Clinical Trial: Optimization of Adjuvant Osimertinib for EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer (A randomized phase III study) (Japan)

Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061687) titled 'Optimization of Adjuvant Osimertinib for EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer (A randomized phase III study)' on May 26.

Study Type: Interventional

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

Primary Sponsor: Institute - Public Health Research Foundation

Condition: Condition - EGFR Mutant Stage II-III Non Squamous Non Small Cell Lung Cancer Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - The aim of the study is to evaluate the non-inferiority of 40 mg/day Osimertinib compared with the standard 80 mg/day regimen in disease free survival in patients with EGFR mutant stage II to III non squamous NSCLC. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Standard treatment group: Osimertinib (80 mg/day) will be administered orally once daily for 3 years, starting on the day of treatment initiation. Interventions/Control_2 - Experimental treatment group: Osimertinib (40 mg/day) will be administered orally once daily for 3 years, starting on the day of treatment initiation.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Histologically confirmed non squamous non small cell lung cancer (NSCLC), including adenocarcinoma, large cell carcinoma (excluding large cell neuroendocrine carcinoma), or NSCLC of unknown histological type. 2) Diagnosed as TNM postoperative pathological stage II to III (not pN3). 3) Presence of EGFR exon 19 deletion or L858R mutation (any testing method allowed). 4) Complete resection (R0) following anatomical resection (segmentectomy or more extensive resection). 5) ECOG performance status (PS) of 0 to 1. 6) 18 years of age or older at the time of registration. 7) No prior treatment such as radiotherapy or chemotherapy, other than surgery. (Molecular targeted therapies and immune checkpoint inhibitors are considered chemotherapy.) Prior adjuvant pharmacotherapy is allowed if completed at least 3 years before registration. Prior hormonal therapy for other malignancies is allowed. 8) Interval from surgery to registration: 4 to 10 weeks (without) or 4 to 26 weeks (with) adjuvant platinum based chemotherapy. (based on the date of surgery; same weekday acceptable). 9) Within 14 days prior to registration (same weekday allowed), the most recent laboratory values meet all of the following: - WBC 3,000 per mm3 or higher - Hemoglobin 9.0 g/dL or higher - Platelets at least 100,000 per mm3 - Total bilirubin no more than 2.0 mg/dL - AST no more than 100 U/L - ALT no more than 100 U/L - Serum creatinine no more than 1.5 mg/dL 10) No evidence of interstitial lung disease or pulmonary fibrosis on CT. 11) Written informed consent obtained from the patient. Key exclusion criteria - 1) Active multiple primary malignancies (synchronous or metachronous with disease-free survival less than 2 years). Exceptions include malignancies with an expected 5-year relative survival rate of 95 percent or higher, such as: stage 0 to I adenocarcinoma of stomach, colon, or rectum; stage 0 esophageal cancer; stage 0 to II breast cancer; stage I endometrial cancer; stage I to II prostate cancer; stage 0 cervical cancer; stage I to III thyroid cancer; stage I renal cancer; non melanoma skin cancer; lentigo maligna without definitive diagnosis; or carcinoma in situ or equivalent (based on UICC TNM 9th edition or equivalent). 2) Active infection requiring systemic therapy, including tuberculosis. 3) Psychiatric conditions precluding study participation. 4) Ongoing systemic steroid therapy exceeding 10 mg per day (prednisolone equivalent). Other immunosuppressive agents may be allowed at investigator discretion. 5) Serious comorbid conditions, including: - frequent transient ischemic attacks - symptomatic heart failure, unstable angina, or myocardial infarction within 1 year - clinically significant arrhythmias (including conduction disorders) - gastrointestinal perforation, fistula, diverticulitis, or history within 1 year - uncontrolled diabetes mellitus - uncontrolled hypertension 6) Pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men planning to conceive; or individuals of reproductive potential unwilling to use effective contraception. 7) Hypersensitivity or allergy to study drug or excipients. 8) Considered unsuitable for participation by investigator. Target Size - 420

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 28 Day Date of IRB - 2026 Year 02 Month 26 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2034 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070586

Disclaimer: Curated by HT Syndication.