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Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic

Primary Purpose

Lung Adenocarcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tislelizumab,Platinum
Sponsored by
Hebei Medical University Fourth Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Adenocarcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII; Patients with brain metastases confirmed by imaging; Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy; ECOG PS: 0-1; Measurable target lesions outside the skull (as per RECIST 1.1); Life expectancy greater than 3 months; Exclusion Criteria: Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy; The patient had received systemic chemotherapy as advanced treatment; Patients with EGFR mutation or ALK gene translocation; The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration; Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;

Sites / Locations

  • The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab Combined With Platinum-containing Drug Chemotherapy

Arm Description

Tislelizumab PD-1 inhibitor Platinum-containing drug chemotherapy

Outcomes

Primary Outcome Measures

1 years PFS
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first

Secondary Outcome Measures

The objective response rate (ORR)
Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Full Information

First Posted
April 11, 2023
Last Updated
September 24, 2023
Sponsor
Hebei Medical University Fourth Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06056115
Brief Title
Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Official Title
Efficacy and Safety of Tislelizumab Combined With Platinum-containing Drug Chemotherapy in First-line Treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
April 12, 2025 (Anticipated)
Study Completion Date
December 12, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University Fourth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Brain metastasis of lung cancer is one of the most important metastasis pathways in patients with life-threatening diseases. This study explore the efficacy and safety of Tislelizumab combining with platinum-containing drug chemotherapy in the first-line treatment of Lung Adenocarcinoma With Asymptomatic Brain Metastatic. Meanwhile, Related biomarkers were explored to provide theoretical basis for efficacy evaluation and resistance mechanism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab Combined With Platinum-containing Drug Chemotherapy
Arm Type
Experimental
Arm Description
Tislelizumab PD-1 inhibitor Platinum-containing drug chemotherapy
Intervention Type
Drug
Intervention Name(s)
Tislelizumab,Platinum
Intervention Description
Induction therapy stage: Tislelizumab plus platinum-containing drug chemotherapy was administered every 3 weeks and was expected to complete 6 cycles of treatment. Maintenance treatment phase: After completion of the induction therapy phase, patients whose antitumor response was confirmed as complete response, partial response, and disease stable according to RECIST v1.1 criteria were admitted to maintenance therapy .
Primary Outcome Measure Information:
Title
1 years PFS
Description
the time from the date of first dose of study treatment to the date of first documentation of disease progression using RECIST v1.1 or death, whichever occurs first
Time Frame
up to 1year
Secondary Outcome Measure Information:
Title
The objective response rate (ORR)
Description
Assessed by the Investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time Frame
Through study completion, an average of 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with metastatic (stage IV) lung adenocarcinoma who have not been systematically treated and are histologically or cytologically confirmed as unable to undergo radical surgery or radiotherapy based on AJCC Stage VIII; Patients with brain metastases confirmed by imaging; Patients with asymptomatic BMS after initial diagnosis, local BMS surgery or radiotherapy; ECOG PS: 0-1; Measurable target lesions outside the skull (as per RECIST 1.1); Life expectancy greater than 3 months; Exclusion Criteria: Patients had been treated with immune checkpoint inhibitors such as anti-PD-1, PD-L1, or CTLA-4 therapy; The patient had received systemic chemotherapy as advanced treatment; Patients with EGFR mutation or ALK gene translocation; The patient had received approved systemic anticancer therapy or systemic immunomodulators (including but not limited to interferon, interleukin 2, and tumor necrosis factor) within 4 weeks prior to initial administration; Clinically uncontrolled pleural fluid or ascites requiring puncture drainage within 2 weeks prior to initial administration;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Shi, Dr.
Phone
+86-311-86095794
Email
Shijian6668@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Shi, Dr.
Organizational Affiliation
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth Hospital of Hebei Medical University (Hebei Tumor Hospital)
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Shi, Dr.
Phone
+86-311-86095794
Email
Shijian6668@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Tislelizumab for Lung Adenocarcinoma With Asymptomatic Brain Metastatic

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