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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06363734 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior cdk4/6 inhibitor disqualifies patients from enrollment.
Does this trial require EGFR?
Yes, EGFR sensitizing mutation is a required biomarker for enrollment.
Does this trial require EGFR?
Yes, EGFR acquired resistance mutation to third-generation EGFR TKI is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify