Tislelizumab Plus Chemotherapy as First-Line Treatment for Advanced Squamous NSCLC With Brain Metastases

Brain Metastases Clinical Trial

Official title:

A Phase II, Prospective Clinical Study to Evaluate the Efficacy and Safety of Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Brain Metastases of Squamous Non-small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05207904
• Other study ID #: B2020-241
• Status: Recruiting
• Phase: Phase 2
• Start date: June 17, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2022
• Source: Sun Yat-sen University
• Contact: Likun Chen, Ph.D
• Phone: 13798019964
• Email: chenlk[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, single-arm, phase II clinical study to evaluate the efficacy and safety of Tislelizumab Plus Chemotherapy in patients with squamous NSCLC with brain metastases who had not previously received systemic therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 41
• Est. completion date: June 30, 2023
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed squamous non-small cell lung cancer;

2. Asymptomatic brain metastases or brain metastases that are relieved by dehydration therapy and remain clinically stable for at least 2 weeks

3. MRI confirmed tumor parenchymal metastases, = 3 brain lesions; or patients with 1-2 brain lesions but do not require local treatment or refuse local treatment. At least one measurable lesion in the brain lesion must be = 5mm in diameter; patients with local meningeal metastasis are allowed, but those with extensive meningeal metastasis are not included

4. Patients with stable brain metastasis symptoms after stereotactic radiotherapy are allowed (the number of stereotactic radiotherapy lesions is not more than 3)

5. No prior systemic treatment for metastatic NSCLC

6. Tumor tissue biomarker detection results must meet the following conditions at the same time: (1)EGFR mutation negative.(2)ALK rearrangement negative.(3)There are sufficient tissue samples for PD-L1 detection

7. Aged = 18 years and = 75 years

8. ECOG (Eastern Cooperative Oncology Group) performance status = 1

9. Life expectancy of more than 3 months

10. Have adequate organ function as indicated by the following laboratory values

11. Written informed consent before any trial-related procedures are performed Exclusion Criteria:

Subjects with any of the following criteria may not be included in this study:

1. With mixed adenosquamous carcinoma or small cell lung cancer mainly composed of adenocarcinoma

2. Currently participating in interventional clinical study treatment, or have received other investigational drugs or investigational device treatment before the first dose;

3. Received prior therapies targeting PD-1, PD-L1, CTLA-4, cytotoxic chemotherapy or other immune checkpoints inhibitors

4. Received solid organ or blood system transplantation

5. Have active autoimmune diseases requiring systemic therapy within 2 years before the first dose

6. Diagnosis of immunodeficiency or systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study

7. History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose

8. Known history of human immunodeficiency virus (HIV) infection

9. Untreated active hepatitis B; Note: hepatitis B subjects who meet the following criteria are also eligible: a) HBV viral load must be < 1000 copies/ml before the first dose, and subjects should receive anti-HBV therapy to avoid viral reactivation throughout the study chemotherapy drug treatment b) For subjects with anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but viral reactivation needs to be closely monitored;

10. Subjects with active HCV infection

11. Pregnant and lactating women

12. Malignant tumors other than NSCLC within 5 years before screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell epithelial skin cancer, local prostate cancer after radical resection, and ductal carcinoma in situ after radical resection

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Lung Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Tislelizumab, paclitaxel, Carboplatin
Tislelizumab, 200mg administered intravenously (IV) on Day 1 of each 21-day cycle paclitaxel 175 mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6cycle Carboplatin AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4-6 cycle

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial progression-free survival (iPFS) after treatment with tislelizumab plus chemotherapy in patients with asymptomatic brain metastases or stable symptoms after stereotactic radiotherapy (according to RECIST 1.1)	Intracranial Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of intracranial disease progression or death, whichever occurs first	12months
Secondary	intracranial objective response rate (iORR) (according to RECIST 1.1)	iORR is defined as the proportion (%) of patients with complete or partial response of intracranial lesions	12months
Secondary	objective response rate (ORR) (according to RECIST 1.1)	ORR is defined as the proportion (%) of patients with complete or partial response of overall lesions	12months
Secondary	progression-free survival (PFS) (according to RECIST 1.1)	Progression-free survival is defined as the time from the starting date of study drug to the date of first documentation of overall disease progression or death, whichever occurs first.	12months
Secondary	overall survival (OS) (according to RECIST 1.1)	OS is defined as the time from the starting date of study drug to the date of death due to any cause	24months
Secondary	Safety of treatment was assessed using NCI-CTCAEv5 version	TEAEs graded according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	24months
Secondary	Assessment of neurocognitive deterioration	Neurocognitive impairment according to Hopkins Verbal Learning Test-Revised(HVLT-R)	24months