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 (May 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
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
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