One of the challenges in our community has been the treatment of earlier stages of ALK-positive lung cancer, including stages IA through 3A. Historically, we've faced a lack of definitive guidelines for addressing the illness that represents 30-40% of the total ALK lung cancer population. Patients in these stages are traditionally treated with surgical tumor removal, followed by platinum chemotherapy. This treatment is a "one size fits all" approach to earlier stage lung cancer, without concern for the presence of the ALK mutation.

This month brings groundbreaking news that could revolutionize how we approach ALK lung cancer in its early stages. Enter the ALINA clinical trial, which has the potential to reshape the treatment landscape for stages IB to 3A ALK-positive lung cancer that are surgically resectable.

In the ALINA trial, the ALK inhibitor alectinib went toe-to-toe with conventional platinum chemotherapy as a post-surgery treatment. The outcome was striking. Those who received alectinib exhibited a 76% reduction in the risk of disease recurrence or death when compared to their counterparts who underwent chemotherapy.

Ben Solomon, Melbourne, Australia, during his Presidential Symposium presentation at the ESMO Congress 2023 (Madrid, Spain, 20-24 October). photo from the *ESMO Daily Reporter*

Now, as we await the FDA's approval of alectinib as a post-surgical treatment for earlier stage lung cancer, the implications are profound. This approval will support a paradigm shift in our approach to treating earlier stage lung cancer bearing targetable mutations.

The critical message from this landmark trial is the paramount importance of biomarker testing at all stages of diagnosis. The power of precision medicine, as exemplified by alectinib's remarkable results, reinforces the necessity of tailoring treatments to individual patient profiles. We need to advocate for comprehensive biomarker testing in all newly diagnosed lung cancer patients regardless of stage or histology.

Let's extend our gratitude to the individuals who participated in the ALINA clinical trial. Their generosity in taking a chance on an untested treatment has revealed a path toward more effective care. We are also grateful that Genentech/Roche invested in a trial that took about 5 years to complete.

Presently, there are approximately 50 trials dedicated to ALK lung cancer across all stages. Among this array of options, there may be a trial that aligns with your needs at any juncture in treatment. Together we can bring in a new era in the fight against ALK-positive lung cancer.

Clinical Trials Currently Recruiting for ALK-positive Cancers.

We need your help to help researchers better understand the journey of ALK-positive lung cancer patients to advance our cancer care and outcomes.

ALK Positive Inc., has funded a longitudinal survey termed the “ALK Life Study” to obtain more information about the experiences of those diagnosed with ALK-positive lung cancer. The survey has many points of interest, including the experiences of those who have participated in clinical trials. The survey is confidential and approved by a research governing body at the University of Washington. To complete the survey, please click here: ALK Life Study.

General Information About Clinical Trials

As of October 2023, there are at least 50 clinical trials that are recruiting specifically for people with ALK-positive lung cancer. Many of these trials have multiple sites worldwide. Due to the large number of trials, it is difficult for any one oncologist to be aware of all the trials available. You can advocate for yourself and find a clinical trial that may be a good fit for you at any juncture in treatment.

*The ALK Positive Clinical Trials Spreadsheet was developed by the ALK Positive Medical Committee. The database is updated monthly. Disclaimer: these trials have been consolidated by volunteers and should not be considered exhaustive. Listing of these trials is not an endorsement, and ALK Positive does not recommend one trial over another. Please talk with your doctor about these or any trials you are interested in.

By Ellee Urban with assistance from ChatGPT.

ALINA Trial Unveils a Paradigm Shift in the Battle Against Early Stage, Resectable ALK-Positive Lung Cancer