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 .
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 mutant forms of EGFR with both TKI-sensitising (activating) mutations and the T790M resistance-conferring mutation. However, resistance to alflutinib inevitably emerges. One promising strategy to further improve patient prognosis and to approach a cure is combination therapy with alflutinib and other agents such as cytotoxic chemotherapeutic drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.
Those in the combination group received concurrent alflutinib (80 mg daily), as well as carboplatin (area under the curve \[AUC\] of 5 on day 1) and pemetrexed (500 mg/m2 on day 1) in a 3-week cycle for up to four cycles, followed by maintenance on alflutinib and pemetrexed until disease progression, unacceptable toxicity, or death.
PFS
Disease-free survival
Time frame: 16 weeks
Objective remission rate (ORR)
Objective remission rate
Time frame: 16 weeks
Disease Control Rate ( DCR)
Disease Control Rate
Time frame: 16 weeks
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