Please note that this summary only contains information from the full scientific abstract: View ESMO Scientific Abstract

Safety of lorlatinib in people with advanced non-small cell lung cancer

Date of summary: September 2019

Study number: NCT01970865


Study start date: January 2014


Estimated study end date: August 2020


The full title of this abstract is: Safety of lorlatinib in subgroups of patients from a phase 1/2 trial

This study drug is not approved to treat the conditions under study that are discussed in this summary. Lorlatinib is approved for ALK-positive NSCLC but not ROS1-positive NSCLC.


Researchers must look at the results of many types of studies to understand whether a study drug works, how it works, and whether it is safe to prescribe to patients.

This summary reports the results of only one study. The results of this study might be different from the results of other studies that the researchers look at.


This summary reports the interim results from the study – results may not be the same when the study is complete.


More information can be found in the scientific
abstract of this study, which you can access here:
View ESMO Scientific Abstract

What did this study look at?

  • Non-small cell lung cancer (NSCLC for short) is the most common type of lung cancer.
  • Some people with NSCLC have cancer cells with a faulty gene called anaplastic lymphoma kinase (ALK for short). This type of cancer is known as ALK-positive NSCLC.
    • ALK-positive NSCLC cells make an altered version of the ALK enzyme that is constantly active. This enzyme causes cancer cells to grow.
  • Lorlatinib is an ALK tyrosine kinase inhibitor (TKI for short).
    • Lorlatinib may stop cancer cells from growing by blocking the actions of proteins such as ALK.
  • Another gene that can be faulty in NSCLC is called ROS1.
    • People with this type of cancer have ROS1-positive NSCLC.
    • This is similar to ALK-positive NSCLC but not identical.
  • Lorlatinib is approved for people with advanced ALK-positive NSCLC whose cancer has spread to other parts of the body. These people have cancer that has spread despite previous treatment with an ALK TKI.
    • At this time, lorlatinib is not approved for people with ROS1-positive NSCLC.
  • There are diferent types of ALK TKIs.
    • Older treatments are known as 1st- or 2nd-generation ALK TKIs.
    • Lorlatinib is a newer treatment, known as a 3rd-generation ALK.
  • This study looked at lorlatinib in people with NSCLC whose cancer had got worse.
    • Some of these people had previously been treated with a 1st- or 2nd-generation ALK TKI or a ROS1 TKI.
  • This summary describes the medical problems that people in this study had.

Who took part in this study?

What were the results of the study?

  • Almost everyone experienced at least one medical problem.
  • People older than 65 were more likely to experience medical problems than people younger than 65.
  • Men and women experienced similar medical problems.
  • In general, non-Asian people had more medical problems than Asian people.

More results from this study can be found here:
View ESMO Scientific Abstract

What were the main conclusions reported by the researchers?

  • In this study, the rates of medical problems with lorlatinib were similar between men and women, but some medical problems were higher in people who were 65 years or older compared with younger people.
  • In general, medical problems were less common in Asian people than in non-Asian people.
    • However, more people from an Asian background had increased levels of a type of fat called triglycerides in the blood.

Who sponsored this study?

Pfizer Inc.
235 East 42nd Street NY,
NY 10017
Phone (United States): +1 212-733-2323

Pfizer would like to thank all of the people who took part in this study.

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