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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508952-21-00 | Registry Identifier | CTIS (EU) |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorlatinib | Experimental | Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | ALK-positive NSCL treatment |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Baseline up to approximately 5 years |
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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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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center and Ambulatory Care | Irvine | California | 92612 | United States | ||
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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| The First affiliated Hospital of Anhui Medical University |
| Hefei |
| Anhui |
| 230022 |
| China |
| Beijing Chest Hospital, Capital Medical University | Beijing | Beijing Municipality | 100000 | China |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | 350014 | China |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| Hunan Provincial Tumor Hospital | Changsha | Hunan | 410013 | China |
| General Hospital of Eastern Theater Command | Nanjing | Jiangsu | 210002 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 130000 | China |
| The first hospital of jilin university | Changchun | Jilin | 130021 | China |
| Sir Run Shaw Hospital | Hangzhou | Qiantang District | 310016 | China |
| The Second Affiliated Hospital of PLA Air Force Medical University | Xi'an | Shaanxi | 710038 | China |
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| Sichuan Cancer hospital | Chengdu | Sichuan | 610041 | China |
| The First Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
| The Second Affiliated Hospital of Zhejiang University College of Medicine | Hangzhou | Zhejiang | 310052 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| CHU de Rennes - Hôpital Pontchaillou | Rennes | 35033 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Healthcare Global Enterprises | Bengaluru | Karnataka | 560027 | India |
| Bhaktivedanta Hospital & Research Institute | Thane | Maharashtra | 401107 | India |
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | 464-8681 | Japan |
| National University Hospital | Singapore | 119074 | Singapore |
| National Cancer Centre Singapore | Singapore | 168583 | Singapore |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |