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

NCT05207904 | Unknown Phase 2

• 1 other identifier: B2020-241
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• intracranial objective response rate (iORR) (according to RECIST 1.1)

  12months

• objective response rate (ORR) (according to RECIST 1.1)

  12months

• progression-free survival (PFS) (according to RECIST 1.1)

  12months

• overall survival (OS) (according to RECIST 1.1)

  24months

• Safety of treatment was assessed using NCI-CTCAEv5 version

  24months

Study Arms (1)

tislelizumab plus chemotherapy

EXPERIMENTAL

Drug: Tislelizumab, paclitaxel, Carboplatin

Interventions

Tislelizumab, paclitaxel, Carboplatin 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

tislelizumab plus chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed squamous non-small cell lung cancer;
• Asymptomatic brain metastases or brain metastases that are relieved by dehydration therapy and remain clinically stable for at least 2 weeks
• 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
• Patients with stable brain metastasis symptoms after stereotactic radiotherapy are allowed (the number of stereotactic radiotherapy lesions is not more than 3)
• No prior systemic treatment for metastatic NSCLC
• 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
• Aged ≥ 18 years and ≤ 75 years
• ECOG (Eastern Cooperative Oncology Group) performance status ≤ 1
• Life expectancy of more than 3 months
• Have adequate organ function as indicated by the following laboratory values
• Written informed consent before any trial-related procedures are performed

You may not qualify if:

• Subjects with any of the following criteria may not be included in this study:
• With mixed adenosquamous carcinoma or small cell lung cancer mainly composed of adenocarcinoma
• Currently participating in interventional clinical study treatment, or have received other investigational drugs or investigational device treatment before the first dose;
• Received prior therapies targeting PD-1, PD-L1, CTLA-4, cytotoxic chemotherapy or other immune checkpoints inhibitors
• Received solid organ or blood system transplantation
• Have active autoimmune diseases requiring systemic therapy within 2 years before the first dose
• Diagnosis of immunodeficiency or systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days before the first dose of the study
• History of non-infectious pneumonia requiring glucocorticoid therapy or current interstitial lung disease within 1 year before the first dose
• Known history of human immunodeficiency virus (HIV) infection
• 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;
• Subjects with active HCV infection
• Pregnant and lactating women
• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

tislelizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Central Study Contacts

Likun Chen, Ph.D

CONTACT

13798019964; chenlk@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: sun yat-sen university cancer center

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 26, 2022
• Study Start: June 17, 2021
• Primary Completion: December 30, 2022
• Study Completion: June 30, 2023
• Last Updated: January 26, 2022

Record last verified: 2022-01

Locations

CN (1)