NSCLCPhase 4NCT05160922
Crizotinib Continuation Clinical Study
A Phase 4 study testing crizotinib in people with NSCLC and ALCL, run by Pfizer at 13 sites in 5 countries.
Trial summary
The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close. Read more about this study
- Who is it for?
- Ages 0 years and older
- What is being tested?
- crizotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 27 Dec 2021to 21 Mar 2028
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Participants with any of the following characteristics/conditions will be excluded:
- Female participants who are pregnant or breastfeeding.
- Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
China9 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Jilin Cancer Hospital
Changchun, Jilin, 130028
Fujian Province Oncology Hospital
Fuzhou, Fujian, 350014
Sun Yat-Sen University Cancer center
Guangzhou, Guangdong, 510060
The First Affiliated Hospital of Guangzhou Medical University.
Guangzhou, Guangzhou, 510120
The First Affiliated Hospital of College of Medicine,Zhejiang University
Hangzhou, Zhejiang, 310003
Shanghai Chest Hospital
Shanghai, 200030
West China Hospital of Sichuan University
Wuhou District, Sichuan, 610041
Japan1 site
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, 460-0001
Russia1 site
Limited Liability Company "EuroCityClinic"
Saint Petersburg, 197022
About this study
Official title: CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES
The purpose of this continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.
Read the detailed description
Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.
- Being tested
- crizotinib
- Keywords
- crizotinib, Xalkori, Anaplastic Lymphoma Kinase, ALK, ROS1, NSCLC, Non-small Cell Lung Cancer, ALCL, anaplastic large cell lymphoma, IMT, inflammatory myofibroblastic tumour
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lymphoma, Large-Cell, Anaplastic, Granuloma, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crizotinibDrug
Also called XALKORI
crizotinib oral treatment
| Study group | Role | What they receive |
|---|---|---|
| crizotinib | Other | crizotinib oral treatment Receives: Drug: crizotinib |
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 data collection in this study will permit further characterization of the safety profile of crizotinib.
Measured: Baseline up to approximately 5 years
Number of serious adverse events reported for all participants
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
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 posted16 Dec 2021
- Study start27 Dec 2021
- Primary completion21 Mar 2028 (estimated)
- Study completion21 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies 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
- 27 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
- NCT05160922
- Sponsor's protocol ID
- A8081075
- Other IDs
- 2024-511128-15-00
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2021
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRIZOTINIB MASTER PROTOCOL: AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED CRIZOTINIB CLINICAL STUDIES
- ClinicalTrials.gov ID
- NCT05160922
- Acronym / sponsor ID
- A8081075
- Keywords
- crizotinib, Xalkori, Anaplastic Lymphoma Kinase, ALK, ROS1, NSCLC, Non-small Cell Lung Cancer, ALCL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2021 (actual)
- Primary completion
- 21 Mar 2028 (estimated)
- Study completion
- 21 Mar 2028 (estimated)
- First posted
- 16 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 continuation study is to provide continued access to crizotinib treatment for eligible participants from a current Pfizer sponsored crizotinib clinical study that is planned to close.
Detailed description
Participants not previously enrolled or who have discontinued study treatment or safety follow-up in a current Pfizer sponsored crizotinib clinical study are not eligible for participation in this continuation study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| crizotinib | Other | Drug: crizotinibcrizotinib oral treatment |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Female participants who are pregnant or breastfeeding.
- 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 |
|---|---|---|
| crizotinibAlso: XALKORIcrizotinib oral treatment | Drug | crizotinib |
Primary outcome
Number of participants with adverse events leading to permanent discontinuation of study intervention
Time frame: Baseline up to approximately 5 years
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
Number of serious adverse events reported for all participants
Time frame: Baseline up to approximately 5 years
Safety data collection in this study will permit further characterization of the safety profile of crizotinib.
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 30 Mar 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing crizotinib in people with NSCLC and ALCL, run by Pfizer at 13 sites in 5 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 0 inclusion and 3 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in China, Italy, Japan, Russia, Taiwan. 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 30 Mar 2026.