Clinical Trial: Phase III Non-Inferiority Trial of Postoperative Immunotherapy vs. Observation after NEoadjuvant chemoimmunotherapy and completE Resection for clinical stage II-IIIB non-small cell lung cancer (PIONEER) (WJOG24225L) (Japan)

Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063371) titled 'Phase III Non-Inferiority Trial of Postoperative Immunotherapy vs. Observation after NEoadjuvant chemoimmunotherapy and completE Resection for clinical stage II-IIIB non-small cell lung cancer (PIONEER) (WJOG24225L)' on Oct. 26.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - West Japan Oncology Group

Condition: Condition - Clinical stage II-IIIB non-small cell lung cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate whether omission of adjuvant immunotherapy is non-inferior to adjuvant immunotherapy in terms of recurrence-free survival (RFS) in patients with EGFR/ALK-negative or unknown non-small cell lung cancer (NSCLC) who have undergone complete resection following neoadjuvant chemoimmunotherapy. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Adjuvant immunotherapy Interventions/Control_2 - Observation

Eligibility: Age-lower limit - 18 years-old =3,000/mm^3 8) No history of chemotherapy*1,*2 or radiotherapy for malignancy within the 2 years before registration, except for neoadjuvant chemoimmunotherapy administered for the NSCLC targeted in this study. Key exclusion criteria - 1) Patients with active multiple primary malignancies. 2) Patients with active systemic infections, active infections including hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection (e.g., patients receiving treatment for an active infection), or uncontrolled active hepatitis B virus (HBV) infection. 3) Patients with autoimmune diseases requiring systemic treatment. Endocrine immune-related adverse events (irAEs), such as hypothyroidism, hyperthyroidism, or adrenal insufficiency, are not exclusion criteria if they are clinically stable with hormone replacement therapy or appropriate endocrine treatment and do not require immunosuppressive therapy. 4) Patients who developed irAEs during or after neoadjuvant immune checkpoint inhibitor therapy for which permanent discontinuation of immune checkpoint inhibitors is recommended according to the ASCO and NCCN guidelines for irAE management. These include myocarditis, encephalitis, transverse myelitis, Grade 3-4 myasthenia gravis, Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), Grade 4 irAEs other than endocrine disorders, and other relevant conditions. 5) Patients with a history of Grade >=2 ICI-related pneumonitis or active interstitial lung disease/pneumonitis at the time of registration. 6) Patients who are pregnant, breastfeeding, suspected to be pregnant, or unwilling to use contraception. 7) Patients who are considered unsuitable for study enrollment due to clinically significant postoperative complications or psychiatric disorders. 8) Patients receiving continuous systemic administration (oral or intravenous) of corticosteroids at a dose exceeding 10 mg/day of prednisolone equivalent or other immunosuppressive agents. 9) Patients with a history of severe hypersensitivity reactions. 10) Patients with postoperative complications of Clavien-Dindo Grade IIIa or higher. Target Size - 366

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 09 Month 30 Day Anticipated trial start date - 2027 Year 02 Month 01 Day Last follow-up date - 2036 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072532

Disclaimer: Curated by HT Syndication.