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

Plain-language summary

This study evaluates the real-world clinical outcomes of Lorlatinib used after Alectinib in Japanese patients with ALK-positive non-small cell lung cancer (NSCLC). Patients with a confirmed ALK gene rearrangement who received Alectinib as first-line therapy and then started Lorlatinib could take part. It was a study without a phase designation and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Pfizer

Intervention

Lortlatinib

Start date

8/2/2021

Estimated completion

12/9/2021

Countries

Japan

Related genes

Locations

• Nagoya, Japan
• Toyoake, Japan
• Yokohama, Japan
• Kurashiki, Japan
• Hirakata, Japan
• Osaka, Japan
• Sakai-shi, Japan
• Sayama, Japan
• Sunto-gun, Japan
• Shimotsuke, Japan
• Bunkyo-ku, Japan
• Iwakuni, Japan
• Ube, Japan
• Koto-ku, Tokyo, Japan
• Tokyo, Japan
• Toyama, Japan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.