NSCLC
Conditions
Keywords
NSCLC ，EGFR(T790M)，alflutinib
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 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.
Interventions
DRUGChemotherapy
Patients in the alflutinib group received alflutinib (80 mg daily) until disease progression, unacceptable toxicity, or death.
DRUGAlflutinib plus chemotherapy
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.
Sponsors
The First Affiliated Hospital of Henan University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 16 weeks | Disease-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate (ORR) | 16 weeks | Objective remission rate |
| Disease Control Rate ( DCR) | 16 weeks | Disease Control Rate |
Contacts
Primary ContactJiachun Sun, PHD
Backup ContactTanyou Shan, MD
Outcome results
None listed