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Sintilimab Combined With Anlotinib Therapy for Initially Unresectable Non-small Cell Lung Cancer

NCT05306847 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2022-04-01

No results posted yet for this study

Summary

Concurrent or sequential chemoradiotherapy has been recommended as the standard treatment for locally advanced and unresectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. PD-1/PD-L1 inhibitors have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents have also been used for the first-line treatment of advanced or metastatic NSCLC. Therefore, we designed this single-arm clinical trial, which aims to investigate the safety and feasibility of sintilimab combined with anlotinib therapy for patients with initially unresectable stage II-III NSCLC.

Conditions

  • Carcinoma, Non-Small-Cell Lung

Interventions

DRUG

Sintilimab

Sintilimab will be given intravenously at a dose of 200mg every 21 days.

DRUG

Anlotinib

Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.

Sponsors & Collaborators

  • Xinda Biopharmaceutical Group

    collaborator UNKNOWN

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Chunmei Bai, Professor · Peking union medical colloge 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
2022-04-01
Primary Completion
2024-04-01
Completion
2026-04-01

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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 NCT05306847 on ClinicalTrials.gov