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RECRUITING
NCT06313541
PHASE2

Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized controlled clinical trial to explore the preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive treatment of advanced NSCLC

Official title: A Multicenter, Randomized Controlled Clinical Trial of Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

146

Start Date

2024-04-10

Completion Date

2025-12-31

Last Updated

2024-06-05

Healthy Volunteers

No

Conditions

Interventions

RADIATION

SBRT or LDRT

Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1 inhibitor combined with chemotherapy (different parts of the lesion could be irradiated separately, but it was required to be completed within 1 week); (2) SBRT: patients received first-line immunotherapy combined with chemotherapy, and their response was evaluated every 6 weeks. Individualized SBRT was planned based on the treatment responses.

DRUG

PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

The control group received standard PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy as first-line treatment, and the experimental group received extra treatment response adapted hybrid radiotherapy.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China