Immune Treatment of Brain Metastasis of Lung Cancer Combined With Large-segmentation Precision Radiotherapy

Hunan Province Tumor Hospital

Status and phase: Enrolling; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Chemotherapy + immunotherapy; Radiation: radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05584267

RENO

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

140 participants in 3 patient groups

cohort A

Active Comparator group

Description:

Chemotherapy + immunotherapy; Every three weeks, up to four cycles of chemotherapy

Treatment:

Drug: Chemotherapy + immunotherapy

cohort B

Experimental group

Description:

Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; WBRT, 3 Gy/ time, 10 times in total

Treatment:

Radiation: radiotherapy

Drug: Chemotherapy + immunotherapy

cohort C

Experimental group

Description:

Chemotherapy + immunotherapy; Once every three weeks, up to 4 cycles of chemotherapy; HFRT, 10 Gy/ time, 3 times in total

Treatment:

Radiation: radiotherapy

Drug: Chemotherapy + immunotherapy