WJOG11118

Phase 2

• Conditions: ung Cancer

• Registration Number: JPRN-jRCTs041200046
• Lead Sponsor: Hirotsugu Kenmotsu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:
1.The age is within 20-75 years.
2.Histologically confirmed non-small cell lung cancer
3.No or unknown activating driver mutation: epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), proto-oncogene receptor tyrosine kinase (ROS1), mesenchymal epithelial transition receptor (MET)
4.Patients who have not received prior systemic chemotherapy
5.Synchronous oligo-metastatic stage IV disease: maximum of three distant metastases*
*The metastatic lesions will be counted as follows: each lesion will individually be counted as one, and intrathoracic lymph node involvement (defined here as hilar, mediastinal, or supraclavicular nodes, N1-N3) will collectively be counted as one.
6.The patient must be a suitable candidate for local therapy (radiotherapy and/or surgery) to every site of disease, as determined by a multidisciplinary tumor board (including specialists in thoracic oncology, radiology, radiotherapy and thoracic surgery).
7.No malignant ascites, leptomeningeal carcinomatosis and malignant pleural effusion Primary
8.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
9.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.History of another primary malignancy within 5 years.
2.Active infection requiring therapy.
3.Active Hepatitis B or C.
4.Active autoimmune disease that has required systemic treatment
5.Unsuitable for thoracic radiotherapy by interstitial lung disease or chronic obstructive lung disease
6.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