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Real-World data reveals how lung cancer drug lorlatinib performs outside the lab

NCT ID NCT07567352

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looks at how patients with ALK-positive advanced non-small cell lung cancer respond to the drug lorlatinib when used as their first treatment in real-world settings. Researchers will analyze data from 200 patients in a U.S. database to see how long they stay on the drug, any dose changes, and their overall health status. The goal is to understand how well the medicine works outside of strict clinical trial conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lorlatinib (Lorbrena)
What this could lead to
If successful, this study could show how well lorlatinib works outside of clinical trials, helping doctors make better treatment decisions for ALK-positive lung cancer.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by patient differences. It does not test a new treatment or prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

May 2026

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population are patients with advanced/metastatic non-small cell lung cancer in Flatiron Health's Advanced NSCLC Panoramic dataset.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Positive for ALK rearrangement * 18 years or older at advanced/metastatic NSCLC diagnosis date * Initiated 1L lorlatinib in the metastatic/advanced setting between 3 March 2021 and latest data cutoff available Exclusion Criteria: * Missing ALK rearrangement status * Use of alectinib in the adjuvant setting * Use of lorlatinib in a clinical trial setting

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Pfizer

    New York, New York, 10001, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.