OncoMatch/Clinical Trials/NCT07207395
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.
Is NCT07207395 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including JBI-802 and Pembrolizumab for lung cancer (nsclc).
Treatment: JBI-802 · Pembrolizumab — The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: STK11 mutation
Disease stage
Metastatic disease required
locally advanced or metastatic NSCLC
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic anticancer therapy
Treatment with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment
Cannot have received: radiation therapy
Exception: palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment
Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment)
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500 cells/mm3; Platelet count ≥100,000 cells/mm3
Kidney function
Calculated creatinine clearance (CrCL) ≥40 mL/min calculated per Institutional standard
Liver function
Total bilirubin ≤1.5×ULN (Gilbert's syndrome up to 3.0xULN); AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed)
Cardiac function
QTcF interval >480 msec for males and females, respectively, at Screening [excluded]; NYHA Class III or IV congestive heart failure, uncontrolled cardiac arrhythmia requiring medication (≥Grade 2), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness [excluded]
Screening laboratory values: ANC ≥1500 cells/mm3; Platelet count ≥100,000 cells/mm3; Total bilirubin ≤1.5×ULN (Gilbert's syndrome up to 3.0xULN); AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed); Calculated creatinine clearance (CrCL) ≥40 mL/min; QTcF interval >480 msec for males and females, respectively, at Screening [excluded]; NYHA Class III or IV congestive heart failure, uncontrolled cardiac arrhythmia requiring medication (≥Grade 2), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The Christ Hospital · Cincinnati, Ohio
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07207395 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anticancer therapy, radiation therapy disqualifies patients from enrollment.
Does this trial require STK11?
Yes, STK11 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages