N/A
N=51
Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
ALK-positive Non-small-cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04979988 ↗Enrolled (actual)
51
Serious AEs
—
Results posted
Apr 2024
Primary outcome: Primary: Age at Start of Lorlatinib Treatment — 57.7; 58.1 Years
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Lortlatinib (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age at Start of Lorlatinib Treatment |
57.7; 58.1 | — |
| PRIMARY Height at Start of Alectinib Treatment |
165.44; 160.40 | — |
| PRIMARY Height at Start of Lorlatinib Treatment |
163.16; 159.01 | — |
| PRIMARY Weight at Start of Alectinib Treatment |
60.52; 58.27 | — |
| PRIMARY Weight at Start of Lorlatinib Treatment |
61.92; 58.19 | — |
| PRIMARY Body Mass Index (BMI) at Start of Alectinib Treatment |
22.10; 22.55 | — |
| PRIMARY BMI at Start of Lorlatinib Treatment |
22.93; 22.42 | — |
| PRIMARY Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment |
4; 4; 12; 8; 5; 2 | — |
| PRIMARY Number of Participants According to ECOG PS at Start of Lorlatinib Treatment |
5; 2; 14; 11; 3; 2 | — |
| PRIMARY Number of Participants According to NSCLC Histopathological Subtype |
27; 21; 1; 1; 1; 0 | — |
| PRIMARY Number of Participants According to Presence of Metastases at Start of Alectinib Treatment |
0; 0; 28; 22; 1; 0 | — |
| PRIMARY Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment |
0; 0; 29; 22; 0; 0 | — |
| PRIMARY Number of Participants According to Sites of Metastases at Start of Alectinib Treatment |
9; 9; 5; 7; 23; 21 | — |
| PRIMARY Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment |
11; 7; 7; 5; 23; 18 | — |
| PRIMARY Number of Participants According to Presence of Previous Medical History |
17; 15; 12; 7 | — |
| PRIMARY Number of Participants According to Details of Previous Medical History |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants According to Presence of Complications |
17; 13; 12; 9 | — |
| PRIMARY Number of Participants According to Details of Complications |
4; 2; 4; 2; 7; 2 | — |
| PRIMARY Number of Participants According to Smoking History |
7; 5; 8; 6; 14; 11 | — |
| PRIMARY Brinkman Index Score |
366.7; 262.9 | — |
| PRIMARY Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result |
29; 22 | — |
| PRIMARY Number of Participants According to Type of ALK Testing Method |
21; 13; 15; 12; 2; 4 | — |
| PRIMARY Number of Participants for Whom Dates of ALK Test Was Available |
29; 22 | — |
| PRIMARY Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment |
7; 15 | — |
| PRIMARY Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy |
10.8; 11.5 | — |
| SECONDARY Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib |
16; 9; 3; 4; 1; 1 | — |
| SECONDARY Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy |
44; 23.5 | — |
| SECONDARY Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants |
18.1 | — |
| SECONDARY Time to Treatment Failure for Subsequent Other Treatment |
NA; NA | — |
| SECONDARY Objective Response Rate for Alectinib |
69.2; 94.7 | — |
| SECONDARY 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; 55.0 | — |
| SECONDARY Time to Last Treatment Failure for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy |
NA; 59.7 | — |
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
-Participating on any clinical trials of which final results has not yet been reported during the study period.
Data sourced from ClinicalTrials.gov (NCT04979988). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.