NCT04790409

Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations

Department of Medical Oncology, Zhejiang Cancer Hospital

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	sintilimab and anlotinib	This study was a one-arm, open-label, phase II study of PD-1 monoclonal antibody combined with ilotinib in the treatment of advanced EGFR rare-mutant non-small cell lung cancer (NSCLC). 21 patients enrolled in the study who underwent platinum-containing systemic chemotherapy and EGFR-TKI failure were enrolled in the study.

Timeline

• Start date: 2019-08-01
• Primary completion: 2023-09-13
• Completion: 2023-09-13
• First posted: 2021-03-10
• Last updated: 2023-09-14

Locations

1 site across 1 country: China