Non-Small-Cell Lung CancerPhase 4NCT05144997
Lorlatinib Continuation Study
A Phase 4 study testing Lorlatinib in people with Non-Small-Cell Lung Cancer and NSCLC, run by Pfizer at 27 sites in 8 countries.
Trial summary
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Cancer, NSCLC
- What is being tested?
- Lorlatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 27 sitesin 8 countries
- Study dates
- 28 Dec 2021to 25 Oct 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
27 sites in 8 countries.
27 sites in 8 countries
China17 sites
Beijing Chest Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130000
The first hospital of jilin university
Changchun, Jilin, 130021
Hunan Provincial Tumor Hospital
Changsha, Hunan, 410013
Sichuan Cancer hospital
Chengdu, Sichuan, 610041
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Sir Run Shaw Hospital
Hangzhou, Qiantang District, 310016
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
The Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310052
The First affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Fudan University Shanghai Cancer Center
Shanghai, 200032
The Second Affiliated Hospital of PLA Air Force Medical University
Xi'an, Shaanxi, 710038
France2 sites
CHU de Rennes - Hôpital Pontchaillou
Rennes, 35033
Institut Gustave Roussy
Villejuif, 94805
India2 sites
Healthcare Global Enterprises
Bengaluru, Karnataka, 560027
Bhaktivedanta Hospital & Research Institute
Thane, Maharashtra, 401107
Singapore2 sites
National University Hospital
Singapore, 119074
National Cancer Centre Singapore
Singapore, 168583
United States1 site
Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, 92612
About this study
Official title: LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
- Conditions
- Non-Small-Cell Lung Cancer, NSCLC
- Being tested
- Lorlatinib
- Keywords
- ALK, anaplastic lymphoma kinase
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
Also called PF-06463922
ALK-positive NSCL treatment
| Study group | Role | What they receive |
|---|---|---|
| Lorlatinib | Experimental | Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events leading to permanent discontinuation of study intervention
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Measured: Baseline up to approximately 5 years
Number of serious adverse events reported for all participants
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Measured: Baseline up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start28 Dec 2021
- Primary completion25 Oct 2029 (estimated)
- Study completion25 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144997
- Sponsor's protocol ID
- B7461039
- Other IDs
- 2023-508952-21-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LORLATINIB (PF-06463922) CONTINUATION PROTOCOL: AN OPEN-LABEL, SINGLE-ARM CONTINUATION STUDY FOR PARTICIPANTS WITH ALK-POSITIVE OR ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) CONTINUING FROM PFIZER SPONSORED LORLATINIB CLINICAL STUDIES
- ClinicalTrials.gov ID
- NCT05144997
- Acronym / sponsor ID
- B7461039
- Conditions
- Non-Small-Cell Lung Cancer, NSCLC
- Keywords
- ALK, anaplastic lymphoma kinase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 76 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 25 Oct 2029 (estimated)
- Study completion
- 25 Oct 2029 (estimated)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to provide continued treatment access and safety follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer sponsored lorlatinib parent studies that will be closed. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lorlatinib | Experimental | Drug: LorlatinibLorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LorlatinibAlso: PF-06463922ALK-positive NSCL treatment | Drug | Lorlatinib |
Primary outcome
Number of participants with adverse events leading to permanent discontinuation of study intervention
Time frame: Baseline up to approximately 5 years
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Number of serious adverse events reported for all participants
Time frame: Baseline up to approximately 5 years
Safety collection in this study will permit further characterization of the safety profile of lorlatinib
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Non-Small-Cell Lung Cancer
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
RecruitingPhase 3
Testing the Impact of an Anti-Cancer Drug, Atezolizumab, After Surgery to Prevent Early Stage Non-small Cell Lung Cancer From Returning, AASI-NSCLC Trial
Lung Non-Small Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lorlatinib in people with Non-Small-Cell Lung Cancer and NSCLC, run by Pfizer at 27 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in China, France, India, Singapore, United States and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events leading to permanent discontinuation of study intervention (time frame: Baseline up to approximately 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.