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Real-World check: does lorlatinib work for ALK lung cancer?

NCT ID NCT06487078

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how effective and safe the drug lorlatinib is for people with a specific type of lung cancer (ALK-positive non-small cell lung cancer) who have not had treatment before. Researchers will follow 90 patients in French clinics to see how long they live without the cancer getting worse and track any side effects. The goal is to understand how well the drug works in real-world settings, not just in controlled trials.

What this could mean

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

Active substance
Lorlatinib
What this could lead to
If successful, this could confirm that lorlatinib is effective and safe for untreated ALK-positive lung cancer patients in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also small (90 patients) and only in France, so findings may not apply to everyone.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Nov 2028

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.

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: Participants are eligible to be included in the study only if all the following criteria apply: * Patients (male or female) 18 years of age or older at age inclusion * Patients with histologically or cytologically confirmed diagnosis of locally advanced or metastatic (TNM 8th classification) ALK-positive NSCLC (IHC 3+/FISH positive/transcriptomic method) * Complete radiological evaluation has to be performed before the start of lorlatinib by contrast enhanced CT-scan of thorax and upper abdomen and brain MRI, as per routine care * Patients with ECOG performance status grade 0, 1, or 2 Exclusion Criteria: Participants are excluded from the study if any of the following criteria Apply * Evidence of active malignancy within the last 2 years prior to inclusion (other than NSCLC, non-melanoma skin cancer, cervical in situ cancer, papillary thyroid cancer, lobular carcinoma in situ/ductal carcinoma in situ (LCIS/DCIS) of the breast, or localized prostate cancer). * Patients who have previously received adjuvant ALK TKI therapy (unless metastatic relapse occurs more than one year after completion of adjuvant therapy). * Patients who have previously received systemic NSCLC therapy in metastatic condition. * Patients using any of the following food or drugs within 12 days prior to the first dose of lorlatinib: * known strong CYP3A inhibitors * known strong CYP3A inducers * known P gp substrates with a narrow therapeutic index * Patients with any medical or psychiatric condition, or that may, in the investigator's judgment, increase the risk of study participation or make the participant inappropriate for the study. * Positive pregnancy test for females of childbearing potential. * Breastfeeding and childbearing potential female unwilling/unable to use a highly effective contraception method for the study duration and for at least 35 days after the last dose of lorlatinib * Fertile male patients unwilling/unable to use a highly effective method of contraception for the duration of the study and for at least 97 days after the last dose of lorlatinib. * Patients participating in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. * Patients deprived of their liberty, under protective custody or guardianship or unable to provide signed consent. * Patients not affiliated to the French social security system. * Patients opposed to the collection of their data. * Patients willing and able to comply with the protocol for the duration of the study including undergoing treatment, scheduled visits and examinations including follow-up. * Patients judged inapt to respond to the questions required for the study due to linguistical, psychological, social, or geographical reasons. * Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

ALK+ non-small-cell lung carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    31 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH ALBI

    RECRUITING

    Albi, 81000, France

  • CHBA

    RECRUITING

    Vannes, 56017, France

  • CHIC

    RECRUITING

    Créteil, 94010, France

  • CHRU Bretonneau

    RECRUITING

    Tours, 37000, France

  • CHRU de Nancy

    NOT_YET_RECRUITING

    Nancy, 54035, France

  • CHU Nantes

    RECRUITING

    Nantes, 44093, France

  • Centre Hospitalier Francois Mitterand

    RECRUITING

    Pau, 64046, France

  • Centre Hospitalier du Pays d AIX

    RECRUITING

    Aix-en-Provence, 13100, France

  • Centre Leon Berard

    NOT_YET_RECRUITING

    Lyon, 69373, France

  • Ch Annecy Genevois

    RECRUITING

    Pringy, 74374, France

  • Ch Avignon

    NOT_YET_RECRUITING

    Avignon, 84000, France

  • Ch Cornouaille

    RECRUITING

    Quimper, 29107, France

  • Ch Troyes

    RECRUITING

    Troyes, 10003, France

  • Chits Ch Sainte Musse

    NOT_YET_RECRUITING

    Toulon, 83000, France

  • Chu Amiens Sud

    RECRUITING

    Amiens, 80000, France

  • Chu Limoges

    RECRUITING

    Limoges, 87042, France

  • Clcc Georges Francois Leclerc

    RECRUITING

    Dijon, 21000, France

  • Clinique Teissier

    RECRUITING

    Valenciennes, 59300, France

  • Hopital Cochin

    NOT_YET_RECRUITING

    Paris, 75014, France

  • Hopital Europeen Georges Pompidou

    RECRUITING

    Paris, 75908, France

  • Hopital Foch

    RECRUITING

    Suresnes, 92151, France

  • Hopital Morvan

    NOT_YET_RECRUITING

    Brest, 29000, France

  • Hopital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Hopital Robert Schuman de Vantoux

    RECRUITING

    Metz, 57070, France

  • Hopital Saint Joseph

    RECRUITING

    Paris, 75674, France

  • Hopital de Rangueil

    RECRUITING

    TSA 50032 Toulouse, 31059, France

  • Hopital de Villefranche Sur Saone

    NOT_YET_RECRUITING

    Gleizé, 69400, France

  • Institut Bergonie

    NOT_YET_RECRUITING

    Bordeaux, 33076, France

  • Institut Curie

    RECRUITING

    Paris, Paris, 75005, France

  • Institut Godinot

    RECRUITING

    Reims, 51056, France

  • Polyclinique Bordeaux Nord Aquitaine

    NOT_YET_RECRUITING

    Bordeaux, 30072, France

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