NSCLC with ALK fusion gene positive by liquid NGS analysis
Conditions
Interventions
investigational material(s)
Generic name etc : RO5424802
INN of investigational material : Alectinib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigationa
Sponsors
Department of Thoracic Oncology, National Cancer Center Hospital East
CHUGAI PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy The objective response rate (ORR) assessed by the Independent Radiology Review (IRR). ORR will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety -ORR by investigator assessment -Duration of response (DoR) -Disease control rate (DCR) -Progression free survival (PFS) -Overall survival (OS) -The efficacy stratified according to mutation status in tissue -Adverse events (AEs), type/frequency/severity of all laboratory abnormalities, and causal relationship with the study drug -Intracranial ORR (iORR) in patients with measurable central nervous system (CNS) metastases -Intracranial DoR (iDoR) in patients with measurable central nervous system (CNS) metastases As for safety assessment, the incidence of AEs occurring during protocol treatment will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | — |
Countries
Japan
Outcome results
None listed