ALK-positive Non-small-cell Lung CancerNCT04979988
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
An observational study of ALK-positive Non-small-cell Lung Cancer, run by Pfizer at 16 sites in Japan.
Trial summary
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- ALK-positive Non-small-cell Lung Cancer
- What is being tested?
- Lortlatinib
- How many people
- 51 participants
- Where
- 16 sitesJapan
- Study dates
- 2 Aug 2021to 9 Dec 2021
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ALK-positive lung cancer diagnosed and confirmed in the medical record as receiving alectinib in the 1st line and lorlatinib in the 2nd line or later between May 2019 and December 2020.
Who may be able to join
- Histologically or cytologically confirmed NSCLC, with any tumor, node and metastasis (TNM) stage.
- Confirmed ALK gene rearrangement by any validated test.
- Confirmed the treatment with alectinib in the first line setting as systemic therapy in the medical record.
- Confirmed the start treatment with lorlatinib as the second/later-line therapy from 1st May 2019 to 31st December 2020.
Who cannot join
- -Participating on any clinical trials of which final results has not yet been reported during the study period.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Kansai Medical University Hirakata Hospital
Hirakata, Osaka, 573-1191
National Hospital Organization Iwakuni Clinical Center
Iwakuni, Yamaguchi, 740-8510
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, 464-8681
Osaka International Cancer Institute
Osaka, Osaka, 541-8567
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai-shi, Osaka, 591-8555
Kinki University Hospital
Sayama, Osaka, 589-8511
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329 0498
Shizuoka Cancer Center
Sunto-gun, Shizuoka, 411-8777
National Cancer Center
Tokyo, 104-0045
Toyama Prefectural Central Hospital
Toyama, 930-8550
Fujita Health University Hospital
Toyoake, Aichi-ken, 470-1192
National Hospital Organization, Yamaguchi-Ube Medical Center
Ube, Yamaguchi, 755-0241
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515
About this study
Official title: Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
To evaluate the clinical real world outcomes of lorlatinib in second/later line setting anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) to TKI sequence sequence treatment after failure of alectinib as a first-line treatment in Japanese ALK positive non-small cell lung cancer (NSCLC).
Read the detailed description
This study is a post-approval, company-sponsored, observational study. This study is a multicenter, non-interventional, retrospective, chart review of patients with ALK+ NSCLC patients treated using lorlatinib as the second/later line therapy in Japan after failure of alectinib treatment as the first line therapy from 20 November 2018.
All decisions regarding clinical management and treatment of the participating patients were made by an investigator as part of standard care in real-world clinical setting and were not contingent upon the patient's participation in the study. Data will be collected if available per study site. Patients in this study are those who started treatment with lorlatinib from 1 May 2019 to 31 December, 2020 in clinical practice.
- Conditions
- ALK-positive Non-small-cell Lung Cancer
- Being tested
- Lortlatinib
- Keywords
- ALK, Lorlatinib, Alectinib, Real World, retrospective
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LortlatinibDrug
as provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Japanese patients with ALK+ NSCLC who received lorlatinib | lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy Receives: Drug: Lortlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at Start of Lorlatinib Treatment
Age at start of lorlatinib treatment was entered based on the data in medical chart. If there were no details about the applicable age, the age was calculated from the date of birth to the start date of lorlatinib treatment.
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Height at Start of Alectinib Treatment
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Height at Start of Lorlatinib Treatment
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Weight at Start of Alectinib Treatment
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Weight at Start of Lorlatinib Treatment
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Body Mass Index (BMI) at Start of Alectinib Treatment
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
BMI at Start of Lorlatinib Treatment
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category "Unknown".
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
ECOG PS is used to measure quality of life of participants with grades ranging from 0 to 5; where Grade 0: fully active; Grade 1: restricted in physically strenuous activity but ambulatory; Grade 2: ambulatory and capable of all self-care but unable to carry out any work activities; Grade 3: capable of only limited self-care; Grade 4: completely disabled and Grade 5: dead. Higher scores indicated worsening of quality of life. Number of participants according to ECOG PS were presented. Participants whose ECOG PS was not known were reported under category "Unknown".
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to NSCLC Histopathological Subtype
Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Number of participants according to sites of metastasis at start of alectinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Number of participants according to sites of metastases at start of lorlatinib treatment were presented in this outcome measure. One participant could have more than one site of metastases.
Measured: At initiation of lorlatinib treatment, anytime between 01-May-2019 to 31-Dec-2020 (approximately 20 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Presence of Previous Medical History
Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Details of Previous Medical History
Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Presence of Complications
Complication was defined as a disease or disorder arising as a consequence of another disease. Number of participants according to presence of complications were reported in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Details of Complications
Number of participants who developed complications such as high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure. One participant may have more than one complication.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Smoking History
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Brinkman Index Score
The Brinkman index (BI) is a measure of cigarette smoke exposure and is used as a predictor of chronic obstructive pulmonary disease (COPD) in smokers. It is calculated as the number of cigarettes smoked per day multiplied by the number of years of smoking. The scores ranged from 20 to 1050, where higher scores indicated higher cigarette smoke exposure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result
ALK test was used to detect specific rearrangements in the ALK gene in cancer cells and tissue. Number of participants with ALK test result were reported in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Type of ALK Testing Method
Number of participants according to the type of ALK testing methods including immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), reverse transcription polymerase chain reaction (RT-PCR) and other methods were presented in this outcome measure. One participant may have more than one type of ALK testing method.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants for Whom Dates of ALK Test Was Available
Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.
Measured: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
Number of participants according to treatment administered (Anaplastic Lymphoma Kinase- Tyrosine Kinase Inhibitor [ALK-TKI] including brigatinib, ceritinib and crizotinib or Other chemotherapy]) for NSCLC prior to start of lorlatinib treatment were presented in this outcome measure.
Measured: Prior to initiation of lorlatinib treatment (up to approximately 23.7 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy
Time to treatment failure (TTF) was the time from the first date of lorlatinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. Disease progression (PD) was defined in a method that complied with Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study
Secondary outcomes (7)
Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study
Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
Objective response rate was defined as the percentage of participants with best overall response (BOR) of either complete response (CR) or partial response (PR) according to RECIST version 1.1 from first date lorlatinib treatment until date of treatment discontinuation. CR: disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, target and non-target must have short axis measures <10 mm. PR: >=30% decrease in sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.
Measured: From the date of initiation of lorlatinib treatment to the date of treatment discontinuation, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this observational study
Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants
Time to treatment failure was the time from the first date of alectinib treatment to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
Measured: From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation or study end (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study
Time to Treatment Failure for Subsequent Other Treatment
Time to treatment failure was the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation including disease progression, treatment toxicity and death. If participants continued treatment, TTF was censored at the available last date of treatment or the study end period. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement. TTF was analyzed using Kaplan-Meier method.
Measured: From the date of initiation of subsequent other treatment to the date of any-cause treatment discontinuation or study end (maximum of 22.9 months of subsequent other treatment); retrospective data was retrieved and analyzed during 4 months of this study
Objective Response Rate for Alectinib
Objective response rate was defined as the percentage of participants with BOR of either CR or PR according to RECIST version 1.1 from the first date of alectinib until the date of treatment discontinuation. CR = disappearance of target and non-target lesions, with exception of nodal disease and normalization of tumor markers. All nodes, both target and non-target must have short axis measures <10 mm. PR = at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined in a method that complied with RECIST version 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgement.
Measured: From the date of initiation of alectinib treatment to the date of any-cause treatment discontinuation (maximum of 61.8 months of alectinib treatment); retrospective data was retrieved and analyzed during 4 months of this observational study
Combined Time to Treatment Failure of the Sum of Alectinib and Subsequent Therapy Including TTF of Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
Combined TTF is defined as sum of the time from the first date of alectinib to the date of any-cause alectinib discontinuation, the time from the first date of lorlatinib to the date of lorlatinib discontinuation and the time from the first date of the other subsequent treatment to the date of other subsequent treatment discontinuation. If participants continued treatment, combined TTF was censored at the available last date of treatment or the study end period. Combined TTF was analyzed using Kaplan-Meier method.
Measured: From date of initiation of alectinib treatment until date of treatment discontinuation or study end, from Sep-2014 until 15-Oct-2021 (up to approximately 85 months); retrospective data was retrieved and analyzed during 4 months of this study
Time to Last Treatment Failure for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
Time to last treatment failure (TLTF) is the time from the first date of lorlatinib to the date of any-cause treatment discontinuation including disease progression, treatment toxicity and death in the last treatment. If participants continued treatment, TLTF was censored at the available last date of treatment or the study end period. PD was defined as >= 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, sum must also demonstrate an absolute increase of at least 5 mm and appearance of one or more new lesions. TLTF was analyzed using Kaplan-Meier method.
Measured: From the date of initiation of lorlatinib treatment to the date of any-cause treatment discontinuation or study end, from 01-May-2019 to 15-Oct-2021 (approximately 30 months); retrospective data was retrieved and analyzed during 4 months of this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start2 Aug 2021
- Primary completion9 Dec 2021
- Study completion9 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ALK-positive Non-small-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979988
- Sponsor's protocol ID
- B7461038
- Status last verified
- Oct 2023
- First submitted
- 19 Jul 2021
- Last updated
- 5 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.