Clinical Trial: A single arm phase III trial to evaluate the efficacy of Alectinib 300 mg BID as adjuvant therapy in resected ALK positive non small cell lung cancer in a Japanese population (Japan)

Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061476) titled 'A single arm phase III trial to evaluate the efficacy of Alectinib 300 mg BID as adjuvant therapy in resected ALK positive non small cell lung cancer in a Japanese population' on May 7.

Study Type: Interventional

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

Primary Sponsor: Institute - Public Health Research Foundation

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

Objective: Narrative objectives1 - The aim of the study is to evaluate the efficacy and safety of Alectinib 300 mg BID as adjuvant therapy in patients with resected ALK positive non small cell lung cancer. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Patients will receive Alectinib 300mg BID for up to 2 years until disease recurrence or occurrence of unacceptable AEs.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1) Histologically proven non small cell lung cancer, excluding neuroendocrine carcinoma, mucoepidermoid carcinoma, and adenoid cystic carcinoma. 2) Diagnosed as TNM postoperative pathological stage II to III (not pN3). 3) Those who underwent anatomical resection (segmentectomy or more extensive resection) with pathologically confirmed complete resection. 4) ALK fusion confirmed in preoperative or surgical specimens by immunohistochemistry, FISH, or multigene testing. 5) 18 years of age or older at the time of consent. 6) ECOG performance status of 0 to 2. 7) No prior treatment such as radiotherapy, chemotherapy, or immunotherapy, other than surgery. 8) No severe dysfunction of major organs including bone marrow, heart, lungs, liver, kidneys, and meet all of the following criteria: A) White blood cell count of 3,000 per mm3 or higher B) Absolute neutrophil count of 1,500 per mm3 or higher C) Hemoglobin level of 9.0 g/dL or higher D) Platelet count of 100,000 per mm3 or higher E) Aspartate aminotransferase (AST) level below 100 IU/L F) Alanine aminotransferase (ALT) level of 126 IU/L or lower G) Total bilirubin level of 1.5 mg/dL or lower H) Serum creatinine level of no more than 1.5 times the upper limit of normal I) PaO2 of 60 torr or higher, or SpO2 of 90 percent or higher 9) At least 4 weeks and no more than 12 weeks after surgery. 10) Written informed consent obtained from the patient. Key exclusion criteria - 1) Those with active multiple primary cancers, including synchronous or metachronous multiple cancers with a disease-free interval of 2 years or less, excluding the following: clinically stage I prostate cancer; stage 0 or I laryngeal cancer with complete response after radiotherapy; or completely resected cancer with an expected 5-year relative survival rate of 95 percent or higher. 2) Those with unresolved postoperative complications. 3) Those with history of hypersensitivity to the protocol drug(s). 4) Those with gastrointestinal disorders that may affect oral intake, such as malabsorption syndrome. 5) Those who use or may need to use strong CYP3A inhibitors within 14 days prior to the first dose, or during Alectinib treatment through Week 3. 6) Those with active local infection requiring surgical intervention (e.g., drainage) or active systemic infection. 7) Those with active hepatitis B or hepatitis C infection. (Those who are positive for anti-HBs antibody and/or HBs antigen are allowed, if the viral load is below the limit of detection and there is no active hepatitis.) 8) Those with interstitial lung disease evident on CT. A history of radiation pneumonitis or organizing radiation pneumonitis in the irradiated field is allowed. 9) Pregnant or breastfeeding women, women of childbearing potential, or women within 28 days after delivery; men planning conception with a partner; those unwilling to use effective contraception during treatment. 10) Those with severe comorbid conditions. 11) Those with any other condition deemed inappropriate as judged by the attending physician. Target Size - 112

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 28 Day Date of IRB - 2026 Year 03 Month 03 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2035 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070344

Disclaimer: Curated by HT Syndication.