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Lung cancer drug lorlatinib gets extended safety check in ongoing study

NCT ID NCT05144997

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 2 times

Summary

This study offers continued access to the drug lorlatinib for people with a specific type of lung cancer (ALK-positive or ROS1-positive non-small cell lung cancer) who are already benefiting from it in earlier Pfizer studies. The main goal is to track long-term safety and side effects. About 76 participants will take the drug and be monitored over time.

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 study will confirm that long-term lorlatinib use is safe and continues to control ALK/ROS1-positive non-small cell lung cancer.
What could go wrong
This is a small, single-arm continuation study, not a new treatment test. It cannot prove lorlatinib works better than other options, and side effects may still occur.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

76 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Dec 2026

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: 1 - Any participant who is receiving study treatment and deriving clinical benefit (as determined by the Principal Investigator) in a Pfizer-sponsored Lorlatinib Parent Study. 2- Participants must agree to follow the reproductive criteria. 3- Adequate Bone Marrow, Liver, Renal, Pancreatic Function Exclusion Criteria: 1 - Female participants who are pregnant or breastfeeding. 2- Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

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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.

Non-small cell lung cancer NSCLC

Contacts and locations

Locations

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681, Japan

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Chest Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100000, China

  • Bhaktivedanta Hospital & Research Institute

    Thane, Maharashtra, 401107, India

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033, France

  • Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, 210002, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080, China

  • Healthcare Global Enterprises

    Bengaluru, Karnataka, 560027, India

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hunan Provincial Tumor Hospital

    Changsha, Hunan, 410013, China

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Jilin Cancer Hospital

    Changchun, Jilin, 130000, China

  • National Cancer Centre Singapore

    Singapore, 168583, Singapore

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • National University Hospital

    Singapore, 119074, Singapore

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030, China

  • Sichuan Cancer hospital

    Chengdu, Sichuan, 610041, China

  • Sir Run Shaw Hospital

    Hangzhou, Qiantang District, 310016, China

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The Second Affiliated Hospital of PLA Air Force Medical University

    Xi'an, Shaanxi, 710038, China

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The first hospital of jilin university

    Changchun, Jilin, 130021, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

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