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Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

Primary Purpose

Non-small Cell Lung Cancer, Consolidation Immunotherapy, Radiotherapy or Sequential Chemoradiation

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery; Intolerable of concurrent chemoradiation; No progression after radiotherapy or sequential chemoradiation; Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy; ECOG PS0-2; PD-L1≥1%; Age≥18 years, and life expectancy>3 months; Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose); Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule. Exclusion Criteria: Patients with EGFR-sensitive mutations and ALK rearrangements; Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway); History of allergy to components of Tislelizumab; Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ); History of interstitial lung disease or pneumonia requiring oral or intravenous steroids; Progression after radiotherapy or sequential chemoradiation; Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia); Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation; Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed); Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start; History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; History of active autoimmune disease requiring systemic therapy; Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications; History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval >480 ms during screening period; Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT/AST > 2.5 times of the upper limit of normal value in patients without liver metastases and ALT/AST > 5 times of the upper limit of normal value in patients with liver metastases], abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value); History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ; History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia; Unsuitable for participation in this study assessed by investigators; Patients who were already enrolled in other clinical studies; Mixed lung cancer with small cell components.

Sites / Locations

  • Peking University Cancer Hospital and InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Consolidation Tislelizumab

Arm Description

Patients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months.

Outcomes

Primary Outcome Measures

Progression-free survival
Defined from the date of enrollment to the date of death or any recurrence.

Secondary Outcome Measures

Overall survival
Defined from the date of enrollment to the date of death.
Objective response rate
Defined as the occurrence of a complete or partial response per RECIST 1.1 criteria.
Treatment-related adverse events
Graded according to NCI-CTCAE v5.0

Full Information

First Posted
February 17, 2023
Last Updated
March 4, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05758116
Brief Title
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Official Title
A Prospective, Open-label, Single-arm, Phase II Trial Investigating the Efficacy and Safety of Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
July 7, 2025 (Anticipated)
Study Completion Date
July 7, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

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
The current standard of care for locally advanced non-small cell lung cancer (NSCLC) is concurrent chemoradiation and consolidation immunotherapy. In real world clinical practice, patients who cannot tolerate concurrent chemoradiation generally received radiotherapy alone or sequential chemoradiation. These patients are more likely to develop distant metastases and therefore may require tolerable systemic consolidation regimens. However, there is a lack of evidence from clinical studies on consolidation immunotherapy after radiotherapy alone or sequential chemoradiation. The aim of the study is to explore the efficacy and safety of Tislelizumab consolidation therapy after radiotherapy or sequential chemoradiation in locally advanced NSCLC patients who are intolerable of concurrent concurrent chemoradiation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Consolidation Immunotherapy, Radiotherapy or Sequential Chemoradiation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Consolidation Tislelizumab
Arm Type
Experimental
Arm Description
Patients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months.
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab: 200mg d1,q21d*17
Primary Outcome Measure Information:
Title
Progression-free survival
Description
Defined from the date of enrollment to the date of death or any recurrence.
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Overall survival
Description
Defined from the date of enrollment to the date of death.
Time Frame
From date of enrollment to maximum of 3 years or death
Title
Objective response rate
Description
Defined as the occurrence of a complete or partial response per RECIST 1.1 criteria.
Time Frame
From date of enrollment to maximum of 3 years or death
Title
Treatment-related adverse events
Description
Graded according to NCI-CTCAE v5.0
Time Frame
Duration of treatment and follow up until death or 3 years after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery; Intolerable of concurrent chemoradiation; No progression after radiotherapy or sequential chemoradiation; Chemotherapy: standard dose of 2-6 cycles of paclitaxel, pemetrexed or gemcitabine in combination with platinum; Radiotherapy: starting within 3 months after chemotherapy using IMRT or VMAT technique. The target volume includes the primary tumor and regional lymph nodes, and the prescription dose 95% PTV ranges from 50Gy to 66Gy; ECOG PS0-2; PD-L1≥1%; Age≥18 years, and life expectancy>3 months; Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose); Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule. Exclusion Criteria: Patients with EGFR-sensitive mutations and ALK rearrangements; Any prior use of anti-PD-1, anti-PD-L1, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibodies (including Ipilimumab or any other antibody targeting the T-cell co-stimulation or checkpoint pathway); History of allergy to components of Tislelizumab; Any active malignancy within 2 years prior to enrollment, except for the specific cancers examined in this study and any locally recurrent cancers that have been eradicated (e.g., resected basal or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer in situ); History of interstitial lung disease or pneumonia requiring oral or intravenous steroids; Progression after radiotherapy or sequential chemoradiation; Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia); Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation; Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed); Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start; History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; History of active autoimmune disease requiring systemic therapy; Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications; History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval >480 ms during screening period; Abnormal liver function [total bilirubin > 1.5 times of the upper limit of normal value; ALT/AST > 2.5 times of the upper limit of normal value in patients without liver metastases and ALT/AST > 5 times of the upper limit of normal value in patients with liver metastases], abnormal renal function (serum creatinine > 1.5 times of the upper limit of normal value); History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ; History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia; Unsuitable for participation in this study assessed by investigators; Patients who were already enrolled in other clinical studies; Mixed lung cancer with small cell components.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Yu, MD
Phone
13501147200
Email
yurong311@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Deng, MD
Phone
18813019080
Email
sherrydw@126.com
Facility Information:
Facility Name
Peking University Cancer Hospital and Institute
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rong Yu, MD
Phone
13501147200
Email
yurong311@aliyun.com
First Name & Middle Initial & Last Name & Degree
Wei Deng, MD
Phone
18813019080
Email
sherrydw@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients

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