Bronchoscopic Microwave Intervention Treatment in Advanced Central NSCLC

April 22, 2020 updated by: Caicun Zhou, Shanghai Pulmonary Hospital, Shanghai, China

A Randomized, Prospective Study of the Efficacy and Safety of the 1st Treatment in Advanced Central NSCLC by PD-1/PD-L1 Inhibitor and Chemotherapy With/Without Bronchoscopic Microwave Intervention

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, prospective study, which will analyze 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. The efficacy will include objective response rate, disease control rate, progression-free survival, and overall survival. The safety will include adverse events and quality of life.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindications to tracheoscopy, chemotherapy, and immunotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Other Names:
  • Systemic treatment
Experimental: combined with bronchoscopic microwave intervention
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy combined with bronchoscopic microwave intervention
Drug: anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
Other Names:
  • Systemic treatment
Procedure: bronchoscopic microwave intervention
bronchoscopic microwave intervention
Other Names:
  • Local treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
objective response rate
Time Frame: 6 weeks
objective response rate
6 weeks
progression-free survival
Time Frame: 1 years
progression-free survival
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 years
overall survival
2 years
disease control rate
Time Frame: 6 weeks
disease control rate
6 weeks
adverse events
Time Frame: 3 weeks
adverse events
3 weeks
quality of life score
Time Frame: World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.
quality of life score
World Health Organization Quality of Life Scale-Brief (WHOQOL-BREF)score 0-100，higher scores mean a better outcome.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Investigators

  • Principal Investigator: Caicun Zhou, MD, PHD, Shanghai Pulmonary Hospital, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

April 20, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Surpass

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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