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Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations

Lung Cancer Clinical Trial

Official title:
Department of Medical Oncology, Zhejiang Cancer Hospital

Clinical Trial Summary

This study was a single-arm, open-label, phase II study of PD-1 monoclonal antibody combined with anlotinib in the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR uncommon mutations. Twenty-one patients of NSCLC harboring rare EGFR mutations after previous treatments, including a platinum-based regimen and a targeted treatment (regardless of EGFR Ex20ins), were enrolled. Patients received sintilimab (anti-PD-1) combined with anlotinib (multi-target anti-angiogenesis). The primary endpoint was the objective response rate (ORR) based on RECIST 1.1. Secondary goals included progression-free survival (PFS), overall survival (OS), disease control rate (DCR) based on RECIST 1.1; safety Sex and tolerance. Exploratory objectives include the use of tumor tissue and plasma specimens to detect biomarkers predicting the efficacy of sidilimumab: including but not limited to tumor mutation burden (TMB), PD-L1 expression, etc.; exploring potential predictions in peripheral blood. Biomarkers for anti-group efficacy, including but not limited to TCR.

Clinical Trial Description

This clinical trial (NCT04790409) entitled " Sintilimab Combined with Anlotinib in Advanced NSCLC with EGFR Uncommon Mutations" has been approved by the Ethics Committee of Zhejiang Cancer Hospital in June 12, 2019 (IRB-2019-81). Meanwhile, we registered our project information on the ClinicalTrials.gov PRS in June, 2019 and obtained the status of "approved". In this study, the first patient received treatment on August 26, 2019. However, due to inexperience and misunderstanding, we wrongly missed the next stage of "released" in PRS. Until we realize our mistakes, the initial release time can only be on 02/18/2021. Therefore, we amend the initial release time here. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04790409
Study type Interventional
Source Zhejiang Cancer Hospital
Contact
Status Completed
Phase Phase 2
Start date August 1, 2019
Completion date September 13, 2023
View Details
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