CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 9 target
Drug / intervention
PD-1 Inhibitors +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05615142
NCT05615142Phase 1ActiveUpdate OverdueCompletion was 26mo ago
Enrollment Stalled
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Phase I Study of Low Dose Radiotherapy and Concurrent SBRT in Combination With PD-1 Inhibitors in Advanced Non-small Cell Lung Cancer (NSCLC) .

Sichuan University·interventional·Posted Nov 14, 2022·Updated May 11, 2026

In Brief

A Phase 1 clinical trial evaluating Low Dose Radiotherapy, stereotactic body radiation therapy, and 1 other intervention for NSCLC and 3 related conditions. Active but no longer recruiting, targeting 9 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNSCLC, Low Dose Radiotherapy, Stereotactic Body Radiotherapy, PD-1 Inhibitor
CountriesChina
Collaborators--

Timeline

Phase 1Active
202220232024202520262027
First PostedNov 14, 2022
Enrollment StartDec 15, 2021
Primary CompletionApr 30, 2024
Study CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 2.4 yearsPosted 3.6 years ago

Interventions

Low Dose Radiotherapyradiation

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

stereotactic body radiation therapyradiation

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

PD-1 Inhibitorsdrug

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