NCT04360655

Brief Summary

A randomized, prospective study of the efficacy and safety of the first-line treatment in advanced central non-small cell lung cancer patients by anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy versus anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2 years

First QC Date

April 20, 2020

Last Update Submit

April 22, 2020

Conditions

Effect IncreasedSafety Issues

Keywords

anti-PD-1 / PD-L1 monoclonal antibodychemotherapybronchoscopic microwave interventionadvanced central non-small cell lung cancer patients

Outcome Measures

Primary Outcomes (2)

  • objective response rate

    objective response rate

    6 weeks

  • progression-free survival

    progression-free survival

    1 years

Secondary Outcomes (4)

  • disease control rate

    6 weeks

  • overall survival

    2 years

  • adverse events

    3 weeks

  • quality of life score

    World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.

Study Arms (2)

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

ACTIVE COMPARATOR

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

combined with bronchoscopic microwave intervention

EXPERIMENTAL

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention

Procedure: bronchoscopic microwave interventionDrug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Interventions

bronchoscopic microwave interventionPROCEDURE

bronchoscopic microwave intervention

Also known as: Local treatment
combined with bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapyDRUG

anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy

Also known as: Systemic treatment
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapycombined with bronchoscopic microwave intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • advanced central non-small cell lung cancer patients, untreated, tolerating bronchoscopy

You may not qualify if:

  • contraindications to tracheoscopy, chemotherapy, and immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Drug TherapyNeoadjuvant Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsCombined Modality Therapy

Study Officials

  • Caicun Zhou, MD, PHD

    Shanghai Pulmonary Hospital, Shanghai, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yayi He

CONTACT

862165115006doctorjael@foxmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Oncology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 20, 2020

First Posted

April 24, 2020

Study Start

May 1, 2020

Primary Completion

April 30, 2022

Study Completion

May 1, 2023

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share