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

NCT04979988 | Completed Results

• 1 other identifier: B7461038
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 16

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).

Conditions

ALK-positive Non-small-cell Lung Cancer

Keywords

ALK; Lorlatinib; Alectinib; Real World; retrospective

Outcome Measures

Primary Outcomes (25)

• Age at Start of Lorlatinib Treatment

  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.

  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

• 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

• 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

• 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

• 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

• 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

• 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

• Number of Participants According to Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of Alectinib Treatment

  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".

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to ECOG PS at Start of Lorlatinib Treatment

  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".

  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

• Number of Participants According to NSCLC Histopathological Subtype

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

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Presence of Metastases at Start of Alectinib Treatment

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Presence of Metastases 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

• Number of Participants According to Sites of Metastases at Start of Alectinib Treatment

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Sites of Metastases at Start of Lorlatinib Treatment

  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.

  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

• Number of Participants According to Presence of Previous Medical History

  Number of participants with previous medical history related to history of treatment for ALK+ NSCLC were reported in this outcome measure.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Details of Previous Medical History

  Number of participants with previous medical history of high blood pressure, diabetes, hyperlipidemia and other were reported in this outcome measure.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Presence of Complications

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Details of Complications

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Smoking History

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Brinkman Index Score

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants With Anaplastic Lymphoma Kinase (ALK) Test Result

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Type of ALK Testing Method

  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.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants for Whom Dates of ALK Test Was Available

  Number of participants for whom dates of performing ALK test was available was presented in this outcome measure.

  At initiation of alectinib treatment (baseline); retrospective data was retrieved and analyzed during 4 months of this observational study

• Number of Participants According to Treatment Administered for NSCLC Prior to Start of Lorlatinib Treatment

  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.

  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

• Time to Treatment Failure for Lorlatinib as the Second Line Therapy and the Third or Later Line Therapy

  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.

  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 (7)

• Number of Participants According to Reasons for Discontinuation of Each Treatment Line of Therapy for Lorlatinib

  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

• Objective Response Rate for Lorlatinib as the Second Line Therapy and the Third Line or Later Therapy

  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

• Time to Treatment Failure for Alectinib as the First-Line Therapy: Overall Participants

  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

• Time to Treatment Failure for Subsequent Other Treatment

  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

• Objective Response Rate for Alectinib

  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

Study Arms (1)

Japanese patients with ALK+ NSCLC who received lorlatinib

lorlatinib as the second-line or later therapy after failure of alectinib treatment as the firstline therapy

Drug: Lortlatinib

Interventions

Lortlatinib DRUG

as provided in real world practice

Japanese patients with ALK+ NSCLC who received lorlatinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Participating on any clinical trials of which final results has not yet been reported during the study period.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (16)

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, 464-8681, Japan

Location

Fujita Health University Hospital

Toyoake, Aichi-ken, 470-1192, Japan

Location

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Kansai Medical University Hirakata Hospital

Hirakata, Osaka, 573-1191, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakai-shi, Osaka, 591-8555, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Jichi Medical University Hospital

Shimotsuke, Tochigi, 329 0498, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Hospital Organization Iwakuni Clinical Center

Iwakuni, Yamaguchi, 740-8510, Japan

Location

National Hospital Organization, Yamaguchi-Ube Medical Center

Ube, Yamaguchi, 755-0241, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, 135-8550, Japan

Location

National Cancer Center

Tokyo, 104-0045, Japan

Location

Toyama Prefectural Central Hospital

Toyama, 930-8550, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: July 28, 2021
• Study Start: August 2, 2021
• Primary Completion: December 9, 2021
• Study Completion: December 9, 2021
• Last Updated: April 5, 2024
• Results First Posted: April 5, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (16)