NCT04979988

Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients

Completed Results posted Last updated 5 April 2024

What this trial tests

trial testing Lortlatinib in ALK-positive Non-small-cell Lung Cancer in 51 participants. Completed in 9 December 2021.

Timeline

2 August 2021

Primary endpoint
9 December 2021

9 December 2021

Quick facts

Lead sponsor	Pfizer
Status	Completed
Study type	OBSERVATIONAL
Enrollment	51
Start date	2 August 2021
Primary completion	9 December 2021
Estimated completion	9 December 2021
Sites	16 locations across Japan

Drugs / interventions tested

• Lortlatinib — full drug profile →

Conditions studied

• ALK-positive Non-small-cell Lung Cancer — all drugs for ALK-positive Non-small-cell Lung Cancer →

Sponsor

Pfizer — full company profile →

Who can join

20 and older, any sex, with ALK-positive Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Age at Start of Lorlatinib Treatment Primary · 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

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.

Group	Value	95% CI
Lorlatinib 2L	57.7	± 11.7
Lorlatinib 3L or Later	58.1	± 14.5

Height at Start of Alectinib Treatment Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Group	Value	95% CI
Lorlatinib 2L	165.44	± 7.16
Lorlatinib 3L or Later	160.40	± 9.23

Height at Start of Lorlatinib Treatment Primary · 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

Group	Value	95% CI
Lorlatinib 2L	163.16	± 7.51
Lorlatinib 3L or Later	159.01	± 8.81

Weight at Start of Alectinib Treatment Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Group	Value	95% CI
Lorlatinib 2L	60.52	± 16.45
Lorlatinib 3L or Later	58.27	± 11.83

Weight at Start of Lorlatinib Treatment Primary · 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

Group	Value	95% CI
Lorlatinib 2L	61.92	± 15.05
Lorlatinib 3L or Later	58.19	± 14.19

Body Mass Index (BMI) at Start of Alectinib Treatment Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Group	Value	95% CI
Lorlatinib 2L	22.10	± 4.72
Lorlatinib 3L or Later	22.55	± 3.77

BMI at Start of Lorlatinib Treatment Primary · 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

Group	Value	95% CI
Lorlatinib 2L	22.93	± 4.74
Lorlatinib 3L or Later	22.42	± 4.98

Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

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".

Group	Value	95% CI
Lorlatinib 2L	4
Lorlatinib 3L or Later	4
Lorlatinib 2L	12
Lorlatinib 3L or Later	8
Lorlatinib 2L	5
Lorlatinib 3L or Later	2
Lorlatinib 2L	1
Lorlatinib 3L or Later	2

Number of Participants According to ECOG PS at Start of Lorlatinib Treatment Primary · 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

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".

Group	Value	95% CI
Lorlatinib 2L	5
Lorlatinib 3L or Later	2
Lorlatinib 2L	14
Lorlatinib 3L or Later	11
Lorlatinib 2L	3
Lorlatinib 3L or Later	2
Lorlatinib 2L	1
Lorlatinib 3L or Later	2

Number of Participants According to NSCLC Histopathological Subtype Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.

Group	Value	95% CI
Lorlatinib 2L	27
Lorlatinib 3L or Later	21
Lorlatinib 2L	1
Lorlatinib 3L or Later	1
Lorlatinib 2L	1
Lorlatinib 3L or Later	0

Number of Participants According to Presence of Metastases at Start of Alectinib Treatment Primary · At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

Group	Value	95% CI
Lorlatinib 2L	0
Lorlatinib 3L or Later	0
Lorlatinib 2L	28
Lorlatinib 3L or Later	22
Lorlatinib 2L	1
Lorlatinib 3L or Later	0

Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment Primary · 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

Group	Value	95% CI
Lorlatinib 2L	0
Lorlatinib 3L or Later	0
Lorlatinib 2L	29
Lorlatinib 3L or Later	22
Lorlatinib 2L	0
Lorlatinib 3L or Later	0

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Retrospective, Multicenter, Observational Study to Evaluate Clinical Outcomes of Lorlatinib After Alectinib in Patients With <i>ALK</i>-Positive NSCLC in Japan.
   Goto Y, Kenmotsu H, Tamiya M, Murakami S, et al · · 2023 · cited 5× · PMID 37250506 · DOI 10.1016/j.jtocrr.2023.100508