A Study to Evaluate the Efficacy and Safety of Adjuvant Alectinib versus Adjuvant Platinum-Based Chemotherapy in Patients with Completely Resected Stage Ib (tumors = 4 cm) to Stage IIIa Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer
- Conditions
- Completely resected, Stage Ib (tumors = 4 cm) to Stage IIIa, Anaplastic Lymphoma Kinase (ALK)-Positive Non-Small Cell Lung Cancer (NSCLC)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506861-76-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 257
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 UICC/AJCC, 7th edition, with negative margins, at 4-12 weeks before enrollment, 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, Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
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 anti-cancer therapy 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., Significant liver disease or impaired liver transaminase enzymes levels, symptomatic bradycardia, any GI disorder that may affect absorption of oral medications, such as malabsorption syndrome or status post-major bowel resection, HIV positivity
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method