Trial · NCT04979988
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
NCT04979988, Completed, Pfizer; results first posted 2024-04-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients. Trials, record NCT04979988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04979988
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
- NCT number
- NCT04979988
- Status
- Completed
- Enrollment
- 51 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- ALK-positive Non-small-cell Lung Cancer
- Interventions
- Lortlatinib
- First posted
- 2021-07-28
- Last updated
- 2024-04-05
- Results first posted
- 2024-04-05
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Age at Start of Lorlatinib Treatment | 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. |
| Primary | Height at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | |
| Primary | Height at Start of Lorlatinib Treatment | 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 | |
| Primary | Weight at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | |
| Primary | Weight at Start of Lorlatinib Treatment | 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 | |
| Primary | Body Mass Index (BMI) at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | |
| Primary | BMI at Start of Lorlatinib Treatment | 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 | |
| Primary | Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment | 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". |
| Primary | Number of Participants According to ECOG PS at Start of Lorlatinib Treatment | 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". |
| Primary | Number of Participants According to NSCLC Histopathological Subtype | 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. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Age at Start of Lorlatinib Treatment | 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 | 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. | Years | MEAN |
| PRIMARY | Height at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | 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. | Centimeter | MEAN |
| PRIMARY | Height at Start of Lorlatinib Treatment | 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 | 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. | Centimeter | MEAN |
| PRIMARY | Weight at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | 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. | Kilograms | MEAN |
| PRIMARY | Weight at Start of Lorlatinib Treatment | 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 | 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. | Kilograms | MEAN |
| PRIMARY | Body Mass Index (BMI) at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | 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. | Kilograms per meter square | MEAN |
| PRIMARY | BMI at Start of Lorlatinib Treatment | 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 | 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. | Kilograms per meter square | MEAN |
| PRIMARY | Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to ECOG PS at Start of Lorlatinib Treatment | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants According to NSCLC Histopathological Subtype | At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Age at Start of Lorlatinib Treatment | Lorlatinib 2L | 57.7 | Standard Deviation 11.7 | Years | |
| Age at Start of Lorlatinib Treatment | Lorlatinib 3L or Later | 58.1 | Standard Deviation 14.5 | Years | |
| Height at Start of Alectinib Treatment | Lorlatinib 2L | 165.44 | Standard Deviation 7.16 | Centimeter | |
| Height at Start of Alectinib Treatment | Lorlatinib 3L or Later | 160.40 | Standard Deviation 9.23 | Centimeter | |
| Height at Start of Lorlatinib Treatment | Lorlatinib 2L | 163.16 | Standard Deviation 7.51 | Centimeter | |
| Height at Start of Lorlatinib Treatment | Lorlatinib 3L or Later | 159.01 | Standard Deviation 8.81 | Centimeter | |
| Weight at Start of Alectinib Treatment | Lorlatinib 2L | 60.52 | Standard Deviation 16.45 | Kilograms | |
| Weight at Start of Alectinib Treatment | Lorlatinib 3L or Later | 58.27 | Standard Deviation 11.83 | Kilograms | |
| Weight at Start of Lorlatinib Treatment | Lorlatinib 2L | 61.92 | Standard Deviation 15.05 | Kilograms | |
| Weight at Start of Lorlatinib Treatment | Lorlatinib 3L or Later | 58.19 | Standard Deviation 14.19 | Kilograms |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lorlatinib 2L | 29 | |
| Overall Study | STARTED | Lorlatinib 3L or Later | 22 | |
| Overall Study | COMPLETED | Lorlatinib 2L | 29 | |
| Overall Study | COMPLETED | Lorlatinib 3L or Later | 22 | |
| Overall Study | NOT COMPLETED | Lorlatinib 2L | 0 | |
| Overall Study | NOT COMPLETED | Lorlatinib 3L or Later | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lorlatinib 2L | 0 | 0 |
| Total, all-cause mortality | Lorlatinib 3L or Later | 0 | 0 |
| Total, other adverse events | Lorlatinib 2L | 0 | 0 |
| Total, other adverse events | Lorlatinib 3L or Later | 0 | 0 |
| Total, serious adverse events | Lorlatinib 2L | 0 | 0 |
| Total, serious adverse events | Lorlatinib 3L or Later | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lorlatinib 2L vs Lorlatinib 3L or Later: Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result | Trial comparisons |
| Lorlatinib 2L vs Lorlatinib 3L or Later: Number of Participants for Whom Dates of ALK Test Was Available | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04979988
GET https://conductscience.org/api/trials/v1/NCT04979988/registered?page=2