About Lung Cancer | Diagnosis | Biomarkers

ALK

ALK-positive lung cancer

ALK-positive stands for Anaplastic Lymphoma Kinase Positive, or ALK+. It occurs in 1 out of 25 non-small-cell lung cancer (NSCLC) patients. Younger patients who have never smoked — usually 55 and under —  are most likely to be diagnosed as being ALK+.

How the ALK Mutation Works

The ALK mutation is a genetic alteration of your lung cells’ DNA that causes these cells to grow abnormally and ultimately behave as cancer cells. As these cancer cells begin to grow in your lung, they can potentially spread to other parts of your body.

Among the many different mutations that can drive cancer to grow, the ALK mutation is one of the more treatable as it often responds dramatically to targeted therapies.

Hope With Answers Classics

Intro to ALK+ Lung Cancer

In this video, Patient and Advocate Shelly Engfer-Triebenbach speaks with researcher Dr. Alice Shaw from Massachusetts General Hospital about ALK-positive lung cancer.

Alk-Positive Lung Cancer Testing

To find out if your lung cancer has this ALK+ mutation, you will need to have a sample of your cancer analyzed in a laboratory. This process is known as biomarker testing. To obtain a sample of the cancer, it is necessary to have a biopsy, typically obtained either with a needle or a small surgical procedure.

Liquid biopsies are simple blood tests that look for circulating cancer cells in your bloodstream. These blood tests are showing promise as less-invasive tests for various points along a lung cancer journey. Currently, liquid biopsies are not used to diagnose lung cancer, but researchers are working to find diagnostic tools, including liquid biopsies, to detect lung cancer in a non-invasive way. Currently, the best way is to test lung cancer is from a biopsy.

NCI-Designated Comprehensive Cancer Centers and other academic centers are excellent choices for and have experience in comprehensive biomarker testing. You can also have the testing done by a commercial lab recommended by your physician.

Search By State

Learn More About Alk-Positive Lung Cancer

  • Shelly Engfer-Triebenbach playing the piano

    Hope With Answers Classics

    Is Immunotherapy an Option for ALK-Positive Lung Cancer?

    Once it is confirmed that your lung cancer tests positive for the ALK mutation, there are many treatment options in addition to targeted therapy.

  • My ALK Inhibitor Stopped Working - What Now?

    Hope With Answers Classics

    My ALK Inhibitor Stopped Working, What Now?

    If your ALK+ treatment stops working, is there a second-line treatment? Fortunately, there are multiple options for patients with ALK+ lung cancer.

  • Sydney Barned

    Knowing Your Biomarker

    What's ALK Got to Do With It?

    Dr Sydney Barned, a physician living with lung cancer, explains biomarkers and how identifying her biomarker led to a treatment that has her taking a daily pill that is a targeted therapies for her ALK+ lung cancer.

Treatment Options for ALK-Positive Lung Cancer

ALK-positive lung cancer refers to a specific type of non-small cell lung cancer (NSCLC) that has a mutation in the ALK gene. Fortunately, there are targeted treatments available for patients with ALK-positive lung cancer. These treatments, known as ALK inhibitors, work by specifically targeting and blocking the activity of the abnormal ALK protein, thereby inhibiting the growth and spread of cancer cells. Some commonly used ALK inhibitors include crizotinib, ceritinib, alectinib, brigatinib, and lorlatinib. These targeted therapies have shown promising results in improving outcomes for patients with ALK-positive lung cancer, offering a more personalized and effective treatment approach. It is important for patients to work closely with their healthcare team to determine the most suitable treatment options based on their individual circumstances and genetic profile.

Treatment Options

  • Targeted Therapies

    For ALK-Positive lung cancer, drugs known as “Tyrosine Kinase Inhibitors (TKI)” or “ALK inhibitors” are often very effecitve. These drugs target your ALK+ mutation and stop your cancer from growing and spreading.

  • Immunotherapy (Potentially)

    Immunotherapy is a very effective treatment option that uses the body’s own immune response to fight the cancer without damaging healthy cells.

  • Chemotherapy

    Chemotherapy for lung cancer treatment uses a drug (or a combination of drugs) that employs cell-killing medications (cytotoxic) to attack cancer cells.

  • Radiation Therapy

    Radiation therapy slows or stops tumor growth by damaging the DNA and stops cancer cells from dividing and growing. In many cases, radiation therapy kills all of the cancer cells, thus shrinking or eliminating tumors.

  • Surgery

    If your lung cancer is in an early stage, you may be a candidate for surgery to have the lung cancer completely removed.

FDA-Approved ALK-Positive Treatment Options

Types

  • Brigatinib (Alunbrig)

    Non-small cell lung cancer that is ALK positive and has metastasized (spread to other parts of the body). It is used in adults.

    Approved for: NSCLC

    Biomarkers: ALK

    FDA Approval Date: 07/12/2025

    Used in: Targeted Therapy

  • Ramucirumab (Cyramza)

    Non-small cell lung cancer that has metastasized. It is used:
    With erlotinib hydrochloride as first-line therapy in patients whose disease has certain mutations in the EGFR gene. With docetaxel in patients whose disease has gotten worse during or after treatment with platinum chemotherapy. For patients whose disease has a mutation in the EGFR gene or ALK gene, ramucirumab is used if their disease has gotten worse after treatment with FDA-approved therapy for these mutations.

    Approved for: NSCLC

    Biomarkers: ALK, EGFR

    FDA Approval Date: 07/12/2025

    Used in: Targeted Therapy

  • Alectinib (Alecensa)

    Non-small cell lung cancer that is ALK-positive and has metastasized (spread to other parts of the body).

    FDA approved alectinib (Alecensa) for people with non-small cell lung cancer (NSCLC) who have ALK-positive tumors that can be removed with surgery. Based on the ALINA trial results, the Food and Drug Administration (FDA) approved alectinib as adjuvant therapy for people with ALK-positive NSCLC.

    Approved for: NSCLC

    Biomarkers: ALK

    FDA Approval Date: 09/30/2024

    Used in: Adjuvant Therapy, Targeted Therapy

  • Lorlatinib (Lorbrena)

    Non-small cell lung cancer that is ALK positive and has metastasized (spread to other parts of the body). It is used in patients whose disease got worse after treatment with: Crizotinib and at least one other ALK inhibitor therapy for metastatic disease, or Alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease. In March, 2021 also approved to include frontline treatment for patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

  • Crizotinib (Xalkori)

    Non-small cell lung cancer that is ALK positiveor ROS1 positive and has metastasized (spread to other parts of the body).

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

  • Ceritinib (Zykadia)

    Non-small cell lung cancer that is ALK positive and has metastasized (spread to other parts of the body). It is used in adults.

    Approved for: NSCLC

    Biomarkers: ALK, ROS1

    FDA Approval Date: 11/03/2023

    Used in: Targeted Therapy

Clinical Trials

If you are accepted into a clinical trial, you will be assigned to a treatment group. You will either receive an investigational drug or you will be randomized to receive the investigational drug or the best standard of care. The specifics of the clinical trial depend on whether you are in a first-in-human trial or a later phase trial. (Best standard of care is the best treatment that physicians are offering patients with that cancer.)

In addition, the care that is included in the clinical trial will be covered financially by the trial sponsor, and you may receive a new treatment that might become a best option for you. There may also be additional expenses that might not be covered by the trial sponsor, so please carefully read the Informed Consent agreement. Discuss any concerns with a trial coordinator prior to making your decision.

Antidote Match™ connects people with medical research studies, in the fastest and easiest way possible. All you need to do is answer a few questions, and they will find the right trials for you. You gain access to the latest medical developments and world-class care.

Match to Clinical Trials in 60 Seconds

ClinicalTrials.gov is a database of privately and publicly funded clinical studies conducted around the world.

Find Clinical Trials

ALK Mutations in Lung Cancer

ALK-targeted therapies are rapidly expanding.

“The field has moved very, very quickly the last ten years, so we actually have numerous different ALK targeted therapies, which is great news for patients.” — Dr. Alice Shaw, Massachusetts General Hospital