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SinTilimab After Radiation (STAR Study)

NCT04167657 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is a single-arm multi-center phase II clinical study, which aims to investigate the efficacy and safety of sintilimab after radiotherapy in patients with advanced NSCLC who failed first-line or second-line systemic treatment.

Conditions

  • Carcinoma, Non-Small Cell Lung

Interventions

DRUG

Sintilimab

Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 24 months. Before enrollment, patient should undergo radiation no less than dose 30Gy( 6 Gy × 5, or other ), or the planned dose could reach 30 Gy. Sintilimab shall be started no later than 3 weeks after radiation. Radiotherapy can be performed on the same day as sintilimab.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Mengzhao Wang, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2023-11-30
Completion
2024-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04167657 on ClinicalTrials.gov