CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
Sintilimab +2 moredrug
Likely dose
Sintilimab 200mgfrom 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/NCT03812549
NCT03812549Phase 1Completed
CompareCT.gov

Multi-center Phase I Study of Sintilimab in Combination With Radiotherapy in Treatment Naive PD-L1 Positive Stage IV Non-small Cell Lung Cancer (NSCLC)

Sichuan University·interventional·Posted Jan 23, 2019·Updated Mar 4, 2025

In Brief

A Phase 1 clinical trial evaluating Sintilimab, stereotactic body radiation therapy, and 1 other intervention for Stage IV NSCLC. Completed, enrolled 29 participants across 1 site.

Detailed Summary

This pilot phase I trial aims to investigate the safety and tolerability of anti-programmed cell death-1 (PD-1) monoclonal antibody Sintilimab (also called IBI308) in combination with concurrent stereotactic body radiation therapy (SBRT) and low dose radiotherapy (LDRT) in treating patients with stage IV non-small cell lung cancer (NSCLC). At least 29 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--
ConditionsStage IV NSCLC
CountriesChina
CollaboratorsInnovent Biologics (Suzhou) Co. Ltd.

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 23, 2019
Enrollment StartJan 18, 2019
Primary CompletionJan 31, 2022
Study CompletionJul 8, 2022
TodayJul 1, 2026
Enrollment to primary: 3.0 yearsPosted 7.4 years ago

Interventions

Sintilimabdrug

Patients will receive treatment with Sintilimab 200mg every 3 weeks for a maximum of 24 months.

stereotactic body radiation therapyradiation

Radiation treatment utilized in this trial consists of SBRT with a standard doses to 30 Gy/3f

Low Dose Radiotherapyradiation

LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 10 Gy/5f with conventional external beam radiation.