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Sintilimab Combined With Anlotinib in Advanced NSCLC With EGFR Uncommon Mutations

NCT04790409 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2023-09-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Yun Fan · Zhejiang Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2023-09-13
Completion
2023-09-13

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT04790409 on ClinicalTrials.gov