NCT04486287

Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer

Phase II Study of PD-1 Inhibitor With Sintilimab After Stereotactic Ablation Brachytherapy for Refractory Oligometastatic Non-Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Tianjin Medical University Second Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study aim to investigator the efficacy and safety of sintilimab after Stereotactic Ablation Brachytherapy(SABT) for refractory oligometastatic non-small cell lung cancer(NSCLC), who had failed second-line systemic therapy.

Detailed description

This study is a single-arm phase II study of sintilimab after SABT for refractory oligometastatic NSCLC, who had failed second-line systemic therapy.In this study, 44 patients with oligometastatic NSCLC were treated with sintilimab after SABT every 3 weeks until disease progression and intolerance. Toxicity, withdrawal of informed consent, death or other cessation of treatment as prescribed by the program, whichever occurs first. The primary end point was the ORR based on RECIS 1.1, which was evaluated by the Independent Imaging Review Board (IRRC). An interim analysis will be conducted during the course of the study. The results and reports will be provided to the Independent Data Audit Committee (IDMC), which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance. Make recommendations to the sponsor. Prior to the interim analysis, the IDMC charter will be finalized and approved by IDMC and the sponsor. The responsibilities and related procedures of IDMC members will be defined in the IDMC charter.

Conditions

• Oligometastasis
• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months. Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-09-01
• Completion: 2023-09-01
• First posted: 2020-07-24
• Last updated: 2020-07-24