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Completed

NCT Number: NCT03727477

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Metastatic ALK Gene Rearrangement Positive Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site ROS-1 Gene Rearrangement Positive Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aix-en-Provence - CH, Aix-en-Provence, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progression free survival

    Time frame: 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 outcomes

  1. Best response

    Time frame: October 2015 - December 2019

    best response recorded from the start of treatment until disease progression or start of further anti-cancer treatment

  2. Duration of treatment

    Time frame: October 2015 - December 2019

    time from first dose of treatment to discontinuation of treatment or death from any cause during the study

  3. Pattern of tumor progression

    Time frame: October 2015 - December 2019

    site of disease progression after each line of treatment

  4. Reason for treatment discontinuation

    Time frame: October 2015 - December 2019

    this may be disease progression, toxicity, death, other

  5. Duration of treatment beyond progression

    Time frame: October 2015 - December 2019

    time between first occurrence of disease progression and discontinuation the treatment

  6. Central Nervous System (CNS) best response

    Time frame: 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

  7. Central Nervous System (CNS) Progression free survival

    Time frame: 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

  8. Overall Survival

    Time frame: October 2015 - December 2019

    is defined as the time from the first dose of treatment dose and death from any cause

  9. Adverse Events

    Time frame: October 2015 - December 2019

    complications of lorlatinib therapy will be recorded

Sponsors and collaborators

Lead sponsor

Intergroupe Francophone de Cancerologie Thoracique

Other

Collaborators

  • Pfizer

Registry information

Official study title

Efficacy of Treatment Sequences in Patients With ALK and ROS-1 Positive Non-small Cell Lung Cancer Who Received Lorlatinib as Part of the French Expanded Access Program

Acronym: LORLATU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 1, 2018
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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