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Cadonilimab in Patients (Pts) With Advanced Non-small Cell Lung Cancer (NSCLC)

NCT05816499 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-06-17

No results posted yet for this study

Summary

This phase Ib/II trial studies how well cadonilimab combined with anlotinib and docetaxel work in treating patients with non-small cell lung cancer that is stage IV or has come back. Cadonilimab, a PD-1/CTLA-4 bispecific antibody, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Anlotinib can regulate tumor microenvironment. Docetaxel was used in standard of care chemotherapy for non-small cell lung cancer, work to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cadonilimab, anlotinib and docetaxel together may work better in treating patients with non-small lung cancer compared to standard of care.

Conditions

  • NSCLC Stage IV
  • NSCLC Stage IIIB
  • NSCLC Stage IIIC

Interventions

DRUG

Cadonilimab

Given IV, 10mg/kg Q3W

DRUG

Anlotinib

oral，6mg/8mg/10mg qd 2W/3W

DRUG

Docetaxel

Given IV, 60-75mg/m2 Q3W

Sponsors & Collaborators

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Anhui Provincial Hospital

    collaborator OTHER_GOV

  • Zhejiang University

    collaborator OTHER

  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Baohui Han, M.D · ShanghaiChest Hospital

  • Jianya Zhou, M.D · Zhejiang University

  • Zhuang Yu, M.D · The Affiliated Hospital of Qingdao University

  • Jing Wang, M.D · The Affiliated Hospital of Qingdao University

  • lejie Cao, M.D · Anhui Provincial Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2024-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT05816499 on ClinicalTrials.gov