RecruitingPhase 1NCT05615142

Safety and Tolerability of Low Dose Radiotherapy Concurrent SBRT and PD-1 Inhibitors in Advanced NSCLC.

Phase I Study of Low Dose Radiotherapy and Concurrent SBRT in Combination With PD-1 Inhibitors in Advanced Non-small Cell Lung Cancer (NSCLC) .


Sponsor

Sichuan University

Enrollment

9 participants

Start Date

Dec 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This pilot phase I trial aims to investigate the safety and tolerability of low dose radiotherapy (LDRT) and concurrent partial stereotactic body radiation therapy (SBRT) in combination with programmed cell death-1 (PD-1) inhibitors in Stage IV non-small cell lung cancer (NSCLC) patients who have failed standard therapy. At least 9 participants will be enrolled in this study. All will take part at West China Hospital, Sichuan University.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two types of radiation — low-dose whole-body radiation plus targeted high-dose radiation (SBRT) — together with an immunotherapy drug (a PD-1 inhibitor) is safe for people with advanced lung cancer that has stopped responding to standard therapy. **You may be eligible if...** - You are 18 or older with stage IV non-small cell lung cancer confirmed by biopsy or lab test - Your cancer has progressed after or is not suitable for standard treatment - You have at least one tumor larger than 5 cm that can be targeted with radiation - Your general health score is 0–2 and your life expectancy is more than 3 months - Your blood counts, liver, and kidney function meet required levels **You may NOT be eligible if...** - Your cancer is still responding to standard treatment - You do not have any measurable tumors on imaging - Your organ function is too poor to tolerate the treatment - You are pregnant or have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONLow Dose Radiotherapy

LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 6 Gy/3f with conventional external beam radiation.

RADIATIONstereotactic body radiation therapy

Partial SBRT at dose escalation levels: 10 Gy/1f, 20 Gy/2f, 30 Gy/3f.

DRUGPD-1 Inhibitors

Patients will receive treatment with PD-1 inhibitor (dose as recommended in the instruction manual) every 3 weeks for a maximum of 48 months.


Locations(1)

West China Hospital, Sichuan University

Chengdu, Sichuan, China

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NCT05615142


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