Lorlatinib Continuation Study

Last updated: November 11, 2024
Sponsor: Pfizer
Overall Status: Active - Not Recruiting

Phase

4

Condition

Non-small Cell Lung Cancer

Treatment

Lorlatinib

Clinical Study ID

NCT05144997
B7461039
2021-005569-42
2023-508952-21-00
  • Ages > 18
  • All Genders

Study 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. Additional follow-up safety data collection will permit further characterization of the safety profile of lorlatinib in participants continuing to receive study intervention

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 74
Treatment Group(s): 1
Primary Treatment: Lorlatinib
Phase: 4
Study Start date:
December 28, 2021
Estimated Completion Date:
December 28, 2026

Connect with a study center

  • The First affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230022
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410006
    China

    Site Not Available

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu 210002
    China

    Site Not Available

  • Jilin Cancer Hospital

    Changchun, Jilin 130000
    China

    Site Not Available

  • The first hospital of jilin university

    Changchun City, Jilin 130021
    China

    Site Not Available

  • Sir Run Shaw Hospital

    Hangzhou, Qiantang District 310016
    China

    Site Not Available

  • The Second Affiliated Hospital of PLA Air Force Medical University

    Xi'an City, Shaanxi 710038
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Site Not Available

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University College of Medicine

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310022
    China

    Site Not Available

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149
    China

    Site Not Available

  • University Cancer Hospital

    Beijing, 100000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, 35033
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif Cedex, 94805
    France

    Site Not Available

  • Healthcare Global Enterprises

    Bengaluru, Karnataka 560027
    India

    Site Not Available

  • Bhaktivedanta Hospital & Research Institute

    Thane, Maharashtra 401107
    India

    Site Not Available

  • Bhakti Vedanta Hospital & Research Institute

    Thane/Mumbai, Maharashtra 401107
    India

    Site Not Available

  • Aichi Cancer Center Hospital

    Nagoya, Aichi 464-8681
    Japan

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • National University Hospital

    Singapore, 119074
    Singapore

    Site Not Available

  • Hospital Vall D´Hebron

    Barcelona, Cataluña 08035
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • UC Irvine Health

    Orange, California 92868-3201
    United States

    Site Not Available

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