Clinical Trial: Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study (Japan)

Tokyo, Aug. 29 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062715) titled 'Single-arm phase II study evaluating supportive therapy for patients with non-small cell lung cancer receiving immune checkpoint inhibitor plus chemotherapy using Juzentaihoto: SUPPORT-JTT study' on Aug. 27.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - University of Toyama

Condition: Condition - non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The present study aims to evaluate the efficacy of Juzentaihoto in reducing adverse event and improvement the efficacy of chemoimmunotherapy for non-small cell lung cancer. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Administering Juzentaihoto to patients with non-small cell lung cancer planned to receive chemoimmunotherapy.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Patients diagnosed with non-squamous non-small cell lung cancer based on histopathological examination 2. Patients with a performance status of 0-1 at the time of enrollment 3. Patients that were determined during the enrollment period to be clinically eligible for initial systemic treatment with pembrolizumab+carboplatin+pemetrexed at Toyama University Hospital or Toyama Prefectural Central Hospital 4. Patients presenting with any of the following symptoms; weakness, fatigue, loss of appetite, night sweats, cold hands and feet, or anemia, for which JuzenTaiho is covered by health insurance in Japan Key exclusion criteria - 1. Patients under 20 years of age 2. Patients who are positive for either an EGFR gene mutation or an ALK fusion gene 3. Patients presenting with Grade 1 or higher hypokalemia (eligible after correction) 4. Patients presenting with Grade 2 or higher elevations in AST, ALT, or Cre 5. Patients presenting with Grade 3 or higher loss of appetite 6. Patients with Grade 3 or higher hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) 7. Patients with an autoimmune disease 8. Patients with interstitial pneumonia (excluding radiation pneumonitis) 9. Patients receiving the treatment with steroids equivalent to prednisolone of 5mg/day. 10. Patients taking Kampo medicine (Patients for whom a 4-week washout period can be arranged are eligible) 11. Patients with a history of treatment with immune checkpoint inhibitors 12. Patients diagnosed with another malignancy within the past 5 years (excluding cases following curative resection or carcinoma in situ) 13. Patients deemed incapable of providing informed consent 14. Patients deemed inappropriate for trial participation by the investigator Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 18 Day Date of IRB - 2026 Year 08 Month 18 Day Anticipated trial start date - 2026 Year 08 Month 31 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071733

Disclaimer: Curated by HT Syndication.