Actively Recruiting
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
Led by National Cancer Center, China · Updated on 2024-07-10
20
Participants Needed
1
Research Sites
97 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.
CONDITIONS
Official Title
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Age 18 years or older, any gender
- Confirmed locally advanced or metastatic non-small cell lung cancer not suitable for curative surgery or radiation
- ECOG Performance Status 0-1 with expected survival of at least 12 weeks
- Prior treatment with third-generation EGFR tyrosine kinase inhibitor with radiological disease progression
- At least one measurable lesion by RECIST 1.1 not previously irradiated
- EGFR mutation-positive confirmed after progression on third-generation EGFR TKI
- Adequate organ and bone marrow function as defined by laboratory criteria
- Able to swallow oral medications
- Women of reproductive age must use effective contraception during and 60 days after treatment; men must use contraception during and 120 days after treatment
- Treatment-related side effects from prior therapy must have recovered to baseline or Grade 1 except stable Grade 2 peripheral neuropathy and alopecia
- Sufficient mental capacity to understand study and risks
You will not qualify if you...
- Prior or current use of anti-tumor drugs targeting CDK4/6
- History of severe allergies or allergic reactions
- Presence of ALK, BRAF V600E mutations, or retinoblastoma protein loss after disease progression
- Anti-tumor treatment received within 2 weeks before study drug start
- Uncontrolled third-space fluid accumulation
- Requirement for long-term steroids
- Unresolved low potassium or magnesium levels
- Significant arrhythmias or conduction abnormalities, recent severe cardiac events or surgeries
- History of interstitial lung disease or drug-induced lung disease requiring steroids
- Active infections such as hepatitis B, hepatitis C, or HIV
- Relapse or concurrent malignancy within 5 years except certain cured cancers
- History of organ or stem cell transplant
- Gastrointestinal conditions affecting drug absorption or swallowing
- Spinal cord compression, leptomeningeal or symptomatic brain metastases; some asymptomatic brain metastases allowed
- Major surgery or severe unhealed wounds within 4 weeks before study start
- Recent local or extensive radiation therapy
- Conditions or factors that may interfere with participation or study assessments such as substance abuse, severe medical or psychiatric illnesses, or inability to comply with protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center
Beijing, China
Actively Recruiting
Research Team
P
Puyuan Xing, Doctorate
CONTACT
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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