Actively Recruiting
Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer
Led by University Health Network, Toronto · Updated on 2025-12-05
40
Participants Needed
4
Research Sites
375 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/Ib study whose purpose is to find out if combining an experimental drug called binimetinib with pembrolizumab is beneficial in people who have advanced non-small cell lung cancer. This study may also see if the combination is safe and may also find the best dose of binimetinib that should be added to pembrolizumab.
CONDITIONS
Official Title
Study of Binimetinib in Combination With Pembrolizumab in Advanced Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-small cell lung carcinoma confirmed by tissue testing with PD-L1 TPS ≥50% and EGFR wild-type, ALK-rearrangement negative metastatic or advanced stage (IV or incurable III)
- Agree to use effective birth control methods during the study and for 120 days after last treatment
- Provide written informed consent to participate
- Have measurable disease
- Provide tumor tissue sample for mutation analysis or new biopsy of non-irradiated tumor
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy over 3 months
- Able to swallow and retain oral medication without significant gastrointestinal problems
- Have adequate organ function as determined by study requirements
You will not qualify if you...
- Female with positive pregnancy test
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, other T-cell receptor agents, or MEK inhibitors
- Received systemic anti-cancer therapy including investigational drugs within 4 weeks before registration
- Received radiotherapy within 2 weeks before study treatment start or have unresolved radiation side effects
- Received live vaccine within 30 days before first dose
- Participated in another investigational drug or device study within 4 weeks before first dose
- Diagnosed with immunodeficiency or on high-dose steroids or immunosuppressive therapy within 7 days before first dose
- Have active progressing second cancer or required treatment for other malignancy within past year
- Have active central nervous system metastases or carcinomatous meningitis, unless stable and off steroids for 14 days
- Severe allergy to pembrolizumab or related compounds or similar to binimetinib
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection needing systemic treatment
- Known HIV infection
- Known active Hepatitis B or C infection
- Active untreated tuberculosis
- History or risk of retinal vein occlusion or retinal degenerative disease
- History of Gilbert's syndrome
- Risk factors or history of QTc prolongation or arrhythmias
- Recent acute coronary syndrome or cardiac procedures within 6 months
- Uncontrolled arrhythmias or severe heart failure
- Presence of cardiac defibrillator or pacemaker
- Treatment-resistant high blood pressure
- History of neuromuscular disorders with high creatine phosphokinase
- Planning to start new strenuous exercise regimen after first dose
- Any condition or therapy interfering with study participation or safety as judged by investigator
- Psychiatric or substance abuse disorders interfering with study cooperation
- Pregnant, breastfeeding, or planning pregnancy or fatherhood during study and 120 days after last dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Actively Recruiting
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5
Actively Recruiting
3
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
4
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
Research Team
N
Natasha Leighl, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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