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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
EU CTIS ID: 2023-506861-76-00
What this study is testing
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
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Pregnant or breastfeeding, or intending to become pregnant during the study and for at least 5 weeks 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
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- United Kingdom
- Russian Federation
- Kazakhstan
- Belarus
- Taiwan
- China
- Israel
- Japan
- Bosnia and Herzegovina
- Australia
- Turkey
- Ukraine
- United States
- Egypt
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; United Kingdom; Russian Federation; Kazakhstan; Belarus; Taiwan and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.