Efficacy of Treatment Sequences in Patients With Non-small Cell Lung Cancer Receiving Lorlatinib

Completed

• Conditions: ALK Gene Rearrangement Positive; ROS-1 Gene Rearrangement Positive; Non-small Cell Lung Cancer Metastatic

• Registration Number: NCT03727477
• Lead Sponsor: Intergroupe Francophone de Cancerologie Thoracique

Brief Summary

The study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib as part of the French expanded access program.

Detailed Description

IFCT-1803 LORLATU study will evaluate progression-free survival, overall survival, best response and duration of treatment in patients with advanced ALK- and ROS1-positive non-small cell lung cancer who received lorlatinib (PF-06463922) as part of the French expanded access program. Those outcomes will be correlated to clinical, pathological, and radiological characteristics of patients.

Study Timeline

• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-10-30
• Study First Posted: 2018-11-01
• Study Start: 2019-02-01
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 291

Inclusion Criteria

• Patients with histologically or cytologically confirmed locally advanced or metastatic NSCLC (Stage IIIB or IV accordingly to American Joint Committee on Cancer [AJCC] classification) at time of lorlatinib initiation
• Patients who received at least one week of treatment with lorlatinib as part of the French Expanded Access Program (ATU program); ATU was granted due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.

Exclusion Criteria

• Patients enrolled in a lorlatinib clinical trial

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival	October 2015 - December 2019	time from first dose of treatment to first occurrence of disease progression or death from any cause during the study

Secondary Outcome Measures

Name	Time	Method
Duration of treatment	October 2015 - December 2019	time from first dose of treatment to discontinuation of treatment or death from any cause during the study
Best response	October 2015 - December 2019	best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment
Duration of treatment beyond progression	October 2015 - December 2019	time between first occurrence of disease progression and discontinuation the treatment
Overall Survival	October 2015 - December 2019	is defined as the time from the first dose of treatment dose and death from any cause
Pattern of tumor progression	October 2015 - December 2019	site of disease progression after each line of treatment
Central Nervous System (CNS) best response	October 2015 - December 2019	in patients with CNS measurable lesion, best response on CNS locations recorded from the start of treatment until disease progression or start of further anti-cancer treatment
Adverse Events	October 2015 - December 2019	complications of lorlatinib therapy will be recorded
Reason for treatment discontinuation	October 2015 - December 2019	this may be disease progression, toxicity, death, other
Central Nervous System (CNS) Progression free survival	October 2015 - December 2019	time from first dose of treatment to first occurrence of disease progression in the CNS or death from any cause during the study

Trial Locations

Locations (30)

Paris - Curie; 🇫🇷 Paris, France

Saint-Etienne - CHU; 🇫🇷 Saint-Étienne, France

Paris - Tenon; 🇫🇷 Paris, France

Créteil - CHI; 🇫🇷 Créteil, France

Angers - CHU; 🇫🇷 Angers, France

Aix-en-Provence - CH; 🇫🇷 Aix-en-Provence, France

Clermont-Ferrand - CHU; 🇫🇷 Clermont-Ferrand, France

Valenciennes - Clinique; 🇫🇷 Valenciennes, France

Annemasse - CH; 🇫🇷 Annemasse, France

Avignon - CH; 🇫🇷 Avignon, France

Bordeaux - Polyclinique; 🇫🇷 Bordeaux, France

Brest - Morvan CHU; 🇫🇷 Brest, France

Chartres-CH; 🇫🇷 Chartres, France

Cahors - CH; 🇫🇷 Cahors, France

Colmar - CH; 🇫🇷 Colmar, France

La Roche-Sur-Yon - CH; 🇫🇷 La Roche-sur-Yon, France

Libourne - CH; 🇫🇷 Libourne, France

Lorient - CHBS; 🇫🇷 Lorient, France

Lyon - CRLCC; 🇫🇷 Lyon, France

Marseille - CRLCC; 🇫🇷 Marseille, France

Mulhouse - GHRMSA; 🇫🇷 Mulhouse, France

Montpellier - ICM; 🇫🇷 Montpellier, France

Paris - Saint-Louis; 🇫🇷 Paris, France

Lyon - URCOT; 🇫🇷 Pierre-Bénite, France

Reims - CHU; 🇫🇷 Reims, France

Tours - CHU; 🇫🇷 Tours, France

Saint-Nazaire - Clinique Mutualiste de l'Estuaire; 🇫🇷 Saint-Nazaire, France

Toulouse - CHU; 🇫🇷 Toulouse, France

Vandoeuvre-lès-Nancy - CRLCC; 🇫🇷 Vandoeuvre-lès-Nancy, France

Villejuif - Gustave Roussy; 🇫🇷 Villejuif, France