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

Phase 2

Recruiting

• Conditions: on-small cell lung cancer; Oligo-Progressive disease

• Registration Number: JPRN-jRCTs031220630
• Lead Sponsor: Takahashi Kazuhisa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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)

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
safety, overall survival, proportion of local therapy completion, proportion of transition to maintenance therapy, form of progressive disease, response rate