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

NCT ID: NCT05207904

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-17
• Study Completion Date: 2023-06-30

Brief 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.

Conditions

Non-Small Cell Squamous Lung Cancer; Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tislelizumab plus chemotherapy

Group Type: EXPERIMENTAL

Tislelizumab, paclitaxel, Carboplatin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Li-kun Chen

sun yat-sen university cancer center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Likun Chen, Ph.D

Role: CONTACT

chenlk@sysucc.org.cn

13798019964

Facility Contacts

Likun Chen, doctor

Role: primary

13798019964

Other Identifiers

B2020-241

Identifier Type: -

Identifier Source: org_study_id