Completely resected, Stage IB (tumors =4 cm) to Stage IIIA, Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC). MedDRA version: 21.1 Level: PT Classification code 10059515 Term: Non-small cell lung cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10029520 Term: Non-small cell lung cancer stage IIIA System Organ Class: 10029104 - Neoplasms benign, mal
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age =18 years - Complete resection of histologically confirmed Stage IB (tumor >= 4 cm) to Stage IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC as per Union Internationale Contre le Cancer/American Joint Committee on Cancer, 7th edition, with negative margins, at 4-12 weeks before enrollment - If mediastinoscopy was not performed preoperatively, it is expected that, at a minimum, mediastinal lymph node systematic sampling will have occurred - Systematic mediastinal lymph node sampling, at a minimum, for patients for whom mediastinoscopy was not performed preoperatively - Documented ALK-positive disease according to an FDA-approved and CE-marked test - Eligible to receive a platinum-based chemotherapy regimen according to the local labels or guidelines - Eastern Cooperative Oncology Group Performance Status of Grade 0 or 1 - Adequate hematologic and renal function - For women of childbearing potential: agreement to remain abstinent or use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 90 days after the last dose of alectinib or according to local labels or guidelines for chemotherapy - Prior adjuvant radiotherapy for NSCLC - Prior exposure to systemic chemotherapy and ALK inhibitors - Stage IIIA N2 patients that, in the investigator's opinion, should receive post-operative radiotherapy treatment are excluded from the study - Known sensitivity to any component of study drug to which the patient may be randomized. This includes, but is not limited to, patients with galactose intolerance, a congenital lactase deficiency or glucose-galactose malabsorption. - Malignancies other than NSCLC within 5 years prior to enrollment, except for curatively treated basal cell carcinoma of the skin, early gastrointestinal (GI) cancer by endoscopic resection, in situ carcinoma of the cervix, ductal carcinoma in situ, papillary thyroid cancer, or any cured cancer that is considered to have no impact on disease free survival or overall survival for the current NSCLC - Any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection - Liver disease characterized by aspartate transaminase and alanine transaminase >= 3 × upper limit of normal or impaired excretory function or synthetic function or other conditions of decompensated liver disease such as coagulopathy, hepatic encephalopathy, hypoalbuminemia, ascites, or bleeding from esophageal varices or acute viral or active autoimmune, alcoholic, or other types of acute hepatitis - Japanese patients participating in the serial/intensive PK sample collection only: administration of strong/potent CYP450 3A inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib up to Week 3 - Any exclusion criteria based on the local labels or guidelines for the chemotherapy regimen - Patients with symptomatic bradycardia - History of organ transplant - Known HIV positivity or AIDS-related illness - Any clinically significant concomitant disease or condition that could interfere with-or for which the treatment might interfere with the conduct of the study or the absorption of oral medications or that would pose an unacceptable risk to the patients in this study, in the opinion of the Principal Investigator - Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage IB (tumors =4 cm) to Stage IIIA, ALK-positive NSCLC based on investigator assessed disease-free survival;Secondary Objective: •To evaluate the efficacy of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage IB (tumors =4 cm) to Stage IIIA, ALK-positive NSCLC based on overall survival •To evaluate the safety and tolerability of alectinib compared with platinum-based chemotherapy in patients with completely resected Stage IB (tumors =4 cm) to Stage IIIA, ALK-positive NSCLC For alectinib arm only •To characterize the pharmacokinetics (PK) of alectinib and its major metabolite(s) in patients with completely resected Stage IB (tumors >= 4 cm) to Stage IIIA, ALK-positive NSCLC •At Japanese sites only: To characterize the pharmacokinetics of alectinib and its major metabolite(s) in Japanese patients ;Primary end point(s): Disease-free survival;Timepoint(s) of evaluation of this end point: Every 12 weeks for the first 2 years, every 24 weeks during Years 3 to 5 and annually thereafter until disease recurrence | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Overall survival 2.Incidence of adverse events, with severity determined through use of National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 3.Incidence of abnormal laboratory findings 4.Changes in vital signs and electrocardiograms 5.Plasma concentrations of alectinib and its major metabolite(s) at specified timepoints for alectinib arm ;Timepoint(s) of evaluation of this end point: 1.Every 6 months after disease recurrence (in survival follow-up period) 2-4. During study treatment period and at safety follow-up visit (28 days after last dose of study drug) 5. At baseline and at Weeks 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, and 96 | — |
Countries
Australia, Austria, Bosnia and Herzegovina, China, Denmark, Egypt, France, Germany, Greece, Hungary, Israel, Italy, Japan, Kazakhstan, Korea, Republic of, Latvia, North Macedonia, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed