Phase II Study of Local Therapy Combined with Immune Checkpoint Inhibitor for Oligo-Progressive disease during First-line Immunotherapy in non-small cell lung cancer - Reverse OLIGO study

Takahashi Kazuhisa0 个研究点目标入组 60 人开始时间: 2023年2月9日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.The age is 20 and older
•2.Agreement has been obtained from the individual patient.
•3.Histologically confirmed non-small cell lung cancer
•4. No or unknown activating driver mutation: EGFR, ALK, ROS1, BRAF, MET, KRAS, RET
•5.Patients who received first-line platinum-based chemotherapy plus immune checkpoint inhibitors and who had progressive disease
•6.Patients whose response to first-line treatment was confirmed SD/PR/CR according to RECIST ver1.1 criteria
•7.Patients with no history of radiotherapy for progressive lesions
•8.Progressive lesions are 1-3.
•9.The patient must be a suitable candidate for local therapy radiotherapy to every site of progressive disease.
•10.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•11.The functions of the main organs are maintained, and all the criteria stated below are satisfied.
•a) WBC >= 1500/mm3
•b) Neutrophil count >= 1,500 /mm3
•c) Hemoglobin: >=9.0 g/dl
•d) Platelet count: >=100,000/mm3
•e) Both AST and ALT: <=100 IU/L
•f) Total bilirubin: <=1.5 mg/dl
•g) Serum creatinine: <=1.5 mg/dl
•h) SpO2: >=92% in the state of no oxygen inhalation (room climate)

•1.Patients with progression exclusively to brain metastases
•2.Patients with progression of malignant pleural effusion, pericardial effusion, ascites, pleural dissemination, meningeal dissemination, or peritoneal dissemination
•3.Patients with progression of carcinomatous lymphangiosis
•4.Patients with history of another primary malignancy
•5.Patients with active infection requiring systemic therapy.
•6.Patients with active hepatitis B or C.
•7.Pregnant women, lactating women, and women who may be currently pregnant
•8.Patients with psychiatric comorbidities resulting in clinical problems
•9.Active autoimmune disease that has required systemic treatment
•10.Patients with poorly controlled diabetes
•11.Patients with symptomatic congestive heart failure, unstable angina pectoris, or history of myocardial infarction within 1 year prior to enrollment
•12.Patients with interstitial lung disease
•13.Patients chronically receiving steroids (PSL 10 mg/day or more) or systemic immunosuppressive drugs.
•14.Patients with a history of serious hypersensitivity reactions to other monoclonal antibodies
•15.Patients with hypersensitivity to the drug to be administered
•16.Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results.

发起方

Takahashi Kazuhisa