR-TKI combined with anlotinib as maintenance therapy following 4 to 6 cycles of chemotherapy and immunotherapy until progressive disease.
Yongchang Zhang
Changsha, Hunan, China
progression-free survival (PFS)
PFS was defined as the duration from the start of standard chemotherapy plus immunotherapy to disease progression or last follow up
Time frame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
Objective Response Rate (ORR)
To assess overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Time frame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
Adverse events (AEs) according to CTCAE 5.0
Number of participants with adverse events (AEs) according to CTCAE 5.0
Time frame: Time from standard chemotherapy plus immunotherapy to study completion, or up to 36 month
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