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

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

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.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Consolidation Immunotherapy; Radiotherapy or Sequential Chemoradiation
• Intervention / Treatment: Drug: Tislelizumab

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Peking University Cancer Hospital and Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with stage III(AJCC 8th) unresectable NSCLC, or resectable but intolerant or refusing surgery;
2. Intolerable of concurrent chemoradiation;
3. No progression after radiotherapy or sequential chemoradiation;
4. 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;
5. ECOG PS0-2;
6. PD-L1≥1%;
7. Age≥18 years, and life expectancy>3 months;
8. Adequate Hematologic, biochemistry and organ function (to be confirmed by test results within 7 days prior to the first dose);
9. Be able to provide written informed consent (ICF) and able to understand and agree to comply with study requirements and assessment schedule.

Exclusion Criteria:

1. Patients with EGFR-sensitive mutations and ALK rearrangements;
2. 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);
3. History of allergy to components of Tislelizumab;
4. 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);
5. History of interstitial lung disease or pneumonia requiring oral or intravenous steroids;
6. Progression after radiotherapy or sequential chemoradiation;
7. Unresolved ≥grade2 toxicities from radiotherapy and sequential chemoradiation, (excluding those that the investigator determines do not affect study treatment, such as alopecia);
8. Grade 2 or severe Pneumonia from radiotherapy or sequential chemoradiation;
9. Administration of a live vaccine within 30 days prior to treatment start (seasonal influenza vaccine without live vaccine is allowed);
10. Severe chronic or active infections (including tuberculosis infections, etc.) requiring systemic antibacterial, antifungal or antiviral therapy ≤ 14 days prior to treatment start;
11. History of immunodeficiency, including a positive HIV test, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation;
12. History of active autoimmune disease requiring systemic therapy;
13. Treatment with long-term systemic immunosuppressive medications (≥10 mg/d prednisone or equivalent doses of other steroids) or other immunosuppressive medications;
14. History of uncontrolled cardiovascular disease; or clinically significant QT interval prolongation, or QTc interval >480 ms during screening period;
15. 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);
16. History of serious concomitant diseases (e.g., severe hypertension, diabetes, thyroid disease, active infection, etc.) ;
17. History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia;
18. Unsuitable for participation in this study assessed by investigators;
19. Patients who were already enrolled in other clinical studies;
20. Mixed lung cancer with small cell components.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Consolidation Tislelizumab; Patients completed radiotherapy alone or sequential chemoradiation with 42 days received consolidation Tislelizumab 200mg every 3 weeks for 12 months.	Drug: Tislelizumab; Tislelizumab: 200mg d1,q21d*17

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Defined from the date of enrollment to the date of death or any recurrence.	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Defined from the date of enrollment to the date of death.	From date of enrollment to maximum of 3 years or death
Objective response rate	Defined as the occurrence of a complete or partial response per RECIST 1.1 criteria.	From date of enrollment to maximum of 3 years or death
Treatment-related adverse events	Graded according to NCI-CTCAE v5.0	Duration of treatment and follow up until death or 3 years after enrollment

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): June 30, 2026
• Study Completion (Actual): June 30, 2026

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: March 4, 2023
• First Posted (Actual): March 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2026
• Last Update Submitted That Met QC Criteria: August 13, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Antineoplastic Agents, Immunological; Antineoplastic Agents; tislelizumab
• Other Study ID Numbers: 2022YJZ46

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