NCT05520853

SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC

An Open, Single-arm, Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. During the period, the overall response rate and toxicities were regularly evaluated.

Conditions

• Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC

Interventions

Type	Name	Description
RADIATION	SBRT combined with PD-1 inhibitors and thoracic hyperthermia	At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression.

Timeline

• Start date: 2020-01-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2022-08-30
• Last updated: 2022-08-30

Locations

1 site across 1 country: China