To hear about similar clinical trials, please enter your email below
Trial Title:
Tislelizumab Consolidation Therapy After Radiotherapy or Sequential Chemoradiation in Locally Advanced NSCLC Patients
NCT ID:
NCT05758116
Condition:
Non-small Cell Lung Cancer
Consolidation Immunotherapy
Radiotherapy or Sequential Chemoradiation
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab: 200mg d1,q21d*17
Arm group label:
Consolidation Tislelizumab
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital and Institute
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Rong Yu, MD
Phone:
13501147200
Email:
yurong311@aliyun.com
Contact backup:
Last name:
Wei Deng, MD
Phone:
18813019080
Email:
sherrydw@126.com
Start date:
July 7, 2022
Completion date:
July 7, 2026
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05758116
