A-Liquid

Phase 2

Completed

• Conditions: SCLC with ALK fusion gene positive by liquid NGS analysis

• Registration Number: JPRN-jRCT2080225060
• Lead Sponsor: Department of Thoracic Oncology, National Cancer Center Hospital East

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Main Inclusion Criteria
-Histologically- or cytologically-confirmed diagnosis of NSCLC.
-Unresectable Stage III without any indications for radiotherapy StageIV or recurrence
-At least one non-irradiated measurable lesions according to RECIST v1.1
-Males and females age >= 20 years on the date of informed consent for study participation
-An ECOG PS score of 0-2
-Has adequate organ functions
-Signed a written consent form after explanation of this study with documents.
-Agree to effective contraception during the study and for at least 90 days after the last dose of alectinib.

Exclusion Criteria

Main exclusion Criteria
-History of ALK inhibitor administration
-History of administration of immune checkpoint inhibitors.
-Any prior treatment including chemotherapy, radiotherapy, and surgery within 2 weeks prior to enrollment
-Has not recovered to grade 1 from acute toxicity of prior treatment
-Symptomatic central nervous system metastasis
- CT-confirmed or a history of interstitial fibrosis, pneumonitis or interstitial lung disease
-Any of Myocardial infarction, severe or unstable angina, heart failure, etc. within 3 months prior to the start of study treatment
-Ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade >= 2, uncontrolled atrial fibrillation of any grade, and QTc > 480 msec
-Pregnancy or breastfeeding
-Patients with a history of hypersensitivity to alectinib or alectinib vehicles

Study & Design

• Study Type: Interventional
• Study Design: Not specified