Lorlatinib Continuation Study

NCT ID: NCT05144997

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-28

Study Completion Date

2026-12-28

Brief Summary

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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

Detailed Description

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Conditions

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Non-Small-Cell Lung Cancer NSCLC

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lorlatinib

Lorlatinib single agent, 100 mg (4 x 25 mg) oral tables, QD, continuously

Group Type EXPERIMENTAL

Lorlatinib

Intervention Type DRUG

ALK-positive NSCL treatment

Interventions

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Lorlatinib

ALK-positive NSCL treatment

Intervention Type DRUG

Other Intervention Names

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PF-06463922

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, United States

Site Status

The First affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

Beijing Chest Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

Hunan Provincial Tumor Hospital

Changsha, Hunan, China

Site Status

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Site Status

Jilin Cancer Hospital

Changchun, Jilin, China

Site Status

The first hospital of jilin university

Changchun, Jilin, China

Site Status

Sir Run Shaw Hospital

Hangzhou, Qiantang District, China

Site Status

The Second Affiliated Hospital of PLA Air Force Medical University

Xi'an, Shaanxi, China

Site Status

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status

Sichuan Cancer hospital

Chengdu, Sichuan, China

Site Status

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of Zhejiang University College of Medicine

Hangzhou, Zhejiang, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

CHU de Rennes - Hôpital Pontchaillou

Rennes, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Healthcare Global Enterprises

Bengaluru, Karnataka, India

Site Status

Bhaktivedanta Hospital & Research Institute

Thāne, Maharashtra, India

Site Status

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status

National University Hospital

Singapore, , Singapore

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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United States China France India Japan Singapore Spain Taiwan

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7461039

To obtain contact information for a study center near you, click here.

Other Identifiers

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B7461039

Identifier Type: -

Identifier Source: org_study_id

2023-508952-21-00

Identifier Type: REGISTRY

Identifier Source: secondary_id