Tirellizumab Combined With Chemotherapy Monotherapy for Non-small Cell Lung Cancer

July 27, 2023 updated by: Second Affiliated Hospital of Guangzhou Medical University

A Prospective, Single-arm, Single-center, Exploratory Clinical Study of Tirelizumab Combined With Chemotherapy in First-line Treatment of ECOG PS 2 Points in Relapsed/Metastatic Non-small Cell Lung Cancer

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirelizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-arm, single-center, exploratory clinical trial to evaluate the efficacy and safety of the PD-1 antibody tirellizumab combined with chemotherapy monotherapy in patients with relapsed/metastatic non-small cell lung cancer. This study prospectively collected disease history, treatment history, demographic data, baseline data during treatment, each treatment visit data, efficacy data, and safety data of NSCLC patients with EGFR and ALK driver negative ECOG PS 2 scores treated with tirellizumab combined with monotherapy. The subjects did not voluntarily withdraw from the test or the researchers believed that the subjects were not suitable for further test. Each subject will be treated until the disease progresses or the toxic and side effects caused by the drugs are intolerable, and the follow-up treatment plan, treatment status and survival data of the patients still need to be collected.

Study Type

Interventional

Enrollment (Estimated)

31

Phase

  • Phase 1

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pathologically confirmed recurrent/metastatic non-small cell lung cancer with local recurrence or distant metastasis after prior radiotherapy and/or surgery, or with distant metastasis at the time of admission.
  2. The age range is between 18 and 85.
  3. Predicted survival ≥12 weeks.

Exclusion Criteria:

  1. Patients with other malignant tumors.
  2. Positive tests for EGFR mutation and ALK fusion gene have been confirmed.
  3. Partial comorbidity.
  4. other.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tirelizumab in combination with chemotherapy monotherapy
This study is a one-arm, exploratory study and does not involve randomization. There was only one trial group of tirellizumab plus chemotherapy monotherapy.
Drug: Tirelizumab；Chemotherapy monotherapy
Tirelizumab combined with chemotherapy in first-line treatment of relapsed/metastatic non-small cell lung cancer with ECOG PS score of 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate
Time Frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Proportion of subjects assessed with CR or PR based on RECIST v1.1 criteria as a percentage of all enrolled patients
Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate
Time Frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Proportion of subjects assessed as CR, PR, or SD based on RECIST v1.1 criteria.
Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Progression-free survival time
Time Frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
The time between the patient's first treatment date and any recorded tumor progression or death from any cause.
Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
Overall survival time
Time Frame: Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.
The time between the patient's date of first treatment and death from any cause.
Baseline C1D21 and C1D21 were followed by radiographic evaluations every 6 weeks (±7 days) until radiographic PD was recorded.

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 1, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 23, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

July 28, 2023

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LCYJ-ZF-10

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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