Lorlatinib Continuation Study

Phase 4

Active, not recruiting

• Conditions: NSCLC; Non-Small-Cell Lung Cancer
• Interventions: Drug: Lorlatinib

• Registration Number: NCT05144997
• Lead Sponsor: Pfizer

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-22
• Study First Submitted QC: 2021-11-22
• Study First Posted: 2021-12-06
• Study Start: 2021-12-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13
• Primary Completion: 2026-12-28
• Study Completion: 2026-12-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events leading to permanent discontinuation of study intervention	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	Baseline up to approximately 5 years	Safety collection in this study will permit further characterization of the safety profile of lorlatinib

Trial Locations

Locations (30)

Healthcare Global Enterprises; 🇮🇳 Bengaluru, Karnataka, India

Bhakti Vedanta Hospital & Research Institute; 🇮🇳 Thane/Mumbai, Maharashtra, India

UC Irvine Health; 🇺🇸 Orange, California, United States

The First affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

Beijing Chest Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China

General Hospital of Eastern Theater Command; 🇨🇳 Nanjing, Jiangsu, China

Scroll for more (20 remaining)