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New treatment option for Non-small Cell Lung Cancer
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
ClinicalTrials.gov ID: NCT06363734
What this study is testing
What is Osimertinib plus Dalpiciclib?
Osimertinib plus Dalpiciclib is an investigational medicine, given as an once-daily, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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
- Evaluable or measurable disease as defined by RECIST, Version 1.1
You likely can't join if
- 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...
- active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of...
- Unstable angina pectoris, Congestive heart failure, Acute myocardial infarction, Stroke or transient ischemic attack or other uncontrolled...
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7...
See the full eligibility criteria
- 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
- Evaluable or measurable disease as defined by RECIST, Version 1.1
- At least one prior line of systemic chemotherapy
- Adequate organ function
- 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...
- Unstable angina pectoris, Congestive heart failure, Acute myocardial infarction, Stroke or transient ischemic attack or other uncontrolled cardiovascular disease currently or within the last 6 months, Mean resting...
- Wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) administered ≤28 days or limited field radiation for palliation ≤7 days prior to starting study drug or has not recovered from side...
- Major surgical procedures ≤28 days of beginning study drug or minor surgical procedures ≤7 days
- Evidence of severe or uncontrolled systemic diseases, including renal transplant, active bleeding diatheses or uncontrolled hypertension
- Active hepatitis B or C or known serious active infection e.g. tuberculosis or human immunodeficiency virus. Viral testing is not required for assessment of eligibility for the study.
- Known serious active infection including, but not limited to, tuberculosis, or human immunodeficiency virus (positive human immunodeficiency virus 1/2 antibodies).
- Presence of other active cancers, or history of treatment for invasive cancer, within the last 5 years.
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment.
- Past medical history of interstitial lung disease(ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD.
- History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs,
- Any cytotoxic chemotherapy, investigational agents or other anticancer drugs for the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days prior to the first dose of study...
- Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers or inhibitors of CYP3A4 within 3 weeks of the first...
- Participation in another clinical study with a cytotoxic, investigational product (IP), or other anticancer drug for the treatment of advanced NSCLC if received IP from that study within 14 days of the first dose of...
- Known hypersensitivity to the active or inactive excipients of osimertinib or dalpiciclib or drugs with a similar chemical structure or class.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.