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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05584267
Other study ID # RENO
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 25, 2022
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Hunan Province Tumor Hospital
Contact Yongchang C Zhang, MD
Phone +8613873123436
Email zhangyongchang@csu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective multicenter clinical study. This study aims to construct an auxiliary decision-making system for lung cancer immunotherapy combined with radiotherapy by fusing three modes of imagomics, clinicopathological features, and molecular pathological features.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 31, 2026
Est. primary completion date November 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years of age on day of signing informed consent - Histopathology confirmed non-small cell lung cancer - Asymptomatic brain metastases - EGFR/ALK ROS1 driver gene mutation negative - RECIST 1.1 based available assessment of lesions - ECOG 0-1 - Brain metastases 1-4 - Single lesion =4cm Exclusion Criteria: - Patients with contraindication of chemotherapy Pregnant or breast feeding women

Study Design


Intervention

Radiation:
radiotherapy
Different cohorts received different doses of radiotherapy
Drug:
Chemotherapy + immunotherapy
Chemotherapy + immunotherapy

Locations

Country Name City State
China Hunan Cancer Hospital Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Hunan Province Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intracranial progression-free survival assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI up to 2 years from enrollment
Primary sPFS assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI up to 2 years from enrollment
Secondary Objective Response rate assessed according to the Response Evaluation Criteria in Solid Tumors RECIST Version 1.1, undergoing enhanced CT/MRI up to 2 years from enrollment
Secondary overall survival the time from enrollment until death or the last follow-up up to 2 years from enrollment
Secondary number of participants with treatment-related adverse events number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 2 years from enrollment
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