This study is a prospective, single-arm, phase II trial. It is aimed to evaluate the efficacy and safety of the combination of osimertinib and dalpiciclib in patients with EGFR-mutant, CDK4/6 pathway aberrant, advanced NSCLC following acquired resistance to third-generation EGFR TKI.
ECOG performance status 0 to 2 with a minimum life expectancy of 12 weeks
Advanced non-small cell lung cancer with EGFR-sensitive mutation
Confirmed medical history of acquired resistance to third-generation EGFR TKI
Concurrent CDK4/6 pathway gene dysfunctional aberrations
Prior treatment with any CDK4/6 inhibitor
Active uncontrolled/unstable CNS metastases, carcinomatous meningitis, or leptomeningeal disease
Unresolved toxicities from any prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum therapy related neuropathy.
active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of oral therapy (eg, ulcerative disease, uncontrolled nausea, vomiting, diarrhoea Grade ≥2, malabsorption syndrome or previous significant bowel resection).
Single group
Osimertinib plus Dalpiciclib
Drugosimertinib 80mg daily plus dalpiciclib 125mg daily for 21 days followed by 7 days off in each 28-day treatment cycle
Objective Response Rate (ORR)
disease control rate (DCR)
Duration of Response (DoR)
Progression Free Survival (PFS)
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