Trial Outcomes & Findings for Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients (NCT NCT04979988)
NCT ID: NCT04979988
Last Updated: 2024-04-05
Results Overview
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.
COMPLETED
51 participants
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
2024-04-05
Participant Flow
Participants with anaplastic lymphoma kinase (ALK) positive (+) non-small cell lung cancer (NSCLC) who started treatment with lorlatinib as the second line (2L) or later line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective chart review study. The study was conducted in Japan.
Data from participants were observed from start of alectinib treatment until 15-Oct-2021 (data cut-off date). Data was collected from medical records and evaluated over approximately 4 months (02-Aug-2021 to 09-Dec-2021) of this retrospective study.
Participant milestones
| Measure |
Lorlatinib 2L
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
22
|
|
Overall Study
COMPLETED
|
29
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.2 Years
STANDARD_DEVIATION 11.5 • n=29 Participants
|
55.6 Years
STANDARD_DEVIATION 14.8 • n=22 Participants
|
55.9 Years
STANDARD_DEVIATION 12.9 • n=51 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=29 Participants
|
15 Participants
n=22 Participants
|
24 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=29 Participants
|
7 Participants
n=22 Participants
|
27 Participants
n=51 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Age at Start of Lorlatinib Treatment
|
57.7 Years
Standard Deviation 11.7
|
58.1 Years
Standard Deviation 14.5
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=21 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=15 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Height at Start of Alectinib Treatment
|
165.44 Centimeter
Standard Deviation 7.16
|
160.40 Centimeter
Standard Deviation 9.23
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=9 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=13 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Height at Start of Lorlatinib Treatment
|
163.16 Centimeter
Standard Deviation 7.51
|
159.01 Centimeter
Standard Deviation 8.81
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=22 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=15 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Weight at Start of Alectinib Treatment
|
60.52 Kilograms
Standard Deviation 16.45
|
58.27 Kilograms
Standard Deviation 11.83
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=12 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=15 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Weight at Start of Lorlatinib Treatment
|
61.92 Kilograms
Standard Deviation 15.05
|
58.19 Kilograms
Standard Deviation 14.19
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=21 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=15 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Body Mass Index (BMI) at Start of Alectinib Treatment
|
22.10 Kilograms per meter square
Standard Deviation 4.72
|
22.55 Kilograms per meter square
Standard Deviation 3.77
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=9 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=13 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
BMI at Start of Lorlatinib Treatment
|
22.93 Kilograms per meter square
Standard Deviation 4.74
|
22.42 Kilograms per meter square
Standard Deviation 4.98
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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".
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
0
|
4 Participants
|
4 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
2
|
5 Participants
|
2 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
1
|
12 Participants
|
8 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
3
|
1 Participants
|
2 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
4
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
5
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
Unknown
|
6 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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".
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
0
|
5 Participants
|
2 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
1
|
14 Participants
|
11 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
2
|
3 Participants
|
2 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
3
|
1 Participants
|
2 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
4
|
0 Participants
|
0 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
5
|
0 Participants
|
0 Participants
|
|
Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
Unknown
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Number of participants according to NSCLC histopathological subtype (adenocarcinoma, squamous cell carcinoma and adenosquamous epithelial carcinoma) were reported in this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to NSCLC Histopathological Subtype
Adenocarcinoma
|
27 Participants
|
21 Participants
|
|
Number of Participants According to NSCLC Histopathological Subtype
Squamous cell carcinoma
|
1 Participants
|
1 Participants
|
|
Number of Participants According to NSCLC Histopathological Subtype
Adenosquamous epithelial carcinoma
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
No
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
Yes
|
28 Participants
|
22 Participants
|
|
Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
Unknown or unconfirmed
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
No
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
Yes
|
29 Participants
|
22 Participants
|
|
Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
Unknown or unconfirmed
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=28 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Bone
|
12 Participants
|
12 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Brain
|
7 Participants
|
7 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Adrenal glands
|
1 Participants
|
1 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Ipsilateral lung
|
9 Participants
|
9 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Contralateral lung
|
5 Participants
|
7 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Lymph node affiliation
|
23 Participants
|
21 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Remote lymph node
|
5 Participants
|
7 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Liver
|
4 Participants
|
6 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Kidney
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
Other
|
11 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Contralateral lung
|
7 Participants
|
5 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Lymph node affiliation
|
23 Participants
|
18 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Remote lymph node
|
5 Participants
|
6 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Liver
|
7 Participants
|
4 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Bone
|
17 Participants
|
14 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Ipsilateral lung
|
11 Participants
|
7 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Brain
|
13 Participants
|
12 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Adrenal glands
|
1 Participants
|
2 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Kidney
|
1 Participants
|
0 Participants
|
|
Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
Other
|
11 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Presence of Previous Medical History
No
|
17 Participants
|
15 Participants
|
|
Number of Participants According to Presence of Previous Medical History
Yes
|
12 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=12 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=7 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Details of Previous Medical History
High blood pressure
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Details of Previous Medical History
Diabetes
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Details of Previous Medical History
Hyperlipidemia
|
0 Participants
|
0 Participants
|
|
Number of Participants According to Details of Previous Medical History
Other
|
12 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Presence of Complications
No
|
17 Participants
|
13 Participants
|
|
Number of Participants According to Presence of Complications
Yes
|
12 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=12 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=9 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Details of Complications
High blood pressure
|
4 Participants
|
2 Participants
|
|
Number of Participants According to Details of Complications
Diabetes
|
4 Participants
|
2 Participants
|
|
Number of Participants According to Details of Complications
Hyperlipidemia
|
7 Participants
|
2 Participants
|
|
Number of Participants According to Details of Complications
Other
|
9 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Smoking History
Former
|
8 Participants
|
6 Participants
|
|
Number of Participants According to Smoking History
Never
|
14 Participants
|
11 Participants
|
|
Number of Participants According to Smoking History
Current
|
7 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=15 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=9 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Brinkman Index Score
|
366.7 (Cigarettes per day)*years
Standard Deviation 271.1
|
262.9 (Cigarettes per day)*years
Standard Deviation 314.1
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result
|
29 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Type of ALK Testing Method
RT-PCR
|
2 Participants
|
4 Participants
|
|
Number of Participants According to Type of ALK Testing Method
IHC
|
21 Participants
|
13 Participants
|
|
Number of Participants According to Type of ALK Testing Method
FISH
|
15 Participants
|
12 Participants
|
|
Number of Participants According to Type of ALK Testing Method
Other
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants for Whom Dates of ALK Test Was Available
|
29 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Prior to initiation of lorlatinib treatment (up to approximately 23.7 months); retrospective data was retrieved and analyzed during 4 months of this observational studyPopulation: FAS: participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in first line setting in a medical record. Only participants with any prior therapy for NSCLC other than alectinib as first line were analysed. All participants in Lorlatinib 2L arm were administered first line treatment of alectinib and did not receive any prior therapy for NSCLC other than alectinib.
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.
Outcome measures
| Measure |
Lorlatinib 2L
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
Other chemotherapy
|
—
|
15 Participants
|
|
Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
ALK-TKI
|
—
|
7 Participants
|
PRIMARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy
|
10.8 Months
Interval 3.9 to 13.8
|
11.5 Months
Interval 2.9 to
Upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
Outcome measures
| Measure |
Lorlatinib 2L
n=20 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=14 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
Progression disease
|
16 Participants
|
9 Participants
|
|
Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
Adverse event
|
3 Participants
|
4 Participants
|
|
Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
Other
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
|
44 Percentage of participants
Interval 24.4 to 65.1
|
23.5 Percentage of participants
Interval 6.8 to 49.9
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=51 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants
|
18.1 Months
Interval 10.5 to 24.2
|
—
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=15 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=7 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Time to Treatment Failure for Subsequent Other Treatment
|
NA Months
Median, upper and lower limits of 95% CI could not be calculated due to insufficient number of participants with events
|
NA Months
Median, upper and lower limits of 95% CI could not be calculated due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Objective Response Rate for Alectinib
|
69.2 Percentage of participants
Interval 48.2 to 85.7
|
94.7 Percentage of participants
Interval 74.0 to 99.9
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective 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
|
NA Months
Interval 27.2 to
Median and upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
55.0 Months
Interval 34.9 to
Upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: 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 studyPopulation: FAS comprised of participants with confirmed ALK+ NSCLC who started treatment with lorlatinib as the second-line or later therapy from 01-May-2019 to 31-Dec-2020 and had confirmed treatment with alectinib in the first line setting in a medical record.
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.
Outcome measures
| Measure |
Lorlatinib 2L
n=29 Participants
Participants with ALK+ NSCLC who started treatment with lorlatinib as the second-line therapy from 01-May-2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
Lorlatinib 3L or Later
n=22 Participants
Participants with ALK positive NSCLC who started treatment with lorlatinib as the third line (3L) or later line therapy from 01-May- 2019 to 31-Dec-2020 in real world clinical practice after failure of alectinib treatment as the first line therapy were observed in this retrospective study.
|
|---|---|---|
|
Time to Last Treatment Failure for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
|
NA Months
Interval 32.2 to
Median and upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
59.7 Months
Interval 35.5 to
Upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
Adverse Events
Lorlatinib 2L
Lorlatinib 3L or Later
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER