Actively Recruiting
A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer Having an STK11 Mutation
Led by The Christ Hospital · Updated on 2025-10-06
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of an oral drug called JBI-802, both alone and combined with Pembrolizumab, in people with non-small cell lung cancer (NSCLC) that has an STK11 mutation. This phase 2, open-label study focuses on patients with advanced NSCLC bearing this specific mutation to understand how these treatments perform and their effects on the cancer. Participants will receive JBI-802 orally at a dose of 10 mg once daily, following a schedule of 4 days on treatment and 3 days off. Those in the combination group will also receive Pembrolizumab at 200 mg every three weeks. The study is non-randomized with two experimental arms: one using JBI-802 alone and the other combining it with Pembrolizumab. During the study, participants will have regular assessments including scans to measure tumor response, laboratory tests to monitor safety, and evaluations of side effects. The primary outcomes are the incidence of adverse events and the investigator-assessed overall response rate up to 28 days after the last dose. Participants will be monitored closely throughout the treatment and follow-up periods to track how they respond to the therapies and to ensure safety.
CONDITIONS
Brief Title
A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Patients With Non-small Cell Lung Cancer With an STK11 Mutation.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 years or older at screening
- Histologically confirmed locally advanced or metastatic non-small cell lung cancer with an STK11 mutation
- Adequate laboratory values including ANC ≥1500 cells/mm3, platelet count ≥100,000 cells/mm3, total bilirubin ≤1.5×ULN (up to 3.0×ULN with Gilbert's syndrome), AST and ALT ≤2.5×ULN (up to 5×ULN with liver metastases), creatinine clearance ≥40 mL/min
- At least one measurable lesion on CT or MRI per RECIST 1.1
- Resolution of prior therapy toxic effects to Grade 0 or 1 (except alopecia and certain neuropathies/endocrinopathies)
- ECOG performance status of 2 or less
- Ability to swallow oral medication
- Willing and able to give informed consent and comply with study requirements
- Willingness to use effective contraception during treatment and for 3 months after last dose
You will not qualify if you...
- Systemic anticancer therapy or investigational agent within 2 weeks or 5 half-lives before study treatment
- Major surgery within 21 days before study drug or not recovered from surgery effects
- Surgery or conditions affecting drug absorption
- Radiotherapy within 2 weeks before study drug (except certain palliative radiation within 7 days) without recovery from toxicities
- Active malignant central nervous system disease except stable treated brain metastases without progression or hemorrhage for at least 4 weeks and off corticosteroids for 14 days
- Severe or unstable medical conditions including certain heart diseases, uncontrolled hypertension or diabetes, psychiatric conditions, or uncontrolled arrhythmias
- Congenital long QT syndrome or corrected QT interval >480 msec
- Other cancers interfering with safety or efficacy assessments
- Live vaccines within 30 days prior to first dose
- Use of glucocorticoids except for specific uses
- Use of strong CYP3A or CYP2D6 inhibitors or inducers within specified timeframes
- Major active infections requiring IV antibiotics
- Active HIV, hepatitis B or C infections
- Active gastrointestinal diseases affecting drug absorption
- Acute illness within 14 days unless mild and approved
- Active infections requiring antibiotics
- Pregnant, breastfeeding, or planning pregnancy during study and 90 days after
- Current participation in another investigational agent study (observational studies may be allowed with approval)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive oral JBI-802 daily on a 4 days on and 3 days off cycle. Some participants also receive Pembrolizumab 200mg every 3 weeks.
Visits every 3 weeks for Pembrolizumab dosing and assessments
Duration - Up to 28 days after last dose
Participants are monitored for safety and response for up to 28 days after the last dose of study drug.
1 to 2 visits depending on individual assessments
Trial Site Locations
Total: 1 location
1
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
A
Abby Reed
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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