A randomized phase II study of consolidative radiotherapy for residual lesions during osimertinib monotherapy in patients with non-small cell lung cancer harbouring EGFR mutation (ORIHALCON trial/WJOG13920L) - ORIHALCON trial/WJOG13920

Kenmotsu Hirotsugu0 sites76 target enrollmentDecember 27, 2022

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Kenmotsu Hirotsugu
Enrollment: 76
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 27, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Kenmotsu Hirotsugu

Eligibility Criteria

Inclusion Criteria

•1\) Patients are at least 18 years of age at the time consent is obtained.
•2\) Written consent has been obtained from the patient himself/herself after a thorough explanation of the study details has been provided prior to enrollment in the study.
•3\) Patients with histologically or cytologically diagnosed non\-small cell lung cancer.
•4\) Patients with a diagnosis of clinical stage IVA/IVB or postoperative recurrence.
•5\) Patients with a confirmed EGFR susceptibility gene mutation (exon19 deletion or exon21 L858R) in a tissue or cytology specimen (any method of measurement is acceptable as long as the method is approved by insurance in Japan). In addition to the above mutations, patients with concomitant EGFR uncommon mutations are also acceptable. However, the coexistence of exon19 deletion and exon21 L858R is ineligible.
•6\) Patients who have received osimertinib monotherapy as initial therapy and have confirmed PR or SD (evaluated according to RECIST ver. 1\.1\). Confirmation of best response is not required. However, SD must be confirmed by efficacy assessment at least 6 weeks after the baseline assessment).
•7\) Patients receiving osimertinib at 80 mg/day or 40 mg/day daily (dose reduction to every other day or less is not allowed).
•8\) Patients who have received osimertinib monotherapy for at least 90 days but not more than 120 days at the time of enrollment after initiation of first\-line osimertinib monotherapy.
•9\) Perioperative chemotherapy in patients with postoperative recurrence is acceptable for enrollment even if perioperative chemotherapy is administered without EGFR\-TKI.
•10\) Patients with residual disease at the time of enrollment based on the following definitions, with a total of 3 or fewer residual lesions.

Exclusion Criteria

•1\) Patients with active overlapping cancers.
•2\) Patients with poorly controlled malignant pleural, pericardial, or ascites effusions.
•3\) Patients with symptomatic brain metastases.
•4\) Patients with local infections or active systemic infections requiring treatment.
•5\) Patients with active hepatitis B, active hepatitis C with treatment or active human immunodeficiency virus (HIV) infection.
•6\) Males who are unwilling to use contraception. 6\) Pregnant or lactating women, women who have had a positive pregnancy test or who are unwilling to use contraception.
•7\) Patients with clinically problematic psychiatric disorders that would preclude enrollment in the study.
•8\) Patients with interstitial lung disease, drug\-induced interstitial lung disease, idiopathic pulmonary fibrosis, history of radiation pneumonitis requiring steroid therapy, or active periodic interstitial lung disease.
•9\) Patients with refractory nausea and vomiting, chronic gastrointestinal disease, dysphagia of preparations, total gastrectomy, or a history of significant bowel resection that would preclude adequate absorption of osimertinib.
•10\) Patients with heart failure, hypokalemia, congenital QT prolongation syndrome, a family history of QT prolongation syndrome, or a family history of unexplained sudden death in the first degree (parent and child) at age less than 40 years, known to prolong the QT interval and induce torsades de pointes (TdP) Cases in which concomitant medications are used.