Actively Recruiting
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
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-04-16
32
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 acquired resistance to third-generation EGFR TKI
- Concurrent CDK4/6 pathway gene dysfunctional aberrations
- Evaluable or measurable disease per RECIST Version 1.1
- At least one prior line of systemic chemotherapy
- Adequate organ function
You will not qualify if you...
- Prior treatment with any CDK4/6 inhibitor
- Active uncontrolled or unstable CNS metastases, carcinomatous meningitis, or leptomeningeal disease
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia and Grade 2 platinum-related neuropathy
- Active gastrointestinal disease or conditions affecting oral therapy absorption or metabolism
- Unstable angina, congestive heart failure, recent myocardial infarction, stroke, or other uncontrolled cardiovascular disease within 6 months
- QTcF interval >470 msec for women and >450 msec for men at screening
- Recent wide field radiotherapy within 28 days or limited field radiation within 7 days prior to study drug
- Major surgery within 28 days or minor surgery within 7 days
- Severe or uncontrolled systemic diseases including renal transplant, bleeding disorders, or uncontrolled hypertension
- Active hepatitis B or C or serious infections such as tuberculosis or HIV
- Presence or history of other active invasive cancers within 5 years
- Spinal cord compression or brain metastases unless asymptomatic, stable, and steroid-free for at least 2 weeks
- History of interstitial lung disease or related lung conditions requiring steroids
- History of liver cirrhosis or serious liver disease
- Chemotherapy or anticancer drugs within 14 days prior to study except monotherapy osimertinib
- Use of strong CYP3A4 inducers or inhibitors within 3 weeks prior to study
- Participation in another clinical study with cytotoxic or investigational agents within 14 days
- Known hypersensitivity to osimertinib, dalpiciclib, or related drugs
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Thoracic Medical Oncology, Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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