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

Sponsor
Tianjin Medical University Cancer Institute and Hospital
Study ID
NCT06363734
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib plus Dalpiciclib — DRUG
    osimertinib 80mg daily plus dalpiciclib 125mg daily for 21 days followed by 7 days off in each 28-day treatment cycle

Study Details

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.

Key Dates

Start date
Apr 9, 2024
Status verified
Apr 2024
Primary completion
Dec 15, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: osimertinib in combination with dalpiciclib

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 12 months ]

Related Studies