Non-Small Cell Lung Carcinoma
Conditions
Keywords
ALK, TKI, Lorlatinib, RWE
Brief summary
The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled. This study is seeking participants who: * have lung cancer that could not be controlled. * have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work. * have received at least 1 treatment before. All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
Detailed description
Non-small cell lung cancer (NSCLC; 80-85% of all lung cancers) remains the most common cause of cancer-related mortality globally, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor molecular alterations, including the echinoderm microtubule-associated protein like 4 (EML4)-anaplastic lymphoma kinase (ALK) translocation. For ALK-positive NSCLC patients, crizotinib, ceritinib, alectinib, and brigatinib, are the first- and second-generation tyrosine kinase inhibitors (TKIs). Although the benefit of them has been demonstrated in series of pivotal clinical trials, most patients who initially derive the benefit latterly develop resistance due to secondary mutations. Lorlatinib, a third-generation inhibitor, is a TKI of ALK and Receptor Tyrosine Kinase C-Ros Oncogene I (ROS-1). It is also a potent TKI that is effectively against known resistant mutants that mediate resistance to first- and second-generation ALK-TKIs. Despite the efficacy and safety data derived from the pivotal phase I/II clinical trial, there are limited data describing the use of lorlatinib and its outcomes in real-world practice settings outside the highly controlled environs of clinical trials. The objective of this study is therefore to evaluate real-world systemic treatment patterns, clinical outcome, therapeutic effect, safety profile of Lorlatinib in advanced NSCLC patients, and also factors associated with clinical outcome in those Lorlatinib treated patients.
Interventions
DRUGLorlatinib
ALK/ROS1 tyrosine kinase inhibitor
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 20 years old * Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019, * Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Patient treated Lorlatinib other than CUP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment | Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days | Number of participants according to first line therapy treatment pattern was reported in this outcome measure. |
| Objective Response Rate (ORR) During Lorlatinib Treatment | From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | ORR was defined as the percentage of participants in whom complete response (CR), or partial response (PR) was observed. According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: 1) CR is defined as disappearance of all target lesions or partial response (PR) defined as \>=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD . |
| Overall Survival | From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | Overall survival was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. Overall survival was evaluated using Kaplan-Meier method. |
| Progression Free Survival (PFS) For Lorlatinib Treatment | From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | PFS refers to the duration from the first study treatment of Lorlatinib to the first documentation of disease progression or death or censored date. According to RECIST, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. PFS was evaluated using the Kaplan-Meier method. |
| 1-year OS Rate on Lorlatinib | 1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days | OS was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. In this outcome measure percentage of participants who survived for 1 year are reported. |
| Time to Treatment Failure (TTF) for All NSCLC Treatment | From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | TTF was defined as duration of first dose of any NSCLC treatment to treatment failure (defined as any discontinuation, including cancer progression, adverse events, or death). |
| TTF for Lorlatinib Treatment Failure | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death). |
| Number of Participants With Common Adverse Drug Reaction (ADRs) | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash \& itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy, thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness and pneumonitis. Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. |
| Duration of Common ADRs | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash \& itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy and others (thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness, pneumonitis). Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. Duration of common ADR is reported in this outcome measure. |
| Number of Participants According to Severity of Common ADRs | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Number of participants with Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Unknown were presented in this outcome measure. Severity grades were assessed upon investigator's discretion, wherein grade 1 was minimum severity and grade 4 was maximum severity. |
| Number of Participants According to Type of Outcome of Common ADRs | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Participants were categorized as per their ADRs outcome as: recovered, recovered with sequelae (Sequelae refer to any complication or condition that results from a pre-existing illness, injury, or medical intervention), recovering, not recovered, and unknown. |
Countries
Taiwan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Participant flow
Recruitment details
Participants who were treated with Lorlatinib for advanced non-small cell lung cancer (NSCLC), progressed on first- or second- generation tyrosine kinase inhibitor (TKI) and who had participated in Lorlatinib compassionate use program (CUP) were observed in this study at the physician's discretion.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.9 Years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 73 |
| other Total, other adverse events | 41 / 73 |
| serious Total, serious adverse events | 0 / 73 |
Outcome results
None listed