Efficacy and safety of Chinese herbal medicine granules plus chemotherapy in
patients with EGFR-mutated advanced lung adenocarcinoma post-progression on
first-line EGFR-TKI: study protocol for a multicenter, double-blind, randomized
controlled trial
#MMPMID41257744
Du Y
; Yao J
; Ye X
; Wu G
; Su L
; Yang W
; Jiao L
; Gong Y
; Xu L
BMC Complement Med Ther
2025[Nov]; 25
(1
): 427
PMID41257744
show ga
BACKGROUND: Lung cancer remains one of the leading causes of mortality globally.
For patients with epidermal growth factor receptor (EGFR) -mutated lung
adenocarcinoma who develop resistance to first-line EGFR-tyrosine kinase
inhibitors (EGFR-TKIs), subsequent treatments typically involve a regimen that
includes pemetrexed and platinum. However, the progression-free survival (PFS)
achieved with this approach is limited to 4-5 months. There is an urgent need for
effective and safe adjuvant therapies. Preliminary research suggests that Chinese
herbal medicine (CHM) granules may extend PFS and improve quality of life (QoL),
potentially offering a therapeutic strategy for advanced non-small-cell lung
cancer (NSCLC). A rigorous, randomized clinical trial is warranted to confirm
these findings. The aim of this study is to evaluate the efficacy and safety of
CHM granules in combination with chemotherapy for patients with EGFR-mutated
advanced lung adenocarcinoma following resistance to first-line EGFR-TKIs.
METHOD/DESIGN: This study is a multicenter, double-blind, randomized,
placebo-controlled clinical trial in China. A total of 244 patients will be
enrolled and randomly assigned to either the treatment group (chemotherapy plus
CHM granules, n?=?122) or the control group (chemotherapy plus placebo granules,
n?=?122). The primary outcome measure is PFS, with secondary outcomes including
overall survival (OS), objective response rate (ORR), disease control rate (DCR),
patient-reported quality of life assessed by the Functional Assessment of Cancer
Therapy-Lung (FACT-L) and Lung Cancer Symptom Scale (LCSS), and Traditional
Chinese Medicine (TCM) clinical syndrome scores. Adverse events will also be
closely monitored. DISCUSSION: The study's findings will provide an
evidence-based evaluation of the combination of CHM granules with chemotherapy
for treating EGFR-mutated advanced lung adenocarcinoma with resistance to
first-line EGFR-TKIs. The results may inform the development of clinical
guidelines for adjuvant therapy in this patient population. TRIAL REGISTRATION:
http://www.chictr.org.cn . TRIAL NUMBER: ChiCTR2000029144, Registered on 19 Aug,
2020.
|*Adenocarcinoma of Lung/drug therapy/genetics
[MESH]
free
free
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