New drug cocktail aims to boost lung cancer treatment
NCT ID NCT03991819
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests whether adding the experimental drug binimetinib to the immunotherapy pembrolizumab (Keytruda) helps people with advanced non-small cell lung cancer. The study includes 40 participants whose tumors have high PD-L1 levels. Researchers are looking at safety, the best dose, and how many tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- binimetinib and pembrolizumab (Keytruda)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced non-small cell lung cancer whose tumors have high PD-L1 levels.
- What could go wrong
- This is an early Phase I trial with only 40 participants, so results are preliminary. The combination may cause side effects or not work better than pembrolizumab alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Histologically confirmed diagnosis of non-small cell lung carcinoma with tumour PDL-1 TPS≥50% by 22C3 pharmDx immunohistochemistry. Patients must have EGFR wild-type, ALK-rearrangement negative metastatic or advanced NSCLC (stage IV or incurable stage III). Patients with neuroendocrine (carcinoid) carcinoma, small cell or mixed small cell and non-small cell carcinoma are not eligible. * Must agree to use methods to prevent pregnancy as agreed upon between the investigator and the participant for at least 120 days after the last dose of study treatment. * The participant provides written informed consent for the trial. * Have measurable disease. * Provide archival tumor tissue sample for KRAS/BRAF/STK11 mutation analysis or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. * Have a life expectancy of greater than 3 months. * Be able to swallow and retain oral medication and not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. * Have adequate organ function. Exclusion Criteria: * Female with positive urine pregnancy test. * Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor, or a prior MEK inhibitor. * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration, excluding supportive medications such as bisphosphonates. * Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-central nervous system disease. * Has received a live vaccine within 30 days prior to the first dose of study drug. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. * Has a known additional malignancy that is progressing or has required active treatment within the past year. * Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment. * Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, or history of allergic reactions attributed to compounds of similar composition to binimetinib. * Has active autoimmune disease that has required systemic treatment in the past 2 years. * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. * Has an active infection requiring systemic therapy. * Has a known history of Human Immunodeficiency Virus. * Has a known history of Hepatitis B or known active Hepatitis C virus infection. * Has a known history of active (untreated) bacillus tuberculosis (TB). * Has a history or current evidence/risk of retinal vein occlusion (RVO) or predisposing factors to RVO * Has a history of retinal degenerative disease. * Has a history of Gilbert's syndrome * Has any factors that increase the risk of QTc prolongation or risk of arrhythmic events or baseline QTcB interval \>480 msec * Has a history of acute coronary syndromes, coronary artery bypass grafting, angioplasty, or stenting within the past 6 months prior to screening or cardiac metastases. * Has history or evidence of current clinically significant uncontrolled arrhythmias. * Has a history or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association (NYHA). * Has an intra-cardiac defibrillator or permanent pacemaker. * Has treatment-refractory hypertension defined as a systolic blood pressure \>140 mmHg and/or diastolic \>90 mmHg which cannot be controlled by anti-hypertensive therapy. * Has a history of neuromuscular disorders associated with elevated creatine phosphokinase (CK). * Is planning to embark on a new strenuous exercise regimen after the first dose of study treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
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Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
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Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z5, Canada
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Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
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