Clinical trial NCT04979988: Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Official title: Retrospective, Multicenter, Observational Study to Evaluate Clinical Real World Outcomes of Lorlatinib After Alectinib in ALK-Positive NSCLC Japanese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ALK-positive Non-small-cell Lung Cancer
Keywords: ALK
Lorlatinib
Alectinib
Real World
retrospective
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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).

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.

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.

Primary outcomes:
measure: Age at Start of Lorlatinib Treatment
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 study
measure: Height at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Height at Start of Lorlatinib Treatment
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 study
measure: Weight at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Weight at Start of Lorlatinib Treatment
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 study
measure: Body Mass Index (BMI) at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: BMI at Start of Lorlatinib Treatment
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 study
measure: Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to ECOG PS at Start of Lorlatinib Treatment
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 study
measure: Number of Participants According to NSCLC Histopathological Subtype
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Presence of Metastases at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Presence of Metastases at Start of Lorlatinib Treatment
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 study
measure: Number of Participants According to Sites of Metastases at Start of Alectinib Treatment
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment
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 study
measure: Number of Participants According to Presence of Previous Medical History
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Details of Previous Medical History
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Presence of Complications
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Details of Complications
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Smoking History
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Brinkman Index Score
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Type of ALK Testing Method
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants for Whom Dates of ALK Test Was Available
timeFrame: At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study
measure: Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment
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 study
measure: Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy
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 study
Secondary outcomes:
measure: Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib
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 study
measure: Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
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 study
measure: Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants
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 study
measure: Time to Treatment Failure for Subsequent Other Treatment
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 study
measure: Objective Response Rate for Alectinib
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 study
measure: 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
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 study
measure: Time to Last Treatment Failure for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy
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 study
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital
state: Aichi
city: Toyoake-City
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Sakai-shi
country: Japan
facility: National Hospital Organization Kinki-Chuo Chest Medical Center
state: Osaka-fu
city: Hirakata-city
country: Japan
facility: Kansai Medical University Hirakata Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Iwakuni City
country: Japan
facility: National Hospital Organization Iwakuni Clinical Center
state: Yamaguchi
city: Ube
country: Japan
facility: National Hospital Organization, Yamaguchi-Ube Medical Center
state: Yamaguchi
city: Koto-ku, Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR
city: Tokyo
country: Japan
facility: National Cancer Center
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: