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

Response to 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: Intracranial and extracranial efficacy of lorlatinib in the post second-generation ALK tyrosine kinase inhibitor (TKI) setting

This study drug is approved to treat the condition under study that is discussed in this summary.


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.
  • Lorlatinib is approved for people with advanced ALK-positive NSCLC whose cancer has already spread to other parts of the body. These people have cancer that has spread despite previous treatment with an ALK TKI.
    • Lorlatinib is a newer treatment, known as a 3rd-generation ALK TKI, which can reach cancer cells that have spread to the brain.
  • This study looked at lorlatinib in people with NSCLC whose cancer had spread despite treatment with 2nd-generation ALK TKIs.
  • This summary describes the responses to treatment of people whose cancer had spread to the brain and to other parts of the body outside the brain.

Who took part in this study?

  • In total, 139 people took part in this study.
  • These people:
    • had advanced ALK-positive NSCLC, and
    • had already taken one or more 2nd-generation ALK TKIs to treat their cancer

What were the results of the study?

  • Overall, around 4 in 10 people had tumors that shrank significantly.
  • Tumors shrank in the brain as well as the rest of the body.
  • People’s responses to lorlatinib treatment lasted around 7 months and people survived for around 7 months without their cancer getting worse.
  • There were no differences in the time until people’s cancer got worse between treatment with lorlatinib and treatment with the previous 2nd-generation ALK TKI.

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, lorlatinib caused tumors to shrink in some people with advanced ALK-positive NSCLC.
    • These people had taken at least one previous 2nd-generation ALK TKI.
  • Lorlatinib caused tumors to shrink in both the brain and the rest of the body.
  • The length of time before patients’ cancer spread after taking lorlatinib was similar to the time after they took a previous 2nd generation ALK TKI.
    • This was despite the fact that their cancer was worse than it was earlier in their treatment.

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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