E-Liquid

Phase 2

Completed

• Conditions: on-small cell lung cancer with EGFR mutation positive by ctDNA based NGS analysis

• Registration Number: JPRN-jRCT2080225059
• 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: 91

Inclusion Criteria

Main Inclusion Criteria
-Histologically- or cytologically-confirmed diagnosis of NSCLC.
-Stage III , IV or postoperative recurrence with unresectable and incapable radical radiation therapy.
-Liquid NGS analysis using Guardant360 revealed that the EGFR gene mutation other than the exon 20 insertion mutation (common mutation [exon19 deletion, exon21 L858R point mutation], or uncommon mutation [exon18 G719X point mutation, exon20 S768I point mutation, exon21 L861Q point mutation]). Compound mutations without the exon 20 insertion mutation are also eligible. (Regardless of EGFR gene mutation in histology or cytology)
-one or more 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 sufficient organ functions
-The patient has signed a written consent form after receiving written information about the trial prior to enrollment

Exclusion Criteria

Main exclusion Criteria
-Participating in another trial and receiving treatment
-History of EGFR inhibitor administration
-History of administration of immune checkpoint inhibitors.
-Patient treated chemotherapy for lung cancer (excluding preoperative and postoperative chemotherapy whose administration has been completed at least 6 months prior to enrollment) or chest radiotherapy.
-Has not recovered to grade 1 from acute toxicity of prior treatment
-Symptomatic central nervous system metastasis
-CT-confirmed or a history of interstitial pulmonary fibrosis, pneumonitis or interstitial lung disease
-Patients with poor control or clinically problematic heart disease, such as myocardial infarction, unstable angina, congestive heart failure, congenital long QT syndrome diagnosed at screening.
-It has factors that increase the risk of QTc prolongation or arrhythmia.
-Pregnancy or breastfeeding
-Patients who have been taking drugsthat have a strong inducing effect on CYP3A4, chinese medicine, or herbal supplements for at least 21 days before.
-Patients with a history of hypersensitivity to Osimertinib or Osimertinib vehicles

Study & Design

• Study Type: Interventional
• Study Design: Not specified