OncoMatch/Clinical Trials/NCT06363734
Osimertinib Plus Dalpiciclib in Patients With EGFR-mutant, CDK4/6 Pathway Aberrant, Advanced Non-small Cell Lung Cancer Following Acquired Resistance to Third-generation EGFR TKI: a Phase II Trial
Is NCT06363734 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Osimertinib plus Dalpiciclib for non-small cell lung cancer.
Treatment: Osimertinib plus Dalpiciclib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR sensitizing mutation
EGFR-sensitive mutation
Required: EGFR acquired resistance mutation to third-generation EGFR TKI
Confirmed medical history of acquired resistance to third-generation EGFR TKI
Disease stage
Metastatic disease required
Evaluable or measurable disease as defined by RECIST, Version 1.1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: third-generation egfr tki
Must have received: systemic chemotherapy
Cannot have received: cdk4/6 inhibitor
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Mean resting correct QT interval (QTcF) >470 msec for women and >450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value.
Adequate organ function; Mean resting correct QT interval (QTcF) >470 msec for women and >450 msec for men at Screening, obtained from 3 ECGs using the screening clinic ECG machine derived QTcF value.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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