Previously untreated advanced or recurrent non-squamous non-small cell lung cancer (NSCLC)
Conditions
Interventions
Platinum-based chemotherapy (cisplatin or carboplatin) plus pemetrexed and pembrolizumab, combined with daily oral administration of Clostridium butyricum MIYAIRI 588 (CBM588).
Sponsors
Hirokazu Taniguchi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically confirmed diagnosis of non-squamous non-small cell lung cancer (NSCLC). 2. Untreated, advanced, or recurrent non-squamous NSCLC. Measurable lesions are not required. 3. Patients presenting with diarrhea, abnormal bowel movements, anorexia, abdominal pain, abdominal distension, nausea, or vomiting at the time of informed consent. 4. Age 18 years or older at the time of informed consent. 5. ECOG Performance Status (PS) of 0 or 1 at the time of informed consent. 6. No active concurrent malignancy. 7. Laboratory values within 14 days prior to registration must meet all of the following: a. Absolute neutrophil count: 1,500 / uL or higher b. Platelet count: 100,000 / uL or higher c. Total bilirubin: 1.5 mg/dL or lower d. AST: 100 U/L or lower (200 U/L or lower if liver metastasis is present) e. ALT: 100 U/L or lower (200 U/L or lower if liver metastasis is present) f. Creatinine clearance: 45 mL/min or higher g. SpO2 on room air: 92 percent or higher 8. Tumor PD-L1 (22C3) Tumor Proportion Score (TPS) less than 50 percent. 9. Negative for activating EGFR mutations (exon 19 deletion, exon 21 L858R, G719X, L861Q, S768I, or combinations with T790M), and negative or unknown for ALK fusion, ROS1 fusion, BRAF V600E, MET exon 14 skipping, and RET fusion. Note: NTRK fusion, KRAS G12C mutation, and HER2 mutation are eligible. 10. No active autoimmune disease and no history of chronic or recurrent autoimmune disease requiring systemic treatment. Exceptions include well-controlled type 1 diabetes mellitus, thyroid disorders treated with oral medication only, and autoimmune skin conditions not requiring systemic therapy. 11. Written informed consent has been obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Stage IA to IIIA NSCLC in which lobectomy is possible. 2. Presence of symptomatic pericardial effusion. 3. Symptoms of superior vena cava syndrome requiring urgent radiation therapy. 4. Uncontrolled serious cardiovascular disease, including unstable angina, myocardial infarction within the past 3 months, or heart failure. 5. Uncontrolled diabetes mellitus. 6. Uncontrolled hypertension. 7. Active systemic infection requiring treatment. 8. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners wish to become pregnant. 9. Psychiatric disorders or symptoms that significantly interfere with daily life and make participation in this study difficult. 10. Continuous systemic administration of corticosteroids (equivalent to >=10 mg prednisolone) or immunosuppressive drugs (oral or intravenous). 11. Positive for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab). 12. Positive for HIV antibody. 13. Interstitial pneumonia, pulmonary fibrosis, severe emphysema, or a combination of these diagnosed by chest CT. 14. Administration of CBM588 within 5 days prior to informed consent. 15. Participation in other clinical trials or studies. 16. Any comorbidity or condition judged to interfere with treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS:Progression-free survival, RR:Response ratio | — |
Contacts
Public ContactTagawa Ryuta
Nagasaki University Graduate School of Biomedical Sciences
Outcome results
None listed