Six Facts About Clinical Research Participation for ALK-Positive Lung Cancer Patients

by Dr. Ken Culver, Executive Director and Medical Director, ALK Positive, Inc.

Did you know?

No. 1 — ALK-positive Patients Are Essential Research Partners

Advances in ALK-positive cancer care — from TKIs to next-generation therapies — are possible only because patients volunteered to participate in research. It took over 6,500 patients to join clinical trials to get the six FDA-approved TKIs to market. Your unique tumor biology, treatment experience, and resistance patterns hold insights that cannot be fully replicated in laboratories or model systems. As a patient-driven organization, ALK Positive champions the role of patients as co-creators of progress, not passive participants.

No. 2 — There Is a Trial (or Several) for You

No matter the stage, treatment history, or mutation subtype, there are clinical studies designed for your situation. These include:

· Newly diagnosed ALK-positive metastatic NSCLC

· Post-TKI resistance

· Next generation agents (e.g., ADCs, immunotherapy, bispecific)

· Quality-of-life focused studies

As a global patient-driven organization, ALK Positive helps connect patients to resources that improve both quality of life and life expectancy.

No. 3 — Not Every Study Tests a Drug

You can contribute to research in meaningful ways without taking an investigational therapy. Examples include:

· Liquid biopsy and ctDNA studies to map resistance

· Tumor tissue donation programs to support biomarker discovery

· Surveys capturing real-world symptom experience and treatment side effects

· Longitudinal studies tracking disease progression

These forms of participation accelerate the development of precision-medicine therapies — a key priority echoed across ALK Positive research initiatives.

No. 4 — Participation Brings Risks and Potential Benefits

As with all cancer therapy trials, risks include side effects and unknown benefits. But participation may also provide:

· Early access to next-generation therapies

· More frequent monitoring and expert oversight

· Contribution to a global movement improving ALK-positive outcomes

· A sense of empowerment and purpose

For many patients, participation aligns with ALK Positive’s mission to transform the future of ALK-positive cancer through research and community action.

No. 5 — Your Safety Is the Highest Priority

Every clinical study must be approved by an Institutional Review Board (IRB) that reviews, approves, and monitors clinical research to protect the rights, safety, and welfare of participants. In addition, research teams continuously monitor:

· Signs of side effects and toxicity

· Laboratory test findings

· Imaging and tumor assessments

· Any medically significant changes

You always have the right to withdraw from a study at any time without having to provide a reason. Safety, respect, and informed choice are at the heart of all ALK Positive–supported research partnerships.

No. 6 — There Are Many Ways to Find ALK-Focused Trials

Patients often discover studies through:

· Their oncologist or cancer center · ClinicalTrials.gov and the ALK Positive Clinical Trial Finder (Clinical Trials | ALK Positive) · ALK Positive, Inc. community support channels (Resources & Support | ALK Positive) · ALK Positive registries and other studies driven by the community (Patient-Focused Research | ALK Positive)

As a global nonprofit committed to research acceleration, ALK Positive collaborates with academia, industry, and advocacy networks to bring promising treatments to patients faster. Please join us, we will get even better treatments faster together!

Interested in Clinical Trials?

Clinical trials have paved the way for better treatment and longer survival for ALK-Positive cancer. There may be a trial that’s right for you.

Clinical Trials Currently Recruiting for ALK-positive Cancers.

General Information About Clinical Trials