Abstract
Background
Osimertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase
inhibitor, is now a standard treatment of previously untreated EGFR-mutated advanced
non–small-cell lung cancer (NSCLC). However, disease progression occurs within 19
months of treatment. In the NEJ009 study, gefitinib plus carboplatin plus pemetrexed
demonstrated significantly better progression-free and overall survival compared with
gefitinib monotherapy. Furthermore, the Lung Oncology Group in Kyushu and North East
Japan Study Group, major clinical trial groups in Japan, conducted a randomized phase
II study to evaluate the efficacy and safety of second-line osimertinib plus carboplatin
plus pemetrexed versus osimertinib monotherapy for patients with disease progression
during first-line EGFR tyrosine kinase inhibitor therapy and the EGFR T790M resistance
mutation (TAKUMI trial; trial registration no., jRCTs071180062). In the first treatment
course for the initial 24 patients, no safety issues were reported in the combination
arm. Thus, we have planned this phase II study to evaluate the safety and preliminary
efficacy of osimertinib plus cisplatin/carboplatin plus pemetrexed therapy for patients
with previously untreated EGFR-mutated NSCLC.
Patients and Methods
A total of 66 patients will be enrolled, because this sample size will be adequate
for assessing treatment safety and efficacy. The co-primary endpoints include safety
and the objective response rate, and the secondary endpoints include the complete
response rate, disease control rate, and progression-free survival.
Conclusions
This is the first study to explore the efficacy and safety of osimertinib combined
with platinum-based chemotherapy in previously untreated NSCLC patients with EGFR-sensitizing
mutations. Our findings could provide valuable information for phase III studies such
as FLAURA2 and for developing treatment strategies for EGFR-mutated NSCLC.
Keywords
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Article info
Publication history
Published online: October 15, 2020
Accepted:
September 24,
2020
Received in revised form:
September 15,
2020
Received:
March 13,
2020
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
